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Trends in EU regulation of software as medical device

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

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Trends in EU regulation of software as medical device

  1. 1. REGULATORY TRENDS IN CONNECTED HEALTH PCHA Alliance 22 May 2017 Erik Vollebregt www.axonadvocaten.nl
  2. 2. Trends • MDR / IVDR • New design / security requirements • New classification rules • Transitional regime
  3. 3. 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
  4. 4. Where are you with your gap assessment and transition?
  5. 5. 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
  6. 6. “only” 88 pages, but:
  7. 7. Read the whole story Digital Health Legal, April 2017, p. 4-9
  8. 8. 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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