Presentation at the Personal Connected Health Alliance about regulatory trends in EU regulation of software as medical device

1. REGULATORY
TRENDS IN
CONNECTED
HEALTH
PCHA Alliance
22 May 2017
Erik Vollebregt
www.axonadvocaten.nl

3. Trends
• MDR / IVDR
• New design / security
requirements
• New classification rules
• Transitional regime

4. Classification MDR
• Under the new rule 11 all CDS and monitoring is class IIa or higher and
class III becomes available for software
• Self-certification will be the exception rather than the rule

5. Where are you with your gap assessment and transition?

6. Connected health
related top 8 points
of attention under
GDRP
1. Informed consent criteria
2. Data concerning health scope
3. Right to be forgotten (applies to commercial collection of
health data)
4. Privacy by design)
• For large scale processing of data concerning health
• In case of profiling
5. Profiling requirements
• including right to object if processing significantly
affects data subject
6. Data portability right of user
7. Security requirements
8. Export of data to extra-EU jurisdictions

7. “only” 88 pages, but:

8. Read the whole story
Digital Health Legal, April 2017, p. 4-9

9. www.axonlawyers.com
THANKS FOR YOUR ATTENTION
Erik Vollebregt
Axon Lawyers
Piet Heinkade 183
1019 HC Amsterdam
T +31 88 650 6500
M +31 6 47 180 683
E erik.vollebregt@axonlawyers.com
@meddevlegal
B http://medicaldeviceslegal.com
READ MY BLOG:
http://medicaldeviceslegal.com