Our Health Debate webinar discusses the barriers to mHealth wihin the regulatory environment. It included a debate with an expert panel and a live audience discussion. Topics discussed in the webinar include: 1. How to protect patient privacy in a mobile world? 2. User consent: what is the best way to agree? 3. mHealth security – high risk, low awareness? 4. mHealth and regulation – when is a device medical? Join the debate on Twitter - #mhealthbarriers You can also download the latest mHealth Insights Guide on this topic here: http://enterprise.vodafone.com/insight_news/2013-01-16-evaluating-mhealth-adoption-barriers-privacy-and-regulation.jsp

1. mHealth Adoption
Barriers: Privacy
& Regulation
Health Debate Webinar
5 February 2013

2. HUMAN POLITICS & PRIVACY &
BEHAVIOUR ECONOMICS REGULATION
MHEALTH BARRIER SERIES
#mHealthbarriers @Vodafone_VGE

3. AGENDA
MHEALTH ADOPTION BARRIERS:
PRIVACY & REGULATION
1. TONY KANE HEAD OF MHEALTH VODAFONE
2. ALEXANDRA WYKE MD PATIENT VIEW
3. MARK STEVENS OPERATIONS DIRECTOR GXPI
4. PANEL &AUDIENCE HEALTH DEBATE
#mHealthbarriers @Vodafone_VGE

4. NEARLY 50% OF PATIENTS PREDICT
THAT MHEALTH WILL IMPROVE THE
CONVENIENCE, QUALITY AND COST OF
HEALTH CARE IN THE NEXT 3 YEARS
PWC SURVEY 2012
#mHealthbarriers @Vodafone_VGE

5. ONLY AROUND HALF OF DOCTORS
BELIEVE THEIR MOBILE INTERNET
FACILITIES ARE REASONABLY SECURE
PWC survey 2012
#mHealthbarriers @Vodafone_VGE

6. CONTINUOUS COLLECTION
THREE NEW
DIMENSIONS TO
HEALTH DATA
QUANTITY CROSS-BORDER
#mHealthbarriers @Vodafone_VGE

7. “INFORMED CONSENT RARELY
FUNCTIONS WELL IN ONLINE
INTERACTIONS IN THE SENSE THAT
IT IS UNLIKELY TO BE TRULY
INFORMED AND FREELY GIVEN”
EnCoRe: Ensuring Consent and Revocation Research 2010
#mHealthbarriers @Vodafone_VGE

8. “MANY ORGANISATIONS NOW
DESTROY OR WIPE COMPUTER HARD
DRIVES BEFORE DECOMMISSIONING.
THE SAME THING IS NOT YET
HAPPENING WITH SMARTPHONES.”
ENISA (European Network and Information Security Agency) 2010
#mHealthbarriers @Vodafone_VGE

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. APPROACHES TO PRIVACY VARY GLOBALLY….
#mHealthbarriers @Vodafone_VGE

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. APPROACHES TO REGULATION VARY
GLOBALLY….
#mHealthbarriers @Vodafone_VGE

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
SERVICES
HEALTH AND TELECOMS
COLLIDING? COLLUDING?
#mHealthbarriers @Vodafone_VGE

14. “SOFTWARE FOR GENERAL PURPOSES
WHEN USED IN A HEALTHCARE
SETTING IS NOT A MEDICAL DEVICE”
EU directive 2007/47/EC
#mHealthbarriers @Vodafone_VGE

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. mHealth Adoption
Barriers: Privacy
& Regulation
Health Debate Webinar
5 February 2013

28. Main contact: Dr Alex Wyke, FRSM
Tel: +44-(0)1547-520-965
Email: alexwyke@patient-view

29. mHealth Adoption
Barriers: Privacy
& Regulation
Health Debate Webinar
5 February 2013

30. Evaluating mHealth Adoption
Barriers: Privacy and Regulation
Mark Stevens

31. • When is a device medical?
• How do we deal with the regulatory
barriers and ensure appropriate
compliance requirements are met for
an mHealth solution?...

32. • It depends!
• There is a matrix of influencing
factors that must be considered in
order to identify the most pragmatic
approach.

33. mHealth system definition
Wellbeing / Healthy Lifestyle
Medical Device
Medical Device
Information
System

34. mHealth system classification

35. mHealth system classification
Patient safety!
What would be the impact upon patient
safety if the mHealth system / device
was to fail or operate incorrectly?

36. Which Regulations and Guidance?
GAMP 5: A Risk‐Based Approach to Compliant GxP Computerised Systems
ISO13485 Standard for Medical Devices Quality Management Systems
FDA Quality System Regulation for Medical Devices, 21 CFR Part 820
HIPAA Health Insurance Portability and Accountability Act, 1996, Title II
FDA 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!

37. Quality & Compliance
Whatever the precise regulatory framework
might be for a new solution, some things
are common sense:
• Quality Management Systems
• Tested, validated software
• Service Level Agreements

38. Introducing the Quality Supply Chain

39. 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

40. 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.

41. Evaluating mHealth Adoption
Barriers: Privacy and Regulation
Mark Stevens
www.GXPi.com
info@GXPi.com

42. mHealth Adoption
Barriers: Privacy
& Regulation
Health Debate Webinar
5 February 2013

43. WHAT IS YOUR VIEW?
CONTINUE THE HEALTH DEBATE ONLINE
TWITTER:
#mhealthbarriers @Vodafone_VGE
LINKEDIN:
mHealth.vodafone.com/linkedin
#mHealthbarriers @Vodafone_VGE