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mHealth Adoption Barriers: Privacy & Regulation - Health Debate Webinar findings from Vodafone Global Enterprise
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mHealth Adoption Barriers: Privacy & Regulation - Health Debate Webinar findings from Vodafone Global Enterprise

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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. ...

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

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mHealth Adoption Barriers: Privacy & Regulation - Health Debate Webinar findings from Vodafone Global Enterprise mHealth Adoption Barriers: Privacy & Regulation - Health Debate Webinar findings from Vodafone Global Enterprise Presentation Transcript

  • mHealth AdoptionBarriers: Privacy& RegulationHealth Debate Webinar5 February 2013
  • HUMAN POLITICS & PRIVACY & BEHAVIOUR ECONOMICS REGULATION MHEALTH BARRIER SERIES#mHealthbarriers @Vodafone_VGE
  • 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
  • NEARLY 50% OF PATIENTS PREDICTTHAT MHEALTH WILL IMPROVE THECONVENIENCE, QUALITY AND COST OFHEALTH CARE IN THE NEXT 3 YEARSPWC SURVEY 2012 #mHealthbarriers @Vodafone_VGE
  • ONLY AROUND HALF OF DOCTORSBELIEVE THEIR MOBILE INTERNETFACILITIES ARE REASONABLY SECUREPWC survey 2012 #mHealthbarriers @Vodafone_VGE
  • CONTINUOUS COLLECTION THREE NEW DIMENSIONS TO HEALTH DATA QUANTITY CROSS-BORDER#mHealthbarriers @Vodafone_VGE
  • “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
  • “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
  • 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
  • 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
  • “SOFTWARE FOR GENERAL PURPOSESWHEN USED IN A HEALTHCARESETTING IS NOT A MEDICAL DEVICE”EU directive 2007/47/EC #mHealthbarriers @Vodafone_VGE
  • 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
  • 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 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 Patient safety!What would be the impact upon patient  safety if the mHealth system / device  was to fail or operate incorrectly?
  • 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!
  • 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
  • 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.com info@GXPi.com
  • mHealth AdoptionBarriers: Privacy& RegulationHealth Debate Webinar5 February 2013
  • WHAT IS YOUR VIEW?CONTINUE THE HEALTH DEBATE ONLINE TWITTER:#mhealthbarriers @Vodafone_VGE LINKEDIN:mHealth.vodafone.com/linkedin #mHealthbarriers @Vodafone_VGE