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

Health Debate Webinar5 February 2013

mHealth Adoption Barriers: Privacy & Regulation

#mHealthbarriers @Vodafone_VGE

HUMAN BEHAVIOUR

POLITICS & ECONOMICS

PRIVACY & REGULATION

MHEALTH BARRIER SERIES


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


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


ONLY AROUND HALF OF DOCTORSBELIEVE THEIR MOBILE INTERNET FACILITIES ARE REASONABLY SECUREPWC survey 2012


CONTINUOUS COLLECTION

QUANTITY CROSS-BORDER

THREE NEW DIMENSIONS TO

HEALTH DATA


“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


“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


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?


APPROACHES TO PRIVACY VARY GLOBALLY….


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.


APPROACHES TO REGULATION VARY GLOBALLY….


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:


“SOFTWARE FOR GENERAL PURPOSES WHEN USED IN A HEALTHCARE SETTING IS NOT A MEDICAL DEVICE” EU directive 2007/47/EC


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?



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



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

[email protected]




WHAT IS YOUR VIEW? CONTINUE THE HEALTH DEBATE ONLINE

TWITTER: #mhealthbarriers @Vodafone_VGE

LINKEDIN:mHealth.vodafone.com/linkedin