United4Health session - COCIR€¦ · 4. State of play on the applicable EU legal framework 5....

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!