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Grader - Instructions Excel 2019
ProjectExcel_7G_Loan_Flowers_Staff
Project Description:
In this project, you will create a named range and use it to set
data validation. You will use a PMT function to calculate a
value and then use it in a two-variable data table. You will also
enter VLOOKUP functions to return values from a table, and
format cells in the workbook. You will also audit a worksheet,
correct errors, and use the MATCH and INDEX functions.
Steps to Perform:
Step
Instructions
Points Possible
1
Open the file
Excel_7G_Loan_Flowers_Staff.xlsx
downloaded with this project.
0
2
Display the second worksheet—Warehouse Payment Table. In
cell B8, enter a PMT function using cell B4 divided by
12 as the rate, cell B3 as the number of
payment periods, and cell B2 as the present value of the loan.
Display the result as a positive number.
8
3
Create a two-variable data table in the range B8:H16. Set cell
B3 as the row input cell, and cell B4 as the column input cell.
From the Cell Styles gallery, apply the Currency cell style to
the range C9:H16. Select the payment option closest to but less
than $10,000 per month for a 120-month loan—cell D15—and
format the option with the Note cell style. Click cell A1 and
Save your workbook.
13
4
Display the fourth worksheet—Job Information. Select the range
A4:C11, and then sort the range by Job Code in ascending
order. By using the Create from Selection command, create a
range named
Job_Code using the data in the range
A4:A11. Click cell A1.
4
5
Display the Staffing Plan worksheet, and then select the range
A9:A18. Create a Data Validation list with Source equal to the
named range
Job_Code
2
6
Click cell A9, click the list arrow, and then click M-AMG.
Click cell B9 to make it the active cell, and then insert a
VLOOKUP function that will look up the Description of the Job
Code in cell A9 using the information in the Job Information
worksheet as the table array. After selecting the table array, be
sure to press F4 to make it an absolute cell reference. The
Description to be looked up is in column
2 of the table array.
9
7
With cell B9 as the active cell, copy the VLOOKUP formula
down through cell B18. In cell C9, type
3 as the # of Positions and in cell D9, type
Management as the Type.
6
8
In cell E9, insert the VLOOKUP function to look up the Salary
of the Job Code in cell A9 by using the information in the Job
Information sheet as the table array; the Salary is in column
3 of the table array. Copy the VLOOKUP
formula in cell E9 down through cell E18.
4
9
Add the following staff position in cell A10:
S-STR 5 Stock
2
10
Delete the unused rows between the last item and the Total row.
Sum the Budget Amount column and apply the Total cell style.
Click cell A1 and Save your workbook.
6
11
Display the Revenue worksheet. Click cell I5, and then on the
Formulas tab, click Trace Precedents. On the ribbon, in the
Formula Auditing group, click Error Checking, and then click
Edit in Formula Bar. Edit the formula so that the formula is
using the Growth Assumption for
Bridal Baskets, not for
Baby Baskets.
8
12
In the Error Checking dialog box, click Resume. In cell M6,
notice the formula is trying to divide by cell L10, which is
empty. Click Edit in Formula Bar, change 10 to
9 Ensure that the reference to L9 is an
absolute reference, and then in the Error Checking dialog box,
click Resume.
8
13
In cell F7, examine the error information, and then click Copy
Formula from Above. Examine the error in cell J8, and then
click Copy Formula from Left. Click OK. Use Format Painter to
copy the format in cell M5 to cell M6. Click cell A1 and Save
your workbook.
10
14
Display the Suppliers worksheet. In cell B2, insert a MATCH
function to find the position of
Rose Boxes in the range c6:c27. In cell B3,
insert a combined INDEX and MATCH function to display the
name of the supplier for
Rose Boxes. Click cell A1, and then Save
your workbook.
10
15
In the sheet tab row, right-click any sheet tab, and then click
Select All Sheets. Display the Page Setup dialog box. From the
Margins tab, center the worksheets on the page horizontally.
From the Header/Footer tab, create a Custom Footer with the
file name in the Left section and the sheet name in the Right
section. Right-click the sheet tab, and then click Ungroup
Sheets. Display the Warehouse Payment Table worksheet, and
then set this sheet’s Orientation to Landscape. Display the
Revenue sheet. For this sheet, set the Orientation to Landscape,
and in the Scale to Fit group, set the Scale to 90%.
9
16
Display Backstage view, click Show All Properties. On the list
of Properties, in the Tags box, type
staffing plan, flower revenue In the Subject
box, type your course name and section number. Under Related
People, be sure that your name displays as the author. On the
left, click Print. Under Settings, click the Print Active Sheets
arrow, and then click Print Entire Workbook. At the bottom of
the window, click Next Page to scroll through the six
worksheets and check for any errors. On the left, click Save.
1
17
Save the workbook. Close the workbook and then exit Excel.
Submit the workbook as directed.
0
Total Points
100
Created On: 06/21/2021 1
GO19_XL_CH07_GRADER_7G_AS - Loan Flowers Staff
1.2
11/10/22, 4:13 AM Module 3 Review a Mobile App Using Third
Party Guidelines
https://sju.instructure.com/courses/32739/assignments/414493?
module_item_id=1192857 1/1
Total Points: 36
Review a Mobile App Using Third Party Guidelines
Criteria Ratings Pts
15 pts
5 pts
4 pts
4 pts
4 pts
4 pts
Coherent Concise and Organized 15 pts
Exceeds
Expectations
12 pts
Meets
Expectations
0 pts
Does Not Meet
Expectations
Spelling and Grammar 5 pts
No Errors
3 pts
Minimal Errors
0 pts
Three or More Errors
F1 History and Goals (SLO 1)
Graduates will understand the history,
goals, methods (including data and
information used and produced), and
current challenges of the major health
science fields. (SLO 1)
threshold: 3.0 pts
4 pts
Exceeds
Expectations
3 pts
Meets
Expectations
2 pts
Near
Mastery
1 pts
Does Not
Meet
Expectations
F5 Human Factors and Design (SLO 2)
Students will draw on socio‐technical
knowledge regarding the social behavioral
sciences and human factors engineering to
apply to the design and implementation of
information systems and technology. (SLO
2)
threshold: 3.0 pts
4 pts
Exceeds
Expectations
3 pts
Meets
Expectations
2 pts
Near
Mastery
1 pts
Does Not
Meet
Expectations
F6 Population Behavior (SLO 1)
Students will identify theories or models
that explain and modify patient or
population behaviors related to health and
health outcome. (SLO 1)
threshold: 3.0 pts
4 pts
Exceeds
Expectations
3 pts
Meets
Expectations
2 pts
Near
Mastery
1 pts
Does Not
Meet
Expectations
F7 Design and Implementation (SLO 2)
Students will identify the theories, models,
and tools from social, business, human
factors, behavioral, and information
sciences and technologies for designing,
implementing, and evaluating health
informatics solutions. (SLO 2)
threshold: 3.0 pts
4 pts
Exceeds
Expectations
3 pts
Meets
Expectations
2 pts
Near
Mastery
1 pts
Does Not
Meet
Expectations
©2013 Happtique, Inc. All rights reserved
HEALTH APP CERTIFICATION PROGRAM
CERTIFICATION STANDARDS
February 27, 2013
1 ©2013 Happtique, Inc. All rights reserved
TABLE OF CONTENTS
Operability Standards Pages 2-5
Privacy Standards Pages 6-9
Security Standards Pages 10-13
Content Standards Pages 14-17
Acronyms Page 18
2 ©2013 Happtique, Inc. All rights reserved
App Operability (OP) Standards1
Standard OP1
The app installs, launches, and runs consistently2 on the target
device(s) and target operating
system(s) for that app.
Performance Requirements for Standard OP1
• OP1.01 The app downloads and installs on the target device(s)
and target
operating system(s).
• OP1.02 The app consistently launches and runs on the target
device(s) that it is
installed upon.
Standard OP2
If applicable, the app connects consistently to any and all
peripheral or accessory devices
(e.g., NFC, Bluetooth), third party mobile application or
software, regulated or unregulated,
required for operation and/or marketed for use in conjunction
with such app.
Performance Requirements for Standard OP2
• OP2.01 The app connects to the peripheral device(s) and
operates consistently.
• OP2.02 The app has a mechanism to notify the user in the
event that the app
fails to connect to any and all peripheral or accessory devices.
• OP2.03 The app connects consistently to any and all third
party mobile
applications, software, and online user accounts, but such
connection
shall only occur after: (i) notifying user; (ii) requesting
permission; and
(iii) receiving consent from the user.
• OP2.04 The app has a mechanism to notify user of any and all
updates applicable
or necessary for app to connect to any such device, application,
software
or online user accounts.
Standard OP3
If the app requires that it be connected to a network, the app is
able to connect and operates
consistently on the intended domestic and global carriers or
Local Area Network (LAN).3
Performance Requirements for Standard OP3
• OP3.01 The app connects to the network via wireless
technology (e.g.,
CDMA2000 and GSM).
• OP3.02 The app connects to the LAN via well-established
standards (e.g., 802.11,
802.15, 802.16).
1
These standards are based, in part, on materials from the
National Alliance for Health Information Technology,
the Mobile Marketing Association’s “Mobile Application
Privacy Policy Framework” (December, 2011), and GSM
Association’s “Privacy Design Guidelines for Mobile
Application Development” (February, 2012).
2
To be defined in conjunction with vendors performing
Technical Standards testing.
3
Due to the number of mobile operators (approx. 800), two U.S.
operators and WiFi will be used as a proxy for
this test.
3 ©2013 Happtique, Inc. All rights reserved
Standard OP4
If the app connects to the network, the IP addresses and URIs
are known or can be
determined.
Performance Requirements for Standard OP4
• OP4.01 The list of IP addresses and/or URIs that the app
connects to are
documented, and the owners of those addresses and domain
names are
either disclosed or are capable of being determined from
testing.
• OP4.02 The app does not connect to any hidden IP addresses
that are used
behind the firewall of a router or gateway, without user’s
knowledge,
control, or consent.
Standard OP5
A method for contacting the App Publisher and technical
support (if different than the App
Publisher) is provided.
Performance Requirements for Standard OP5
• OP5.01 The App Publisher’s contact information―including
but not limited to,
mailing address, email address for support and general
inquiries, web
address and/or DNS address—is provided within the app, or the
app
provides a link to a webpage that contains the same information.
• OP5.02 The app provides a method for users to submit
feedback to the App
Publisher for purposes of improving the user experience,
including
without limitation, any technical issues, bugs, and errors
detected by
users.
Standard OP64
The app shall be designed to operate in a manner that supports a
usable and useful end-user
experience.
Performance Requirements for Standard OP6
• OP6.01 App Publisher has a documented process to review,
escalate and
incorporate, on a timely basis, modifications needed to address
suspected
errors and other technical issues.
• OP6.02 In designing and maintaining the app, the App
Publisher has a
documented process for addressing:
o User feedback regarding efficiency (the speed with which
users can
complete their tasks), effectiveness (the accuracy and
completeness
with which users can complete tasks), and satisfaction (the
user’s
satisfaction with how well the app operates); and
4
This Standard is derived from the mHIMSS report, “Selecting A
Mobile App: Evaluating the Usability of Medical
Applications” (see http://www.mhimss.org/resource/selecting-
mobile-app-evaluating-usability-medical-
applications).
4 ©2013 Happtique, Inc. All rights reserved
o Reasonable requests by users regarding features and
functionality
not supported by the app (e.g., support in additional languages,
audiology assistance, visual impairment support, and other
requests
specific to the demographic of the app’s intended audience).
Standard OP7
Electronic health record (EHR) systems optimized for mobile
devices are apps for certified
EHRs (EHRs that have been certified by a Federally-designated
Authorized Testing and
Certification Body). Certified EHRs may consist of complete
EHRs or EHR modules.
Performance Requirements for Standard OP7
• OP7.01 The app operates in accordance with the documented
functionality
provided by the Certified EHR.
• OP7.02 Documentation is provided regarding any relevant
EHR certification
received.
Standard OP8
An app that is intended to connect to an Electronic Health
Record (EHR) or Personal Health
Record (PHR) enables users to send and retrieve patient
information between a mobile device
and the EHR/PHR, and does so in a secure manner.
Performance Requirements for Standard OP8:
• OP8.01 The EHR and/or PHR systems with which the app
connects (e.g.,
Allscripts, Epic, Microsoft HealthVault, etc.) are specifically
enumerated
and documentation of the interoperability with each specified
EHR and
PHR is provided.
• OP8.02 The details and description of the data fields that the
app saves, sends
to, and/or receives from each specified EHR/PHR systems
regarding
patient information (e.g., medical history, diagnoses, treatment
plan,
medications, laboratory results, radiology images, etc.) is
provided.
• OP8.03 The app maintains (at rest) and transmits (in motion)
patient information
in a secure, HIPAA-compliant manner, as applicable (see
Standards S2,
S3, and S4).
Standard OP9
The App Publisher certifies that the app constitutes a medical
device as defined by the U.S.
Food and Drug Administration (FDA), has ascertained its
correct classification, and either
certifies that the app complies with all applicable FDA
regulatory requirements5 or certifies
that it is not a medical device.
Performance Requirements for Standard OP9
• OP9.01 The App Publisher has ascertained that the app,
including any and all
peripheral devices required or intended for operation and/or
marketed for
5
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuida
nce/Overview/default.htm
5 ©2013 Happtique, Inc. All rights reserved
use in conjunction with such peripheral devices, is a Class I, II
or III
medical device6.
• OP9.02 The App Publisher provides documentation
demonstrating that the app
complies with all applicable FDA requirements, including but
not limited
to: Establishment registration; Medical Device Listing;
Premarket
Notification 510(k)7, unless exempt, or Premarket Approval
(PMA)8;
Investigational Device Exemption (IDE) for clinical studies;
Quality
System (QS) regulation; Labeling requirements; and Medical
Device
Reporting (MDR).
• OP9.03 The App’s Publisher has a mechanism to immediately
notify all users and
Happtique about an FDA-approved app that is recalled, the
subject of an
FDA advisory, or similar status that calls the app’s safety
and/or
effectiveness into question.
• OP9.04 If the app does not constitute a medical device as
defined by the FDA,
the App Publisher certifies that the app is not a medical device
by written
attestation on the HACP App Submission Form.
6
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuida
nce/Overview/ClassifyYourDevice/default.htm
7
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuida
nce/HowtoMarketYourDevice/PremarketSubmi
ssions/PremarketNotification510k/default.htm
8
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuida
nce/HowtoMarketYourDevice/PremarketSubmi
ssions/PremarketApprovalPMA/default.htm
6 ©2013 Happtique, Inc. All rights reserved
App Privacy (P) Standards9
Standard P1
The type(s) of data that the app obtains, and how and by whom
that information is used, is
disclosed to the user in a Privacy Policy.
Performance Requirements for Standard P1
• P1.01 Prior to downloading, installing, or activating an app,
the identity of any
entities that will have access to, collect and/or use of the user’s
personal
information, including a company or individual name, country
of origin, and
related contact information is disclosed to the user.
• P1.02 App Publisher discloses any and all ownership, rights
or licenses to any
data collected in connection with the app and its usage,
including the use
of any data for commercial purposes.
• P1.03 The app has a section (tab, button or equivalent) or
active link to its
Privacy Policy, and owner represents that commercially
reasonable efforts
are used to notify users of any material changes to its Privacy
Policy.
• P1.04 If registration is required to use all or some of the
app’s features, the user
is provided with an explanation as to the uses of the registration
information.
• P1.05 User is provided (or has access to) a clear list of all
data points collected
and/or accessed by the app, including by App Publisher and any
and all
third parties such as in-app advertisers, pertaining to the usage
of the app,
including but not limited to browsing history, device (e.g.,
unique
identifiers), operating system, and IP addresses. How and from
where such
data points are collected is disclosed.
• P1.06 User is provided (or has access to) a clear list of all
data points collected
and/or accessed by the app pertaining to the specific user,
including user-
generated data and data that are collected automatically about
the user
through other means or technologies of the app. This includes
data points
collected for the purpose of any third-party sharing. How and
from where
such data points are collected is disclosed.
• P1.07 App Publisher obtains affirmative express consent
before using user data in
a materially different manner than was previously disclosed
when collecting
the data or collecting new data, including for the purpose of
third-party
sharing.
• P1.08 App Publisher obtains affirmative express consent
before collecting
personal data, in particular information about children, financial
and health
information, Social Security numbers, and location data.
• P1.09 The Privacy Policy informs users how they can get a
copy of their personal
information that was collected by the app. The Privacy Policy
also informs
users how they can correct and update information supplied by,
or
collected about them, held by or on behalf of the owner, or
shared with
9
In general, these Privacy Standards are intended to be
consistent with the principles set forth in “Protecting
Consumer Privacy in an Era of Rapid Change:
Recommendations for Businesses and Policymakers,” Federal
Trade
Commission, March, 2012.
7 ©2013 Happtique, Inc. All rights reserved
third parties, including the identity of such third parties,
particularly in
compliance with the HIPAA Privacy Rule10, if applicable, and
any other laws,
rules, or regulations to the extent applicable.
• P1.10 If not otherwise provided by default, the app allows
users to control the
collection and use of their in-app browsing data by supporting
an online Do
Not Track mechanism, if applicable.
• P1.11 If not otherwise provided by default, the app allows
users to control their
receipt of commercial messages from the App Publisher and
third parties
through an “opt out” option, “do not contact,” or substantially
similar
feature.
• P1.12 Each major component of the Privacy Policy is
affirmatively agreed to by
the user. Such components include, but are not limited to,
entities that will
have access to, collect and/or use of the user’s personal
information; all
ownership, rights or licenses to any data collected and its usage;
list of all
data points collected; and so forth.
• P1.13 Except when expressly disclaimed by App Publisher and
the user provides
an affirmative consent, App Publisher does not share any user
data with
third parties, unless App Publisher: (i) has an agreement with
such third
party that addresses safeguarding any and all such user data;
and (ii) takes
the necessary measures to anonymize/de-identify all user data.
The App
Publisher has documented this within the Privacy Policy.
Standard P2
If data are collected, the user is informed about how long the
data are retained.
Performance Requirements for Standard P2
• P2.01 The Privacy Policy discloses the retention policy
regarding user information.
Such statement includes policies with respect to data retention
under any
third-party data sharing arrangement.
• P2.02 Retention and deletion time periods, which are based
on clearly defined
business needs or legal obligations, are set. If business needs
are defined
as “in perpetuity,” this is disclosed.
Standard P3
The app user is informed if the app accesses local resources
(e.g., device address book,
mobile and/or LAN network interface, GPS and other location-
based services, contacts,
camera, photos, SMS or MMS messaging, and Bluetooth) or
resources from and/or for social
networking platforms, provided with an explanation by any
appropriate means (e.g., the
“About” section) as to how and why such resources are used,
and prior consent is obtained to
access such resources.
10
http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrul
e/index.html
8 ©2013 Happtique, Inc. All rights reserved
Performance Requirements for Standard P3
• P3.01 If the app uses the mobile network, why the network is
being used and a
reasonably likely estimate of the average amount of bandwidth
consumed
per user per month is disclosed to the user.
• P3.02 If the app uses a LAN, why the network is accessed and
a likely estimate of
the average amount of bandwidth consumed per user per month
is
disclosed to the user.
• P3.03 If the app or App Publisher uses SMS or MMS
messaging, the user is
provided with a likely estimate of the average number of
messages per
month, and a disclosure that data rates will apply.
• P3.04 If the app or App Publisher sends emails, the user is
provided with a likely
estimate of the number of emails sent per month.
• P3.05 If the app uses Bluetooth, why Bluetooth is being used
and which of the
Bluetooth profiles are being used is disclosed to the user.
• P3.06 If the app uses the device’s camera, why the camera is
being used is
disclosed to the user.
• P3.07 If the app uses device-available methods to determine
location, why the
location is being determined is disclosed to the user.
• P3.08 If the app accesses the device’s native address book,
why the address book
is being used is disclosed to the user.
• P3.09 If the app accesses the device’s native calendaring or
alarm system, why
the calendar and/or alarm system is being used is disclosed to
the user.
• P3.10 If the app accesses the Public Switched Telephone
Network (PSTN), why
the PSTN is being accessed is disclosed to the user.
• P3.11 If the app accesses social networking sites, the reason
why such sites are
being accessed is disclosed to the user.
Standard P4
If the app, on behalf of a Covered Entity or a Business
Associate (each as defined by HIPAA
and HITECH and the rules thereunder), collects, stores, and/or
transmits information that
constitutes Protected Health Information (as defined by HIPAA
and HITECH and the rules
thereunder), it does so in full compliance with HIPAA,
HITECH, and all applicable laws, rules
and regulations.
Performance Requirements for Standard P4
• P4.01 The user can affirmatively opt in or out (at any time) of
information shared
with or given access by third parties.
• P4.02 The App Publisher certifies that a Business Associate
Agreement (BAA) has
been executed pursuant to HIPAA with any and all necessary
third parties.
• P4.03 The user has the ability to access or request any of
his/her Protected
Health Information (PHI) collected, stored and/or transmitted
by the app,
and has the ability to learn the identity of any person or entity
who had or
has been granted access to his/her PHI.
• P4.04 The App Publisher uses requisite efforts to limit the
use and disclosure of
PHI, including ePHI, to the minimum necessary to accomplish
the intended
purpose (e.g., “need-to-know”).
9 ©2013 Happtique, Inc. All rights reserved
Standard P5
The app has measures in place to protect children in accordance
with applicable laws and
regulations (e.g., Children’s Online Privacy Protection Act11).
Performance Requirements for Standard P5
• P5.01 The app provides clear notice of the content that will be
made available
and its suitability for specific age groups.
• P5.02 The app includes a clear and conspicuous Privacy Policy
that addresses use
by any child under the age of 13.
• P5.03 The app provides for an age verification process—
either automatic or self-
reported—to control access to age-restricted content and to
minimize the
inappropriate collection, use, or disclosure of personal
information from a
child.
• P5.04 The app does not, without obtaining verifiable
parental/legal guardian
consent, collect, use, or disclose data from any child under the
age of 13.
• P5.05 The app enables a parent/legal guardian who becomes
aware that the child
has provided information without his/her consent to contact the
App
Publisher.
• P5.06 The Privacy Policy provides that the App Publisher will
delete any child’s
personal information upon notice, or in the event that the App
Publisher
becomes aware or has knowledge, that such information was
provided
without the consent of a parent/legal guardian, including
information that
was shared with a third party.
• P5.07 Apps that are intended for children must have a
location default setting that
enables parents/legal guardians to prevent the app from
automatically
publishing their child’s location.
Standard P6
Retroactive or prospective material changes to Privacy Policies
require the prior consent of
the user.
Performance Requirements for Standard P6
• P6.01 A mechanism is in place to notify users of changes to
the Privacy Policy.
• P6.02 A mechanism is provided that enables users to
acknowledge and consent to
changes to the Privacy Policy.
11
http://www.ftc.gov/ogc/coppa1.htm
10 ©2013 Happtique, Inc. All rights reserved
App Security (S) Standards
Standard S1
The app, including without limitation, any advertisement
displayed or supported through the
app, is free of known malicious code or software such as
malware, including, but not limited
to, viruses, worms, trojan horses, spyware, adware, rootkits,
backdoors, keystroke loggers,
and/or botnets.
Performance Requirements for Standard S1
• S1.01 A scan of the app using scanning software does not
reveal any known
malicious code or software objects.
• S1.02 A scan of any third party code, including advertising
networks, incorporated
into app for purposes of displaying or supporting
advertisements (e.g.,
banner, interstitial) does not reveal any known malicious code
or software.
Standard S2
The App Publisher ensures that the app’s security procedures
comply at all times with
generally recognized best practices and applicable rules and
regulations for jurisdiction(s) in
which the app is intended to be sold or used and such
procedures are explained or made
available to users.
Performance Requirements for Standard S2
• S2.01 Administrative, physical, and technical safeguards to
protect users’
information from unauthorized disclosure or access are provided
and
employed.
• S2.02 Access to user’s information is limited to those
authorized employees or
contractors who need to know the information in order to
operate,
maintain, develop, or improve the app.
• S2.03 If the app utilizes unique identifiers, the identifier is
linked to the correct
user and is not shared with third parties.
• S2.04 Where possible, risk-appropriate authentication methods
are used to
authenticate users.
• S2.05 A written description of security procedures (in detail
sufficient to apprise
end users about how their personal information is safeguarded)
is provided
in a section of the app (tab, button, or equivalent) or through an
active
link. The security procedures are written in clear, easy-to-
understand
language and terms and are affirmatively agreed to by the user.
Such
components include, but are not limited to, how personal
information is
safeguarded, how unique identifiers are linked to the correct
user, and
authentication methods used.
• S2.06 The App Publisher has a mechanism in place to review
security procedures
on an ongoing basis and update security procedures, as
necessary, to
ensure that they comply at all times with applicable rules and
regulations
for jurisdiction(s) in which the app is intended to be sold or
used.
• S2.07 Cloud-based apps meet Statement on Standards for
Attestation
Engagements (SSAE) No. 16 requirements and a SSAE No. 16
audit report
is provided.
11 ©2013 Happtique, Inc. All rights reserved
• S2.08 If the app uses SMS or MMS, the user is informed
whether messages are
encrypted and, if so, the level of encryption.
• S2.09 The App Publisher has a formal and documented secure
software
development lifecycle (SDLC) process that has been
implemented
throughout the inception, testing, implementation, deployment,
and
maintenance of the app.
Standard S3
If the app collects, stores or transmits any personal information,
including, but not limited to,
usernames and passwords, such information is collected, stored,
and transmitted using
encryption.
Performance Requirements for Standard S3
• S3.01 Passwords are stored using a random length, one-way
salted hash, SHA-1
or better.
• S3.02 Usernames and passwords are collected and transmitted
only when using
encryption between the client app and the server.
• S3.03 Other personal information while at rest and/or in
motion is encrypted using
a generally recognized, industry-accepted encryption method
(e.g., FIPS
140-212, ISO/IEC) for such information and the encryption
level is disclosed.
• S3.04 App contains security safeguards to verify the identity
of intended user in
the event of forgotten, lost or unknown user name, password
and/or
passcode (“unique identifiers”), for purposes of reminders, re-
linking, or
creation of new unique identifiers.
Standard S4
If the app collects, stores and/or transmits information that
constitutes PHI as defined by
HIPAA, HITECH, and the rules thereunder (e.g., App Publisher
constitutes a Business
Associate pursuant to HIPAA and HITECH), it uses requisite
efforts to maintain and protect
the confidentiality, integrity, and availability of individually
identifiable health information that
is in electronic form (e.g., ePHI).
Performance Requirements for Standard S4
• S4.01 If the app, or through its use, subjects the user or any
party to HIPAA or
HITECH, the App Publisher has implemented administrative,
physical and
technical safeguards, and developed policies and procedures,
pursuant to
the HIPAA Security Rule13, as applicable. For purposes of the
technical
safeguards/security controls, only certain certified encryption
technologies
are permissible for compliance with HIPAA and HITECH.
• S4.02 If the app is, or through its use becomes, subject to
HIPAA or HITECH, all
PHI collected and/or stored is encrypted at all times and is
otherwise
protected in accordance with HIPAA and HITECH.
12
http://csrc.nist.gov/groups/STM/cmvp/standards.html#02
13
http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrul
e/index.html
12 ©2013 Happtique, Inc. All rights reserved
• S4.03 If the app is or becomes subject to HIPAA or HITECH,
all data transmission
to and/or from the app through any network with any server,
system,
software, application and third party is encrypted at all times.
• S4.04 If applicable, the app or the App Publisher has
safeguards in place and/or
uses requisite efforts to comply with any and all obligations
pursuant to any
BAA, including capabilities to assist a covered entity in curing
any breach,
and address all other requirements of HITECH in the event of a
breach.
• S4.05 The App Publisher has the capabilities to enable
compliance, and shall
comply with any and all applicable notification requirements to
its users in
the event that users’ PHI is or is suspected to be compromised
(e.g.,
Breach Notification Rule pursuant to HIPAA and HITECH
including the
capability to support and execute notification requirements14).
Standard S5
If the app collects, stores and/or transmits personal information,
the app offers one or more
industry-accepted methods for guarding against identity theft.
Performance Requirements for Standard S5
• S5.01 The app provides a method for securely authenticating
the user at a
session level (e.g., password, pass phrase, PIN, challenge
phrase) and also
utilizes additional methods or techniques15 to further secure the
identity of
the users whenever the system is initially establishing identity
or the
system has indications that the identity might have been
compromised
(e.g., multiple password failures).
Standard S6
The App Publisher has a mechanism to notify end users about
apps that are banned or
recalled by the App Publisher or any regulatory entity (e.g.,
FDA, FTC, FCC).
Performance Requirements for Standard S6
• S6.01 In the event that an app is banned or recalled, a
mechanism or process is
in place to notify all users about the ban or recall and render
the app
inoperable.
• S6.02 In the event that the app constitutes a medical device
(e.g., 510(k)) or is
regulated by the FDA in any other capacity, the App Publisher
has a policy
and a mechanism in place to comply with any and all applicable
rules and
regulations for purposes of handling all aspects of a product
notification or
recall, including all corrections and removals.
14
http://www.hhs.gov/ocr/privacy/hipaa/administrative/breachnoti
ficationrule/index.html
15
Examples of additional methods or techniques might be the use
of certificates signed by recognized certificate
authorities, two-factor authentication methods, static knowledge
based authentication methods, and/or
dynamic knowledge-based authentications.
13 ©2013 Happtique, Inc. All rights reserved
Standard S716
The app implements reasonable and requisite security measures
to safeguard user financial
data in accordance with any and all applicable laws, regulations,
industry best practices, and
standards.
Performance Requirements for Standard S7
• S7.01 Any app that collects, stores and/or transmits user
financial data for any
purpose, including payment processing, or the app directs to any
website
for the purpose of collecting and/or processing of financial
information,
including any third party website, shall comply with any and all
applicable
Federal and state laws, rules and regulations, and private sector
regulatory
best practices guidelines and initiatives regarding data security
requirements (e.g., Section 5 of the FTC Act, Fair Credit
Reporting Act,
Gramm-Leach-Bliley Act, Payment Card Institute Data Security
Standards,
the SANS Institute’s security policy templates, and standards
and best
practices guidelines for the financial services industry provided
by BITS, the
technology policy division of the Financial Services
Roundtable).
16
FTC Act, Section 5, available at:
http://www.federalreserve.gov/boarddocs/supmanual/cch/ftca.pd
f
PCI Security Standards Council, PCI SSC Data Security
Standards Overview, available at:
https://www.pcisecuritystandards.org/security_standards/
SANS Institute, Information Security Policy Templates,
available at:
http://www.sans.org/security-resources/policies/
BITS, Financial Services Roundtable BITS Publications,
available at:
http://www.bits.org/publications/index.php
14 ©2013 Happtique, Inc. All rights reserved
App Content (C) Standards17
Standard C1
The app is based on one or more credible information sources
such as an accepted protocol,
published guidelines, evidence-based practice, peer-reviewed
journal, etc.
Performance Requirements for Standard C1
• C1.01 If the app is based on content from a recognized source
(e.g., guidelines
from a public or private entity), documentation (e.g., link to
journal article,
medical textbook citation) about the information source and
copyright
compliance is provided.
• C1.02 If the app is based on content other than from a
recognized source,
documentation about how the content was formulated is
provided,
including information regarding its relevancy and reliability.
Standard C2
The app’s content reflects up-to-date information (as of the date
that the app is submitted for
certification).
Performance Requirements for Standard C2
• C2.01 Documentation about the source of the app’s content
and explanation as to
why it is deemed to be up-to-date is provided.
• C2.02 The date(s)/source(s) of the app’s content is provided
through an “About”
section (tab, button or equivalent).
• C2.03 The App Publisher has a method or protocol for
determining if an app’s
content requires updating in order to remain up-to-date.
• C2.04 The App Publisher has a method or protocol for
updating the app’s content
when new or changing information warrants. Updates should
include a
description of and documentation for each change.
Standard C3
For any app that contains content that is derived from a third-
party source (e.g., accepted
protocol, published guidelines, evidence-based practice, peer-
reviewed journal), any
significant deviations in an app’s content from the original
source (e.g., excerpts, abbreviated
versions) are indicated and explained. Any such app shall also
provide a method or citation to
enable the user to locate to the complete content.
Performance Requirements for Standard C3
• C3.01 For any app derived from a third-party source that does
not contain the
original source’s complete content, such app’s description or
“About”
17
These standards are based, in part, on materials from the
Association of American Medical Colleges (AAMC),
including AAMC’s MedEdPORTAL Submission Standards and
Scholarly Criteria
(https://www.mededportal.org/download/262700/data/mepsubmi
ssionstandards.pdf).
15 ©2013 Happtique, Inc. All rights reserved
section shall indicate the specific portion(s) absent and contain
an
explanation as to why each portion(s) is not included.
• C3.02 For any app derived from a third-party source that does
not contain the
original source’s complete content, the app provides a link,
reference, or
other appropriate method to enable the user to locate the
complete
content.
Standard C418
The app’s description and content are truthful, fair, and not
misleading.
Performance Requirements for Standard C4
• C4.01 Backup documentation is provided to substantiate any
claims made in the
description and/or content.
• C4.02 Disclosures are provided, as needed, to prevent
deception. Such disclosures
shall be presented in a clear and conspicuous manner.
• C4.03 Disclosures are provided, as needed, if the app requires
an additional fee(s)
(e.g., subscription fee) in order to fully access the app, its
associated
functionality, and/or content.
Standard C5
An app that contains tools that perform user or patient
management functions, including but
not limited to, mathematical formulae, calculations, data
tracking, reminders, timers,
measurements, or other such functions, does so with consistent
accuracy and reliability to the
degree specified in the app.
Performance Requirements for Standard C5
• C5.01 When operated, the app produces consistent and
accurate results that are
independently verifiable.
Standard C6
Reference apps (e.g., apps that are used for reference purposes
to inform clinical decision-
making, etc.) derive their content from one or more
authoritative sources.
Performance Requirements for Standard C6
• C6.01 The app’s content is based on authoritative sources as
recognized by the
field or discipline that is the subject of the app.
• C6.02 As appropriate, prior accepted work (e.g., published,
peer reviewed) is
used to derive the content of the app.
• C6.03 The source(s) and date(s) (e.g., published, last
modified) of the app’s
content are cited.
18
For further information and guidance, refer to “Dot Com
Disclosures: Information about Online Advertising,”
Federal Trade Commission.
(http://www.ftc.gov/os/2000/05/0005dotcomstaffreport.pdf)
16 ©2013 Happtique, Inc. All rights reserved
Standard C7
Instructional, educational assessment, and other such apps (e.g.,
apps used in educational
settings for physicians, nurses, students, etc.) derive their
content from one or more
authoritative sources and are based on accepted pedagogy
and/or learning strategies or
techniques that are appropriate for the intended audience(s).
Performance Requirements for Standard C7
• C7.01 The app’s content is based on authoritative sources as
recognized by the
field or discipline that is the subject of the app (e.g., recognized
textbook
and/or peer-reviewed journals in an applicable field or
discipline).
• C7.02 As appropriate, prior accepted work (e.g., published,
peer reviewed) is
used to derive the content of the app.
• C7.03 The source(s) and date(s) (e.g., published, last modified
date) of the app’s
content are cited.
• C7.04 The app’s learning goals and objectives are clearly
stated.
• C7.05 The app uses suitable teaching and/or learning
approaches to meet its
stated objectives.
• C7.06 A process or method for assessing and documenting
improvements in
knowledge or skills is provided.
Standard C8
Apps that constitute clinical decision support (CDS) software
and apps that integrate or work
in conjunction with CDS software, comply with current rules
and regulations, if applicable
(e.g., for CDS software that is regulated by the FDA), and
evidence-based/accepted practice
guidelines.
Performance Requirements for Standard C8
• C8.01 Documentation is provided regarding the regulations
and any applicable
evidence-based/accepted practice guidelines that the app
operates in
accordance with.
• C8.02 App has a process and mechanism to deliver all
applicable updates
pursuant to any relevant guidelines when such guidelines are
issued or
made available.
Standard C9
For a multi-purpose app (e.g., apps that have reference,
instructional, or educational
assessment content, integrate or work with CDS software,
etc.),where each element of the
app can be separated for testing, each element of the app meets
the requirements of the
relevant Content Standard(s) herein.
Performance Requirements for Standard C9
• C9.01 Each separate function and/or content area is defined,
documented, and
operates in accordance with relevant Content Standards
described herein.
17 ©2013 Happtique, Inc. All rights reserved
Standard C10
An app that contains advertisements clearly identifies the
advertising and complies with any
and all applicable regulatory requirements, particularly
advertisements that involve or relate to
products or services that are clinical or related to health.
Performance Requirements for Standard C10
• C10.01 Information in any app that constitutes advertising is
denoted by the
message “This is an advertisement” or equivalent.
• C10.02 Information in any app that constitutes advertising will
at all times comply
with all applicable regulatory requirements related to the
marketing of
any product or service, including, but not limited to those of the
FDA,
FTC, FCC, and any laws, rules, regulations and policies of other
regulatory entities in all jurisdictions that app’s owner makes
its app
available.
• C10.03 App Publisher takes commercially reasonable efforts
to clearly and
prominently indicate (e.g., in the “About” section) that any
advertisement, which may be perceived as health care or
medical advice
or treatment, is being displayed for the sole purpose of
advertising and
should not be construed as a substitute for medical or clinical
advice.
Standard C11
The content of apps should be written and presented in a manner
that is appropriate for the
intended audience.
Performance Requirements for Standard C11
• C11.01 The content of an app is designed and written in a way
that is
appropriate for the target audience (e.g., age, educational
background,
healthcare professional versus patient or consumer, caregiver,
and so
forth).
18 ©2013 Happtique, Inc. All rights reserved
Appendix 1. Acronyms
A number of acronyms are used in this document. The
following table provides the full term
for each acronym.
Acronym Full Term
AAMC Association of American Medical Colleges
BA
Business Associate refers to a person/entity that requires
disclosure of
ePHI in order to deliver their product/service to or on behalf of
a
Covered Entity.
BAA
Business Associate Agreement (required in certain
circumstances under
HIPAA and HITECH [defined below])
CDMA2000
Refers to a family of 3G standards providing high-quality voice
and
broadband data services over wireless networks
CDS Clinical Decision Support software
DNS Domain Name System
EHR
Electronic Health Record (also referred to as EMR – Electronic
Medical
Record)
FCC Federal Communications Commission
FDA U.S. Food and Drug Administration
FTC Federal Trade Commission
GPS Global Positioning System (a satellite-based navigation
system)
GSM
Global System for Mobile Communications (originally, Groupe
Spécial
Mobile)
HIPAA Health Insurance Portability and Accountability Act
HITECH Health Information Technology for Economic and
Clinical Health
LAN Local Area Network
MMS Multimedia Messaging Service
NFC Near Field Communication
PHI Protected Health Information
PSTN Public Switched Telephone Network
SMS Short Message Service
URI Uniform Resource Identifier
This document contains proprietary and confidential
information of Xcertia and shall not be used, disclosed or
reproduced, in whole or in part, for any purpose other
than to view this document, without the prior written
consent of Xcertia.
2019 Board Approved Xcertia
Guidelines
Issued on: August 12, 2019
Xcertia mHealth App Guidelines 2019
2019 Proprietary & Confidential 2
The Xcertia Guidelines History
Today’s Xcertia Guidelines were first conceived in 2012. As
part of the development process, a panel comprised of
thought leaders in the healthcare industry such as the
Association of American Medical Colleges, Mobile Marketing
Association, Healthcare Information and Management Systems
Society (HIMSS), the U.S. Food and Drug Administration
(FDA), and other federal agencies, was formed. In the spirit of
collaboration, and to seek public input, these guidelines
were published for review and comment to maximize public and
interested parties’ input.
In 2015 those same guidelines were updated with input from
subject matter experts in the key areas of Operability,
Privacy, Security and Content. Shortly thereafter these
guidelines were transferred to the newly formed non-profit.
Today, these guidelines now known as the Xcertia Guidelines,
are backed by its founding members, the American
Medical Association (AMA), the American Heart Association
(AHA), HIMSS, and the DHX Group, with a shared purpose to
provide a level of assurance to clinicians and consumers alike,
that the mobile health apps that comply with the
guidelines are vetted to deliver value to the end user.
Under the Xcertia watch, the guidelines were updated in 2017
and then posted on the Xcertia website for public
comment. At the Connected Health Conference 2018 the
Privacy and Security sections of the guidelines were again
updated and issued for public comment following that update by
the Xcertia Work Groups in these two disciplines.
In February of 2019 the Xcertia Guidelines will have gone
through a complete review and editing process by the
organization’s various work groups. These groups consisted of
over forty individuals and contained subject matter
experts from a number of healthcare organizations and
disciplines with expertise in the various sections within the
guidelines. As part of that effort the Xcertia Guidelines are
divided into five sections, Privacy, Security, Usability,
Operability and Content, reflecting the key areas of guidance to
ensure mHealth apps deliver true value in a trusted
environment to improve product adoption and use.
Since their release in February of 2019 the guidelines were
available for public comment up until May 15, 2019. Those
comments have been considered by the work group leaders and
their teams and where appropriate incorporated into
the Final 2019 Version of the Xcertia Guidelines.
Xcertia mHealth App Guidelines 2019
2019 Proprietary & Confidential 3
App Privacy Guidelines
App Privacy (P) Guidelines
Privacy will assess whether a mobile health app protects the
user’s information, including Protected Health Information
(PHI), Personal Information (PI), Personally Identifiable
Information (PII) in full compliance with all applicable laws,
rules
and regulations. Where jurisdictions may conflict, the App
Designer shall comply with the more rigorous requirements.
It is incumbent upon the developer to understand the scope and
full requirements of the Privacy Rules and potential
notification requirements of the region(s) for which they intend
to operate. Developers should have relevant procedures
in place and be able to document those procedures.
Guideline P1 – Notice of Use and Disclosure
The Privacy Notice is externally facing and describes to an app
user how the organization collects, uses, and retains their
data (e.g., PHI, PI, PII). This notice should be unbundled from
other information notices regarding the application. The
type(s) of data that the app obtains, and how and by whom that
information is used, is disclosed to the user in a Privacy
Notice
Requirements for Guideline P1
• P1.01 Access: The identity of any entities that will have
access to, collect and/or use of the user’s personal
information, shall be made available and disclosed to the user
on an at least an annual basis and shall disclose use
by any parties as a part of the use chain.
• P1.02 Usage: The app publisher shall disclose any and all
ownership, rights or licenses to any data collected about
the app and its usage, including the use of any data for
commercial purposes.
• P1.03 Material Changes to Use: The app shall have a section
(tab, button or equivalent) or active link to its Privacy
Policy, and owner represents that commercially reasonable
efforts are used to notify users of any material
changes to its Privacy Policy.
• P1.04 User Registration: If registration is required to use all
or some of the app’s features, the user shall be
provided with an explanation as to the uses of the registration
information.
• P1.05 Data Collected and Opt Out: User shall be provided (or
have access to) a clear list of all data points collected
and/or accessed by the app, including by the app publisher and
all third parties such as in-app advertisers. This
includes personal data pertaining to the usage of the app,
including but not limited to browsing history, device
Xcertia mHealth App Guidelines 2019
2019 Proprietary & Confidential 4
(e.g., unique identifiers), operating system, and IP addresses.
How and from where such data points are collected
shall be disclosed. An Option should exist for user to opt-out
of passing data to in-app advertisers.
• P1.06 Data Collected and Disclosed: User shall be provided
(or has access to) a clear list of all data points collected
and/or accessed by the app pertaining to the specific user,
including user-generated data and data that are
collected automatically about the user through other means or
technologies of the app. This includes data points
collected for the purpose of any third-party sharing. How and
from where such data points are collected is
disclosed.
• P1.07 Affirmative Consent to Use Data: The app publisher
shall obtain affirmative express consent before using
user data in a materially different manner than was previously
disclosed when collecting the data or collecting
new data, including for third-party sharing.
• P1.08 Affirmative Consent to Collect Data: The app publisher
shall obtain affirmative express consent before
collecting personal data, in particular, Personally Identifiable
Information (PII), Personal Health Information (PHI),
financial data or location data, including obtaining HIPAA
authorizations where applicable.
• P1.09 Use and Updates of Information: The privacy policy
shall inform users how they can get a copy of their
personal information that was collected by the app. A
designated individual or toll-free number may be required
to be listed depending on domicile of user. The privacy policy
shall also inform users how they can correct and
update information supplied by, or collected about them, held
by or on behalf of the owner, or shared with third
parties, including the identity of such third parties, particularly
in compliance with the HIPAA Privacy Rule, if
applicable, and any other state or
• international laws, rules, or regulations to the extent
applicable.
• P1.10 Do Not Track Mechanism: If not otherwise provided by
default, the app shall allow users to control the
collection and use of their in-app browsing data by supporting
an online Do Not Track mechanism.
• P1.11 Opt Out or Do Not Contact: If not otherwise provided
by default, the app shall allow users to control their
receipt of commercial messages from the app publisher and
third parties through an “opt out” option, “do not
contact,” or substantially similar feature.
• P1.12 Sharing of Data: The app publisher shall not share any
personal data with third parties, unless the app
publisher: (i) has an agreement with such third party that
addresses safeguarding any and all such user data (BAA);
and (ii) takes the necessary measures to anonymize/de-identify
all user data in accordance with the Health and
Human Services Safe Harbor guidelines for de-
identification.(iii) the user provides an affirmative user consent
(iv)
except when expressly disclaimed by app publisher (v) The app
publisher has documented this within the Privacy
Policy.
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html
Xcertia mHealth App Guidelines 2019
2019 Proprietary & Confidential 5
• P1.13 User Ability to Delete Data/Accounts: App publisher
should allow a user to delete all personal data from
systems if canceling or deleting accounts. This functionality
could be accessed by the user in app or by app owner.
• P1. 14 Changes to Privacy Policy: A mechanism shall be in
place to notify users of changes to the Privacy Policy.
• P1.15 Consent to Changes in Privacy Policy: A mechanism
shall be provided that enables users to acknowledge
and consent to changes to the Privacy Policy.
• P1.16 Notification in Event of Breach: User will be promptly
notified (according to state or federal laws or
contractual obligations) if breach occurs that has compromised
their information in accordance with applicable
state, federal and country laws.
Guideline P2 - Retention
If data is collected, the user shall be informed about how long
the data is retained.
Requirements for Guideline P2
• P2.01 The Privacy Policy shall disclose the retention policy
regarding user information. Such statement shall
include policies with respect to data retention under any third-
party data sharing arrangement.
• P2.02 Retention and deletion time periods, which are based on
clearly defined business needs or legal obligations,
shall be set. If business needs are defined as “in perpetuity,”
this shall also be disclosed.
Guideline P3 – Access Mechanisms
The app user is informed, through an End User License
Agreement, if the app accesses local resources (e.g., device
address book, mobile and/or LAN network interface, system
stored credit card information, GPS and other location-
based services, contacts, camera, photos, SMS or MMS
messaging, and Bluetooth) or resources from and/or for social
networking platforms, provided with an explanation by any
appropriate means (e.g., the “About” section) as to how and
why such resources are used, and opt-in consent is obtained to
access such resources.
Requirements for Guideline P3
• P3.01 If the app accesses any of the mobile device’s native
hardware (camera, microphone, GPS/location,
Calendar, Address Book, etc.) the express reason for requiring
such access shall be disclosed to the user, separate
from any warning/consent present in the mobile operating
system.
Xcertia mHealth App Guidelines 2019
2019 Proprietary & Confidential 6
• P3.02 If the app accesses or uses any Wi-Fi, LAN, or mobile
network data connections, an estimate of the amount
of data consumed shall be provided to the user along with a
notice that carrier data charges may apply.
• P3.03 If the app accesses social networking sites (such as
Facebook, Instagram, or like social media), the reason
why such sites are being accessed is disclosed to the user.
Guideline P4 - Health Insurance Portability and Accountability
Act (HIPAA) Entity or
Business Associate
If the app, on behalf of a Covered Entity or a Business
Associate (each as defined by HIPAA and the rules thereunder),
collects, stores, and/or transmits information that constitutes
Protected Health Information (as defined by HIPAA and
the rules thereunder), it does so in full compliance with HIPAA
and all applicable state and international laws, rules and
regulations.
Requirements for Guideline P4
• P4.01 The user can affirmatively opt in or out (at any time) of
information shared with or given access by third
parties.
• P4.02 The app publisher certifies that a Business Associate
Agreement (BAA) has been executed pursuant to
HIPAA with any and all necessary third parties.
• P4.03 The user can access or request any of his/her Protected
Health Information (PHI) collected, stored and/or
transmitted by the app.
• P4.04 The app publisher uses requisite efforts to limit the use
and disclosure of PHI, including ePHI, to the
minimum necessary to accomplish the intended purpose (e.g.,
“need-to- know”).
• P4.05 The publisher must demonstrate that procedures are in
place so that in the event of a breach the app
publisher shall notify affected individuals, HHS, and in some
cases, the media (news agencies, print, radio, etc.) of
a breach of unsecured PHI. Most notifications must be provided
without unreasonable delay and no later than 60
days following the discovery of a breach.
Guideline P5 – Children’s Online Privacy Protection Act
(COPPA)
The app has measures in place to protect children in accordance
with applicable laws and regulations if website is
directed at children (see specific guidance Children’s Online
Privacy Protection Act).
https://www.ftc.gov/enforcement/rules/rulemaking-regulatory-
reform-proceedings/childrens-online-privacy-protection-rule
Xcertia mHealth App Guidelines 2019
2019 Proprietary & Confidential 7
Requirements for Guideline P5
• P5.01 The app provides clear notice of the content that will be
made available and its suitability for specific age
groups.
• P5.02 The app includes a clear and conspicuous Privacy
Notice/Policy that addresses use by any child under the
age of 13 and prevents usage without verifiable parental
authority (please note state laws may have additional
carve out regulations for children).
• P5.03 The app provides for an age verification process—either
automatic or self-reported—to control access to
age-restricted content and to minimize the inappropriate
collection, use, or disclosure of personal information
from a child.
• P5.04 The app does not, without obtaining verifiable
parental/legal guardian consent, collect, use, or disclose data
from any child under the age of 13.
• P5.05 The app enables a parent/legal guardian who becomes
aware that the child has provided information
without his/her consent to contact the app publisher and
eliminate account/delete that data.
• P5.06 The Privacy Policy provides that the app publisher will
delete any child’s personal information upon notice,
or if the App publisher becomes aware or has knowledge, that
such information was provided without the
consent of a parent/legal guardian, including information that
was shared with a third party.
• P5.07 Apps that are intended for children must have a location
default setting that enables parents/legal
guardians to prevent the app from automatically publishing their
child’s location.
• P5.08 Apps that are directed at children under the age of 13
will have a default setting that prevents in-app
purchases.
• P5.09 Apps that are directed at children under the age of 13
will have a default setting that prevents usage of
camera and microphone.
Guideline P6 - General Data Protection Regulation (GDPR)
The app has measures in place to comply with applicable laws
and regulations related to the European Union General
Data Protection Regulation (GDPR).
Requirements for Guideline P6
• P6.01 Provide Privacy Notice at the time user is providing
information to the app. The Privacy Notice should be
available in search feature.
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• P6.02 The Privacy Notice must be concise (plain language),
transparent and accessible. For the Privacy Notice to be
easily readable, key information is at front of notice and in a
layered notice approach links are available for
additional information in full version.
• P6.03 The Privacy Notice must include the name of the
organization, processor, name and contact details of the
representative, and contact details of the Data Protection
Officer (DPO) if a DPO is required.
• P6.04 The Privacy Notice must state the lawful basis,
legitimate purposes, and rights available to individuals in
respect of processing.
• P6.05 The user must be informed of the categories/source of
personal data obtained if it is obtained from third party
sources. This must be provided within a reasonable period of
obtaining the personal data and no later than one
month. Notice must be provided of the recipients of categories
of personal data, whether the individuals are under a
statutory or contractual obligation to provide personal data and
the details of transfers of personal data to any third
countries or international organizations.
• P6.06 The details and existence of automated decision-making
including profiling (if applicable) and the retention
periods for personal data must be provided.
• P6.07 Unexpected uses of user data should be posted on the
front page of the Privacy Notice and there must be
separate consent for different uses. A user must be given a
simple way to consent to all types of uses listed (e.g. opt
in/opt out boxes for each). If the app is requesting the user to
receive direct marketing materials, then there should
be a separate opt out box.
• P6.08 The user must be put on notice that they have the right
to withdraw from further use of data (if applicable
through respective regional data governance laws) and the right
to file a complaint with the respective regional
supervisory authority.
• P6.09 Best practice is to conduct audits to see what personal
information the app maintains and conduct user
testing to see if the privacy notice is easily understandable.
• P6.10 The app developer must ensure the Privacy Notice is
consistent with current use. If a material change is made
to the collection or use of data, the Privacy Notice must updated
prior to processing.
• P6.11 If the event of a breach of personal data, understand the
type of data that has been impacted. Prepare a
written report. And, based upon notice requirements of area of
operation, Report within 72 hours of becoming
aware of the reportable breach to the relevant supervisory
authority.
• P6.12 The App Developer shall be responsible for knowing
relevant and appropriate regulations for the Regions in
which they intend to operate
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• P6.13 The End User Licensing Agreement (EULA) should
document how notice shall be provided to individual and
appropriate authorities.
References: Additional information may be found at these sites:
US State Breach Notification Requirements:
http://www.ncsl.org/research/telecommunications-and-
information-
technology/security-breach-notification-laws.aspx
European Union General Data Protection Requirements-
Information Commissioners Office UK: https://ico.org.uk/for-
organisations/guide-to-the-general-data-protection-regulation-
gdpr/individual-rights/right-to-be-informed
Health and Human Services Safe Harbor:
https://www.ecfr.gov/cgi-
bin/retrieveECFR?gp=1&SID=90f45f0c857144405b17a43c3560
0c16&ty=HTML&h=L&mc=true&r=SECTION&n=se42.5.10
01_1952
HIPAA: https://www.hhs.gov/hipaa/for-
professionals/privacy/laws-regulations/index.html?language=en
http://www.ncsl.org/research/telecommunications-and-
information-technology/security-breach-notification-laws.aspx
http://www.ncsl.org/research/telecommunications-and-
information-technology/security-breach-notification-laws.aspx
https://ico.org.uk/for-organisations/guide-to-the-general-data-
protection-regulation-gdpr/individual-rights/right-to-be-
informed
https://ico.org.uk/for-organisations/guide-to-the-general-data-
protection-regulation-gdpr/individual-rights/right-to-be-
informed
https://www.ecfr.gov/cgi-
bin/retrieveECFR?gp=1&SID=90f45f0c857144405b17a43c3560
0c16&ty=HTML&h=L&mc=true&r=SECTION&n=se42.5.1001_
1952
https://www.ecfr.gov/cgi-
bin/retrieveECFR?gp=1&SID=90f45f0c857144405b17a43c3560
0c16&ty=HTML&h=L&mc=true&r=SECTION&n=se42.5.1001_
1952
https://www.ecfr.gov/cgi-
bin/retrieveECFR?gp=1&SID=90f45f0c857144405b17a43c3560
0c16&ty=HTML&h=L&mc=true&r=SECTION&n=se42.5.1001_
1952
https://www.hhs.gov/hipaa/for-professionals/privacy/laws-
regulations/index.html?language=en
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App Security Guidelines
App Security (S) Guidelines
The Security Guidelines will assess if the application is
protected from external threats and maintain the integrity,
availability, confidentiality, and resilience of the data.
Guideline S1 – Security Operations
The app publisher ensures that the app’s security procedures
comply at all times with generally recognized best
practices and applicable rules and regulations for jurisdiction(s)
in which the app is intended to be sold or used and such
procedures are explained or made available to users.
Requirements for Guideline S1
• S1.01 Administrative, physical, and technical safeguards to
protect user’s information from unauthorized
disclosure or access are provided and employed.
• S1.02 Access to user’s information is limited to those
authorized employees or contractors who need to know the
information in order to operate, maintain, develop, or improve
the app.
• S1.03 If the app utilizes unique identifiers, the identifier is
linked to the correct user and is not shared with third
parties.
• S1.04 If any third-party vendor services are utilized as part
of the app, an information security risk assessment
should be conducted of the respective third parties.
• S1.05 If your organization is subject to HIPAA or other
Information Security and/or Privacy regulations, an internal
risk assessment for any systems related to PHI/PII should be
conducted.
• S1.06 App publisher should create and maintain a baseline
configuration document for potential risks to be
identified.
• S1.07 Risk-appropriate authentication methods are used to
authenticate users.
• S1.08 A written description of security procedures is provided
in a section of the app (tab, button, or equivalent)
or through an active link. The security procedures are written in
clear, easy-to-understand language and terms
and are affirmatively agreed to by the user. Such components
include, but are not limited to, how personal
information is safeguarded, how unique identifiers are linked to
the correct user, and authentication methods
used.
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• S1.09 App publisher should designate someone to be
responsible for information security.
• S1.10 App publisher staff designated for information security
should have a baseline of information security
knowledge.
• S1.11 Responsibilities for information security staff should be
clearly documented.
• S1.12 Any staff members handling PHI/PII should be required
to take Information Security Awareness training,
highlighting HIPAA.
• S1.13 The app publisher has a mechanism in place to review
security procedures on an ongoing basis and update
security procedures, as necessary, to ensure that they comply at
all times with applicable rules and regulations for
jurisdiction(s) in which the app is intended to be sold or used.
• S1.14 Cloud-based apps meet Statement on Guidelines for
Attestation Engagements (SSAE) No. 16 requirements
and a SSAE No. 16 audit report is provided.
(http://ssae16.com/SSAE16_overview.html)
• S1.15 If the app uses Short Messaging Service (SMS) or
Multi-Media Message Service (MMS), the user is informed
whether messages are encrypted and, if so, the level of
encryption.
• S1.16 Any app that collects, stores and/or transmits user
financial data for any purpose, including payment
processing, or the app directs to any website for the purpose of
collecting and/or processing of financial
information, including any third-party website, shall comply
with all applicable Federal and state laws, rules and
regulations, and private sector regulatory best practices
guidelines and initiatives regarding data security
requirements.
Guideline S2 – Vulnerability Management
The app, including without limitation, any advertisement
displayed or supported through the app, is free from known
malicious code or software such as malware, including, but not
limited to, viruses, worms, trojan horses, spyware,
adware, rootkits, backdoors, keystroke loggers, and/or botnets
at time of release and/or upgrades.
Requirements for Guideline S2
• S2.01 A scan of the app by the app developer using scanning
software does not reveal any known malicious code
or software objects prior to release.
• S2.02 A scan of any third-party code, including advertising
networks, incorporated into app for purposes of
displaying or supporting advertisements (e.g., banner,
interstitial) does not reveal any known malicious code or
software.
http://ssae16.com/SSAE16_overview.html
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• S2.03 If ongoing scanning does produce evidence of malicious
code or software objects, proactively work to
update the app and notify end users.
Guideline S3 – Systems & Communication Protection
If the app collects, stores or transmits any personal data,
including, but not limited to, usernames and passwords, such
information is collected, stored, and transmitted using
encryption.
Requirements for Guideline S3
S3.01 Passwords are stored using a random length, , one-way
salted hash, or current accepted guideline.
• S3.02 Usernames and passwords are collected and transmitted
only when using encryption between the client
app and the server.
• S3.03 Other personal information while at rest and/or in
motion is encrypted using a generally recognized,
industry-accepted encryption method (e.g., FIPS 140-2,
ISO/IEC) for such information and the encryption level is
disclosed.
• S3.04 App contains security safeguards to verify the identity
of intended user in the event of forgotten, lost or
unknown user name, password and/or passcode (“unique
identifiers”), for purposes of reminders, re-linking, or
creation of new unique identifiers.
• S3.05 Organization should have a change management process
when changes are made to the app or critical
systems in operability check there and if okay delete from here.
• S3.06 Information systems related to the app should have
antivirus software and mechanism to keep application
environment up to date with security patches.
• S3.07 Application data should be backed up regularly.
• S3.08 Firewalls should be used for internal and external
connections.
• S3.09 Vulnerability assessments should be conducted on the
application and organizational network on a regular
basis.
• S3.10 If removable media is used for the storage of personal
data, the media should be encrypted to protect the
data from unauthorized access.
• S3.11 Organization should have a documented patch
management process for systems and app.
• S3.12 Installed App and respective infrastructure should have
the capability to log and audit activity within the
system, e.g. who did what, when and how.
• S3.13 Installed App Audit logs should be maintained for a
minimum of 90 days.
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Guideline S4 – Compliance
If the app collects, stores or transmits information that
constitutes PHI as defined by HIPAA and the rules thereunder
(e.g., app publisher constitutes a Business Associate pursuant to
HIPAA), it uses requisite efforts to maintain and protect
the confidentiality, integrity, and availability of individually
identifiable health information that is in electronic form (e.g.,
ePHI).
Requirements for Guideline S4
• S4.01 If the app, or through its use, subjects the user or any
party to HIPAA, the app publisher has implemented
administrative, physical and technical safeguards, and
developed policies and procedures, pursuant to the
HIPAA Security Rule, as applicable. For purposes of the
technical safeguards/security controls, only certain
certified encryption technologies are permissible for compliance
with HIPAA.
• S4.02 If applicable, the app or the app publisher has
safeguards in place or uses requisite efforts to comply with all
obligations pursuant to any BAA, including capabilities to assist
a covered entity in curing any breach, and address
all other requirements of HIPAA in the event of a breach
including notifying affected users.
• S4.03 The app publisher has the capabilities to enable
compliance, and shall comply with any and all applicable
notification requirements to its users in the event that users’
PHI is or is suspected to be compromised (e.g.,
Breach Notification Rule pursuant to HIPAA including the
capability to support and execute notification
requirements).
S4.04 The app publisher has a mechanism to notify end users
about apps that are banned or recalled by the app
publisher or any regulatory entity (e.g., FDA, FTC, FCC, UL).
• S4.05 In the event that an app is banned or recalled, a
mechanism or process is in place to notify all users about
the ban or recall and render the app inoperable.
• S4.06 If the app constitutes a medical device (e.g., 510(k)) or
is regulated by the FDA in any other capacity, the app
publisher has a policy and a mechanism in place to comply with
all applicable rules and regulations for purposes of
handling all aspects of a product notification or recall,
including all corrections and removals.
Guideline S5 – Access Control and Authentication
If the app collects, stores and/or transmits personal information,
the app offers one or more industry-accepted methods
for guarding against identity theft.
https://www.hhs.gov/hipaa/for-professionals/security/index.html
https://www.hhs.gov/hipaa/for-professionals/breach-
notification/index.html
https://www.hhs.gov/hipaa/for-professionals/breach-
notification/index.html
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Requirements for Guideline S5
• S5.01 The app provides a method for securely authenticating
the user at a session level (e.g., password, pass
phrase, PIN, challenge phrase) and utilizes additional methods
or techniques to further secure the identity of the
users whenever the system is initially establishing identity, or
the system has indications that the identity might
have been compromised (e.g., multiple password failures).
• S5.02 Unique user IDs should be used for access to all
functions within the application.
• S5.03 Access within the application should be limited to what
is needed for that individual’s specific role.
• S5.04 A process for provisioning and deprovisioning access in
a timely fashion should be documented.
• S5.05 For remote access or privileged access should require
two factor authentication to reduce the risk of
unauthorized access.
Guideline S6 – Asset Management
If the app collects, stores and or transmits personal information,
the app maintains a methodology for documenting
those Assets.
Requirements for Guideline S6
• S6.01 Organization should have a process for tracking
information and physical assets.
• S6.02 Information assets should be classified based upon
value to the organizations and outside regulations, e.g.
public, internal confidential, sensitive.
Guideline S7 – Physical & Environmental Security
If the app collects, stores or transmits personal information, the
app the app publisher shall maintain a record of how
Security is maintained.
Requirements for Guideline S7
• S7.01 Organization should have a physical security program.
• S7.02 Physical security program should include security and
environmental controls for the building/data center
which contains information assets and system.
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Guideline S8 – Incident Response
If the app collects, stores or transmits personal information, the
app publisher shall create and maintain an Incident
Response system.
Requirements for Guideline S8
• S8.01 Organization should have an incident response plan in
the event of an information security incident.
• S8.02 If breach is determined, the organization should notify
customers and individuals affected in accordance
with applicable regulation.
Guideline S9 – Disaster Recovery & Business Continuity
If the app collects, stores or transmits personal information, the
app publisher shall provide a documented plan when
the app, data or access is not available for use.
Requirements for Guideline S9
• S9.01 Organization should have a documented DR/BC plan in
the event that the application, data, or its
infrastructure is not available for use.
• S9.02 Tests from data back-up should happen on a regular
basis.
• S9.03 Tests of the DR/BC plan should happen on a regular
basis.
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Content Guidelines
Content guidelines will assess whether the information provided
in the application is current and accurate.
Guideline C1 Credible Information Sources
The app is based on one or more credible information sources
including, but not limited to: protocols, published
guidelines, evidence-based practice and peer-reviewed journals.
Appendix 2 provides a selected number of accepted
condition specific guidelines.
Requirements for Guideline C1
• C1.01 The app should specify the source of content with
documentation. Is it based on content from a
recognized source (e.g., guidelines from a public or private
entity) with, and documentation (e.g., link to journal
article, medical textbook citation) about the information source
and copyright compliance is provided. The source
should point to current and accepted protocols and guidelines.
Additionally, the content within the application
should align and not deviate from the referenced source.
• C1.02 If the app is based on content other than from a
recognized source, documentation about how and when
the content was formulated is provided, including information
regarding its relevancy and reliability.
• C1.03 If a previous version of an app or its content becomes
medically dangerous due to updated current
medical guidelines, the app publisher has a documented process
and annual review period or mechanism to
update or retract the outdated content version and notify users.
Guideline C2 Current Information
The app’s content reflects up-to-date information.
Requirements for Guideline C2
• C2.01 Documentation about the source of the app’s content
and explanation as to why it is deemed to be up-
to-date is provided.
• C2.02 The date(s)/source(s) of the app’s content is provided
through an “About” section (tab, button or
equivalent).
• C2.03 The app publisher has a method or protocol for
determining if an app’s content requires updating to
remain up-to-date. The app publisher will provide an annual
review schedule to ensure that content contained in
the app is up to date.
• C2.04 The app publisher has a method or protocol for
updating the app’s content when new or changing
information warrants. Updates should include a description of
and documentation for each change and be made
readily available for app users to identify the timing up these
updates.
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• C2.05 Any significant deviations in an app’s content from the
original source (e.g., excerpts, abbreviated
versions) are indicated and explained.
Guideline C3 Information Accuracy
The app’s description and content are truthful, fair, and not
misleading.
Requirements for Guideline C3
• C3.01 documentation is provided to substantiate any claims
made in the description and/or content.
• C3.02 Disclosures are provided, as needed, to prevent
deception. Such disclosures shall be presented in a clear
and conspicuous manner.
• C3.03 Disclosures are provided, as needed, if the app requires
an additional fee(s) (e.g., subscription fee) in order
to fully access the app, its associated functionality, and/or
content.
Guideline C4 Accuracy of Results
An app that contains tools that perform user or patient
management functions, including but not limited to,
mathematical
formulae, calculations, data tracking, reminders, timers,
measurements, or other such functions, does so with consistent
accuracy and reliability to the degree specified in the app.
Requirements for Guideline C4
• C4.01 When operated, the app produces consistent and
accurate results that are independently verifiable.
• C4.02 The app publisher will provide the accuracy and
reliability of any calculations in product
documentation. Product documentation will also include
appropriate sources that support the validity of
calculations, measures and other functions
Guideline C5 Advertising Within the App
An app that contains advertisements clearly identifies the
advertising and complies with all applicable regulatory
requirements, particularly advertisements that involve or relate
to products or services that are clinical or related to
health.
Requirements for Guideline C5
• C5.01 Information in any app that constitutes advertising is
denoted by the message “This is an
advertisement” or equivalent legibly displayed next to the
advertisement or clearly super-imposed on the actual
ad or advertorial..
• C5.02 Information in any app that constitutes advertising will
always comply with all applicable regulatory
requirements related to the marketing of any product or service,
including, but not limited to those of the FDA,
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FTC, FCC, and any laws, rules, regulations and policies of other
regulatory entities in all jurisdictions that app’s
owner makes its product available.
• Advertisements should be placed within the app in such a
manner as to not create confusion or uncertainty as to
what is advertising vs educational information.
• C5.03 App publisher takes commercially reasonable efforts
to clearly and prominently indicate (e.g., in the
“About” section) that any advertisement, which may be
perceived as health care or medical advice or treatment,
is being displayed for the sole purpose of advertising and
should not be construed as a substitute for medical or
clinical advice.
Guideline C6 Documentation of Evidence
The level of evidence and quality of evidence for an app should
be transparent and visible to users and health
professionals.
Requirements for Guideline C6
* C6.01 The app’s public description should clearly state which
type of research has been performed to validate its
content. These can include the following levels of research:
I. Systematic review or meta-analysis of randomized control
trials
II. Randomized control trial/s (number of trials if more than
one)
III. Quasi-experimental study
IV. Case-control or cohort studies
V. Systematic reviews of descriptive and qualitative studies
VI. Single descriptive or qualitative study
VII. Expert medical or academic opinion
• C6.02 If level of research performed on the opinion is based
on expert or academic opinion (VII) or no study, the
app’s public description should clearly state, “The effectiveness
of the app has not been studied”.
• C6.03 If a study was performed, documentation should clearly
state who performed such study (C7.01) and
whether the study was performed by an independent entity.
Furthermore, the app’s documentation should
state if the study has been published in a peer-reviewed journal,
and if so, include the date and the title for both
the journal and article. App’s documentation should also state
any ownership that the study authors (C7.01)
have in the solution company, its partners or investors, either
currently or at the time the study was performed.
• C6.04 If a study was performed, documentation should state
the exposure environment (e.g. hospital, home,
community health center, etc.). It should also state the
demographics, socioeconomic status, IT literacy,
rural/urban, and type/stage of illness of study participants. The
relevance of these characteristics to app’s goals
should be explained.
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Guideline C7 Transparency of Evidence
The basis of evidence in literature for the app and the app’s
design should be transparent and visible to users and health
professionals.
Requirements for Guideline C7
• C7.01 App documentation should state whether the app is
based upon the results of a study/studies published
in peer-reviewed journals. This can include studies of non-
digital health interventions that have inspired solution
designs. If based on peer-reviewed publications, documentation
should state that the app is “informed by the
independent study of a separate intervention in a peer-reviewed
journal” and include the date and the title for
both the journal and article. This statement is in addition to, not
replacement, of the preceding statement of
which type of research has been specifically performed on the
app.
Given that literature reviews are significantly less costly than
performing studies,
• C7.02 Documentation should state whether such study authors
(C7.01) have had any cooperation with the app
publisher, and whether the study authors provide any active
input on the app. App documentation should also
state any financial relationships that are planned, exist or have
existed between such study authors (C8.01) and
the app publisher, its partners or investors.
• C7.03 If an app is based on peer-reviewed literature, the
documentation should state what type of user research
was performed to adapt the literature and solution to the needs
of the target user. This could include, but is not
limited to design research, human centered design, formative
research, user centered design, and co-creation
with users. This type of qualitative research can complement
and translate quantitative research, but it should
not be presented as a replacement for quantitative research.
Guideline C8 Publishing Outcomes Data
The types of results achieved by the app or study of the app
should be transparent and visible to users and health
professionals.
Requirements for Guideline C8
• C8.01 Documentation should clearly state what metric or
indicator is used in studies and claimed to be
accomplished by the application. This can include the following
type of indicators:
I. Health outcomes
II. Biological outcomes
III. Health behavior outcomes
IV. Online analytics or online behavior outcomes
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If the cited indicator is only an online outcome (IV),
documentation should clearly state that results do not include
“tangible outcomes in health behavior or health outcomes”.
• C8.02 The public source of the metric definition should be
cited in the app’s documentation. This could include
a health association, peer-reviewed journal, health standards
body.
Guideline C9 Transparency of Data
The context of the app and data should be clear to users and
health professionals.
Requirements for Guideline C9
• C9.01 The app’s public description should accurately state in
plain language what type of individual health data
is collected by the app, who it is shared with, and what it used
for. This description should specify whether this
data is sold to app publisher’s partners.
•
• C9.02 App documentation should specify in which types of
environments it is designed to operate for all
relevant users (e.g. hospital, home, community health center,
etc.). This description should explain how the app
has been designed to operate in this environment with the
minimum burden.
For further information and guidance, refer to “How to Make
Effective Disclosures in Digital Advertising,”
Federal Trade Commission.
(https://www.ftc.gov/sites/default/files/attachments/press-
releases/ftc-staff-
revises-online-advertising-disclosure-
guidelines/130312dotcomdisclosures.pdf)
https://www.ftc.gov/sites/default/files/attachments/press-
releases/ftc-staff-revises-online-advertising-disclosure-
guidelines/130312dotcomdisclosures.pdf
https://www.ftc.gov/sites/default/files/attachments/press-
releases/ftc-staff-revises-online-advertising-disclosure-
guidelines/130312dotcomdisclosures.pdf
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Usability Guidelines
App Usability (U) Guidelines
The Usability Guidelines assess how a mobile health app is
designed to be safe and easy to use by incorporating five key
quality aspects of usability: learnability, efficiency,
memorability, prevention of errors, and user satisfaction. Apps
designed based on sound usability principles will be optimized
for use by the intended users within the intended use
environments.
Guideline U1 Visual Design
Apps should follow standards of visual design that promote
legibility, clarity of content, and user engagement without
introducing unnecessary distraction. Apps that leverage user
expectations in their design strategy shorten the learning
curve and decrease user frustration.
Performance Requirements for Guideline U1
● U1.01 App layout should be adaptable such that usability and
functionality do not differ between landscape or
portrait mode. Ideally, interfaces should be flexible to operate
in both orientations.
● U1.02 Readability and meaning of content within the app
should be consistent across a variety of mobile screen
sizes and operating systems.
● U1.03 Contrasting colors should be utilized to help users
distinguish between the different elements on the
screen, with an emphasis on contrast between the screen
background and content (i.e., text and graphics).
● U1.04 Multiple redundant identifiers should be used to
indicate critical or safety-related information. Cues can
include color, iconography, labeling, or other text.
● U1.05 Extraneous text, graphics, and animation should be
used sparingly. Information that is actively populating
should serve a purpose and avoid distracting the user or
cluttering the screen if only for aesthetic purposes.
● U1.06 Elements critical to app functionality and content
understandability should be positioned above the scroll
line to minimize the opportunity for missed information. Users
should be able to clearly identify when screens
extend beyond the scroll line.
● U1.07 App design should provide clear indications that
elements are actionable. Interactive elements can be
differentiated from non-selectable content through design
choices that should be used consistently throughout
the app (i.e., color, text style).
● U1.08 App design should support recognition over recall by
keeping relevant information on screen rather than
forcing users to remember it.
● U1.09 When possible, reduce the probability of data entry
error by providing users with selectable options rather
than requiring text entry.
Xcertia mHealth App Guidelines 2019
2019 Proprietary & Confidential 22
● U1.10 Selectable items should be a minimum of 7 to 10
millimeters in length and width, with appropriate spacing
allowance between items to avoid unintended selections.
Guideline U2 Readability
Text used within the app must be readable, understandable, and
adjustable to accommodate ease of operation for a
variety of devices, users and use environments. Text size
adjustments should not alter the screen layout in a manner
that could confuse users or prohibit ease of use.
Performance Requirements for Guideline U2
● U2.01 The default font size for paragraph text should follow
the minimum standard guidelines for the platform of
use (e.g., 17pt for iOS, 14sp for Android).
● U2.02 Different font sizes should be utilized to establish text
hierarchy, with larger font sizes signifying headers
and smaller font sizes used for paragraph text.
● U2.03 Apps should avoid presenting information in paragraph
form when possible. When large amounts of
information must be displayed, implement information chunking
(i.e., intuitive grouping) or utilize lists and tables
to facilitate learnability and memorability.
● U2.04 Text should incorporate appropriate spacing allowance
between lines (e.g., 1.2 times the font height) to
allow for breathability and readability.
● U2.05 Content should be written at reading level appropriate
for the user population. Language for adult lay users
without clinical knowledge should be written at or below a
sixth-grade reading level.
● U2.06 Text should avoid use of jargon or acronyms that may
not be familiar to users, particularly for lay users
without clinical knowledge.
Guideline U3 App Navigation
Users should be able to navigate quickly and easily between
screens to complete tasks. Navigation should meet user
expectations, and should not dominate the interface or draw
focus away from content.
Performance Requirements for Guideline U3
● U3.01 Users should be able to easily identify where they are
in the app and how to navigate to different
destinations. The navigational path should be logical,
predictable, and easy to follow. For screens that users may
need to access in succession, providing shortcuts may improve
ease of navigation.
● U3.02 Minimize the number of taps, swipes, or screens
required to navigate from one area of the app to another.
● U3.03 App design should facilitate reversible actions by
allowing the user to navigate back to previous pages.
● U3.04 Menu options should be labeled intuitively such that
users can easily locate information within the app.
Users should not have to locate information by trial and error.
Xcertia mHealth App Guidelines 2019
2019 Proprietary & Confidential 23
● U3.05 The app’s main menu should be easily located and
identified. Standard app design conventions would likely
lead most users to look for a menu on the top, left-hand side of
the screen. A collapsed menu is often associated
with the three-bar “hamburger” icon that frequent app users are
expected to be familiar with.
Guideline U4 Onboarding
Apps should facilitate an intuitive process for launching,
registering, entering personal information (if applicable), and
preparing for first-time use. As the users’ first introduction to
the app, a simple and intuitive onboarding process is
critical in instilling user confidence that the app will provide a
satisfying overall user experience.
Performance Requirements for Guideline U4
● U4.01 The app provides a launch screen that clearly identifies
the name and purpose of the app, and gives the
user intuitive options for initiating use.
● U4.02 Provide the user with opportunities either to access
detailed instructions and product information or to
bypass this and immediately begin app setup.
● U4.03 Users should be allowed to bypass entry of personal
data if it is not critical for app functionality. Data that is
needed for the app to work as intended (e.g., alert and
notification parameters) should be mandatory to avoid
inaccurate app behavior.
● U4.04 For apps with complex onboarding processes, entered
data should be stored so that users can recover and
avoid reentry if they are disconnected during the onboarding
process.
● U4.05 When setup is complete, provide options for a
walkthrough or tutorial on app use.
● U4.06 Apps should bypass onboarding for returning users, but
allow users to update the data entered during
onboarding at any time through intuitively named menu
selections (e.g., Profile, Settings).
Guideline U5 App Feedback
Apps should provide sufficient feedback to inform the user of
the results of their actions and promote understanding of
what is going on in the system. Feedback includes how an app
responds to user input, including providing messages to
the user. Efficient and informative feedback ensures that users
will be able to understand and perceive app actions
without frustration. Guidelines associated with feedback related
to notifications, alarms, and alerts can be found within
Guideline U6.
Performance Requirements for Guideline U5
● U5.01 Feedback messages should appear in an expected and
consistent location within the interface so that they
are noticeable to the user (e.g., near the input location).
● U5.02 Feedback messages that are not urgent or associated
with a safety risk should be unobtrusive to app
operation.
Grader - InstructionsExcel 2019 ProjectExcel_7G_Loan_Flowers_Staf.docx
Grader - InstructionsExcel 2019 ProjectExcel_7G_Loan_Flowers_Staf.docx
Grader - InstructionsExcel 2019 ProjectExcel_7G_Loan_Flowers_Staf.docx
Grader - InstructionsExcel 2019 ProjectExcel_7G_Loan_Flowers_Staf.docx
Grader - InstructionsExcel 2019 ProjectExcel_7G_Loan_Flowers_Staf.docx
Grader - InstructionsExcel 2019 ProjectExcel_7G_Loan_Flowers_Staf.docx
Grader - InstructionsExcel 2019 ProjectExcel_7G_Loan_Flowers_Staf.docx
Grader - InstructionsExcel 2019 ProjectExcel_7G_Loan_Flowers_Staf.docx
Grader - InstructionsExcel 2019 ProjectExcel_7G_Loan_Flowers_Staf.docx
Grader - InstructionsExcel 2019 ProjectExcel_7G_Loan_Flowers_Staf.docx
Grader - InstructionsExcel 2019 ProjectExcel_7G_Loan_Flowers_Staf.docx
Grader - InstructionsExcel 2019 ProjectExcel_7G_Loan_Flowers_Staf.docx
Grader - InstructionsExcel 2019 ProjectExcel_7G_Loan_Flowers_Staf.docx
Grader - InstructionsExcel 2019 ProjectExcel_7G_Loan_Flowers_Staf.docx
Grader - InstructionsExcel 2019 ProjectExcel_7G_Loan_Flowers_Staf.docx
Grader - InstructionsExcel 2019 ProjectExcel_7G_Loan_Flowers_Staf.docx
Grader - InstructionsExcel 2019 ProjectExcel_7G_Loan_Flowers_Staf.docx
Grader - InstructionsExcel 2019 ProjectExcel_7G_Loan_Flowers_Staf.docx
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Grader - InstructionsExcel 2019 ProjectExcel_7G_Loan_Flowers_Staf.docx
Grader - InstructionsExcel 2019 ProjectExcel_7G_Loan_Flowers_Staf.docx
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Grader - InstructionsExcel 2019 ProjectExcel_7G_Loan_Flowers_Staf.docx
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Grader - InstructionsExcel 2019 ProjectExcel_7G_Loan_Flowers_Staf.docx

  • 1. Grader - Instructions Excel 2019 ProjectExcel_7G_Loan_Flowers_Staff Project Description: In this project, you will create a named range and use it to set data validation. You will use a PMT function to calculate a value and then use it in a two-variable data table. You will also enter VLOOKUP functions to return values from a table, and format cells in the workbook. You will also audit a worksheet, correct errors, and use the MATCH and INDEX functions. Steps to Perform: Step Instructions Points Possible 1 Open the file Excel_7G_Loan_Flowers_Staff.xlsx downloaded with this project. 0 2 Display the second worksheet—Warehouse Payment Table. In cell B8, enter a PMT function using cell B4 divided by 12 as the rate, cell B3 as the number of payment periods, and cell B2 as the present value of the loan. Display the result as a positive number. 8 3 Create a two-variable data table in the range B8:H16. Set cell B3 as the row input cell, and cell B4 as the column input cell. From the Cell Styles gallery, apply the Currency cell style to the range C9:H16. Select the payment option closest to but less than $10,000 per month for a 120-month loan—cell D15—and format the option with the Note cell style. Click cell A1 and
  • 2. Save your workbook. 13 4 Display the fourth worksheet—Job Information. Select the range A4:C11, and then sort the range by Job Code in ascending order. By using the Create from Selection command, create a range named Job_Code using the data in the range A4:A11. Click cell A1. 4 5 Display the Staffing Plan worksheet, and then select the range A9:A18. Create a Data Validation list with Source equal to the named range Job_Code 2 6 Click cell A9, click the list arrow, and then click M-AMG. Click cell B9 to make it the active cell, and then insert a VLOOKUP function that will look up the Description of the Job Code in cell A9 using the information in the Job Information worksheet as the table array. After selecting the table array, be sure to press F4 to make it an absolute cell reference. The Description to be looked up is in column 2 of the table array. 9 7 With cell B9 as the active cell, copy the VLOOKUP formula down through cell B18. In cell C9, type 3 as the # of Positions and in cell D9, type Management as the Type. 6 8
  • 3. In cell E9, insert the VLOOKUP function to look up the Salary of the Job Code in cell A9 by using the information in the Job Information sheet as the table array; the Salary is in column 3 of the table array. Copy the VLOOKUP formula in cell E9 down through cell E18. 4 9 Add the following staff position in cell A10: S-STR 5 Stock 2 10 Delete the unused rows between the last item and the Total row. Sum the Budget Amount column and apply the Total cell style. Click cell A1 and Save your workbook. 6 11 Display the Revenue worksheet. Click cell I5, and then on the Formulas tab, click Trace Precedents. On the ribbon, in the Formula Auditing group, click Error Checking, and then click Edit in Formula Bar. Edit the formula so that the formula is using the Growth Assumption for Bridal Baskets, not for Baby Baskets. 8 12 In the Error Checking dialog box, click Resume. In cell M6, notice the formula is trying to divide by cell L10, which is empty. Click Edit in Formula Bar, change 10 to 9 Ensure that the reference to L9 is an absolute reference, and then in the Error Checking dialog box, click Resume.
  • 4. 8 13 In cell F7, examine the error information, and then click Copy Formula from Above. Examine the error in cell J8, and then click Copy Formula from Left. Click OK. Use Format Painter to copy the format in cell M5 to cell M6. Click cell A1 and Save your workbook. 10 14 Display the Suppliers worksheet. In cell B2, insert a MATCH function to find the position of Rose Boxes in the range c6:c27. In cell B3, insert a combined INDEX and MATCH function to display the name of the supplier for Rose Boxes. Click cell A1, and then Save your workbook. 10 15 In the sheet tab row, right-click any sheet tab, and then click Select All Sheets. Display the Page Setup dialog box. From the Margins tab, center the worksheets on the page horizontally. From the Header/Footer tab, create a Custom Footer with the file name in the Left section and the sheet name in the Right section. Right-click the sheet tab, and then click Ungroup Sheets. Display the Warehouse Payment Table worksheet, and then set this sheet’s Orientation to Landscape. Display the Revenue sheet. For this sheet, set the Orientation to Landscape, and in the Scale to Fit group, set the Scale to 90%. 9 16 Display Backstage view, click Show All Properties. On the list of Properties, in the Tags box, type staffing plan, flower revenue In the Subject box, type your course name and section number. Under Related People, be sure that your name displays as the author. On the
  • 5. left, click Print. Under Settings, click the Print Active Sheets arrow, and then click Print Entire Workbook. At the bottom of the window, click Next Page to scroll through the six worksheets and check for any errors. On the left, click Save. 1 17 Save the workbook. Close the workbook and then exit Excel. Submit the workbook as directed. 0 Total Points 100 Created On: 06/21/2021 1 GO19_XL_CH07_GRADER_7G_AS - Loan Flowers Staff 1.2 11/10/22, 4:13 AM Module 3 Review a Mobile App Using Third Party Guidelines https://sju.instructure.com/courses/32739/assignments/414493? module_item_id=1192857 1/1 Total Points: 36 Review a Mobile App Using Third Party Guidelines Criteria Ratings Pts 15 pts 5 pts 4 pts
  • 6. 4 pts 4 pts 4 pts Coherent Concise and Organized 15 pts Exceeds Expectations 12 pts Meets Expectations 0 pts Does Not Meet Expectations Spelling and Grammar 5 pts No Errors 3 pts Minimal Errors 0 pts Three or More Errors F1 History and Goals (SLO 1) Graduates will understand the history, goals, methods (including data and information used and produced), and current challenges of the major health science fields. (SLO 1) threshold: 3.0 pts
  • 7. 4 pts Exceeds Expectations 3 pts Meets Expectations 2 pts Near Mastery 1 pts Does Not Meet Expectations F5 Human Factors and Design (SLO 2) Students will draw on socio‐technical knowledge regarding the social behavioral sciences and human factors engineering to apply to the design and implementation of information systems and technology. (SLO 2) threshold: 3.0 pts 4 pts Exceeds Expectations 3 pts Meets Expectations 2 pts Near
  • 8. Mastery 1 pts Does Not Meet Expectations F6 Population Behavior (SLO 1) Students will identify theories or models that explain and modify patient or population behaviors related to health and health outcome. (SLO 1) threshold: 3.0 pts 4 pts Exceeds Expectations 3 pts Meets Expectations 2 pts Near Mastery 1 pts Does Not Meet Expectations F7 Design and Implementation (SLO 2) Students will identify the theories, models, and tools from social, business, human factors, behavioral, and information sciences and technologies for designing,
  • 9. implementing, and evaluating health informatics solutions. (SLO 2) threshold: 3.0 pts 4 pts Exceeds Expectations 3 pts Meets Expectations 2 pts Near Mastery 1 pts Does Not Meet Expectations ©2013 Happtique, Inc. All rights reserved
  • 10. HEALTH APP CERTIFICATION PROGRAM CERTIFICATION STANDARDS February 27, 2013 1 ©2013 Happtique, Inc. All rights reserved TABLE OF CONTENTS Operability Standards Pages 2-5 Privacy Standards Pages 6-9 Security Standards Pages 10-13 Content Standards Pages 14-17 Acronyms Page 18
  • 11. 2 ©2013 Happtique, Inc. All rights reserved App Operability (OP) Standards1 Standard OP1 The app installs, launches, and runs consistently2 on the target device(s) and target operating system(s) for that app. Performance Requirements for Standard OP1 • OP1.01 The app downloads and installs on the target device(s) and target operating system(s). • OP1.02 The app consistently launches and runs on the target device(s) that it is installed upon. Standard OP2 If applicable, the app connects consistently to any and all peripheral or accessory devices (e.g., NFC, Bluetooth), third party mobile application or software, regulated or unregulated, required for operation and/or marketed for use in conjunction with such app. Performance Requirements for Standard OP2 • OP2.01 The app connects to the peripheral device(s) and
  • 12. operates consistently. • OP2.02 The app has a mechanism to notify the user in the event that the app fails to connect to any and all peripheral or accessory devices. • OP2.03 The app connects consistently to any and all third party mobile applications, software, and online user accounts, but such connection shall only occur after: (i) notifying user; (ii) requesting permission; and (iii) receiving consent from the user. • OP2.04 The app has a mechanism to notify user of any and all updates applicable or necessary for app to connect to any such device, application, software or online user accounts. Standard OP3 If the app requires that it be connected to a network, the app is able to connect and operates consistently on the intended domestic and global carriers or Local Area Network (LAN).3 Performance Requirements for Standard OP3 • OP3.01 The app connects to the network via wireless technology (e.g., CDMA2000 and GSM).
  • 13. • OP3.02 The app connects to the LAN via well-established standards (e.g., 802.11, 802.15, 802.16). 1 These standards are based, in part, on materials from the National Alliance for Health Information Technology, the Mobile Marketing Association’s “Mobile Application Privacy Policy Framework” (December, 2011), and GSM Association’s “Privacy Design Guidelines for Mobile Application Development” (February, 2012). 2 To be defined in conjunction with vendors performing Technical Standards testing. 3 Due to the number of mobile operators (approx. 800), two U.S. operators and WiFi will be used as a proxy for this test. 3 ©2013 Happtique, Inc. All rights reserved Standard OP4
  • 14. If the app connects to the network, the IP addresses and URIs are known or can be determined. Performance Requirements for Standard OP4 • OP4.01 The list of IP addresses and/or URIs that the app connects to are documented, and the owners of those addresses and domain names are either disclosed or are capable of being determined from testing. • OP4.02 The app does not connect to any hidden IP addresses that are used behind the firewall of a router or gateway, without user’s knowledge, control, or consent. Standard OP5 A method for contacting the App Publisher and technical support (if different than the App Publisher) is provided. Performance Requirements for Standard OP5 • OP5.01 The App Publisher’s contact information―including but not limited to, mailing address, email address for support and general inquiries, web
  • 15. address and/or DNS address—is provided within the app, or the app provides a link to a webpage that contains the same information. • OP5.02 The app provides a method for users to submit feedback to the App Publisher for purposes of improving the user experience, including without limitation, any technical issues, bugs, and errors detected by users. Standard OP64 The app shall be designed to operate in a manner that supports a usable and useful end-user experience. Performance Requirements for Standard OP6 • OP6.01 App Publisher has a documented process to review, escalate and incorporate, on a timely basis, modifications needed to address suspected errors and other technical issues. • OP6.02 In designing and maintaining the app, the App Publisher has a documented process for addressing: o User feedback regarding efficiency (the speed with which users can complete their tasks), effectiveness (the accuracy and completeness
  • 16. with which users can complete tasks), and satisfaction (the user’s satisfaction with how well the app operates); and 4 This Standard is derived from the mHIMSS report, “Selecting A Mobile App: Evaluating the Usability of Medical Applications” (see http://www.mhimss.org/resource/selecting- mobile-app-evaluating-usability-medical- applications). 4 ©2013 Happtique, Inc. All rights reserved o Reasonable requests by users regarding features and functionality not supported by the app (e.g., support in additional languages, audiology assistance, visual impairment support, and other requests specific to the demographic of the app’s intended audience). Standard OP7 Electronic health record (EHR) systems optimized for mobile devices are apps for certified EHRs (EHRs that have been certified by a Federally-designated Authorized Testing and
  • 17. Certification Body). Certified EHRs may consist of complete EHRs or EHR modules. Performance Requirements for Standard OP7 • OP7.01 The app operates in accordance with the documented functionality provided by the Certified EHR. • OP7.02 Documentation is provided regarding any relevant EHR certification received. Standard OP8 An app that is intended to connect to an Electronic Health Record (EHR) or Personal Health Record (PHR) enables users to send and retrieve patient information between a mobile device and the EHR/PHR, and does so in a secure manner. Performance Requirements for Standard OP8: • OP8.01 The EHR and/or PHR systems with which the app connects (e.g., Allscripts, Epic, Microsoft HealthVault, etc.) are specifically enumerated and documentation of the interoperability with each specified EHR and PHR is provided. • OP8.02 The details and description of the data fields that the app saves, sends to, and/or receives from each specified EHR/PHR systems regarding
  • 18. patient information (e.g., medical history, diagnoses, treatment plan, medications, laboratory results, radiology images, etc.) is provided. • OP8.03 The app maintains (at rest) and transmits (in motion) patient information in a secure, HIPAA-compliant manner, as applicable (see Standards S2, S3, and S4). Standard OP9 The App Publisher certifies that the app constitutes a medical device as defined by the U.S. Food and Drug Administration (FDA), has ascertained its correct classification, and either certifies that the app complies with all applicable FDA regulatory requirements5 or certifies that it is not a medical device. Performance Requirements for Standard OP9 • OP9.01 The App Publisher has ascertained that the app, including any and all peripheral devices required or intended for operation and/or marketed for 5 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuida nce/Overview/default.htm
  • 19. 5 ©2013 Happtique, Inc. All rights reserved use in conjunction with such peripheral devices, is a Class I, II or III medical device6. • OP9.02 The App Publisher provides documentation demonstrating that the app complies with all applicable FDA requirements, including but not limited to: Establishment registration; Medical Device Listing; Premarket Notification 510(k)7, unless exempt, or Premarket Approval (PMA)8; Investigational Device Exemption (IDE) for clinical studies; Quality System (QS) regulation; Labeling requirements; and Medical Device Reporting (MDR). • OP9.03 The App’s Publisher has a mechanism to immediately notify all users and Happtique about an FDA-approved app that is recalled, the subject of an FDA advisory, or similar status that calls the app’s safety and/or effectiveness into question. • OP9.04 If the app does not constitute a medical device as defined by the FDA, the App Publisher certifies that the app is not a medical device by written
  • 20. attestation on the HACP App Submission Form. 6 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuida nce/Overview/ClassifyYourDevice/default.htm 7 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuida nce/HowtoMarketYourDevice/PremarketSubmi ssions/PremarketNotification510k/default.htm 8 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuida nce/HowtoMarketYourDevice/PremarketSubmi ssions/PremarketApprovalPMA/default.htm 6 ©2013 Happtique, Inc. All rights reserved App Privacy (P) Standards9 Standard P1 The type(s) of data that the app obtains, and how and by whom
  • 21. that information is used, is disclosed to the user in a Privacy Policy. Performance Requirements for Standard P1 • P1.01 Prior to downloading, installing, or activating an app, the identity of any entities that will have access to, collect and/or use of the user’s personal information, including a company or individual name, country of origin, and related contact information is disclosed to the user. • P1.02 App Publisher discloses any and all ownership, rights or licenses to any data collected in connection with the app and its usage, including the use of any data for commercial purposes. • P1.03 The app has a section (tab, button or equivalent) or active link to its Privacy Policy, and owner represents that commercially reasonable efforts are used to notify users of any material changes to its Privacy Policy. • P1.04 If registration is required to use all or some of the app’s features, the user is provided with an explanation as to the uses of the registration information. • P1.05 User is provided (or has access to) a clear list of all data points collected and/or accessed by the app, including by App Publisher and any and all third parties such as in-app advertisers, pertaining to the usage
  • 22. of the app, including but not limited to browsing history, device (e.g., unique identifiers), operating system, and IP addresses. How and from where such data points are collected is disclosed. • P1.06 User is provided (or has access to) a clear list of all data points collected and/or accessed by the app pertaining to the specific user, including user- generated data and data that are collected automatically about the user through other means or technologies of the app. This includes data points collected for the purpose of any third-party sharing. How and from where such data points are collected is disclosed. • P1.07 App Publisher obtains affirmative express consent before using user data in a materially different manner than was previously disclosed when collecting the data or collecting new data, including for the purpose of third-party sharing. • P1.08 App Publisher obtains affirmative express consent before collecting personal data, in particular information about children, financial and health information, Social Security numbers, and location data. • P1.09 The Privacy Policy informs users how they can get a copy of their personal information that was collected by the app. The Privacy Policy
  • 23. also informs users how they can correct and update information supplied by, or collected about them, held by or on behalf of the owner, or shared with 9 In general, these Privacy Standards are intended to be consistent with the principles set forth in “Protecting Consumer Privacy in an Era of Rapid Change: Recommendations for Businesses and Policymakers,” Federal Trade Commission, March, 2012. 7 ©2013 Happtique, Inc. All rights reserved third parties, including the identity of such third parties, particularly in compliance with the HIPAA Privacy Rule10, if applicable, and any other laws, rules, or regulations to the extent applicable. • P1.10 If not otherwise provided by default, the app allows users to control the collection and use of their in-app browsing data by supporting an online Do Not Track mechanism, if applicable. • P1.11 If not otherwise provided by default, the app allows
  • 24. users to control their receipt of commercial messages from the App Publisher and third parties through an “opt out” option, “do not contact,” or substantially similar feature. • P1.12 Each major component of the Privacy Policy is affirmatively agreed to by the user. Such components include, but are not limited to, entities that will have access to, collect and/or use of the user’s personal information; all ownership, rights or licenses to any data collected and its usage; list of all data points collected; and so forth. • P1.13 Except when expressly disclaimed by App Publisher and the user provides an affirmative consent, App Publisher does not share any user data with third parties, unless App Publisher: (i) has an agreement with such third party that addresses safeguarding any and all such user data; and (ii) takes the necessary measures to anonymize/de-identify all user data. The App Publisher has documented this within the Privacy Policy. Standard P2 If data are collected, the user is informed about how long the data are retained. Performance Requirements for Standard P2
  • 25. • P2.01 The Privacy Policy discloses the retention policy regarding user information. Such statement includes policies with respect to data retention under any third-party data sharing arrangement. • P2.02 Retention and deletion time periods, which are based on clearly defined business needs or legal obligations, are set. If business needs are defined as “in perpetuity,” this is disclosed. Standard P3 The app user is informed if the app accesses local resources (e.g., device address book, mobile and/or LAN network interface, GPS and other location- based services, contacts, camera, photos, SMS or MMS messaging, and Bluetooth) or resources from and/or for social networking platforms, provided with an explanation by any appropriate means (e.g., the “About” section) as to how and why such resources are used, and prior consent is obtained to access such resources. 10 http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrul e/index.html
  • 26. 8 ©2013 Happtique, Inc. All rights reserved Performance Requirements for Standard P3 • P3.01 If the app uses the mobile network, why the network is being used and a reasonably likely estimate of the average amount of bandwidth consumed per user per month is disclosed to the user. • P3.02 If the app uses a LAN, why the network is accessed and a likely estimate of the average amount of bandwidth consumed per user per month is disclosed to the user. • P3.03 If the app or App Publisher uses SMS or MMS messaging, the user is provided with a likely estimate of the average number of messages per month, and a disclosure that data rates will apply. • P3.04 If the app or App Publisher sends emails, the user is provided with a likely estimate of the number of emails sent per month. • P3.05 If the app uses Bluetooth, why Bluetooth is being used and which of the Bluetooth profiles are being used is disclosed to the user.
  • 27. • P3.06 If the app uses the device’s camera, why the camera is being used is disclosed to the user. • P3.07 If the app uses device-available methods to determine location, why the location is being determined is disclosed to the user. • P3.08 If the app accesses the device’s native address book, why the address book is being used is disclosed to the user. • P3.09 If the app accesses the device’s native calendaring or alarm system, why the calendar and/or alarm system is being used is disclosed to the user. • P3.10 If the app accesses the Public Switched Telephone Network (PSTN), why the PSTN is being accessed is disclosed to the user. • P3.11 If the app accesses social networking sites, the reason why such sites are being accessed is disclosed to the user. Standard P4 If the app, on behalf of a Covered Entity or a Business Associate (each as defined by HIPAA and HITECH and the rules thereunder), collects, stores, and/or transmits information that constitutes Protected Health Information (as defined by HIPAA and HITECH and the rules thereunder), it does so in full compliance with HIPAA, HITECH, and all applicable laws, rules
  • 28. and regulations. Performance Requirements for Standard P4 • P4.01 The user can affirmatively opt in or out (at any time) of information shared with or given access by third parties. • P4.02 The App Publisher certifies that a Business Associate Agreement (BAA) has been executed pursuant to HIPAA with any and all necessary third parties. • P4.03 The user has the ability to access or request any of his/her Protected Health Information (PHI) collected, stored and/or transmitted by the app, and has the ability to learn the identity of any person or entity who had or has been granted access to his/her PHI. • P4.04 The App Publisher uses requisite efforts to limit the use and disclosure of PHI, including ePHI, to the minimum necessary to accomplish the intended purpose (e.g., “need-to-know”). 9 ©2013 Happtique, Inc. All rights reserved Standard P5
  • 29. The app has measures in place to protect children in accordance with applicable laws and regulations (e.g., Children’s Online Privacy Protection Act11). Performance Requirements for Standard P5 • P5.01 The app provides clear notice of the content that will be made available and its suitability for specific age groups. • P5.02 The app includes a clear and conspicuous Privacy Policy that addresses use by any child under the age of 13. • P5.03 The app provides for an age verification process— either automatic or self- reported—to control access to age-restricted content and to minimize the inappropriate collection, use, or disclosure of personal information from a child. • P5.04 The app does not, without obtaining verifiable parental/legal guardian consent, collect, use, or disclose data from any child under the age of 13. • P5.05 The app enables a parent/legal guardian who becomes aware that the child has provided information without his/her consent to contact the App Publisher. • P5.06 The Privacy Policy provides that the App Publisher will delete any child’s
  • 30. personal information upon notice, or in the event that the App Publisher becomes aware or has knowledge, that such information was provided without the consent of a parent/legal guardian, including information that was shared with a third party. • P5.07 Apps that are intended for children must have a location default setting that enables parents/legal guardians to prevent the app from automatically publishing their child’s location. Standard P6 Retroactive or prospective material changes to Privacy Policies require the prior consent of the user. Performance Requirements for Standard P6 • P6.01 A mechanism is in place to notify users of changes to the Privacy Policy. • P6.02 A mechanism is provided that enables users to acknowledge and consent to changes to the Privacy Policy. 11 http://www.ftc.gov/ogc/coppa1.htm
  • 31. 10 ©2013 Happtique, Inc. All rights reserved App Security (S) Standards Standard S1 The app, including without limitation, any advertisement displayed or supported through the app, is free of known malicious code or software such as malware, including, but not limited to, viruses, worms, trojan horses, spyware, adware, rootkits, backdoors, keystroke loggers, and/or botnets. Performance Requirements for Standard S1 • S1.01 A scan of the app using scanning software does not reveal any known malicious code or software objects. • S1.02 A scan of any third party code, including advertising networks, incorporated into app for purposes of displaying or supporting advertisements (e.g., banner, interstitial) does not reveal any known malicious code or software. Standard S2
  • 32. The App Publisher ensures that the app’s security procedures comply at all times with generally recognized best practices and applicable rules and regulations for jurisdiction(s) in which the app is intended to be sold or used and such procedures are explained or made available to users. Performance Requirements for Standard S2 • S2.01 Administrative, physical, and technical safeguards to protect users’ information from unauthorized disclosure or access are provided and employed. • S2.02 Access to user’s information is limited to those authorized employees or contractors who need to know the information in order to operate, maintain, develop, or improve the app. • S2.03 If the app utilizes unique identifiers, the identifier is linked to the correct user and is not shared with third parties. • S2.04 Where possible, risk-appropriate authentication methods are used to authenticate users. • S2.05 A written description of security procedures (in detail sufficient to apprise end users about how their personal information is safeguarded) is provided in a section of the app (tab, button, or equivalent) or through an active
  • 33. link. The security procedures are written in clear, easy-to- understand language and terms and are affirmatively agreed to by the user. Such components include, but are not limited to, how personal information is safeguarded, how unique identifiers are linked to the correct user, and authentication methods used. • S2.06 The App Publisher has a mechanism in place to review security procedures on an ongoing basis and update security procedures, as necessary, to ensure that they comply at all times with applicable rules and regulations for jurisdiction(s) in which the app is intended to be sold or used. • S2.07 Cloud-based apps meet Statement on Standards for Attestation Engagements (SSAE) No. 16 requirements and a SSAE No. 16 audit report is provided. 11 ©2013 Happtique, Inc. All rights reserved • S2.08 If the app uses SMS or MMS, the user is informed whether messages are encrypted and, if so, the level of encryption. • S2.09 The App Publisher has a formal and documented secure
  • 34. software development lifecycle (SDLC) process that has been implemented throughout the inception, testing, implementation, deployment, and maintenance of the app. Standard S3 If the app collects, stores or transmits any personal information, including, but not limited to, usernames and passwords, such information is collected, stored, and transmitted using encryption. Performance Requirements for Standard S3 • S3.01 Passwords are stored using a random length, one-way salted hash, SHA-1 or better. • S3.02 Usernames and passwords are collected and transmitted only when using encryption between the client app and the server. • S3.03 Other personal information while at rest and/or in motion is encrypted using a generally recognized, industry-accepted encryption method (e.g., FIPS 140-212, ISO/IEC) for such information and the encryption level is disclosed. • S3.04 App contains security safeguards to verify the identity
  • 35. of intended user in the event of forgotten, lost or unknown user name, password and/or passcode (“unique identifiers”), for purposes of reminders, re- linking, or creation of new unique identifiers. Standard S4 If the app collects, stores and/or transmits information that constitutes PHI as defined by HIPAA, HITECH, and the rules thereunder (e.g., App Publisher constitutes a Business Associate pursuant to HIPAA and HITECH), it uses requisite efforts to maintain and protect the confidentiality, integrity, and availability of individually identifiable health information that is in electronic form (e.g., ePHI). Performance Requirements for Standard S4 • S4.01 If the app, or through its use, subjects the user or any party to HIPAA or HITECH, the App Publisher has implemented administrative, physical and technical safeguards, and developed policies and procedures, pursuant to the HIPAA Security Rule13, as applicable. For purposes of the technical safeguards/security controls, only certain certified encryption technologies are permissible for compliance with HIPAA and HITECH.
  • 36. • S4.02 If the app is, or through its use becomes, subject to HIPAA or HITECH, all PHI collected and/or stored is encrypted at all times and is otherwise protected in accordance with HIPAA and HITECH. 12 http://csrc.nist.gov/groups/STM/cmvp/standards.html#02 13 http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrul e/index.html 12 ©2013 Happtique, Inc. All rights reserved • S4.03 If the app is or becomes subject to HIPAA or HITECH, all data transmission to and/or from the app through any network with any server, system, software, application and third party is encrypted at all times. • S4.04 If applicable, the app or the App Publisher has safeguards in place and/or uses requisite efforts to comply with any and all obligations pursuant to any BAA, including capabilities to assist a covered entity in curing any breach, and address all other requirements of HITECH in the event of a
  • 37. breach. • S4.05 The App Publisher has the capabilities to enable compliance, and shall comply with any and all applicable notification requirements to its users in the event that users’ PHI is or is suspected to be compromised (e.g., Breach Notification Rule pursuant to HIPAA and HITECH including the capability to support and execute notification requirements14). Standard S5 If the app collects, stores and/or transmits personal information, the app offers one or more industry-accepted methods for guarding against identity theft. Performance Requirements for Standard S5 • S5.01 The app provides a method for securely authenticating the user at a session level (e.g., password, pass phrase, PIN, challenge phrase) and also utilizes additional methods or techniques15 to further secure the identity of the users whenever the system is initially establishing identity or the system has indications that the identity might have been compromised (e.g., multiple password failures). Standard S6 The App Publisher has a mechanism to notify end users about
  • 38. apps that are banned or recalled by the App Publisher or any regulatory entity (e.g., FDA, FTC, FCC). Performance Requirements for Standard S6 • S6.01 In the event that an app is banned or recalled, a mechanism or process is in place to notify all users about the ban or recall and render the app inoperable. • S6.02 In the event that the app constitutes a medical device (e.g., 510(k)) or is regulated by the FDA in any other capacity, the App Publisher has a policy and a mechanism in place to comply with any and all applicable rules and regulations for purposes of handling all aspects of a product notification or recall, including all corrections and removals. 14 http://www.hhs.gov/ocr/privacy/hipaa/administrative/breachnoti ficationrule/index.html 15 Examples of additional methods or techniques might be the use of certificates signed by recognized certificate
  • 39. authorities, two-factor authentication methods, static knowledge based authentication methods, and/or dynamic knowledge-based authentications. 13 ©2013 Happtique, Inc. All rights reserved Standard S716 The app implements reasonable and requisite security measures to safeguard user financial data in accordance with any and all applicable laws, regulations, industry best practices, and standards. Performance Requirements for Standard S7 • S7.01 Any app that collects, stores and/or transmits user financial data for any purpose, including payment processing, or the app directs to any website for the purpose of collecting and/or processing of financial information, including any third party website, shall comply with any and all applicable Federal and state laws, rules and regulations, and private sector regulatory best practices guidelines and initiatives regarding data security requirements (e.g., Section 5 of the FTC Act, Fair Credit Reporting Act,
  • 40. Gramm-Leach-Bliley Act, Payment Card Institute Data Security Standards, the SANS Institute’s security policy templates, and standards and best practices guidelines for the financial services industry provided by BITS, the technology policy division of the Financial Services Roundtable). 16 FTC Act, Section 5, available at: http://www.federalreserve.gov/boarddocs/supmanual/cch/ftca.pd f PCI Security Standards Council, PCI SSC Data Security Standards Overview, available at: https://www.pcisecuritystandards.org/security_standards/ SANS Institute, Information Security Policy Templates, available at: http://www.sans.org/security-resources/policies/ BITS, Financial Services Roundtable BITS Publications, available at: http://www.bits.org/publications/index.php
  • 41. 14 ©2013 Happtique, Inc. All rights reserved App Content (C) Standards17 Standard C1 The app is based on one or more credible information sources such as an accepted protocol, published guidelines, evidence-based practice, peer-reviewed journal, etc. Performance Requirements for Standard C1 • C1.01 If the app is based on content from a recognized source (e.g., guidelines from a public or private entity), documentation (e.g., link to journal article, medical textbook citation) about the information source and copyright compliance is provided. • C1.02 If the app is based on content other than from a recognized source, documentation about how the content was formulated is provided, including information regarding its relevancy and reliability.
  • 42. Standard C2 The app’s content reflects up-to-date information (as of the date that the app is submitted for certification). Performance Requirements for Standard C2 • C2.01 Documentation about the source of the app’s content and explanation as to why it is deemed to be up-to-date is provided. • C2.02 The date(s)/source(s) of the app’s content is provided through an “About” section (tab, button or equivalent). • C2.03 The App Publisher has a method or protocol for determining if an app’s content requires updating in order to remain up-to-date. • C2.04 The App Publisher has a method or protocol for updating the app’s content when new or changing information warrants. Updates should include a description of and documentation for each change. Standard C3 For any app that contains content that is derived from a third- party source (e.g., accepted protocol, published guidelines, evidence-based practice, peer- reviewed journal), any significant deviations in an app’s content from the original source (e.g., excerpts, abbreviated versions) are indicated and explained. Any such app shall also
  • 43. provide a method or citation to enable the user to locate to the complete content. Performance Requirements for Standard C3 • C3.01 For any app derived from a third-party source that does not contain the original source’s complete content, such app’s description or “About” 17 These standards are based, in part, on materials from the Association of American Medical Colleges (AAMC), including AAMC’s MedEdPORTAL Submission Standards and Scholarly Criteria (https://www.mededportal.org/download/262700/data/mepsubmi ssionstandards.pdf). 15 ©2013 Happtique, Inc. All rights reserved section shall indicate the specific portion(s) absent and contain an explanation as to why each portion(s) is not included. • C3.02 For any app derived from a third-party source that does not contain the
  • 44. original source’s complete content, the app provides a link, reference, or other appropriate method to enable the user to locate the complete content. Standard C418 The app’s description and content are truthful, fair, and not misleading. Performance Requirements for Standard C4 • C4.01 Backup documentation is provided to substantiate any claims made in the description and/or content. • C4.02 Disclosures are provided, as needed, to prevent deception. Such disclosures shall be presented in a clear and conspicuous manner. • C4.03 Disclosures are provided, as needed, if the app requires an additional fee(s) (e.g., subscription fee) in order to fully access the app, its associated functionality, and/or content. Standard C5 An app that contains tools that perform user or patient management functions, including but not limited to, mathematical formulae, calculations, data tracking, reminders, timers, measurements, or other such functions, does so with consistent accuracy and reliability to the
  • 45. degree specified in the app. Performance Requirements for Standard C5 • C5.01 When operated, the app produces consistent and accurate results that are independently verifiable. Standard C6 Reference apps (e.g., apps that are used for reference purposes to inform clinical decision- making, etc.) derive their content from one or more authoritative sources. Performance Requirements for Standard C6 • C6.01 The app’s content is based on authoritative sources as recognized by the field or discipline that is the subject of the app. • C6.02 As appropriate, prior accepted work (e.g., published, peer reviewed) is used to derive the content of the app. • C6.03 The source(s) and date(s) (e.g., published, last modified) of the app’s content are cited. 18 For further information and guidance, refer to “Dot Com Disclosures: Information about Online Advertising,”
  • 46. Federal Trade Commission. (http://www.ftc.gov/os/2000/05/0005dotcomstaffreport.pdf) 16 ©2013 Happtique, Inc. All rights reserved Standard C7 Instructional, educational assessment, and other such apps (e.g., apps used in educational settings for physicians, nurses, students, etc.) derive their content from one or more authoritative sources and are based on accepted pedagogy and/or learning strategies or techniques that are appropriate for the intended audience(s). Performance Requirements for Standard C7 • C7.01 The app’s content is based on authoritative sources as recognized by the field or discipline that is the subject of the app (e.g., recognized textbook and/or peer-reviewed journals in an applicable field or discipline). • C7.02 As appropriate, prior accepted work (e.g., published, peer reviewed) is used to derive the content of the app. • C7.03 The source(s) and date(s) (e.g., published, last modified date) of the app’s
  • 47. content are cited. • C7.04 The app’s learning goals and objectives are clearly stated. • C7.05 The app uses suitable teaching and/or learning approaches to meet its stated objectives. • C7.06 A process or method for assessing and documenting improvements in knowledge or skills is provided. Standard C8 Apps that constitute clinical decision support (CDS) software and apps that integrate or work in conjunction with CDS software, comply with current rules and regulations, if applicable (e.g., for CDS software that is regulated by the FDA), and evidence-based/accepted practice guidelines. Performance Requirements for Standard C8 • C8.01 Documentation is provided regarding the regulations and any applicable evidence-based/accepted practice guidelines that the app operates in accordance with. • C8.02 App has a process and mechanism to deliver all applicable updates pursuant to any relevant guidelines when such guidelines are issued or
  • 48. made available. Standard C9 For a multi-purpose app (e.g., apps that have reference, instructional, or educational assessment content, integrate or work with CDS software, etc.),where each element of the app can be separated for testing, each element of the app meets the requirements of the relevant Content Standard(s) herein. Performance Requirements for Standard C9 • C9.01 Each separate function and/or content area is defined, documented, and operates in accordance with relevant Content Standards described herein. 17 ©2013 Happtique, Inc. All rights reserved Standard C10 An app that contains advertisements clearly identifies the advertising and complies with any and all applicable regulatory requirements, particularly advertisements that involve or relate to products or services that are clinical or related to health.
  • 49. Performance Requirements for Standard C10 • C10.01 Information in any app that constitutes advertising is denoted by the message “This is an advertisement” or equivalent. • C10.02 Information in any app that constitutes advertising will at all times comply with all applicable regulatory requirements related to the marketing of any product or service, including, but not limited to those of the FDA, FTC, FCC, and any laws, rules, regulations and policies of other regulatory entities in all jurisdictions that app’s owner makes its app available. • C10.03 App Publisher takes commercially reasonable efforts to clearly and prominently indicate (e.g., in the “About” section) that any advertisement, which may be perceived as health care or medical advice or treatment, is being displayed for the sole purpose of advertising and should not be construed as a substitute for medical or clinical advice. Standard C11 The content of apps should be written and presented in a manner that is appropriate for the intended audience. Performance Requirements for Standard C11
  • 50. • C11.01 The content of an app is designed and written in a way that is appropriate for the target audience (e.g., age, educational background, healthcare professional versus patient or consumer, caregiver, and so forth). 18 ©2013 Happtique, Inc. All rights reserved Appendix 1. Acronyms A number of acronyms are used in this document. The following table provides the full term for each acronym. Acronym Full Term AAMC Association of American Medical Colleges BA Business Associate refers to a person/entity that requires disclosure of ePHI in order to deliver their product/service to or on behalf of a
  • 51. Covered Entity. BAA Business Associate Agreement (required in certain circumstances under HIPAA and HITECH [defined below]) CDMA2000 Refers to a family of 3G standards providing high-quality voice and broadband data services over wireless networks CDS Clinical Decision Support software DNS Domain Name System EHR Electronic Health Record (also referred to as EMR – Electronic Medical Record) FCC Federal Communications Commission FDA U.S. Food and Drug Administration FTC Federal Trade Commission GPS Global Positioning System (a satellite-based navigation system) GSM Global System for Mobile Communications (originally, Groupe Spécial Mobile)
  • 52. HIPAA Health Insurance Portability and Accountability Act HITECH Health Information Technology for Economic and Clinical Health LAN Local Area Network MMS Multimedia Messaging Service NFC Near Field Communication PHI Protected Health Information PSTN Public Switched Telephone Network SMS Short Message Service URI Uniform Resource Identifier
  • 53. This document contains proprietary and confidential information of Xcertia and shall not be used, disclosed or reproduced, in whole or in part, for any purpose other than to view this document, without the prior written consent of Xcertia. 2019 Board Approved Xcertia Guidelines Issued on: August 12, 2019 Xcertia mHealth App Guidelines 2019
  • 54. 2019 Proprietary & Confidential 2 The Xcertia Guidelines History Today’s Xcertia Guidelines were first conceived in 2012. As part of the development process, a panel comprised of thought leaders in the healthcare industry such as the Association of American Medical Colleges, Mobile Marketing Association, Healthcare Information and Management Systems Society (HIMSS), the U.S. Food and Drug Administration (FDA), and other federal agencies, was formed. In the spirit of collaboration, and to seek public input, these guidelines were published for review and comment to maximize public and interested parties’ input. In 2015 those same guidelines were updated with input from subject matter experts in the key areas of Operability, Privacy, Security and Content. Shortly thereafter these guidelines were transferred to the newly formed non-profit. Today, these guidelines now known as the Xcertia Guidelines, are backed by its founding members, the American Medical Association (AMA), the American Heart Association (AHA), HIMSS, and the DHX Group, with a shared purpose to
  • 55. provide a level of assurance to clinicians and consumers alike, that the mobile health apps that comply with the guidelines are vetted to deliver value to the end user. Under the Xcertia watch, the guidelines were updated in 2017 and then posted on the Xcertia website for public comment. At the Connected Health Conference 2018 the Privacy and Security sections of the guidelines were again updated and issued for public comment following that update by the Xcertia Work Groups in these two disciplines. In February of 2019 the Xcertia Guidelines will have gone through a complete review and editing process by the organization’s various work groups. These groups consisted of over forty individuals and contained subject matter experts from a number of healthcare organizations and disciplines with expertise in the various sections within the guidelines. As part of that effort the Xcertia Guidelines are divided into five sections, Privacy, Security, Usability, Operability and Content, reflecting the key areas of guidance to ensure mHealth apps deliver true value in a trusted environment to improve product adoption and use. Since their release in February of 2019 the guidelines were available for public comment up until May 15, 2019. Those comments have been considered by the work group leaders and their teams and where appropriate incorporated into
  • 56. the Final 2019 Version of the Xcertia Guidelines. Xcertia mHealth App Guidelines 2019 2019 Proprietary & Confidential 3 App Privacy Guidelines App Privacy (P) Guidelines Privacy will assess whether a mobile health app protects the user’s information, including Protected Health Information (PHI), Personal Information (PI), Personally Identifiable Information (PII) in full compliance with all applicable laws, rules and regulations. Where jurisdictions may conflict, the App Designer shall comply with the more rigorous requirements. It is incumbent upon the developer to understand the scope and full requirements of the Privacy Rules and potential
  • 57. notification requirements of the region(s) for which they intend to operate. Developers should have relevant procedures in place and be able to document those procedures. Guideline P1 – Notice of Use and Disclosure The Privacy Notice is externally facing and describes to an app user how the organization collects, uses, and retains their data (e.g., PHI, PI, PII). This notice should be unbundled from other information notices regarding the application. The type(s) of data that the app obtains, and how and by whom that information is used, is disclosed to the user in a Privacy Notice Requirements for Guideline P1 • P1.01 Access: The identity of any entities that will have access to, collect and/or use of the user’s personal information, shall be made available and disclosed to the user on an at least an annual basis and shall disclose use by any parties as a part of the use chain. • P1.02 Usage: The app publisher shall disclose any and all ownership, rights or licenses to any data collected about the app and its usage, including the use of any data for commercial purposes. • P1.03 Material Changes to Use: The app shall have a section
  • 58. (tab, button or equivalent) or active link to its Privacy Policy, and owner represents that commercially reasonable efforts are used to notify users of any material changes to its Privacy Policy. • P1.04 User Registration: If registration is required to use all or some of the app’s features, the user shall be provided with an explanation as to the uses of the registration information. • P1.05 Data Collected and Opt Out: User shall be provided (or have access to) a clear list of all data points collected and/or accessed by the app, including by the app publisher and all third parties such as in-app advertisers. This includes personal data pertaining to the usage of the app, including but not limited to browsing history, device Xcertia mHealth App Guidelines 2019 2019 Proprietary & Confidential 4 (e.g., unique identifiers), operating system, and IP addresses. How and from where such data points are collected shall be disclosed. An Option should exist for user to opt-out of passing data to in-app advertisers.
  • 59. • P1.06 Data Collected and Disclosed: User shall be provided (or has access to) a clear list of all data points collected and/or accessed by the app pertaining to the specific user, including user-generated data and data that are collected automatically about the user through other means or technologies of the app. This includes data points collected for the purpose of any third-party sharing. How and from where such data points are collected is disclosed. • P1.07 Affirmative Consent to Use Data: The app publisher shall obtain affirmative express consent before using user data in a materially different manner than was previously disclosed when collecting the data or collecting new data, including for third-party sharing. • P1.08 Affirmative Consent to Collect Data: The app publisher shall obtain affirmative express consent before collecting personal data, in particular, Personally Identifiable Information (PII), Personal Health Information (PHI), financial data or location data, including obtaining HIPAA authorizations where applicable. • P1.09 Use and Updates of Information: The privacy policy shall inform users how they can get a copy of their personal information that was collected by the app. A
  • 60. designated individual or toll-free number may be required to be listed depending on domicile of user. The privacy policy shall also inform users how they can correct and update information supplied by, or collected about them, held by or on behalf of the owner, or shared with third parties, including the identity of such third parties, particularly in compliance with the HIPAA Privacy Rule, if applicable, and any other state or • international laws, rules, or regulations to the extent applicable. • P1.10 Do Not Track Mechanism: If not otherwise provided by default, the app shall allow users to control the collection and use of their in-app browsing data by supporting an online Do Not Track mechanism. • P1.11 Opt Out or Do Not Contact: If not otherwise provided by default, the app shall allow users to control their receipt of commercial messages from the app publisher and third parties through an “opt out” option, “do not contact,” or substantially similar feature. • P1.12 Sharing of Data: The app publisher shall not share any personal data with third parties, unless the app publisher: (i) has an agreement with such third party that addresses safeguarding any and all such user data (BAA);
  • 61. and (ii) takes the necessary measures to anonymize/de-identify all user data in accordance with the Health and Human Services Safe Harbor guidelines for de- identification.(iii) the user provides an affirmative user consent (iv) except when expressly disclaimed by app publisher (v) The app publisher has documented this within the Privacy Policy. https://www.hhs.gov/hipaa/for-professionals/privacy/index.html Xcertia mHealth App Guidelines 2019 2019 Proprietary & Confidential 5 • P1.13 User Ability to Delete Data/Accounts: App publisher should allow a user to delete all personal data from systems if canceling or deleting accounts. This functionality could be accessed by the user in app or by app owner. • P1. 14 Changes to Privacy Policy: A mechanism shall be in place to notify users of changes to the Privacy Policy. • P1.15 Consent to Changes in Privacy Policy: A mechanism shall be provided that enables users to acknowledge and consent to changes to the Privacy Policy.
  • 62. • P1.16 Notification in Event of Breach: User will be promptly notified (according to state or federal laws or contractual obligations) if breach occurs that has compromised their information in accordance with applicable state, federal and country laws. Guideline P2 - Retention If data is collected, the user shall be informed about how long the data is retained. Requirements for Guideline P2 • P2.01 The Privacy Policy shall disclose the retention policy regarding user information. Such statement shall include policies with respect to data retention under any third- party data sharing arrangement. • P2.02 Retention and deletion time periods, which are based on clearly defined business needs or legal obligations, shall be set. If business needs are defined as “in perpetuity,” this shall also be disclosed. Guideline P3 – Access Mechanisms The app user is informed, through an End User License Agreement, if the app accesses local resources (e.g., device address book, mobile and/or LAN network interface, system stored credit card information, GPS and other location-
  • 63. based services, contacts, camera, photos, SMS or MMS messaging, and Bluetooth) or resources from and/or for social networking platforms, provided with an explanation by any appropriate means (e.g., the “About” section) as to how and why such resources are used, and opt-in consent is obtained to access such resources. Requirements for Guideline P3 • P3.01 If the app accesses any of the mobile device’s native hardware (camera, microphone, GPS/location, Calendar, Address Book, etc.) the express reason for requiring such access shall be disclosed to the user, separate from any warning/consent present in the mobile operating system. Xcertia mHealth App Guidelines 2019 2019 Proprietary & Confidential 6 • P3.02 If the app accesses or uses any Wi-Fi, LAN, or mobile network data connections, an estimate of the amount of data consumed shall be provided to the user along with a notice that carrier data charges may apply.
  • 64. • P3.03 If the app accesses social networking sites (such as Facebook, Instagram, or like social media), the reason why such sites are being accessed is disclosed to the user. Guideline P4 - Health Insurance Portability and Accountability Act (HIPAA) Entity or Business Associate If the app, on behalf of a Covered Entity or a Business Associate (each as defined by HIPAA and the rules thereunder), collects, stores, and/or transmits information that constitutes Protected Health Information (as defined by HIPAA and the rules thereunder), it does so in full compliance with HIPAA and all applicable state and international laws, rules and regulations. Requirements for Guideline P4 • P4.01 The user can affirmatively opt in or out (at any time) of information shared with or given access by third parties. • P4.02 The app publisher certifies that a Business Associate Agreement (BAA) has been executed pursuant to HIPAA with any and all necessary third parties. • P4.03 The user can access or request any of his/her Protected Health Information (PHI) collected, stored and/or
  • 65. transmitted by the app. • P4.04 The app publisher uses requisite efforts to limit the use and disclosure of PHI, including ePHI, to the minimum necessary to accomplish the intended purpose (e.g., “need-to- know”). • P4.05 The publisher must demonstrate that procedures are in place so that in the event of a breach the app publisher shall notify affected individuals, HHS, and in some cases, the media (news agencies, print, radio, etc.) of a breach of unsecured PHI. Most notifications must be provided without unreasonable delay and no later than 60 days following the discovery of a breach. Guideline P5 – Children’s Online Privacy Protection Act (COPPA) The app has measures in place to protect children in accordance with applicable laws and regulations if website is directed at children (see specific guidance Children’s Online Privacy Protection Act). https://www.ftc.gov/enforcement/rules/rulemaking-regulatory- reform-proceedings/childrens-online-privacy-protection-rule
  • 66. Xcertia mHealth App Guidelines 2019 2019 Proprietary & Confidential 7 Requirements for Guideline P5 • P5.01 The app provides clear notice of the content that will be made available and its suitability for specific age groups. • P5.02 The app includes a clear and conspicuous Privacy Notice/Policy that addresses use by any child under the age of 13 and prevents usage without verifiable parental authority (please note state laws may have additional carve out regulations for children). • P5.03 The app provides for an age verification process—either automatic or self-reported—to control access to age-restricted content and to minimize the inappropriate collection, use, or disclosure of personal information from a child. • P5.04 The app does not, without obtaining verifiable parental/legal guardian consent, collect, use, or disclose data from any child under the age of 13.
  • 67. • P5.05 The app enables a parent/legal guardian who becomes aware that the child has provided information without his/her consent to contact the app publisher and eliminate account/delete that data. • P5.06 The Privacy Policy provides that the app publisher will delete any child’s personal information upon notice, or if the App publisher becomes aware or has knowledge, that such information was provided without the consent of a parent/legal guardian, including information that was shared with a third party. • P5.07 Apps that are intended for children must have a location default setting that enables parents/legal guardians to prevent the app from automatically publishing their child’s location. • P5.08 Apps that are directed at children under the age of 13 will have a default setting that prevents in-app purchases. • P5.09 Apps that are directed at children under the age of 13 will have a default setting that prevents usage of camera and microphone. Guideline P6 - General Data Protection Regulation (GDPR) The app has measures in place to comply with applicable laws and regulations related to the European Union General
  • 68. Data Protection Regulation (GDPR). Requirements for Guideline P6 • P6.01 Provide Privacy Notice at the time user is providing information to the app. The Privacy Notice should be available in search feature. Xcertia mHealth App Guidelines 2019 2019 Proprietary & Confidential 8 • P6.02 The Privacy Notice must be concise (plain language), transparent and accessible. For the Privacy Notice to be easily readable, key information is at front of notice and in a layered notice approach links are available for additional information in full version. • P6.03 The Privacy Notice must include the name of the organization, processor, name and contact details of the representative, and contact details of the Data Protection Officer (DPO) if a DPO is required. • P6.04 The Privacy Notice must state the lawful basis, legitimate purposes, and rights available to individuals in
  • 69. respect of processing. • P6.05 The user must be informed of the categories/source of personal data obtained if it is obtained from third party sources. This must be provided within a reasonable period of obtaining the personal data and no later than one month. Notice must be provided of the recipients of categories of personal data, whether the individuals are under a statutory or contractual obligation to provide personal data and the details of transfers of personal data to any third countries or international organizations. • P6.06 The details and existence of automated decision-making including profiling (if applicable) and the retention periods for personal data must be provided. • P6.07 Unexpected uses of user data should be posted on the front page of the Privacy Notice and there must be separate consent for different uses. A user must be given a simple way to consent to all types of uses listed (e.g. opt in/opt out boxes for each). If the app is requesting the user to receive direct marketing materials, then there should be a separate opt out box. • P6.08 The user must be put on notice that they have the right to withdraw from further use of data (if applicable
  • 70. through respective regional data governance laws) and the right to file a complaint with the respective regional supervisory authority. • P6.09 Best practice is to conduct audits to see what personal information the app maintains and conduct user testing to see if the privacy notice is easily understandable. • P6.10 The app developer must ensure the Privacy Notice is consistent with current use. If a material change is made to the collection or use of data, the Privacy Notice must updated prior to processing. • P6.11 If the event of a breach of personal data, understand the type of data that has been impacted. Prepare a written report. And, based upon notice requirements of area of operation, Report within 72 hours of becoming aware of the reportable breach to the relevant supervisory authority. • P6.12 The App Developer shall be responsible for knowing relevant and appropriate regulations for the Regions in which they intend to operate Xcertia mHealth App Guidelines 2019
  • 71. 2019 Proprietary & Confidential 9 • P6.13 The End User Licensing Agreement (EULA) should document how notice shall be provided to individual and appropriate authorities. References: Additional information may be found at these sites: US State Breach Notification Requirements: http://www.ncsl.org/research/telecommunications-and- information- technology/security-breach-notification-laws.aspx European Union General Data Protection Requirements- Information Commissioners Office UK: https://ico.org.uk/for- organisations/guide-to-the-general-data-protection-regulation- gdpr/individual-rights/right-to-be-informed Health and Human Services Safe Harbor: https://www.ecfr.gov/cgi- bin/retrieveECFR?gp=1&SID=90f45f0c857144405b17a43c3560 0c16&ty=HTML&h=L&mc=true&r=SECTION&n=se42.5.10 01_1952 HIPAA: https://www.hhs.gov/hipaa/for- professionals/privacy/laws-regulations/index.html?language=en
  • 72. http://www.ncsl.org/research/telecommunications-and- information-technology/security-breach-notification-laws.aspx http://www.ncsl.org/research/telecommunications-and- information-technology/security-breach-notification-laws.aspx https://ico.org.uk/for-organisations/guide-to-the-general-data- protection-regulation-gdpr/individual-rights/right-to-be- informed https://ico.org.uk/for-organisations/guide-to-the-general-data- protection-regulation-gdpr/individual-rights/right-to-be- informed https://www.ecfr.gov/cgi- bin/retrieveECFR?gp=1&SID=90f45f0c857144405b17a43c3560 0c16&ty=HTML&h=L&mc=true&r=SECTION&n=se42.5.1001_ 1952 https://www.ecfr.gov/cgi- bin/retrieveECFR?gp=1&SID=90f45f0c857144405b17a43c3560 0c16&ty=HTML&h=L&mc=true&r=SECTION&n=se42.5.1001_ 1952 https://www.ecfr.gov/cgi- bin/retrieveECFR?gp=1&SID=90f45f0c857144405b17a43c3560 0c16&ty=HTML&h=L&mc=true&r=SECTION&n=se42.5.1001_ 1952 https://www.hhs.gov/hipaa/for-professionals/privacy/laws- regulations/index.html?language=en
  • 73. Xcertia mHealth App Guidelines 2019 2019 Proprietary & Confidential 10 App Security Guidelines App Security (S) Guidelines The Security Guidelines will assess if the application is protected from external threats and maintain the integrity, availability, confidentiality, and resilience of the data. Guideline S1 – Security Operations The app publisher ensures that the app’s security procedures comply at all times with generally recognized best practices and applicable rules and regulations for jurisdiction(s) in which the app is intended to be sold or used and such procedures are explained or made available to users. Requirements for Guideline S1 • S1.01 Administrative, physical, and technical safeguards to protect user’s information from unauthorized disclosure or access are provided and employed. • S1.02 Access to user’s information is limited to those
  • 74. authorized employees or contractors who need to know the information in order to operate, maintain, develop, or improve the app. • S1.03 If the app utilizes unique identifiers, the identifier is linked to the correct user and is not shared with third parties. • S1.04 If any third-party vendor services are utilized as part of the app, an information security risk assessment should be conducted of the respective third parties. • S1.05 If your organization is subject to HIPAA or other Information Security and/or Privacy regulations, an internal risk assessment for any systems related to PHI/PII should be conducted. • S1.06 App publisher should create and maintain a baseline configuration document for potential risks to be identified. • S1.07 Risk-appropriate authentication methods are used to authenticate users. • S1.08 A written description of security procedures is provided in a section of the app (tab, button, or equivalent) or through an active link. The security procedures are written in clear, easy-to-understand language and terms and are affirmatively agreed to by the user. Such components
  • 75. include, but are not limited to, how personal information is safeguarded, how unique identifiers are linked to the correct user, and authentication methods used. Xcertia mHealth App Guidelines 2019 2019 Proprietary & Confidential 11 • S1.09 App publisher should designate someone to be responsible for information security. • S1.10 App publisher staff designated for information security should have a baseline of information security knowledge. • S1.11 Responsibilities for information security staff should be clearly documented. • S1.12 Any staff members handling PHI/PII should be required to take Information Security Awareness training, highlighting HIPAA. • S1.13 The app publisher has a mechanism in place to review security procedures on an ongoing basis and update security procedures, as necessary, to ensure that they comply at
  • 76. all times with applicable rules and regulations for jurisdiction(s) in which the app is intended to be sold or used. • S1.14 Cloud-based apps meet Statement on Guidelines for Attestation Engagements (SSAE) No. 16 requirements and a SSAE No. 16 audit report is provided. (http://ssae16.com/SSAE16_overview.html) • S1.15 If the app uses Short Messaging Service (SMS) or Multi-Media Message Service (MMS), the user is informed whether messages are encrypted and, if so, the level of encryption. • S1.16 Any app that collects, stores and/or transmits user financial data for any purpose, including payment processing, or the app directs to any website for the purpose of collecting and/or processing of financial information, including any third-party website, shall comply with all applicable Federal and state laws, rules and regulations, and private sector regulatory best practices guidelines and initiatives regarding data security requirements. Guideline S2 – Vulnerability Management The app, including without limitation, any advertisement displayed or supported through the app, is free from known
  • 77. malicious code or software such as malware, including, but not limited to, viruses, worms, trojan horses, spyware, adware, rootkits, backdoors, keystroke loggers, and/or botnets at time of release and/or upgrades. Requirements for Guideline S2 • S2.01 A scan of the app by the app developer using scanning software does not reveal any known malicious code or software objects prior to release. • S2.02 A scan of any third-party code, including advertising networks, incorporated into app for purposes of displaying or supporting advertisements (e.g., banner, interstitial) does not reveal any known malicious code or software. http://ssae16.com/SSAE16_overview.html Xcertia mHealth App Guidelines 2019 2019 Proprietary & Confidential 12 • S2.03 If ongoing scanning does produce evidence of malicious code or software objects, proactively work to update the app and notify end users.
  • 78. Guideline S3 – Systems & Communication Protection If the app collects, stores or transmits any personal data, including, but not limited to, usernames and passwords, such information is collected, stored, and transmitted using encryption. Requirements for Guideline S3 S3.01 Passwords are stored using a random length, , one-way salted hash, or current accepted guideline. • S3.02 Usernames and passwords are collected and transmitted only when using encryption between the client app and the server. • S3.03 Other personal information while at rest and/or in motion is encrypted using a generally recognized, industry-accepted encryption method (e.g., FIPS 140-2, ISO/IEC) for such information and the encryption level is disclosed. • S3.04 App contains security safeguards to verify the identity of intended user in the event of forgotten, lost or unknown user name, password and/or passcode (“unique identifiers”), for purposes of reminders, re-linking, or creation of new unique identifiers. • S3.05 Organization should have a change management process when changes are made to the app or critical
  • 79. systems in operability check there and if okay delete from here. • S3.06 Information systems related to the app should have antivirus software and mechanism to keep application environment up to date with security patches. • S3.07 Application data should be backed up regularly. • S3.08 Firewalls should be used for internal and external connections. • S3.09 Vulnerability assessments should be conducted on the application and organizational network on a regular basis. • S3.10 If removable media is used for the storage of personal data, the media should be encrypted to protect the data from unauthorized access. • S3.11 Organization should have a documented patch management process for systems and app. • S3.12 Installed App and respective infrastructure should have the capability to log and audit activity within the system, e.g. who did what, when and how. • S3.13 Installed App Audit logs should be maintained for a minimum of 90 days.
  • 80. Xcertia mHealth App Guidelines 2019 2019 Proprietary & Confidential 13 Guideline S4 – Compliance If the app collects, stores or transmits information that constitutes PHI as defined by HIPAA and the rules thereunder (e.g., app publisher constitutes a Business Associate pursuant to HIPAA), it uses requisite efforts to maintain and protect the confidentiality, integrity, and availability of individually identifiable health information that is in electronic form (e.g., ePHI). Requirements for Guideline S4 • S4.01 If the app, or through its use, subjects the user or any party to HIPAA, the app publisher has implemented administrative, physical and technical safeguards, and developed policies and procedures, pursuant to the HIPAA Security Rule, as applicable. For purposes of the technical safeguards/security controls, only certain certified encryption technologies are permissible for compliance with HIPAA.
  • 81. • S4.02 If applicable, the app or the app publisher has safeguards in place or uses requisite efforts to comply with all obligations pursuant to any BAA, including capabilities to assist a covered entity in curing any breach, and address all other requirements of HIPAA in the event of a breach including notifying affected users. • S4.03 The app publisher has the capabilities to enable compliance, and shall comply with any and all applicable notification requirements to its users in the event that users’ PHI is or is suspected to be compromised (e.g., Breach Notification Rule pursuant to HIPAA including the capability to support and execute notification requirements). S4.04 The app publisher has a mechanism to notify end users about apps that are banned or recalled by the app publisher or any regulatory entity (e.g., FDA, FTC, FCC, UL). • S4.05 In the event that an app is banned or recalled, a mechanism or process is in place to notify all users about the ban or recall and render the app inoperable. • S4.06 If the app constitutes a medical device (e.g., 510(k)) or is regulated by the FDA in any other capacity, the app publisher has a policy and a mechanism in place to comply with all applicable rules and regulations for purposes of
  • 82. handling all aspects of a product notification or recall, including all corrections and removals. Guideline S5 – Access Control and Authentication If the app collects, stores and/or transmits personal information, the app offers one or more industry-accepted methods for guarding against identity theft. https://www.hhs.gov/hipaa/for-professionals/security/index.html https://www.hhs.gov/hipaa/for-professionals/breach- notification/index.html https://www.hhs.gov/hipaa/for-professionals/breach- notification/index.html Xcertia mHealth App Guidelines 2019 2019 Proprietary & Confidential 14 Requirements for Guideline S5 • S5.01 The app provides a method for securely authenticating the user at a session level (e.g., password, pass phrase, PIN, challenge phrase) and utilizes additional methods or techniques to further secure the identity of the users whenever the system is initially establishing identity, or
  • 83. the system has indications that the identity might have been compromised (e.g., multiple password failures). • S5.02 Unique user IDs should be used for access to all functions within the application. • S5.03 Access within the application should be limited to what is needed for that individual’s specific role. • S5.04 A process for provisioning and deprovisioning access in a timely fashion should be documented. • S5.05 For remote access or privileged access should require two factor authentication to reduce the risk of unauthorized access. Guideline S6 – Asset Management If the app collects, stores and or transmits personal information, the app maintains a methodology for documenting those Assets. Requirements for Guideline S6 • S6.01 Organization should have a process for tracking information and physical assets. • S6.02 Information assets should be classified based upon value to the organizations and outside regulations, e.g. public, internal confidential, sensitive.
  • 84. Guideline S7 – Physical & Environmental Security If the app collects, stores or transmits personal information, the app the app publisher shall maintain a record of how Security is maintained. Requirements for Guideline S7 • S7.01 Organization should have a physical security program. • S7.02 Physical security program should include security and environmental controls for the building/data center which contains information assets and system. Xcertia mHealth App Guidelines 2019 2019 Proprietary & Confidential 15 Guideline S8 – Incident Response If the app collects, stores or transmits personal information, the app publisher shall create and maintain an Incident Response system.
  • 85. Requirements for Guideline S8 • S8.01 Organization should have an incident response plan in the event of an information security incident. • S8.02 If breach is determined, the organization should notify customers and individuals affected in accordance with applicable regulation. Guideline S9 – Disaster Recovery & Business Continuity If the app collects, stores or transmits personal information, the app publisher shall provide a documented plan when the app, data or access is not available for use. Requirements for Guideline S9 • S9.01 Organization should have a documented DR/BC plan in the event that the application, data, or its infrastructure is not available for use. • S9.02 Tests from data back-up should happen on a regular basis. • S9.03 Tests of the DR/BC plan should happen on a regular basis.
  • 86. Xcertia mHealth App Guidelines 2019 2019 Proprietary & Confidential 16 Content Guidelines Content guidelines will assess whether the information provided in the application is current and accurate. Guideline C1 Credible Information Sources The app is based on one or more credible information sources including, but not limited to: protocols, published guidelines, evidence-based practice and peer-reviewed journals. Appendix 2 provides a selected number of accepted condition specific guidelines. Requirements for Guideline C1 • C1.01 The app should specify the source of content with documentation. Is it based on content from a recognized source (e.g., guidelines from a public or private entity) with, and documentation (e.g., link to journal article, medical textbook citation) about the information source and copyright compliance is provided. The source should point to current and accepted protocols and guidelines. Additionally, the content within the application should align and not deviate from the referenced source.
  • 87. • C1.02 If the app is based on content other than from a recognized source, documentation about how and when the content was formulated is provided, including information regarding its relevancy and reliability. • C1.03 If a previous version of an app or its content becomes medically dangerous due to updated current medical guidelines, the app publisher has a documented process and annual review period or mechanism to update or retract the outdated content version and notify users. Guideline C2 Current Information The app’s content reflects up-to-date information. Requirements for Guideline C2 • C2.01 Documentation about the source of the app’s content and explanation as to why it is deemed to be up- to-date is provided. • C2.02 The date(s)/source(s) of the app’s content is provided through an “About” section (tab, button or equivalent). • C2.03 The app publisher has a method or protocol for determining if an app’s content requires updating to remain up-to-date. The app publisher will provide an annual review schedule to ensure that content contained in
  • 88. the app is up to date. • C2.04 The app publisher has a method or protocol for updating the app’s content when new or changing information warrants. Updates should include a description of and documentation for each change and be made readily available for app users to identify the timing up these updates. Xcertia mHealth App Guidelines 2019 2019 Proprietary & Confidential 17 • C2.05 Any significant deviations in an app’s content from the original source (e.g., excerpts, abbreviated versions) are indicated and explained. Guideline C3 Information Accuracy The app’s description and content are truthful, fair, and not misleading. Requirements for Guideline C3 • C3.01 documentation is provided to substantiate any claims made in the description and/or content.
  • 89. • C3.02 Disclosures are provided, as needed, to prevent deception. Such disclosures shall be presented in a clear and conspicuous manner. • C3.03 Disclosures are provided, as needed, if the app requires an additional fee(s) (e.g., subscription fee) in order to fully access the app, its associated functionality, and/or content. Guideline C4 Accuracy of Results An app that contains tools that perform user or patient management functions, including but not limited to, mathematical formulae, calculations, data tracking, reminders, timers, measurements, or other such functions, does so with consistent accuracy and reliability to the degree specified in the app. Requirements for Guideline C4 • C4.01 When operated, the app produces consistent and accurate results that are independently verifiable. • C4.02 The app publisher will provide the accuracy and reliability of any calculations in product documentation. Product documentation will also include appropriate sources that support the validity of calculations, measures and other functions Guideline C5 Advertising Within the App
  • 90. An app that contains advertisements clearly identifies the advertising and complies with all applicable regulatory requirements, particularly advertisements that involve or relate to products or services that are clinical or related to health. Requirements for Guideline C5 • C5.01 Information in any app that constitutes advertising is denoted by the message “This is an advertisement” or equivalent legibly displayed next to the advertisement or clearly super-imposed on the actual ad or advertorial.. • C5.02 Information in any app that constitutes advertising will always comply with all applicable regulatory requirements related to the marketing of any product or service, including, but not limited to those of the FDA, Xcertia mHealth App Guidelines 2019 2019 Proprietary & Confidential 18 FTC, FCC, and any laws, rules, regulations and policies of other regulatory entities in all jurisdictions that app’s owner makes its product available. • Advertisements should be placed within the app in such a manner as to not create confusion or uncertainty as to
  • 91. what is advertising vs educational information. • C5.03 App publisher takes commercially reasonable efforts to clearly and prominently indicate (e.g., in the “About” section) that any advertisement, which may be perceived as health care or medical advice or treatment, is being displayed for the sole purpose of advertising and should not be construed as a substitute for medical or clinical advice. Guideline C6 Documentation of Evidence The level of evidence and quality of evidence for an app should be transparent and visible to users and health professionals. Requirements for Guideline C6 * C6.01 The app’s public description should clearly state which type of research has been performed to validate its content. These can include the following levels of research: I. Systematic review or meta-analysis of randomized control trials II. Randomized control trial/s (number of trials if more than one) III. Quasi-experimental study IV. Case-control or cohort studies V. Systematic reviews of descriptive and qualitative studies VI. Single descriptive or qualitative study VII. Expert medical or academic opinion
  • 92. • C6.02 If level of research performed on the opinion is based on expert or academic opinion (VII) or no study, the app’s public description should clearly state, “The effectiveness of the app has not been studied”. • C6.03 If a study was performed, documentation should clearly state who performed such study (C7.01) and whether the study was performed by an independent entity. Furthermore, the app’s documentation should state if the study has been published in a peer-reviewed journal, and if so, include the date and the title for both the journal and article. App’s documentation should also state any ownership that the study authors (C7.01) have in the solution company, its partners or investors, either currently or at the time the study was performed. • C6.04 If a study was performed, documentation should state the exposure environment (e.g. hospital, home, community health center, etc.). It should also state the demographics, socioeconomic status, IT literacy, rural/urban, and type/stage of illness of study participants. The relevance of these characteristics to app’s goals should be explained. Xcertia mHealth App Guidelines 2019
  • 93. 2019 Proprietary & Confidential 19 Guideline C7 Transparency of Evidence The basis of evidence in literature for the app and the app’s design should be transparent and visible to users and health professionals. Requirements for Guideline C7 • C7.01 App documentation should state whether the app is based upon the results of a study/studies published in peer-reviewed journals. This can include studies of non- digital health interventions that have inspired solution designs. If based on peer-reviewed publications, documentation should state that the app is “informed by the independent study of a separate intervention in a peer-reviewed journal” and include the date and the title for both the journal and article. This statement is in addition to, not replacement, of the preceding statement of which type of research has been specifically performed on the app. Given that literature reviews are significantly less costly than performing studies, • C7.02 Documentation should state whether such study authors (C7.01) have had any cooperation with the app publisher, and whether the study authors provide any active input on the app. App documentation should also
  • 94. state any financial relationships that are planned, exist or have existed between such study authors (C8.01) and the app publisher, its partners or investors. • C7.03 If an app is based on peer-reviewed literature, the documentation should state what type of user research was performed to adapt the literature and solution to the needs of the target user. This could include, but is not limited to design research, human centered design, formative research, user centered design, and co-creation with users. This type of qualitative research can complement and translate quantitative research, but it should not be presented as a replacement for quantitative research. Guideline C8 Publishing Outcomes Data The types of results achieved by the app or study of the app should be transparent and visible to users and health professionals. Requirements for Guideline C8 • C8.01 Documentation should clearly state what metric or indicator is used in studies and claimed to be accomplished by the application. This can include the following type of indicators: I. Health outcomes
  • 95. II. Biological outcomes III. Health behavior outcomes IV. Online analytics or online behavior outcomes Xcertia mHealth App Guidelines 2019 2019 Proprietary & Confidential 20 If the cited indicator is only an online outcome (IV), documentation should clearly state that results do not include “tangible outcomes in health behavior or health outcomes”. • C8.02 The public source of the metric definition should be cited in the app’s documentation. This could include a health association, peer-reviewed journal, health standards body. Guideline C9 Transparency of Data The context of the app and data should be clear to users and health professionals. Requirements for Guideline C9 • C9.01 The app’s public description should accurately state in
  • 96. plain language what type of individual health data is collected by the app, who it is shared with, and what it used for. This description should specify whether this data is sold to app publisher’s partners. • • C9.02 App documentation should specify in which types of environments it is designed to operate for all relevant users (e.g. hospital, home, community health center, etc.). This description should explain how the app has been designed to operate in this environment with the minimum burden. For further information and guidance, refer to “How to Make Effective Disclosures in Digital Advertising,” Federal Trade Commission. (https://www.ftc.gov/sites/default/files/attachments/press- releases/ftc-staff- revises-online-advertising-disclosure- guidelines/130312dotcomdisclosures.pdf)
  • 97. https://www.ftc.gov/sites/default/files/attachments/press- releases/ftc-staff-revises-online-advertising-disclosure- guidelines/130312dotcomdisclosures.pdf https://www.ftc.gov/sites/default/files/attachments/press- releases/ftc-staff-revises-online-advertising-disclosure- guidelines/130312dotcomdisclosures.pdf Xcertia mHealth App Guidelines 2019 2019 Proprietary & Confidential 21 Usability Guidelines App Usability (U) Guidelines The Usability Guidelines assess how a mobile health app is designed to be safe and easy to use by incorporating five key quality aspects of usability: learnability, efficiency, memorability, prevention of errors, and user satisfaction. Apps designed based on sound usability principles will be optimized for use by the intended users within the intended use environments. Guideline U1 Visual Design
  • 98. Apps should follow standards of visual design that promote legibility, clarity of content, and user engagement without introducing unnecessary distraction. Apps that leverage user expectations in their design strategy shorten the learning curve and decrease user frustration. Performance Requirements for Guideline U1 ● U1.01 App layout should be adaptable such that usability and functionality do not differ between landscape or portrait mode. Ideally, interfaces should be flexible to operate in both orientations. ● U1.02 Readability and meaning of content within the app should be consistent across a variety of mobile screen sizes and operating systems. ● U1.03 Contrasting colors should be utilized to help users distinguish between the different elements on the screen, with an emphasis on contrast between the screen background and content (i.e., text and graphics). ● U1.04 Multiple redundant identifiers should be used to indicate critical or safety-related information. Cues can include color, iconography, labeling, or other text. ● U1.05 Extraneous text, graphics, and animation should be used sparingly. Information that is actively populating
  • 99. should serve a purpose and avoid distracting the user or cluttering the screen if only for aesthetic purposes. ● U1.06 Elements critical to app functionality and content understandability should be positioned above the scroll line to minimize the opportunity for missed information. Users should be able to clearly identify when screens extend beyond the scroll line. ● U1.07 App design should provide clear indications that elements are actionable. Interactive elements can be differentiated from non-selectable content through design choices that should be used consistently throughout the app (i.e., color, text style). ● U1.08 App design should support recognition over recall by keeping relevant information on screen rather than forcing users to remember it. ● U1.09 When possible, reduce the probability of data entry error by providing users with selectable options rather than requiring text entry. Xcertia mHealth App Guidelines 2019 2019 Proprietary & Confidential 22
  • 100. ● U1.10 Selectable items should be a minimum of 7 to 10 millimeters in length and width, with appropriate spacing allowance between items to avoid unintended selections. Guideline U2 Readability Text used within the app must be readable, understandable, and adjustable to accommodate ease of operation for a variety of devices, users and use environments. Text size adjustments should not alter the screen layout in a manner that could confuse users or prohibit ease of use. Performance Requirements for Guideline U2 ● U2.01 The default font size for paragraph text should follow the minimum standard guidelines for the platform of use (e.g., 17pt for iOS, 14sp for Android). ● U2.02 Different font sizes should be utilized to establish text hierarchy, with larger font sizes signifying headers and smaller font sizes used for paragraph text. ● U2.03 Apps should avoid presenting information in paragraph form when possible. When large amounts of information must be displayed, implement information chunking (i.e., intuitive grouping) or utilize lists and tables
  • 101. to facilitate learnability and memorability. ● U2.04 Text should incorporate appropriate spacing allowance between lines (e.g., 1.2 times the font height) to allow for breathability and readability. ● U2.05 Content should be written at reading level appropriate for the user population. Language for adult lay users without clinical knowledge should be written at or below a sixth-grade reading level. ● U2.06 Text should avoid use of jargon or acronyms that may not be familiar to users, particularly for lay users without clinical knowledge. Guideline U3 App Navigation Users should be able to navigate quickly and easily between screens to complete tasks. Navigation should meet user expectations, and should not dominate the interface or draw focus away from content. Performance Requirements for Guideline U3 ● U3.01 Users should be able to easily identify where they are in the app and how to navigate to different destinations. The navigational path should be logical, predictable, and easy to follow. For screens that users may need to access in succession, providing shortcuts may improve
  • 102. ease of navigation. ● U3.02 Minimize the number of taps, swipes, or screens required to navigate from one area of the app to another. ● U3.03 App design should facilitate reversible actions by allowing the user to navigate back to previous pages. ● U3.04 Menu options should be labeled intuitively such that users can easily locate information within the app. Users should not have to locate information by trial and error. Xcertia mHealth App Guidelines 2019 2019 Proprietary & Confidential 23 ● U3.05 The app’s main menu should be easily located and identified. Standard app design conventions would likely lead most users to look for a menu on the top, left-hand side of the screen. A collapsed menu is often associated with the three-bar “hamburger” icon that frequent app users are expected to be familiar with. Guideline U4 Onboarding Apps should facilitate an intuitive process for launching, registering, entering personal information (if applicable), and
  • 103. preparing for first-time use. As the users’ first introduction to the app, a simple and intuitive onboarding process is critical in instilling user confidence that the app will provide a satisfying overall user experience. Performance Requirements for Guideline U4 ● U4.01 The app provides a launch screen that clearly identifies the name and purpose of the app, and gives the user intuitive options for initiating use. ● U4.02 Provide the user with opportunities either to access detailed instructions and product information or to bypass this and immediately begin app setup. ● U4.03 Users should be allowed to bypass entry of personal data if it is not critical for app functionality. Data that is needed for the app to work as intended (e.g., alert and notification parameters) should be mandatory to avoid inaccurate app behavior. ● U4.04 For apps with complex onboarding processes, entered data should be stored so that users can recover and avoid reentry if they are disconnected during the onboarding process. ● U4.05 When setup is complete, provide options for a walkthrough or tutorial on app use.
  • 104. ● U4.06 Apps should bypass onboarding for returning users, but allow users to update the data entered during onboarding at any time through intuitively named menu selections (e.g., Profile, Settings). Guideline U5 App Feedback Apps should provide sufficient feedback to inform the user of the results of their actions and promote understanding of what is going on in the system. Feedback includes how an app responds to user input, including providing messages to the user. Efficient and informative feedback ensures that users will be able to understand and perceive app actions without frustration. Guidelines associated with feedback related to notifications, alarms, and alerts can be found within Guideline U6. Performance Requirements for Guideline U5 ● U5.01 Feedback messages should appear in an expected and consistent location within the interface so that they are noticeable to the user (e.g., near the input location). ● U5.02 Feedback messages that are not urgent or associated with a safety risk should be unobtrusive to app operation.