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TRANSCRIPT
United4Health session Regulatory Framework Trends & Updates
Nicole Denjoy – COCIR Secretary General Wed. 7 May 2014, Berlin (Germany)
Outline 1. What is COCIR ?
2. COCIR’s vision on eHealth
3. Overview on mHealth
4. Legal & Regulatory Trends
1. What is COCIR?
What is COCIR?
COCIR covers 3 key industry sectors: • Medical Imaging • Electromedical • Health ICT
Our Industry leads in state-of-art advanced technology and provides integrated
solutions covering the complete care cycle
With offices in Brussels and in China, COCIR promotes the use of advanced medical and ICT technology towards seamless care delivery and shared knowledge to build a better world with improved access to affordable, quality and safe healthcare
COCIR is a non-profit trade association, founded in 1959, representing the medical technology industry in Europe
COCIR Member Companies
COCIR National Trade Associations Members
Belgium UK Spain
Netherlands Netherlands Finland France
Germany Germany Sweden Turkey
Germany
COCIR at international level
2. COCIR’s vision on eHealth
COCIR vision on eHealth
Vision:
Transform Healthcare
towards seamless integrated care
Mission:
Act as a EU Hub
& Support national and regional deployment
COCIR presence and influence on eHealth
National level
European level
International level
Cooperation with national trade associations Direct links with governments, competent authorites, national agencies Participation in national events
COCIR sits in various fora: eHGI, eHealth stakeholder group, Strong relationship with EU insitutions Participates in EU funded projects Stakeholder federator: COCIR is the initiator of the Healthcare Coalition on Data Protection
COCIR chairs the BIAC Healthcare Task Force COCIR contributes to EU-US cooperation on interoperability COCIR contributes to EU-China cooperation COCIR is a driving force behind the IMDRF COCIR is a member of DITTA
COCIR Toolkits Concept
2010 2011 2012 2013 2014
3. Overview on mHealth
The mHealth value chain A multiplicity of actors
The mHealth market Growth perspectives
Sources: Commonwealth Fund, 2009; CSC, PhRMA, ANA, AHA, 2011; Deloitte, CMS, 2012; GSMA 2012
Estimated mHealth revenue, 2013-2017
+117%
+158%
Growth of mHealth apps between 2010 & 2012
Source: Research2Guidance, 2013
17 350
37 609
97.119
0
20 000
40 000
60 000
80 000
100 000
120 000
2010 2011 2012
Total number of mHealth apps
Better access to healthcare
Helps address demographic trends
Improves efficiency of healthcare
Benefits of mHealth
mHealth - COCIR recommendations
1. Integrate mHealth into care
delivery structures
2. Enable citizens’ access
to their data
3. Develop appropriate
reimbursement strategies
4. Establish a harmonised data
protection regime that allows innovation
6. Provide clear
regulatory guidance
7. Foster use of widely
recognised standards
5. Support mobile
broadbacnd policies
4. Legal and Regulatory Trends
A – Regulatory Trends on Medical Software
B - Data protection
C – Standardisation initiatives
Global landscape Proliferation of initiatives, lack of harmonisation compared to the fast development of technologies
FDA guidance on mobile medical apps
Towards Global Harmonisation
- EU Medical Devices Directive
-EU guidelines on standalone software (+ national initiatives) -EU data protection Directive
-Under discussions: -EU Medical Device Regulation -EU General Data Protection Regulation -Green Paper on mHealth - consultation
EU
EU political agenda on eHealth
2004 2007 2008 2010 2012 2009 2011 2013 2014
Green paper on mHealth
1. The Green Paper: – https://ec.europa.eu/digital-agenda/en/public-
consultation-green-paper-mobile-health
– Launched on 10 April 2014 is a wide public consultation to collect ideas to unlock mHealth potential in Europe .
– Consultation will close on 3 July 2014
2. This consultation is accompanied with a Staff Working Document which clarifies the current legal framework applicable to lifestyle and wellbeing apps
1. Contents of the Consultation
1. General information on respondents
2. Data protection including security of health data
3. Big data
4. State of play on the applicable EU legal framework
5. Patient safety and transparency of information
6. The role of mHealth in healthcare systems and equal access
7. Interoperability
8. Reimbursement models
9. Liability
10. Research and innovation in mHealth
11. International cooperation
12. Access of web entrepreneurs to the mHealth market
13. Concluding remarks & references
2. Staff Working Paper - Structure
• Introduction
• EU Safety and performance requirements
• App Users’ Rights
– Right to privacy and to data protection
– Other rights
• Consumers’ Rights Dirctive
• Rights enshrined in eCommerce Directive
• Rights enshrined in unfair commercial practice Directive
Most Important
One
2. Important References
1. Medical Device Directive 93/42 & 47/2007
If mHealth apps fall under the definition of a medical devices, or of an in-vitro diagnostic medical device: they have to comply with Dir. 93/42 & 47/2007.
A-Safety & performance requirements
2. MEDDEV 2012
EC guidance to determine whether an app qualifies as a medical device (decision tree).
A-Safety & performance requirements
3. General Products Safety Directive & Directive on Liability for Defective Products
It is not clear whether these Directives apply to health apps.
A-Safety & performance requirements
Other initiatives:
• IMDRF
• Canada
• Japan
• USA
A-Safety & performance requirements
IMDRF work item « SaMD: Software As a medical Device »
Objective to achieve global regulatory convergence on medical software by determining:
1. Common key criteria whether software is a MD or not,
2. Risk stratification framework for generic types of SaMD on their unique risks
3. Corresponding controls for the different SaMD types
B – Privacy &Data Protection
• Data Protection Directive (95/46/EC)
• ePrivacy Directive (2002/58/EC)
Health data cannot be processed, with a few exceptions: •Explicit consent of data subject •Vital interest of data subject •For purposes of preventive medicine, medical diagnosis, provision of care, or the management of HC services, where these data are managed by a HC professional with a professional obligation of secrecy •Data controllers must notify dataprotection authorities before processing personal data.
B – Privacy &Data Protection
• Article 29 Working Party opinion on apps on smart devices
• Article 29 Working Party opinion on cloud computing
B – Privacy &Data Protection
Timeline
• 1995 Directive
• 2012 EC adopted Draft Regulation
• 2013 Vote in EP committee
• 2014 Vote in EP plenary
• 2015 Adoption … if Council reaches consensus
B- Privacy & Data Protection
• Draft regulation intends to regulate how to collect, store, process and share health data: – Art 4: Any data related directy or indirectly to the patient
will be considered medical data, incl. a device identifier
– Art 81: Only health professionals can access health data
– Art 33 : Important data protection impact assessment obligations
– Joint liability with data controller (healthcare provider)
• Can negatively impact the benefits of data driven healthcare
B – Privacy & Data Protection
Healthcare Coalition on Data protection informs decision-makers on the health aspects in the Regulation.
C - Standardisation initiatives
• Standards play an important role, complementing the existing regulatory framework and brining consistency
• 3 Key International Committees:
– ISO TC 210
– ISO TC 215
– IEC TC 62
reference: IEC 62304 and 82304-1
COCIR recommendations
1. Build a supportive, predictable, and cost efficient regulatory system, to consolidate the EU’s leadership in MD innovation and maintain patients rapide acces to healthcare
2. Provide clear & simple guidance on what is a medical device
3. Promote the adoption of market-driven standards, while avoiding strict technology mandates
4. Adopt clear, workable data protection regime that allows data sharing in healthcare
5. Integrate health data from consumer/personal apps in EPRs and healthcare system
6. Strengthen IT skills in healthcare workforce
Thank you for your attention!