eHealth, mHealth and Apps

Erik VollebregtPartnerAxon Lawyers

26th AnnualEuroMeeting

25-27 March 2014ACV, Vienna

Austria

• Some words about the law

• Practical problems companies run into

• Modest proposals for solutions

Agenda

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• eHealth Action Plan 2012 – 2020– struggles with Lisbon competences (“EU action shall

respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care.”)

• Pretty big changes in – regulation of medicinal products and medical

devices / IVDs– regulation of collection and processing of health data

EU political background

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• Currently in flux with General Data Protection Regulation proposal

• Horizontal approach to all data causes friction in mHealth/eHealth sector– What we want to limit in marketing

and social media, we actually want to promote in healthcare (e.g. monitoring, profiling, further processing, traceability)

Personal data concerning health

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General Data Protection Regulation• Privacy-by-design/privacy-by-default

requirements• Software that captures health data must

be compliant by default with the design requirements

• Companies struggle with design requirements

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General Data Protection Regulation• Data subject’s rights implementation

– Right to correct, information, be forgotten and of erasure problematic in clinical context

– Right to request interoperable and open source format copy of processed data

– Right to understand automated processing logic

• MEDDEV 2.1/6 on standalone software, currently under revision

• Differences in interpretation of what software constitutes a medical device

• EN 62304 standard• Lack of harmonised

interoperability standards

Regulation of software as MD / IVD

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Standalone software as medical device• Proposed new expansive definition of ‘medical

device’ that will impact mobile health

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Accessories• Accessories are regulated as medical devices,

even if they are not medical devices themselves• Accessory 2.0 under new MDR and IVDD

proposals:– “an article which, whilst not being a medical device, is

intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable or assist the device(s) to be used in accordance with its/their intended purpose(s)”

• Addition of concept “or assist” potentially enlarges the scope considerably

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Standalone software as a medical device• Some new requirements software

validation and verification under proposed new medical devices rules– Introduction of ‘mobile computing platform’– Environmental factors

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Software as medical device

• MDEG on borderline and classification is working on several software matters

• EU court Lycocentre case– “every member state can qualify device

differently on different scientific considerations”

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Borderline health / wellness

• Commission Green Paper on Health & Wellness to be released any moment

• EU court Brain Products case: “medical context” needed for medical device qualification

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Standalone software as medical device• No eIFU for apps – compliance catch 22

• Professional liability• Contractual liability• Defective product

– Member states differ in whether e/mHealth software is a “product” under EU Product Liability Directive (85/374)

• Network outages?

Liability

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Case study

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Case study

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