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Regulating mobile Health: international perspectivesEuropean Commission update on European perspective
Céline DeswarteEuropean Commission, DG CONNECT
Policy Officer
1. Is my health app a medical device?
Definition of a medical deviceSource: 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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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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1. Is my health app a medical device?
Consequence for software with medical purposemandatory 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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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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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: draftregulation name under discussion )
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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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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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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
