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
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).
Some patients have discovered their private confessions are being quietly fed into AI.
Help! My therapist is secretly using ChatGPT
Some patients have discovered their private confessions are being quietly fed into AI.
www.technologyreview.com
September 9, 2025 at 1:46 PM
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...
The new version is accessible here: health.ec.europa.eu/document/dow...
September 3, 2025 at 2:12 PM
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...
The new version is accessible here: health.ec.europa.eu/document/dow...
Reposted by Elisabetta Biasin
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...
Closing date 02 Oct 2025.
elxw.fa.em3.oraclecloud.com/hcmUI/Candid...
Postdoctoral Fellow LGBTQ
The Centre for Biomedicine, Self and Society at the Usher Institute within The University of Edinburgh is looking for a 5-year postdoctoral Fellow to work on the Wellcome funded Discovery Award Medici...
elxw.fa.em3.oraclecloud.com
August 25, 2025 at 4:57 PM
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...
Closing date 02 Oct 2025.
elxw.fa.em3.oraclecloud.com/hcmUI/Candid...
'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!
I've been arguing for some time that this is a much needed discussion. (not many happening) So happy to see this out!
Synthetic data for development of AI as a medical device (AIaMDs) - PHG Foundation
www.phgfoundation.org
July 31, 2025 at 9:58 AM
'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!
I've been arguing for some time that this is a much needed discussion. (not many happening) So happy to see this out!
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"
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"
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)
health.ec.europa.eu
June 17, 2025 at 2:20 PM
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"
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"
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....
Patients and generative AI: Who owns your diagnosis?
Click on the article title to read more.
bjui-journals.onlinelibrary.wiley.com
June 11, 2025 at 8:36 AM
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....
Reposted by Elisabetta Biasin
@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
April 30, 2025 at 10:06 AM
@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
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...
in 'Los expertos alertan de «lagunas de privacidad» en la iniciativa europea sobre datos sanitarios' by Pirinay via @euractiv.com
euractiv.es/section/heal...
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 ...
euractiv.es
April 28, 2025 at 10:28 AM
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...
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 & "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...
The agreement proposal will be submitted to World Health Assembly in May 2025 for consideration.
www.nytimes.com/2025/04/16/h...
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.
www.nytimes.com
April 17, 2025 at 8:43 AM
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...
The agreement proposal will be submitted to World Health Assembly in May 2025 for consideration.
www.nytimes.com/2025/04/16/h...
Reposted by Elisabetta Biasin
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...
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...
April 2, 2025 at 9:31 PM
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...
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...
"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...
www.europeandatajournalism.eu/cp_data_news...
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...
www.europeandatajournalism.eu
April 14, 2025 at 4:15 PM
"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...
www.europeandatajournalism.eu/cp_data_news...
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...
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...
Open Book Environment (OBE) Dashboard
docs.google.com
April 10, 2025 at 12:00 PM
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...
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...
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/...
The resulting paper is now available in CPT: Pharmacometrics & Systems Pharmacology
ascpt.onlinelibrary.wiley.com/doi/10.1002/...
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...
ascpt.onlinelibrary.wiley.com
April 9, 2025 at 2:30 PM
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/...
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 👇
📣New blog post!
Flavia Giglio discusses the legal implications of the Paragon case, concerning the alleged involvement of the Italian government in the surveillance of journalists and other members of civil society by means of a military spyware.
Flavia Giglio discusses the legal implications of the Paragon case, concerning the alleged involvement of the Italian government in the surveillance of journalists and other members of civil society by means of a military spyware.
The Paragon case: Walking the fine line between press freedom and national security in Italy and the EU - CiTiP blog
The Italian government has recently been at the center of a controversy, due to its alleged role in surveilling journalists and other members of the civil society with military spyware. This blog post...
www.law.kuleuven.be
April 7, 2025 at 9:53 AM
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 👇
Reposted by Elisabetta Biasin
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...
noyb.eu/en/ai-halluc...
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
noyb.eu
March 20, 2025 at 8:19 AM
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...
noyb.eu/en/ai-halluc...
Reposted by Elisabetta Biasin
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...
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...
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
criticallegalthinking.com
March 18, 2025 at 10:25 AM
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...
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...
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 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
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 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...
The text is accessible here eur-lex.europa.eu/legal-conten...
March 5, 2025 at 12:11 PM
The #EHDS Regulation is now officially published in the EU OJ.
The text is accessible here eur-lex.europa.eu/legal-conten...
The text is accessible here eur-lex.europa.eu/legal-conten...
Reposted by Elisabetta Biasin
@technis4.bsky.social Seminar Series on Smart-PHARMA: DATA, Innovation & market power. Details about joining can be found at technisnet.org/seminars/
February 24, 2025 at 11:40 AM
@technis4.bsky.social Seminar Series on Smart-PHARMA: DATA, Innovation & market power. Details about joining can be found at technisnet.org/seminars/
Reposted by Elisabetta Biasin
🚀 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
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
February 27, 2025 at 10:28 AM
🚀 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
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...
petrieflom.law.harvard.edu/2025/02/24/e...
Europe Tightens Data Protection Rules for AI Models—And It’s a Big Deal for Healthcare and Life Sciences - Petrie-Flom Center
Imagine you’re a researcher developing an AI model, such as an algorithm or other computer process, that can predict early-stage cancer using data from thousands of patient records. You’ve been carefu...
petrieflom.law.harvard.edu
February 26, 2025 at 1:40 PM
'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...
petrieflom.law.harvard.edu/2025/02/24/e...
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!)
www.voxweb.nl/nieuws/five-... (now curious to chat w/ some NL-based researchers on that!)
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.
www.voxweb.nl
February 25, 2025 at 11:50 AM
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!)
www.voxweb.nl/nieuws/five-... (now curious to chat w/ some NL-based researchers on that!)
Reposted by Elisabetta Biasin
"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...
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
www.theguardian.com
February 19, 2025 at 6:03 PM
"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 👇
🎉Exciting news from CiTiP! Our contributions to the CORE-MD project have led to a high-impact publication in NPJ Digital Medicine (Nature)!
👏 Congratulations to the CiTiP co-authors @bisilisib.bsky.social & @erikkamenjasevic.bsky.social!
📖Read more👇
👏 Congratulations to the CiTiP co-authors @bisilisib.bsky.social & @erikkamenjasevic.bsky.social!
📖Read more👇
CORE-MD clinical risk score for regulatory evaluation of artificial intelligence-based medical device software - npj Digital Medicine
npj Digital Medicine - CORE-MD clinical risk score for regulatory evaluation of artificial intelligence-based medical device software
www.nature.com
February 19, 2025 at 9:56 AM
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 👇
Reposted by Elisabetta Biasin
🚨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...
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...
EWAF'25 - Call for Papers
Important Dates
Submission deadline: Thursday, March 13, 2025
Acceptance notifications: Monday, May 5, 2025
2025.ewaf.org
November 22, 2024 at 3:58 PM
🚨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...
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...