Elisabetta Biasin
bisilisib.bsky.social
Elisabetta Biasin
@bisilisib.bsky.social
🦿🌈 Researcher in Law @CiTiP KU Leuven | eHealth & Technology Regulation | Writing a PhD on #Accuracy in data & AI | External Expert @WHO Europe's Strategic Partnership on Digital Health
After-summer realisation, last June the MDCG updated it guidance on medical device software classification, to update it with #EHDS Regulation aspects -- especially regarding interoperability. (!)

The new version is accessible here: health.ec.europa.eu/document/dow...
September 3, 2025 at 2:12 PM
It has been quite a week for health data law. Yesterday, the ITA OJ published the ministerial decree on the Italian "Health Data Ecosystem."

The document is available at this link: www.gazzettaufficiale.it/eli/id/2025/03/05/25A01321/sg
in Italian, "Ecosistema Dati Sanitari" #EDS
March 6, 2025 at 4:26 PM
The #EHDS Regulation is now officially published in the EU OJ.

The text is accessible here eur-lex.europa.eu/legal-conten...
March 5, 2025 at 12:11 PM
Going to the Bicocca Privacy Day tomorrow! I've also joined in 2023 & had a great time; many speakers had a critical pov. Tomorrow, I will speak about issues of health data sharing/EHDS, patients' privacy + collective trust in EU public healthcare systems

+info here: www.unimib.it/eventi/bicoc...
January 27, 2025 at 4:35 PM