Elisabetta Biasin

Short read on the use of genAI in psychology settings -- and the concrete trust/transparency issues between technology users and persons concerned by their use in that given setting. Looks like a necessary discussion to have (even beyond psychology).

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...

Exciting new post-doc fellow post just announced at University of Edinburgh - working alongside The Love Tank on the new Medicine Without Doctors collaboration.

Closing date 02 Oct 2025.

elxw.fa.em3.oraclecloud.com/hcmUI/Candid...

Synthetic data for development of AI as a medical device (AIaMDs) - PHG Foundation

'Synthetic data for development of AI as a medical device. Regulatory considerations' www.phgfoundation.org/publications... by Reich, V. et al (MHRA & PHG Foundation. 2025)

I've been arguing for some time that this is a much needed discussion. (not many happening) So happy to see this out!

MDCG 2025-4 - Guidance on the safe making available of medical device software (MDSW) apps on online platforms (June 2025) MDCG 2025-4 - Guidance on the safe making available of medical device software (MDSW) apps on online platforms (June 2025)

MDCG's latest: 2025-4 - Guidance on the safe making available of medical device software apps on online platforms (June 2025)

health.ec.europa.eu/latest-updat...

> Interesting to read how MDR/IVDR & DSA intersect in case of "illegal content related to MDs such as non-compliant or unsafe products"

Patients and generative AI: Who owns your diagnosis? Click on the article title to read more.

Quite some interesting questions there: re ownership, AI and imbalance of power in healthcare> 'Patients and generative AI: Who owns your diagnosis?' by Asher Mandel, Michael DeMeo, Ashutosh Maheshwari, Ash Tewari bjui-journals.onlinelibrary.wiley.com/doi/full/10....

@technis4.bsky.social webinar Saheli Datta Burton, @stsucl.bsky.social : "The (Geo)Politics of Standardisation in Medicine". Tuesday the 6th of May, 11:00 London time. To find out how to join please visit technisnet.org/seminars.html

Los expertos alertan de "lagunas de privacidad" en la iniciativa europea sobre datos sanitarios - Euractiv.es Para evitar polémicos casos de filtración de datos y ataques de hackers –como el de 23andMe-  los países de la Unión Europea (UE) deberían reforzar las leyes nacionales y restringir el intercambio de ...

Super interesting view by @hvkolfschooten.bsky.social: Having opt-in for secondary use of genetic data in the #EHDS

in 'Los expertos alertan de «lagunas de privacidad» en la iniciativa europea sobre datos sanitarios' by Pirinay via @euractiv.com

euractiv.es/section/heal...

WHO Member Countries Agree to Pandemic Treaty The World Health Organization finally reached a compromise on a pandemic treaty after three years of talks. The United States withdrew from negotiations after President Trump took office.

WHO & "Pandemic Treaty": 'Countries Agree on Treaty Aimed at Preventing Global Health Crises' By Stephanie Nolen and Emily Anthes via @nytimes.com

The agreement proposal will be submitted to World Health Assembly in May 2025 for consideration.
www.nytimes.com/2025/04/16/h...

Join us on April 25 @ox.ac.uk @greentempleton.bsky.social as we discuss navigating decolonizing #globalhealth in diverse settings.
Grateful to share this space w/ Dr. Maria Julia (Maju) Brunette & Dr. Neelika Malavige
You can join online or in person.
Register at www.gtc.ox.ac.uk/students/stu...

European patient data gold fever is on the rise - European Data Journalism Network - EDJNet Developing a cloud service to manage, store, and make patient data available promises to be a huge business - it's hardly surprising that digital giants, familiar on our smartphones, are already linin...

"Developing a cloud service to manage, store, and make patient data available promises to be a huge business - it's hardly surprising that digital giants (...) are already lining up. But are national health systems ready for full digitalization?"

www.europeandatajournalism.eu/cp_data_news...

Open Book Environment (OBE) Dashboard

Helpful resource for academics looking for transparent info on book publication fees: the 'Open Book Environment Dashboard'.

via Limbert, H. & DeSanto, D., (2025), Journal of Librarianship and Scholarly Communication: doi.org/10.31274/jls...

Link to the tool docs.google.com/spreadsheets...

leading author: Giuseppe Pasculli, co-authors: Marco Virgolin, Puja Myles, Anna Vidovszky, @charleskfisher.bsky.social, Miranda Mourby, Francesco Pappalardo, Saverio D'Amico, Mario Torchia, Alexander Chebykin, Vincenzo Carbone, Luca Emili, Daniel Roeshammar

#SyntheticData #Healthcare

Synthetic Data in Healthcare and Drug Development: Definitions, Regulatory Frameworks, Issues With the recent and evolving regulatory frameworks regarding the usage of Artificial Intelligence (AI) in both drug and medical device development, the differentiation between data derived from obser...

In the last months, I had the opportunity to contribute to the research on synthetic data in healthcare, led by Giuseppe Pasculli (In Silico Trials).

The resulting paper is now available in CPT: Pharmacometrics & Systems Pharmacology

ascpt.onlinelibrary.wiley.com/doi/10.1002/...

How can the "state secret" influence the forthcoming judicial events about the Paragon case (spyware) in Italy? @citip.bsky.social colleague Flavia Giglio had it covered here, clearly and simply 👇

AI hallucinations: ChatGPT created a fake child murderer ChatGPT created a fake story about a Norwegian man, claiming that he killed his two children and went to jail. This never happened

Today @noyb.eu has filed a complaint with the Norwegian DPA against OpenAI for knowingly allowing its AI model to create defamatory outputs about users, which violates the GDPR’s principle of data accuracy
noyb.eu/en/ai-halluc...

To Reclaim or Resist: Can Digital Sovereignty Ever Be Feminist? Anne-Mie Van Kerckhoven / AMVK; Bloem van Smarten (1990-1991) On 30 and 31 January 2025, a group of researchers participated in a workshop examining

During a workshop on 30-31 January, we critically examined #digitalsovereignty through a #feminist lens.

Our collective writing exercise resulted in a blog post just published on Critical Legal Thinking. It is available via the link below!

criticallegalthinking.com/2025/03/18/t...

Parere sullo schema di decreto del Ministero della salute sull’Ecosistema Dati Sanitari (EDS), ai sensi dell’art. 12, comma 15-quater, del decreto-legge 18 ottobre 2012, n. 179 - 26 settembre 2024 [10...

Will now start wondering about its relationship and interaction with #EHDS. -- Meanwhile, interesting to read on how the former act's versions were deemed unacceptable by the ITA data protection authority

www.garanteprivacy.it/home/docweb/...

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

The #EHDS Regulation is now officially published in the EU OJ.

The text is accessible here eur-lex.europa.eu/legal-conten...

@technis4.bsky.social Seminar Series on Smart-PHARMA: DATA, Innovation & market power. Details about joining can be found at technisnet.org/seminars/

🚀 Call for Submissions!

The 1st International Conference for an Inclusive Digital Society (IDS2025) is happening on Sept 15-16, 2025, in Leuven!

📢 Submit by March 3, 2025
🔗 More info: inclusivedigitalsociety.eu

Join the conversation on digital inclusion!
#KULeuven

Photo by Robs on Unsplash

'Europe Tightens Data Protection Rules for AI Models—And It’s a Big Deal for Healthcare and Life Sciences' by Corrales Compagnucci via PetrieFlom blog

petrieflom.law.harvard.edu/2025/02/24/e...

Five Dutch universities are experimenting with alternative European cloud - Vox magazine Scientists from five Dutch universities are experimenting with a cloud system that could provide an alternative to Microsoft365. Radboud University is watching the developments with interest.

Interesting news 'Five Dutch universities are experimenting with alternative European cloud' via Vox (Radboud's online magazine)

www.voxweb.nl/nieuws/five-... (now curious to chat w/ some NL-based researchers on that!)

Journalists launch legal action against Italian government over spyware claims Union submits criminal complaint to prosecutors as ministers refuse to answer questions about alleged hacks

"Italy’s national union for journalists has submitted a criminal complaint to prosecutors in Rome after Giorgia Meloni’s government shut down questions in parliament over suspicions it had illegally used spyware technology to hack the phones of critics" www.theguardian.com/world/2025/f...

Back in 2023, Frank Rademakers invited us to join a collective work to publish the results of CORE-MD (an EU project on AI-based high-risk medical devices). The findings from the project are now available in NPJ 👇

EWAF'25 - Call for Papers Important Dates Submission deadline: Thursday, March 13, 2025 Acceptance notifications: Monday, May 5, 2025

🚨Call for Papers #EWAF2025🚨

We are very excited to invite submissions (full papers and extended abstracts) for the European Workshop on Algorithmic Fairness #EWAF2025, happening June 30 - July 2, 2025, in Eindhoven, The Netherlands!

2025.ewaf.org/submitting/c...

Delighted to announce the 5th(!) edition of the KU Leuven #SummerSchool on the Law, Ethics & Policy of #AI.

- Dates: 30 June - 9 July
- Apply: 10 Feb - 17 March
- Info: www.law.kuleuven.be/ai-summer-sc...

We'll celebrate this jubileum with some special activities which we hope you'll join!👇 (1/2)

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...

but I also wonder on transparency, stakeholders' involvement, DPIAs & AI Act reqs so on. etc.

(would be happy to study further documentation / exchange thoughts on this, if anyone is working on that!)