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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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Health Debate Webinar5 February 2013
mHealth Adoption Barriers: Privacy & Regulation
#mHealthbarriers @Vodafone_VGE
HUMAN BEHAVIOUR
POLITICS & ECONOMICS
PRIVACY & REGULATION
MHEALTH BARRIER SERIES
#mHealthbarriers @Vodafone_VGE
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
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
ONLY AROUND HALF OF DOCTORSBELIEVE THEIR MOBILE INTERNET FACILITIES ARE REASONABLY SECUREPWC survey 2012
#mHealthbarriers @Vodafone_VGE
CONTINUOUS COLLECTION
QUANTITY CROSS-BORDER
THREE NEW DIMENSIONS TO
HEALTH DATA
#mHealthbarriers @Vodafone_VGE
“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
“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
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
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 SHOULD BE REVIEWED AS REGULATABLE.
#mHealthbarriers @Vodafone_VGE
APPROACHES TO REGULATION VARY GLOBALLY….
#mHealthbarriers @Vodafone_VGE
HEALTH AND TELECOMS COLLIDING? COLLUDING?
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
US Federal Communications Commission 2012 task force recommendations:
#mHealthbarriers @Vodafone_VGE
“SOFTWARE FOR GENERAL PURPOSES WHEN USED IN A HEALTHCARE SETTING IS NOT A MEDICAL DEVICE” EU directive 2007/47/EC
#mHealthbarriers @Vodafone_VGE
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
POSSIBLE SOLUTIONS?
Health Debate Webinar5 February 2013
mHealth Adoption Barriers: Privacy & Regulation
Main contact: Dr Alex Wyke, FRSM Tel: +44-(0)1547-520-965Email: alexwyke@patient-view
Health Debate Webinar5 February 2013
mHealth Adoption Barriers: Privacy & Regulation
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 requirements are met for an mHealth solution?...
• It depends!
• There is a matrix of influencing factors that must be considered in order to identify the most pragmatic approach.
mHealth system definition
Wellbeing / Healthy Lifestyle
Medical Device
Medical Device
Information System
mHealth system classification
mHealth system classification
What would be the impact upon patient safety if the mHealth system / device was to fail or operate incorrectly?
Patient safety!
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!
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
Introducing the Quality Supply Chain
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
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.
Evaluating mHealth Adoption Barriers: Privacy and Regulation
Mark Stevens
www.GXPi.cominfo@GXPi.com
Health Debate Webinar5 February 2013
mHealth Adoption Barriers: Privacy & Regulation
#mHealthbarriers @Vodafone_VGE
WHAT IS YOUR VIEW? CONTINUE THE HEALTH DEBATE ONLINE
TWITTER: #mhealthbarriers @Vodafone_VGE
LINKEDIN:mHealth.vodafone.com/linkedin
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