The document summarizes the European regulatory perspectives on mobile health apps. It outlines that health apps that meet the definition of a medical device must obtain a CE marking and comply with essential safety and performance requirements. It also notes that health apps must comply with EU data protection and consumer protection rules by obtaining consent for data collection, only collecting necessary data, and providing privacy policies. Finally, it announces that the European Commission will publish a Green Paper on mobile health in 2014 to launch a debate on developing the mHealth sector in Europe.

1. Regulating mobile Health: international perspectives
European Commission update on European perspective
Céline Deswarte
European Commission, DG CONNECT
Policy Officer

2. 1. Is my health app a medical device?
 Definition of a medical device
Source: Medical Devices Directive 93/42/EC (art.1) and In Vitro Medical Device
Directive 98/79/EC
'medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone
or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or
therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human
beings for the purpose of: ◄
— diagnosis, prevention, monitoring, treatment or alleviation of disease, or compensation for an injury or handicap,
— investigation, replacement or modification of the anatomy or of a physiological process,
— control of conception,
and
which does not achieve its principal intended action in or on the human body by pharmacological,immunological or
metabolic means, but which may be assisted in its function by such means;
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3. 1. Is my health app a medical device?
 Guidance on whether an health app is a medical device
can be found in EU "Guidelines on the Qualification and
Classification of stand-alone software" (MEDDEV 2.1/6)
 Clarification in EU Court of Justice judgement of 22
November 2012 in case 219/11, Brain Products GmbH.
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4. 1. Is my health app a medical device?
 Consequence for software with medical purpose
mandatory compliance with EU essential requirements
(safety & performance):
• need to obtain a CE-marking in the country of
registered business
• Safety requirements according to risk class (I, II a, II
b, III)
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5. 2. Do I need to obtain a CE marking?
• Yes, if my mHealth solution is a medical device.
• Yes, if mHealth solution includes a radio equipment or
telecommunication equipment terminal (i.e. receives radio
frequency)
• Sources: Medical Device Directive 93/42/EC, In vitro Medical Devices 98/79/EC
(currently being revised) & RTTE Directive 1999/5/EC
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6. 3. What are the data protection rules?
Principle:
 Prohibition to process health data but exemptions, e.g:
 with explicit consent of the data subject.
Source: Data Protection Directive 95/46/EC (currently being revised: draft
regulation name under discussion )
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7. 3. What are the data protection rules?
Recommendations:
• request consent before apps collect data
• only collect data necessary for the performance of app
• provide a reference to privacy policy
Guidelines: Article 29 Working Party opinion "on apps on smart devices"
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8. 4. Do I have to comply with consumer rules?
Yes. provision of clear information on:
 main characteristics of the app
 identity of the trader
 price and any additional charges of the app
prohibition of unfair commercial practices:
 using trust or quality marks without the necessary authorisation
 false claims that a product is able to cure illnesses
Sources: Directive 2011/83/EU and Directive 2005/29/EC
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9.  The Commission Green Paper on mHealth will launch a
debate among stakeholders on what should be done at EU
level to release the potential of mHealth in Europe.
• It will be accompanied by a Staff Working Document
explaining the legal framework applicable to lifestyle and
wellbeing apps
→Due in March/April 2014
Green Paper on mHealth

10. Thank you!
To contact me:
Celine.Deswarte@ec.europa.eu
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