Se ha denunciado esta presentación.
Utilizamos tu perfil de LinkedIn y tus datos de actividad para personalizar los anuncios y mostrarte publicidad más relevante. Puedes cambiar tus preferencias de publicidad en cualquier momento.

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

  • Inicia sesión para ver los comentarios

Trends in EU regulation of software as medical device

  1. 1. REGULATORY TRENDS IN CONNECTED HEALTH PCHA Alliance 22 May 2017 Erik Vollebregt
  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. 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 @meddevlegal B READ MY BLOG: