Presentation at the DIA Euromeeting 2014

1. eHealth, mHealth and
Apps
Erik Vollebregt
Partner
Axon Lawyers
26th Annual
EuroMeeting
25-27 March 2014
ACV, Vienna
Austria

2. • Some words about
the law
• Practical problems
companies run into
• Modest proposals for
solutions
Agenda
2

3. • 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
3

4. • 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
4

5. 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
5

6. 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
6

7. • 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
7

8. Standalone software as medical
device
• Proposed new expansive definition of „medical
device‟ that will impact mobile health
8

9. 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
9

10. 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
10

11. 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”
11

12. Borderline health / wellness
12
• Commission Green
Paper on Health &
Wellness to be
released any moment
• EU court Brain
Products case:
“medical context”
needed for medical
device qualification

13. Standalone software as medical
device
• No eIFU for apps – compliance catch 22
13

14. • 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
14

15. Case study
15

16. Case study
16

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