The right to data portability in the European Health Data Space: A follow-up
By Wenkai Li, 19th October 2024
The expanded and enhanced right to data portability envisaged by the EHDS, combined with the interoperability requirements and the introduction of the European electronic health record exchange format, represents considerable progress compared to Article 20 of the GDPR. The relevant provision in the latest text of the EHDS has indeed resolved some of the questions raised by the paper on the initial proposal, but also seemingly made changes, in particular, to exactly what data can be mobilised based on a data portability request, which is still yet to be confirmed. Read more
NAVIGATING THE REGULATORY LANDSCAPE OF CYBERSECURITY FOR MEDICAL DEVICES IN THE EU LAW
By Ruoxin Su & Oguzhan Yesiltuna, 27th August 2024
As the digital transformation of healthcare continues to accelerate, the importance of robust cybersecurity for medical devices has never been more critical. Medical devices, from wearable health monitors to advanced diagnostic tools, are increasingly connected to networks, making them susceptible to cyber threats. A successful cyber-attack on a medical device can compromise patient safety, lead to data breaches, and disrupt healthcare services.In the EU, ensuring the security of these devices is a complex challenge that intersects with various regulatory frameworks. This blog post provides a brief overview of the current regulatory landscape for cybersecurity in medical devices within the EU. Read more
Opt-in vs opt-out rules for secondary use of health data: can the European Health Data Space learn from Switzerland?
By Andrea Martani, 10th July 2024
The European Union (EU) institutions have just reached a deal for passing the European Health Data Space (EHDS) Regulation, which was described as “the most important health legislation of this mandate”. This landmark piece of law is aimed to set clear rule for the use of data in the health and biomedical sector, and finding an agreement on its content was far from easy. Indeed, the regulation is very ambitious, in that it aims to harmonise throughout the EU the rules for both primary (e.g. in the context of care provision) and secondary (e.g. for research purposes) use of health data. Read more
EU LAW & TAKE-UP OF SCIENTIFIC EVIDENCE DURING THE COVID-19 PANDEMIC
By Danaja Fabcic Povse, 11th June 2024
Who still remembers the covid-19 pandemic in 2024? To many, though perhaps not health (law) scholars, it may feel like it happened in another lifetime, although it’s only been a little over one year since WHO officially declared it over on May 5, 2023. This blogpost takes advantage of the anniversary to offer a retrospective on the challenges of take-up of evidence in the EU’s pandemic response and suggest some ways forward. It asks the question how can the EU improve the take-up of scientific evidence in legislative processes be improved, based on the covid-19 experience. Read more
NAVIGATING THE INTERSECTION OF HEALTHCARE, AI, AND LAW: A PREVIEW OF HELT 2024 SYMPOSIUM
By Cong Yao, 6th March 2024
The HELT symposium, a yearly multi-disciplinary event initiated by HALL at VUB, seeks to explore a series of discussions relating to matters of health and ageing. In particular, it focuses on areas such as privacy and data protection; the use of advanced technologies in healthcare, pharmaceutical development and research; e-Health and m-Health; and healthy ageing. With interdisciplinary collaboration at its core, the symposium aims to bridge gaps between health sciences, engineering, law, and technology to drive innovation and address the most pressing challenges in healthcare. It serves as a platform for leading experts, researchers, and practitioners to converge, exchange ideas, and chart the course for the healthcare landscape of tomorrow.
HELT 2024 Symposium is scheduled to take place on April 25th, 2024, at the Sparks venue, Rue Ravenstein 60 in Brussels. This year’s theme is “Health(y) AI – Bridging Innovation and Regulation”. The discussion will focus on the application of AI in healthcare and its impacts on research, data governance, and future regulation. Attendees can anticipate a series of insightful keynote presentations, thought-provoking panel discussions, and interactive workshops covering a wide range of topics. Read more
ANONYMITY IN THE EYE OF THE BEHOLDER...OR IS IT?
By Karen Cruyt, 1st December 2023
Is personal data always personal? A key question when thinking about many forms of health data. That is the question that the HALL members tackled in their workshop on the 1st of December, in light of the Court of Justice of the European Union’s recent judgment “Scania” (C-319/22) and two older cases of the General Court, “SRB v. EDPS” and “OC v. European Commission”, which all touch upon the (potentially?) relative notion of personal data. Read more
