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Mobile Health - Overview
Recording Health Monitoring Data                       SV Forum Mobile Internet SIG

August 4, 2011
© David M. Snyder, 42TEK, Inc., 2011   www.42tek.com                                  1
This Evening
✤   iHealth & MedApps Examples
✤   Mobile Health Overview - David Snyder, 42TEK, Inc.
    ✤   Setting the context
✤   Tracking Personal Health - Rajiv Mehta, Bhageera, Inc.
    ✤   Self-Quanti cation & Tonic iPhone app
✤   Dr. Justin Graham, Chief Medical Information Officer, NorthBay Healthcare
    ✤   The Healthcare Practitioner’s Perspective
✤   Panel Discussion/Questions & Answers



© David M. Snyder, 42TEK, Inc., 2011   www.42tek.com                          2
Setting the Stage
✤   Healthcare Issues, including costs                 ✤   Regulations & Standards

✤   Healthcare IT                                      ✤   Reimbursement

✤   Staying Healthy & Treating Illness                 ✤   Market, including obstacles

✤   Chronic Illness                                    ✤   Technologies & Use Cases

✤   Systems and Processes                              ✤   Privacy & Security

✤   Electronic Health Records                          ✤   Interoperability

✤   What is Mobile Health?                             ✤   Companies

© David M. Snyder, 42TEK, Inc., 2011   www.42tek.com                                     3
What Is Mobile Health?
✤   No single de nition, but the main focus seems to be the use of
    telecommunications devices to (a) collect monitoring data outside of traditional
    clinic or hospital settings, (b) transmit such data from a remote location to a
    doctor or other healthcare professional, or to an electronic health record
    system, and (c) provide remote access to health care data and references.

✤   “m-health,” “remote monitoring,” “mobile health,” ...

✤   Telehealth seems to be about doctor (or other healthcare provider) interacting
    with a patient, or consulting with a medical colleague, via phone, video, email,
    text, etc.

✤   Telemedicine seems to be about conducting medical procedures via a
    telecommunications link. For example, remotely controlled robotic surgery.
© David M. Snyder, 42TEK, Inc., 2011   www.42tek.com                                   4
MedApps




✤   http://www.medapps.com/HealthPAL.html              ✤   http://www.youtube.com/watch?v=GiV239PR0R4&feature=player_embedded#at=18

© David M. Snyder, 42TEK, Inc., 2011   www.42tek.com                                                                                  5
Healthcare Issues
✤   $2.7 Trillion/year = one-sixth of US GDP and growing
                                                       Complica)ons	
  from	
  chronic	
  
✤   Aging population, with associated needs            disease	
  account	
  for	
  ~75%	
  of	
  
                                                       US	
  healthcare	
  spending
                                                       Smith,	
  Joseph,	
  Iden%fying	
  Unmet	
  Public	
  Health	
  Needs	
  and	
  
✤   Chronic illness accounts for ~75% of costs         Facilita%ng	
  Innova%on	
  in	
  Medical	
  Device	
  Development,	
  
                                                       6/24/2010.	
  	
  FDA	
  Public	
  Workshop



✤   Reactive, not proactive model - costs more once you are ill
                                                                               Remote health monitoring
                                                                               has the potential to reduce
✤   Potentially not enough healthcare professionals                            the demand on primary
                                                                               care providers by allowing
                                                                               chronically ill patients to
✤   Inertia and regulatory obstacles                                           monitor and manage
                                                                               conditions at home.
                                                                               Sarasohn-Kahn, Jane, The Connected
                                                                               Patient: Charting the Vital Signs of Remote
                                                                               Health Monitoring, February 2011


© David M. Snyder, 42TEK, Inc., 2011   www.42tek.com                                                                                      6
Healthcare IT Trends
✤   Shifting from paper to electronic records

✤   Smaller and more portable devices with increasing computing power

✤   Convergence of clinical engineering and IT networks

✤   “Business intelligence” analytics to see patterns in data




© David M. Snyder, 42TEK, Inc., 2011   www.42tek.com                    7
Complex Landscape




© David M. Snyder, 42TEK, Inc., 2011   www.42tek.com   8
Staying Healthy & Managing
                     Illness
✤   Exercise                                           ✤   Medication

✤   Diet                                               ✤   Therapy

✤   Sleep                                              ✤   Physical observations

✤   Community                                          ✤   Analytical measurements




© David M. Snyder, 42TEK, Inc., 2011   www.42tek.com                                 9
Consumer Goods
✤   What used to be found only in hospitals is now on the shelves in Frys.




© David M. Snyder, 42TEK, Inc., 2011   www.42tek.com                         10
Chronic Illness

✤   Major chronic illnesses where remote monitoring can help

    ✤   Chronic Obstructive Pulmonary Disease

    ✤   Congestive heart failure

    ✤   Diabetes                       Taking medicines as
                                       directed, careful monitoring,
                                       and doing the right things in
                                                                       •reminders
    ✤   Hypertension                   terms of diet, exercise, and
                                                                       •monitoring devices
                                       sleep can help prevent
                                                                       •tracking tools
                                       people from getting sicker.



© David M. Snyder, 42TEK, Inc., 2011     www.42tek.com                                       11
Data That Doctors Want




© David M. Snyder, 42TEK, Inc., 2011   www.42tek.com   12
Connecting Devices is Just
                             Part of the Picture
                                                                             Electronic
                                                                               Health
                                                                              Record




                                                                                                       Is intervention needed?

                                                                                                        What sort of follow-up
                                                                                                            is required?



Source for Image: Identifying Unmet Public Needs and Facilitating Innovation in Medical Device Development, June 24, 2010
Joseph M. Smith, MD, PhD [EHR added] - http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM221033.pdf


© David M. Snyder, 42TEK, Inc., 2011               www.42tek.com                                                                   13
Electronic Health Records
✤   Large focus in recent healthcare legislation - federal incentives to doctors and
    hospitals to implement

✤   Growing provision of access to patients and authorized family members

✤   Various Personal Health Record initiatives, like Microsoft HealthVault and
    Google Health

✤   Health Information Exchanges being built to support interoperability
    between organizations (e.g., Kaiser Permanente and Veterans Administration)

✤   Growth in automatic input of monitoring data in EHRs - including from
    mobile health devices

© David M. Snyder, 42TEK, Inc., 2011   www.42tek.com                              14
Interoperability




© David M. Snyder, 42TEK, Inc., 2011   www.42tek.com   IHE = Integrating the Healthcare Enterprise   15
Parts of the Puzzle
                                                                   Patient           Payer
                                                                   Family            Regulator
          Design                                                   Caregiver         Vendor
      Development                                   People         Provider          Supplier
         Testing
    Documentation                                                                   Devices
    Implementation                        Process            Technology           Environment
      Maintenance                                                                  Interfaces
         Support                                                                   Computers
      Replacement                                   Policy                    Telecommunications
     Discontinuance
                                                                          Don’t underestimate the potential
              Statutes & Regulations                                      need for work ow changes when
              Organizational Policies                                            technology changes
© David M. Snyder, 42TEK, Inc., 2011   www.42tek.com                                                          16
Regulations
✤   Food & Drug Administration (FDA) regulates medical devices

    ✤   Medical Device Data Systems rule in February 2011

    ✤   Draft Guidance on Mobile Medical Applications in July 2011

✤   FCC/FDA Joint Meeting on Life Saving Wireless Medical Technology in July
    2010




© David M. Snyder, 42TEK, Inc., 2011   www.42tek.com                       17
Standards
✤   IHE PCD (Integrating the Healthcare                ✤   HITSP IS77 (Remote Monitoring
    Environment Patient Care Devices                       Interoperability Speci cation)
    Domain)
                                                       ✤   ICE (Integrating the Clinical
✤   IEEE 11073 (Point of Care Medical                      Environment)
    Device Information)
                                                       ✤   IEC 80001-1 & ISO 14971 (risk
✤   HL7 (Health Level 7)                                   management)

✤   MD FIRE (Medical Device Free                       ✤   IEC 60601 (medical electrical
    Interoperability Requirements for the                  equipment design)
    Enterprise)
                                                       ✤   IEC 62304 (medical software design)
✤   HITSP TN905 (Common Device
    Connectivity)
© David M. Snyder, 42TEK, Inc., 2011   www.42tek.com                                             18
Regulatory Drivers




          Source: Health Information Technology Standards Panel Report on HITSP/TN905 – Safe? Effective? Say what?!, January 26, 2010, Todd Cooper




© David M. Snyder, 42TEK, Inc., 2011                       www.42tek.com                                                                            19
Reimbursement
✤   “The ATA* said HHS should waive                                                “...broad adoption [of remote
      ve current Medicare rules that                                               health monitoring] will require
    ‘contain major, arbitrary barriers                                             three fundamental shifts in the
    to Accountable Care                                                            way health care services are
    Organizations.’ They include:”                                                 structured and paid for — namely,
    “restriction on paying for videoconferencing except in
    rural counties”
                                                                                   changes in reimbursement from
    “...restriction of Medicare payment for "store-and-
                                                                                   insurers, a new service model for
    forward" telehealth services, such as transmission of
    medical images to federal demonstration programs in
                                                                                   providers, and greater
    Alaska and Hawaii”                                                             engagement by patients and
    “Restrictions on what types of telehealth services
    Medicare covers”                                                               consumers in managing their
    “Bans on originating telehealth communication from                             own health.”
    certain locations, including a patient's home, hospices,                       Sarasohn-Kahn, Jane, The Connected Patient: Charting the Vital
    and some dialysis facilities...”                                               Signs of Remote Health Monitoring, February 2011
    “Restrictions on Medicare paying physical therapists,
    occupational therapists, and speech- language
    pathologists for telehealth services”
                                                          * American Telemedicine Association
    Versel, Neil, ACO Rules Limit Patient Telehealth Options, Information Week, April 29, 2011

© David M. Snyder, 42TEK, Inc., 2011                       www.42tek.com                                                                            20
Medical Device Data Security
✤   HIPAA Privacy & Security:
        ✤   Con dentiality (only authorized users)
        ✤   Integrity (precise, accurate, and complete - not altered or destroyed)
        ✤   Availability (accessible when and where needed)
✤   Data at Rest: on devices; on computers; on servers
✤   Data in Motion: wired and wireless communications channels; storage media
    being transported (CDs, DVDs, USB drives)
✤   Roles: who has access to what and what are their security obligations?
✤   “Business associates”
✤   Authentication: key management and updating roles/access
© David M. Snyder, 42TEK, Inc., 2011   www.42tek.com                                 21
Home Health Security
✤   Less controlled environment than healthcare provider facilities

✤   Less sophisticated users with less training and experience

✤   The more connected things become, the more vulnerabilities there are

✤   Finding the balance between security and ease-of-use




© David M. Snyder, 42TEK, Inc., 2011   www.42tek.com                       22
Market for Mobile Health

✤   Estimates vary, but the
    numbers are in the
    billions of dollars




                                                   Source: http://mobihealthnews.com/04-15-10-mhealth-predictions-verizons-new-mhealth-platform/




© David M. Snyder, 42TEK, Inc., 2011   www.42tek.com                                                                                        23
Examples

✤   Blood Pressure Tracker                             ✤   Practice Fusion

✤   Digi t                                             ✤   Runkeeper

✤   Heart Rate                                         ✤   Sleep Cycle

✤   Heartwise                                          ✤   Tonic

✤   iHealth

✤   MedApps
© David M. Snyder, 42TEK, Inc., 2011   www.42tek.com                         24
Blood Pressure Tracker




© David M. Snyder, 42TEK, Inc., 2011   www.42tek.com   25
Heart Rate
✤   Uses camera lens and ash on
    back of iPhone 4

✤   Simple app - no export




© David M. Snyder, 42TEK, Inc., 2011   www.42tek.com   26
Sleep Cycle Alarm Clock




© David M. Snyder, 42TEK, Inc., 2011   www.42tek.com   27
Information Sources
✤   http://www.mobilehealthwatch.com/

✤   http://mobihealthnews.com

✤   http://www. ercemobilehealthcare.com/

✤   http://www.mobilehealthcomputing.com/

✤   http://www.mhealthupdate.com/




© David M. Snyder, 42TEK, Inc., 2011   www.42tek.com   28
David Snyder
                                      President
                                     42TEK, Inc.
                                  www.42tek.com
                                 david@42tek.com
                        http://www.linkedin.com/in/dmsnyder




© David M. Snyder, 42TEK, Inc., 2011   www.42tek.com          29

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Mobile healthaug4 snyder

  • 1. Mobile Health - Overview Recording Health Monitoring Data SV Forum Mobile Internet SIG August 4, 2011 © David M. Snyder, 42TEK, Inc., 2011 www.42tek.com 1
  • 2. This Evening ✤ iHealth & MedApps Examples ✤ Mobile Health Overview - David Snyder, 42TEK, Inc. ✤ Setting the context ✤ Tracking Personal Health - Rajiv Mehta, Bhageera, Inc. ✤ Self-Quanti cation & Tonic iPhone app ✤ Dr. Justin Graham, Chief Medical Information Officer, NorthBay Healthcare ✤ The Healthcare Practitioner’s Perspective ✤ Panel Discussion/Questions & Answers © David M. Snyder, 42TEK, Inc., 2011 www.42tek.com 2
  • 3. Setting the Stage ✤ Healthcare Issues, including costs ✤ Regulations & Standards ✤ Healthcare IT ✤ Reimbursement ✤ Staying Healthy & Treating Illness ✤ Market, including obstacles ✤ Chronic Illness ✤ Technologies & Use Cases ✤ Systems and Processes ✤ Privacy & Security ✤ Electronic Health Records ✤ Interoperability ✤ What is Mobile Health? ✤ Companies © David M. Snyder, 42TEK, Inc., 2011 www.42tek.com 3
  • 4. What Is Mobile Health? ✤ No single de nition, but the main focus seems to be the use of telecommunications devices to (a) collect monitoring data outside of traditional clinic or hospital settings, (b) transmit such data from a remote location to a doctor or other healthcare professional, or to an electronic health record system, and (c) provide remote access to health care data and references. ✤ “m-health,” “remote monitoring,” “mobile health,” ... ✤ Telehealth seems to be about doctor (or other healthcare provider) interacting with a patient, or consulting with a medical colleague, via phone, video, email, text, etc. ✤ Telemedicine seems to be about conducting medical procedures via a telecommunications link. For example, remotely controlled robotic surgery. © David M. Snyder, 42TEK, Inc., 2011 www.42tek.com 4
  • 5. MedApps ✤ http://www.medapps.com/HealthPAL.html ✤ http://www.youtube.com/watch?v=GiV239PR0R4&feature=player_embedded#at=18 © David M. Snyder, 42TEK, Inc., 2011 www.42tek.com 5
  • 6. Healthcare Issues ✤ $2.7 Trillion/year = one-sixth of US GDP and growing Complica)ons  from  chronic   ✤ Aging population, with associated needs disease  account  for  ~75%  of   US  healthcare  spending Smith,  Joseph,  Iden%fying  Unmet  Public  Health  Needs  and   ✤ Chronic illness accounts for ~75% of costs Facilita%ng  Innova%on  in  Medical  Device  Development,   6/24/2010.    FDA  Public  Workshop ✤ Reactive, not proactive model - costs more once you are ill Remote health monitoring has the potential to reduce ✤ Potentially not enough healthcare professionals the demand on primary care providers by allowing chronically ill patients to ✤ Inertia and regulatory obstacles monitor and manage conditions at home. Sarasohn-Kahn, Jane, The Connected Patient: Charting the Vital Signs of Remote Health Monitoring, February 2011 © David M. Snyder, 42TEK, Inc., 2011 www.42tek.com 6
  • 7. Healthcare IT Trends ✤ Shifting from paper to electronic records ✤ Smaller and more portable devices with increasing computing power ✤ Convergence of clinical engineering and IT networks ✤ “Business intelligence” analytics to see patterns in data © David M. Snyder, 42TEK, Inc., 2011 www.42tek.com 7
  • 8. Complex Landscape © David M. Snyder, 42TEK, Inc., 2011 www.42tek.com 8
  • 9. Staying Healthy & Managing Illness ✤ Exercise ✤ Medication ✤ Diet ✤ Therapy ✤ Sleep ✤ Physical observations ✤ Community ✤ Analytical measurements © David M. Snyder, 42TEK, Inc., 2011 www.42tek.com 9
  • 10. Consumer Goods ✤ What used to be found only in hospitals is now on the shelves in Frys. © David M. Snyder, 42TEK, Inc., 2011 www.42tek.com 10
  • 11. Chronic Illness ✤ Major chronic illnesses where remote monitoring can help ✤ Chronic Obstructive Pulmonary Disease ✤ Congestive heart failure ✤ Diabetes Taking medicines as directed, careful monitoring, and doing the right things in •reminders ✤ Hypertension terms of diet, exercise, and •monitoring devices sleep can help prevent •tracking tools people from getting sicker. © David M. Snyder, 42TEK, Inc., 2011 www.42tek.com 11
  • 12. Data That Doctors Want © David M. Snyder, 42TEK, Inc., 2011 www.42tek.com 12
  • 13. Connecting Devices is Just Part of the Picture Electronic Health Record Is intervention needed? What sort of follow-up is required? Source for Image: Identifying Unmet Public Needs and Facilitating Innovation in Medical Device Development, June 24, 2010 Joseph M. Smith, MD, PhD [EHR added] - http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM221033.pdf © David M. Snyder, 42TEK, Inc., 2011 www.42tek.com 13
  • 14. Electronic Health Records ✤ Large focus in recent healthcare legislation - federal incentives to doctors and hospitals to implement ✤ Growing provision of access to patients and authorized family members ✤ Various Personal Health Record initiatives, like Microsoft HealthVault and Google Health ✤ Health Information Exchanges being built to support interoperability between organizations (e.g., Kaiser Permanente and Veterans Administration) ✤ Growth in automatic input of monitoring data in EHRs - including from mobile health devices © David M. Snyder, 42TEK, Inc., 2011 www.42tek.com 14
  • 15. Interoperability © David M. Snyder, 42TEK, Inc., 2011 www.42tek.com IHE = Integrating the Healthcare Enterprise 15
  • 16. Parts of the Puzzle Patient Payer Family Regulator Design Caregiver Vendor Development People Provider Supplier Testing Documentation Devices Implementation Process Technology Environment Maintenance Interfaces Support Computers Replacement Policy Telecommunications Discontinuance Don’t underestimate the potential Statutes & Regulations need for work ow changes when Organizational Policies technology changes © David M. Snyder, 42TEK, Inc., 2011 www.42tek.com 16
  • 17. Regulations ✤ Food & Drug Administration (FDA) regulates medical devices ✤ Medical Device Data Systems rule in February 2011 ✤ Draft Guidance on Mobile Medical Applications in July 2011 ✤ FCC/FDA Joint Meeting on Life Saving Wireless Medical Technology in July 2010 © David M. Snyder, 42TEK, Inc., 2011 www.42tek.com 17
  • 18. Standards ✤ IHE PCD (Integrating the Healthcare ✤ HITSP IS77 (Remote Monitoring Environment Patient Care Devices Interoperability Speci cation) Domain) ✤ ICE (Integrating the Clinical ✤ IEEE 11073 (Point of Care Medical Environment) Device Information) ✤ IEC 80001-1 & ISO 14971 (risk ✤ HL7 (Health Level 7) management) ✤ MD FIRE (Medical Device Free ✤ IEC 60601 (medical electrical Interoperability Requirements for the equipment design) Enterprise) ✤ IEC 62304 (medical software design) ✤ HITSP TN905 (Common Device Connectivity) © David M. Snyder, 42TEK, Inc., 2011 www.42tek.com 18
  • 19. Regulatory Drivers Source: Health Information Technology Standards Panel Report on HITSP/TN905 – Safe? Effective? Say what?!, January 26, 2010, Todd Cooper © David M. Snyder, 42TEK, Inc., 2011 www.42tek.com 19
  • 20. Reimbursement ✤ “The ATA* said HHS should waive “...broad adoption [of remote ve current Medicare rules that health monitoring] will require ‘contain major, arbitrary barriers three fundamental shifts in the to Accountable Care way health care services are Organizations.’ They include:” structured and paid for — namely, “restriction on paying for videoconferencing except in rural counties” changes in reimbursement from “...restriction of Medicare payment for "store-and- insurers, a new service model for forward" telehealth services, such as transmission of medical images to federal demonstration programs in providers, and greater Alaska and Hawaii” engagement by patients and “Restrictions on what types of telehealth services Medicare covers” consumers in managing their “Bans on originating telehealth communication from own health.” certain locations, including a patient's home, hospices, Sarasohn-Kahn, Jane, The Connected Patient: Charting the Vital and some dialysis facilities...” Signs of Remote Health Monitoring, February 2011 “Restrictions on Medicare paying physical therapists, occupational therapists, and speech- language pathologists for telehealth services” * American Telemedicine Association Versel, Neil, ACO Rules Limit Patient Telehealth Options, Information Week, April 29, 2011 © David M. Snyder, 42TEK, Inc., 2011 www.42tek.com 20
  • 21. Medical Device Data Security ✤ HIPAA Privacy & Security: ✤ Con dentiality (only authorized users) ✤ Integrity (precise, accurate, and complete - not altered or destroyed) ✤ Availability (accessible when and where needed) ✤ Data at Rest: on devices; on computers; on servers ✤ Data in Motion: wired and wireless communications channels; storage media being transported (CDs, DVDs, USB drives) ✤ Roles: who has access to what and what are their security obligations? ✤ “Business associates” ✤ Authentication: key management and updating roles/access © David M. Snyder, 42TEK, Inc., 2011 www.42tek.com 21
  • 22. Home Health Security ✤ Less controlled environment than healthcare provider facilities ✤ Less sophisticated users with less training and experience ✤ The more connected things become, the more vulnerabilities there are ✤ Finding the balance between security and ease-of-use © David M. Snyder, 42TEK, Inc., 2011 www.42tek.com 22
  • 23. Market for Mobile Health ✤ Estimates vary, but the numbers are in the billions of dollars Source: http://mobihealthnews.com/04-15-10-mhealth-predictions-verizons-new-mhealth-platform/ © David M. Snyder, 42TEK, Inc., 2011 www.42tek.com 23
  • 24. Examples ✤ Blood Pressure Tracker ✤ Practice Fusion ✤ Digi t ✤ Runkeeper ✤ Heart Rate ✤ Sleep Cycle ✤ Heartwise ✤ Tonic ✤ iHealth ✤ MedApps © David M. Snyder, 42TEK, Inc., 2011 www.42tek.com 24
  • 25. Blood Pressure Tracker © David M. Snyder, 42TEK, Inc., 2011 www.42tek.com 25
  • 26. Heart Rate ✤ Uses camera lens and ash on back of iPhone 4 ✤ Simple app - no export © David M. Snyder, 42TEK, Inc., 2011 www.42tek.com 26
  • 27. Sleep Cycle Alarm Clock © David M. Snyder, 42TEK, Inc., 2011 www.42tek.com 27
  • 28. Information Sources ✤ http://www.mobilehealthwatch.com/ ✤ http://mobihealthnews.com ✤ http://www. ercemobilehealthcare.com/ ✤ http://www.mobilehealthcomputing.com/ ✤ http://www.mhealthupdate.com/ © David M. Snyder, 42TEK, Inc., 2011 www.42tek.com 28
  • 29. David Snyder President 42TEK, Inc. www.42tek.com david@42tek.com http://www.linkedin.com/in/dmsnyder © David M. Snyder, 42TEK, Inc., 2011 www.42tek.com 29