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mHealth AdoptionBarriers: Privacy& RegulationHealth Debate Webinar5 February 2013
HUMAN           POLITICS &    PRIVACY &               BEHAVIOUR         ECONOMICS    REGULATION            MHEALTH BARRIER...
AGENDAMHEALTH ADOPTION BARRIERS:PRIVACY & REGULATION1.            TONY KANE HEAD OF MHEALTH VODAFONE2.            ALEXANDR...
NEARLY 50% OF PATIENTS      PREDICTTHAT MHEALTH WILL IMPROVE THECONVENIENCE, QUALITY AND COST OFHEALTH CARE IN THE NEXT 3 ...
ONLY AROUND HALF OF DOCTORSBELIEVE THEIR MOBILE INTERNETFACILITIES ARE REASONABLY SECUREPWC survey 2012     #mHealthbarrie...
CONTINUOUS COLLECTION                                       THREE NEW                                     DIMENSIONS TO   ...
“INFORMED CONSENT RARELYFUNCTIONS WELL IN ONLINEINTERACTIONS IN THE SENSE THATIT IS UNLIKELY TO BE TRULYINFORMED AND FREEL...
“MANY ORGANISATIONS NOWDESTROY OR WIPE COMPUTER HARDDRIVES BEFORE DECOMMISSIONING.THE SAME THING IS NOT YETHAPPENING WITH ...
WHO OWNS THE DATA ANYWAY?                                  Is it an either/or situation:                                  ...
APPROACHES TO PRIVACY VARY GLOBALLY…. #mHealthbarriers @Vodafone_VGE
WHEN IS MY PHONE A MEDICAL DEVICE? 13,000 APPS ON ITUNES RELATE TO HEALTH AND WELLNESS. POTENTIALLY   ONE THIRD OF THESE S...
APPROACHES TO REGULATION VARY                     GLOBALLY….#mHealthbarriers @Vodafone_VGE
US Federal Communications Commission 2012 task force recommendations:              1. FCC SHOULD APPOINT A HEALTHCARE DIRE...
“SOFTWARE FOR GENERAL PURPOSESWHEN USED IN A HEALTHCARESETTING IS NOT A MEDICAL DEVICE”EU directive 2007/47/EC     #mHealt...
POSSIBLE SOLUTIONS   ?1. Consent needs to move from a “box-ticking approach” to   compliance to a more sophisticated and f...
mHealth AdoptionBarriers: Privacy& RegulationHealth Debate Webinar5 February 2013
Main contact: Dr Alex Wyke, FRSMTel: +44-(0)1547-520-965Email: alexwyke@patient-view
mHealth AdoptionBarriers: Privacy& RegulationHealth Debate Webinar5 February 2013
Evaluating mHealth Adoption Barriers: Privacy and Regulation           Mark Stevens 
• When is a device medical?• How do we deal with the regulatory   barriers and ensure appropriate   compliance requirement...
• It depends!• There is a matrix of influencing   factors that must be considered in   order to identify the most pragmati...
mHealth system definition       Wellbeing / Healthy Lifestyle                               Medical Device                ...
mHealth system classification
mHealth system classification           Patient safety!What would be the impact upon patient  safety if the mHealth system...
Which Regulations and Guidance?GAMP 5: A Risk‐Based Approach to Compliant GxP Computerised Systems ISO13485 Standard for M...
Quality & ComplianceWhatever the precise regulatory framework might be for a new solution, some things are common sense:• ...
Introducing the Quality Supply Chain
The challenges• Good progress being made on convergence but still a long way to go – interpretation needed •Dynamic enviro...
Pushing through the barriers• Simple is good!• Be mindful that mHealth solution is a component of a process that must supp...
Evaluating mHealth Adoption Barriers: Privacy and Regulation           Mark Stevens           www.GXPi.com          info@G...
mHealth AdoptionBarriers: Privacy& RegulationHealth Debate Webinar5 February 2013
WHAT IS YOUR VIEW?CONTINUE THE HEALTH DEBATE ONLINE      TWITTER:#mhealthbarriers @Vodafone_VGE      LINKEDIN:mHealth.voda...
Health debate webinar   patient privacy and regulations reviewed as an m health barrier
Health debate webinar   patient privacy and regulations reviewed as an m health barrier
Health debate webinar   patient privacy and regulations reviewed as an m health barrier
Health debate webinar   patient privacy and regulations reviewed as an m health barrier
Health debate webinar   patient privacy and regulations reviewed as an m health barrier
Health debate webinar   patient privacy and regulations reviewed as an m health barrier
Health debate webinar   patient privacy and regulations reviewed as an m health barrier
Health debate webinar   patient privacy and regulations reviewed as an m health barrier
Health debate webinar   patient privacy and regulations reviewed as an m health barrier
Health debate webinar   patient privacy and regulations reviewed as an m health barrier
Health debate webinar   patient privacy and regulations reviewed as an m health barrier
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Health debate webinar patient privacy and regulations reviewed as an m health barrier

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Slidedeck used for the VF Health Debate webinar with panel speakers from Patientview and GXPi on 05/02/13

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Transcript of "Health debate webinar patient privacy and regulations reviewed as an m health barrier"

  1. 1. mHealth AdoptionBarriers: Privacy& RegulationHealth Debate Webinar5 February 2013
  2. 2. HUMAN POLITICS & PRIVACY & BEHAVIOUR ECONOMICS REGULATION MHEALTH BARRIER SERIES#mHealthbarriers @Vodafone_VGE
  3. 3. AGENDAMHEALTH ADOPTION BARRIERS:PRIVACY & REGULATION1. TONY KANE HEAD OF MHEALTH VODAFONE2. ALEXANDRA WYKE MD PATIENT VIEW3. MARK STEVENS OPERATIONS DIRECTOR GXPI4. PANEL &AUDIENCE HEALTH DEBATE #mHealthbarriers @Vodafone_VGE
  4. 4. NEARLY 50% OF PATIENTS PREDICTTHAT MHEALTH WILL IMPROVE THECONVENIENCE, QUALITY AND COST OFHEALTH CARE IN THE NEXT 3 YEARSPWC SURVEY 2012 #mHealthbarriers @Vodafone_VGE
  5. 5. ONLY AROUND HALF OF DOCTORSBELIEVE THEIR MOBILE INTERNETFACILITIES ARE REASONABLY SECUREPWC survey 2012 #mHealthbarriers @Vodafone_VGE
  6. 6. CONTINUOUS COLLECTION THREE NEW DIMENSIONS TO HEALTH DATA QUANTITY CROSS-BORDER#mHealthbarriers @Vodafone_VGE
  7. 7. “INFORMED CONSENT RARELYFUNCTIONS WELL IN ONLINEINTERACTIONS IN THE SENSE THATIT IS UNLIKELY TO BE TRULYINFORMED AND FREELY GIVEN”EnCoRe: Ensuring Consent and Revocation Research 2010 #mHealthbarriers @Vodafone_VGE
  8. 8. “MANY ORGANISATIONS NOWDESTROY OR WIPE COMPUTER HARDDRIVES BEFORE DECOMMISSIONING.THE SAME THING IS NOT YETHAPPENING WITH SMARTPHONES.”ENISA (European Network and Information Security Agency) 2010 #mHealthbarriers @Vodafone_VGE
  9. 9. WHO OWNS THE DATA ANYWAY? Is it an either/or situation: the data is freely available for research purposes? Or is it owned by the patient? #mHealthbarriers @Vodafone_VGE
  10. 10. APPROACHES TO PRIVACY VARY GLOBALLY…. #mHealthbarriers @Vodafone_VGE
  11. 11. WHEN IS MY PHONE A MEDICAL DEVICE? 13,000 APPS ON ITUNES RELATE TO HEALTH AND WELLNESS. POTENTIALLY ONE THIRD OF THESE SHOULD BE REVIEWED AS REGULATABLE. #mHealthbarriers @Vodafone_VGE
  12. 12. APPROACHES TO REGULATION VARY GLOBALLY….#mHealthbarriers @Vodafone_VGE
  13. 13. US Federal Communications Commission 2012 task force recommendations: 1. FCC SHOULD APPOINT A HEALTHCARE DIRECTOR 2. SEEK PUBLIC INPUT ON REGULATORY ISSUES 3. COLLABORATION ACROSS FCC AND FDA 4. BUILD ON EXISTING PROGRAMS SUCH AS EXPANDING RURAL ACCESS TO BROADBAND SERVICESHEALTH AND TELECOMSCOLLIDING? COLLUDING? #mHealthbarriers @Vodafone_VGE
  14. 14. “SOFTWARE FOR GENERAL PURPOSESWHEN USED IN A HEALTHCARESETTING IS NOT A MEDICAL DEVICE”EU directive 2007/47/EC #mHealthbarriers @Vodafone_VGE
  15. 15. POSSIBLE SOLUTIONS ?1. Consent needs to move from a “box-ticking approach” to compliance to a more sophisticated and flexible on-going dialogue with the patient about data usage and consent.2. Governments and Regulators need to provide more clarity around what is regulatable, and co-operate internationally on this topic.3. All stakeholders need to collaborate… … no single party can make this happen #mHealthbarriers @Vodafone_VGE
  16. 16. mHealth AdoptionBarriers: Privacy& RegulationHealth Debate Webinar5 February 2013
  17. 17. Main contact: Dr Alex Wyke, FRSMTel: +44-(0)1547-520-965Email: alexwyke@patient-view
  18. 18. mHealth AdoptionBarriers: Privacy& RegulationHealth Debate Webinar5 February 2013
  19. 19. Evaluating mHealth Adoption Barriers: Privacy and Regulation Mark Stevens 
  20. 20. • When is a device medical?• How do we deal with the regulatory  barriers and ensure appropriate  compliance requirements are met for  an mHealth solution?...
  21. 21. • It depends!• There is a matrix of influencing  factors that must be considered in  order to identify the most pragmatic  approach.
  22. 22. mHealth system definition Wellbeing / Healthy Lifestyle Medical Device Medical Device Information  System
  23. 23. mHealth system classification
  24. 24. mHealth system classification Patient safety!What would be the impact upon patient  safety if the mHealth system / device  was to fail or operate incorrectly?
  25. 25. Which Regulations and Guidance?GAMP 5: A Risk‐Based Approach to Compliant GxP Computerised Systems ISO13485 Standard for Medical Devices Quality Management SystemsFDA Quality System Regulation for Medical Devices, 21 CFR Part 820 HIPAA Health Insurance Portability and Accountability Act, 1996, Title IIFDA Medical Device Data Systems, Final Rule, effective April 18 2011.FDA Draft Guidance – Mobile Medical Applications, July 2011 Note that Technology changes faster than the Regulations!
  26. 26. Quality & ComplianceWhatever the precise regulatory framework might be for a new solution, some things are common sense:• Quality Management Systems• Tested, validated software• Service Level Agreements
  27. 27. Introducing the Quality Supply Chain
  28. 28. The challenges• Good progress being made on convergence but still a long way to go – interpretation needed •Dynamic environments – traditional approaches to validation and compliance not appropriate• Requires a shared responsibility and ownership to the implementation and maintaining a compliant system• Different views and definitions of what constitutes a medical device and where mHealth does or can fit in
  29. 29. Pushing through the barriers• Simple is good!• Be mindful that mHealth solution is a component of a process that must support patients and those responsible for their care• Plan for success – mHealth solution categorisation, community acceptance, pilot study• Patient Safety. Patient Safety. Patient Safety.
  30. 30. Evaluating mHealth Adoption Barriers: Privacy and Regulation Mark Stevens  www.GXPi.com info@GXPi.com
  31. 31. mHealth AdoptionBarriers: Privacy& RegulationHealth Debate Webinar5 February 2013
  32. 32. WHAT IS YOUR VIEW?CONTINUE THE HEALTH DEBATE ONLINE TWITTER:#mhealthbarriers @Vodafone_VGE LINKEDIN:mHealth.vodafone.com/linkedin #mHealthbarriers @Vodafone_VGE
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