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After completing this presentation participants should be able to:

   Define Covered Entity, Protected Health Information and Business
   Associates

   Identify major legislation regarding patient privacy laws in Texas

   Explain why protecting Protected Health Information is important and
   consequences for non-compliance with state and federal laws

   Sketch out a plan to achieve compliance for their organizations
HIPAA Privacy

HIPAA Security

HB 300 (Texas Medical Privacy Act)

HITECH
Took effect on April 1st, 2003

First major regulation in recent years to control fraud, waste and
abuse of government programs

Mandated mechanisms for exchange of information between
healthcare clearinghouses, health plans and providers.
Took effect in 2009

Provided Federal money for providers to help incorporate EHR into
health care practices

Recognized the majority of data breaches was by Business
Associates and there were (previously) no accountability to enforce
HIPAA provisions over unlicensed BA‟s
Took effect on 09/01/2012

Re-defined “Protected Health Information”

Expanded definition of “Covered Entity” to include entities that
come into possession of, obtain, assemble, collect, analyze,
evaluate, store or transmit PHI.
Expanded privacy and security mandates on covered entities such as:

      Employee training (within 60 days of hire and every 2 years)

      Patient access to electronic health records (EHRs) (15 days)

      Identifies state agencies that regulate covered entities and the
      agency‟s compliance enforcement process (Office of Attorney
      General for non-licensed C.E.‟s)
Consumer Information Website

Prohibits sale or disclosure of PHI

Consumer Notice and Authorization Required for Electronic
Disclosure of PHI

Fines and penalties include civil and criminal remedies for non-
compliance
American Recovery and Reinvestment Act of 2009 (ARRA) became
federal law on February 12, 2009. HITECH is part of that law.
The goal of HITECH is to enhance and expand the HIPAA Privacy Rule
and Security Rules.
The HITECH Act not only makes privacy regulations more strict, but it
also gives more power to federal and state authorities to enforce privacy
and security protections for resident information and data.
It increases HIPAA‟s patient rights regarding control over their PHI
(medical information)
It limits the use of PHI for marketing purposes
It mandates breach (unauthorized access or loss of PHI) notification
It also extends a lot of the same requirements to those business
associates outside of our company to whom we give PHI so they can do
their jobs.
Published January 25th, 2013

Expands the definition of Business Associates - now include
entities that “maintain” PHI, in addition to those that create, receive,
or transmit PHI for a function or activity such as claims processing
or administration, data analysis, utilization review, quality
assurance, patient safety activities, billing, benefit management,
practice management, and re-pricing.

The definition extends fully to subcontractors of BAs who perform
these functions.
Solidifies that BAs are directly liable for compliance with
HIPAA. Under the new rules, BAs are statutorily liable for violations
of the HIPAA security rules. They are also subject to the same
HIPAA privacy restrictions as covered entities. This includes
requirements that BAs create and implement HIPAA privacy and
security policies and procedures in relation to the handling of PHI of
a covered entity. BAs may be subject to compliance reviews by the
federal Department of Health and Human Services (HHS).
Require BAs to report to the covered entities breaches of
unsecured PHI.

Breach is the unauthorized access of PHI by unintended or
unauthorized persons or entities.
As per HB 300 and HITECH Final Rule:

Basically, all persons or entities who receive, possess, or generate
protected health information (PHI) or who store and „could
potentially‟ access PHI
Individually Identifiable Health Information (including demographic
data, that relates to:

   The individual‟s past, present or future physical or mental health or
   condition;

   The provision of health care to the individual, or

   The past, present, or future payment for the provision of health care
   to the individual
EXAMPLES: Names, Addresses, Date and place of birth, Race,
Marital Status, Phone numbers, Fax numbers, Email addresses, Social
Security numbers, Medical record numbers, Health insurance
beneficiary numbers, Account numbers, Certificate/license numbers,
Vehicle identifiers and serial numbers, including license plate numbers,
Device identifiers and serial numbers, Web URLs, IP address
numbers, Biometric identifiers (including finger, retinal and voice
prints), Full face photographic images and any comparable images
Required (R) means that complying with the given standard is
mandatory and, therefore, must be complied with.



Addressable (A) means that the given standards must be
implemented by the organization unless assessments and in depth
risk analysis conclude that implementation is not reasonable and
appropriate specific to a given business setting. Important Note:
Addressable does not mean optional.
Safeguard documents and communications involving PHI (oral,
written and otherwise)

Shred or definitively destroy documents that are no longer needed

Notify Covered Entities if any information has been breached

Have written policies and procedures to account for this information

See HIPAA Privacy summary for additional
Risk Analysis: (R) Perform and document a risk analysis to see
where PHI is being used and stored and to determine what all
possible ways HIPAA could be violated are
Risk Management: (R) Implement measures sufficient to reduce
these risks to an appropriate level.
Sanction Policy: (R) Implement sanction policies for employees
who fail to comply.
Information Systems Activity Reviews: (R) Regularly review
system activity, logs, audit trails, etc.
Officers: (R) Designate HIPAA Security and Privacy Officers
Employee Oversight: (A) Implement procedures to authorize and
supervise employees who work with PHI, and for granting and
removing PHI access to employees. Ensure that an employee‟s
access to PHI ends with termination of employment.
Multiple Organizations: (R) Ensure that PHI is not accessed by
parent or partner organizations or subcontractors that are not
authorized for access.
ePHI Access: (A) Implement procedures for granting access to
ePHI and which document access to ePHI or to services and
systems which grant access to ePHI.
Security Reminders: (A) Periodically send updates and reminders
of security and privacy policies to employees.
Protection against Malware: (A) Have procedures for guarding
against, detecting, and reporting malicious software.
Login Monitoring: (A) Institute monitoring of logins to systems and
reporting of discrepancies.
Password Management: (A) Ensure there are procedures for
creating, changing, and protecting passwords.
Response and Reporting: (R) Identify, document, and respond to
security incidents.
Contingency Plans: (R) Ensure there are accessible backups of
ePHI and that there are procedures for restore any lost data.
Contingency Plans Updates and Analysis: (A) Have procedures for periodic
testing and revision of contingency plans. Assess the relative criticality of
specific applications and data in support of other contingency plan
components.

Emergency Mode: (R) Establish (and implement as needed) procedures to
enable continuation of critical business processes for protection of the security
of electronic protected health information while operating in emergency mode.

Evaluations: (R) Perform periodic evaluations to see if any changes in your
business or the law require changes to your HIPAA compliance procedures.

Business Associate Agreements: (R) Have contracts with business partners
who will have access to your PHI to ensure that they will be compliant.
Contingency Operations: (A) Establish (and implement as needed) procedures
that allow facility access in support of restoration of lost data under the disaster
recovery plan and emergency mode operations plan in the event of an emergency.

Facility Security: (A) Implement policies and procedures to safeguard the facility
and the equipment therein from unauthorized physical access, tampering, and theft.

Access Control and Validation: (A) Implement procedures to control and validate
a person‟s access to facilities based on their role or function, including visitor
control, and control of access to software programs for testing and revision.

Maintenance Records: (A) Implement policies and procedures to document repairs
and modifications to the physical components of a facility which are related to
security
Workstations: (R) Implement policies governing what software can/must
be run and how it should be configured on systems that provide access
ePHI. Safeguard all workstations providing access to ePHI and restrict
access to authorized users.
Devices and Media Disposal and Re-use: (R) Create procedures for the
secure final disposal of media that contain ePHI and for the reuse of
devices and media that could have been used for ePHI.
Media Movement: (A) Record movements of hardware and media
associated with ePHI storage. Create a retrievable, exact copy of
electronic protected health information, when needed, before movement of
equipment.
Unique User Identification: (R) Assign a unique name and/or number for
identifying and tracking user identity.

Emergency Access: (R) Establish (and implement as needed) procedures
for obtaining necessary electronic protected health information during an
emergency.

Automatic Logoff: (A) Implement electronic procedures that terminate an
electronic session after a predetermined time of inactivity.

Encryption and Decryption: (A) Implement a mechanism to encrypt and
decrypt electronic protected health information when deemed appropriate.
Audit Controls: (R) Implement hardware, software, and/or procedural
mechanisms that record and examine activity in information systems that
contain or use electronic protected health information.

ePHI Integrity: (A) Implement policies and procedures to Protect electronic
protected health information from improper alteration or destruction.

Authentication: (R) Implement procedures to verify that a person or entity
seeking access to electronic protected health information is the one claimed.

Transmission Security: (A) Implement technical security measures to guard
against unauthorized access to electronic protected health information that is
being transmitted over an electronic communications network.
Create, revise, and/or implement HIPAA policies and
procedures. Diligently pursue HIPAA-compliant policies and
procedures as they relate to HIPAA security and privacy
requirements.
Ensure you have Business Associate agreements on file with
the Covered Entities whose patients’ PHI you have access
to. Ensure you have BA agreements with covered entity clients, as
well as with subcontractors to whom it delegates BA functions
(consider relationships with lenders, transition specialists, practice
management, attorneys, other vendors).
For you and ALL employees or persons for whom you are
responsible receive training as required:

   within 60 days of beginning new employment, and;

   every two years

Training must include State and Federal requirements
This presentation is NOT comprehensive and is only intended as a high-level
   overview of information relevant to Covered Entities and Business
   Associates. My team and I are happy to provide you with additional
   information or you can surf the Internet at:

    http://www.hhs.gov/ocr/privacy/hipaa/administrative/statute/index.html
Duane Tinker traded his gun and badge for a clipboard and classroom
to inform and teach Dental professionals how to stay off the radar and
out of the news! As President & CEO of Dental Compliance
Specialists, LLC -- a company specializing in Dental office regulatory
compliance – he has taken his expertise as a former law enforcement
officer responsible for investigating criminal and civil complaints
against practices and now uses this knowledge to assist Dental
professionals in avoiding these legal pitfalls. He is a much sought-after
speaker and consultant and a member of the Speaking Consulting
Network. In this pursuit, today his passion is all about helping
beleaguered oral healthcare providers find justice!

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Dental Compliance for Dentists and Business Associates

  • 1. For Free compliance tips join our list! www.DentalCompliance.com
  • 2. Neither of these guys are licensed peace officers, attorneys, or dentists…. they‟re not very funny either!
  • 3. After completing this presentation participants should be able to: Define Covered Entity, Protected Health Information and Business Associates Identify major legislation regarding patient privacy laws in Texas Explain why protecting Protected Health Information is important and consequences for non-compliance with state and federal laws Sketch out a plan to achieve compliance for their organizations
  • 4.
  • 5. HIPAA Privacy HIPAA Security HB 300 (Texas Medical Privacy Act) HITECH
  • 6. Took effect on April 1st, 2003 First major regulation in recent years to control fraud, waste and abuse of government programs Mandated mechanisms for exchange of information between healthcare clearinghouses, health plans and providers.
  • 7. Took effect in 2009 Provided Federal money for providers to help incorporate EHR into health care practices Recognized the majority of data breaches was by Business Associates and there were (previously) no accountability to enforce HIPAA provisions over unlicensed BA‟s
  • 8. Took effect on 09/01/2012 Re-defined “Protected Health Information” Expanded definition of “Covered Entity” to include entities that come into possession of, obtain, assemble, collect, analyze, evaluate, store or transmit PHI.
  • 9. Expanded privacy and security mandates on covered entities such as: Employee training (within 60 days of hire and every 2 years) Patient access to electronic health records (EHRs) (15 days) Identifies state agencies that regulate covered entities and the agency‟s compliance enforcement process (Office of Attorney General for non-licensed C.E.‟s)
  • 10. Consumer Information Website Prohibits sale or disclosure of PHI Consumer Notice and Authorization Required for Electronic Disclosure of PHI Fines and penalties include civil and criminal remedies for non- compliance
  • 11. American Recovery and Reinvestment Act of 2009 (ARRA) became federal law on February 12, 2009. HITECH is part of that law. The goal of HITECH is to enhance and expand the HIPAA Privacy Rule and Security Rules. The HITECH Act not only makes privacy regulations more strict, but it also gives more power to federal and state authorities to enforce privacy and security protections for resident information and data.
  • 12. It increases HIPAA‟s patient rights regarding control over their PHI (medical information) It limits the use of PHI for marketing purposes It mandates breach (unauthorized access or loss of PHI) notification It also extends a lot of the same requirements to those business associates outside of our company to whom we give PHI so they can do their jobs.
  • 13. Published January 25th, 2013 Expands the definition of Business Associates - now include entities that “maintain” PHI, in addition to those that create, receive, or transmit PHI for a function or activity such as claims processing or administration, data analysis, utilization review, quality assurance, patient safety activities, billing, benefit management, practice management, and re-pricing. The definition extends fully to subcontractors of BAs who perform these functions.
  • 14. Solidifies that BAs are directly liable for compliance with HIPAA. Under the new rules, BAs are statutorily liable for violations of the HIPAA security rules. They are also subject to the same HIPAA privacy restrictions as covered entities. This includes requirements that BAs create and implement HIPAA privacy and security policies and procedures in relation to the handling of PHI of a covered entity. BAs may be subject to compliance reviews by the federal Department of Health and Human Services (HHS).
  • 15. Require BAs to report to the covered entities breaches of unsecured PHI. Breach is the unauthorized access of PHI by unintended or unauthorized persons or entities.
  • 16.
  • 17. As per HB 300 and HITECH Final Rule: Basically, all persons or entities who receive, possess, or generate protected health information (PHI) or who store and „could potentially‟ access PHI
  • 18. Individually Identifiable Health Information (including demographic data, that relates to: The individual‟s past, present or future physical or mental health or condition; The provision of health care to the individual, or The past, present, or future payment for the provision of health care to the individual
  • 19. EXAMPLES: Names, Addresses, Date and place of birth, Race, Marital Status, Phone numbers, Fax numbers, Email addresses, Social Security numbers, Medical record numbers, Health insurance beneficiary numbers, Account numbers, Certificate/license numbers, Vehicle identifiers and serial numbers, including license plate numbers, Device identifiers and serial numbers, Web URLs, IP address numbers, Biometric identifiers (including finger, retinal and voice prints), Full face photographic images and any comparable images
  • 20.
  • 21. Required (R) means that complying with the given standard is mandatory and, therefore, must be complied with. Addressable (A) means that the given standards must be implemented by the organization unless assessments and in depth risk analysis conclude that implementation is not reasonable and appropriate specific to a given business setting. Important Note: Addressable does not mean optional.
  • 22.
  • 23. Safeguard documents and communications involving PHI (oral, written and otherwise) Shred or definitively destroy documents that are no longer needed Notify Covered Entities if any information has been breached Have written policies and procedures to account for this information See HIPAA Privacy summary for additional
  • 24.
  • 25. Risk Analysis: (R) Perform and document a risk analysis to see where PHI is being used and stored and to determine what all possible ways HIPAA could be violated are Risk Management: (R) Implement measures sufficient to reduce these risks to an appropriate level. Sanction Policy: (R) Implement sanction policies for employees who fail to comply. Information Systems Activity Reviews: (R) Regularly review system activity, logs, audit trails, etc. Officers: (R) Designate HIPAA Security and Privacy Officers
  • 26. Employee Oversight: (A) Implement procedures to authorize and supervise employees who work with PHI, and for granting and removing PHI access to employees. Ensure that an employee‟s access to PHI ends with termination of employment. Multiple Organizations: (R) Ensure that PHI is not accessed by parent or partner organizations or subcontractors that are not authorized for access. ePHI Access: (A) Implement procedures for granting access to ePHI and which document access to ePHI or to services and systems which grant access to ePHI. Security Reminders: (A) Periodically send updates and reminders of security and privacy policies to employees.
  • 27. Protection against Malware: (A) Have procedures for guarding against, detecting, and reporting malicious software. Login Monitoring: (A) Institute monitoring of logins to systems and reporting of discrepancies. Password Management: (A) Ensure there are procedures for creating, changing, and protecting passwords. Response and Reporting: (R) Identify, document, and respond to security incidents. Contingency Plans: (R) Ensure there are accessible backups of ePHI and that there are procedures for restore any lost data.
  • 28. Contingency Plans Updates and Analysis: (A) Have procedures for periodic testing and revision of contingency plans. Assess the relative criticality of specific applications and data in support of other contingency plan components. Emergency Mode: (R) Establish (and implement as needed) procedures to enable continuation of critical business processes for protection of the security of electronic protected health information while operating in emergency mode. Evaluations: (R) Perform periodic evaluations to see if any changes in your business or the law require changes to your HIPAA compliance procedures. Business Associate Agreements: (R) Have contracts with business partners who will have access to your PHI to ensure that they will be compliant.
  • 29. Contingency Operations: (A) Establish (and implement as needed) procedures that allow facility access in support of restoration of lost data under the disaster recovery plan and emergency mode operations plan in the event of an emergency. Facility Security: (A) Implement policies and procedures to safeguard the facility and the equipment therein from unauthorized physical access, tampering, and theft. Access Control and Validation: (A) Implement procedures to control and validate a person‟s access to facilities based on their role or function, including visitor control, and control of access to software programs for testing and revision. Maintenance Records: (A) Implement policies and procedures to document repairs and modifications to the physical components of a facility which are related to security
  • 30. Workstations: (R) Implement policies governing what software can/must be run and how it should be configured on systems that provide access ePHI. Safeguard all workstations providing access to ePHI and restrict access to authorized users. Devices and Media Disposal and Re-use: (R) Create procedures for the secure final disposal of media that contain ePHI and for the reuse of devices and media that could have been used for ePHI. Media Movement: (A) Record movements of hardware and media associated with ePHI storage. Create a retrievable, exact copy of electronic protected health information, when needed, before movement of equipment.
  • 31. Unique User Identification: (R) Assign a unique name and/or number for identifying and tracking user identity. Emergency Access: (R) Establish (and implement as needed) procedures for obtaining necessary electronic protected health information during an emergency. Automatic Logoff: (A) Implement electronic procedures that terminate an electronic session after a predetermined time of inactivity. Encryption and Decryption: (A) Implement a mechanism to encrypt and decrypt electronic protected health information when deemed appropriate.
  • 32. Audit Controls: (R) Implement hardware, software, and/or procedural mechanisms that record and examine activity in information systems that contain or use electronic protected health information. ePHI Integrity: (A) Implement policies and procedures to Protect electronic protected health information from improper alteration or destruction. Authentication: (R) Implement procedures to verify that a person or entity seeking access to electronic protected health information is the one claimed. Transmission Security: (A) Implement technical security measures to guard against unauthorized access to electronic protected health information that is being transmitted over an electronic communications network.
  • 33.
  • 34. Create, revise, and/or implement HIPAA policies and procedures. Diligently pursue HIPAA-compliant policies and procedures as they relate to HIPAA security and privacy requirements.
  • 35. Ensure you have Business Associate agreements on file with the Covered Entities whose patients’ PHI you have access to. Ensure you have BA agreements with covered entity clients, as well as with subcontractors to whom it delegates BA functions (consider relationships with lenders, transition specialists, practice management, attorneys, other vendors).
  • 36. For you and ALL employees or persons for whom you are responsible receive training as required: within 60 days of beginning new employment, and; every two years Training must include State and Federal requirements
  • 37. This presentation is NOT comprehensive and is only intended as a high-level overview of information relevant to Covered Entities and Business Associates. My team and I are happy to provide you with additional information or you can surf the Internet at: http://www.hhs.gov/ocr/privacy/hipaa/administrative/statute/index.html
  • 38. Duane Tinker traded his gun and badge for a clipboard and classroom to inform and teach Dental professionals how to stay off the radar and out of the news! As President & CEO of Dental Compliance Specialists, LLC -- a company specializing in Dental office regulatory compliance – he has taken his expertise as a former law enforcement officer responsible for investigating criminal and civil complaints against practices and now uses this knowledge to assist Dental professionals in avoiding these legal pitfalls. He is a much sought-after speaker and consultant and a member of the Speaking Consulting Network. In this pursuit, today his passion is all about helping beleaguered oral healthcare providers find justice!

Notes de l'éditeur

  1. For more information, contact Duane at Duane@DentalCompliance.com