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REGULATORY
TRENDS IN
CONNECTED
HEALTH
PCHA Alliance
22 May 2017
Erik Vollebregt
www.axonadvocaten.nl
Trends
• MDR / IVDR
• New design / security
requirements
• New classification rules
• Transitional regime
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
Where are you with your gap assessment and transition?
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
“only” 88 pages, but:
Read the whole story
Digital Health Legal, April 2017, p. 4-9
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

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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
  • 2.
  • 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
  • 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