HELT TALKS

What are the 'HELT Talks' ?

HELT stands for Health, Law, and Technology – three broad subject areas that intersect each other in discourses around improving quality and access to health care, or advancing medical research beyond the state-of-the-art. Following on the success of the HELT Symposium, our annual flagship event which brings together representatives from the academia, industry, research organisations, healthcare professionals and policymakers, the HELT Talks was conceived as a year-round (monthly) event, providing a dynamic platform for thought-provoking discussions and stimulating debates on the future of digital health and care, through the prism of regulatory responses and relevant policy initiatives.

What is the typical format of a session at HELT Talks?

HELT Talks sessions are typically divided into two parts. In the first part, each speaker gives a presentation on a specific topic, touching upon particular challenges and open issues around the integration of technology in the realm of health care that require delving into legal and regulatory frameworks. The second part of the session aims at encouraging a deeper level of reflection on the topic under discussion, through organic conversations between the speakers and the audience.

What kind of topics are covered at HELT Talks?

HELT Talks cover a breadth of topics on law, health and technology, ranging from legal challenges for the use of health data and regulatory issues concerning advanced medical technology, to the use of artificial intelligence in medicine, data governance and data extraterritoriality in health care.

TALK of the Month

21 November 2025 | 13:00-15:00

Building Trust in Data Reuse: The Role of TEHDAS 2 and the EHDS in Shaping the Future of Omics Research

Electronic health data has become a cornerstone of contemporary biomedical research, and omics technologies are among its most data-intensive beneficiaries. Ensuring the responsible and ethically sound reuse of such data is now central to Europe’s vision for data-driven health innovation. This session invites participants to examine how Europe can unlock the full research potential of electronic health data while maintaining robust safeguards for individual rights and public trust.

Dr. Roxana Albu will explore the ethical, legal, and societal implications (ELSI) that shape secondary uses of health data for research and the evolving regulatory landscape influencing scientists, data custodians, and policymakers. The discussion will highlight the role of TEHDAS 2 in shaping the implementing acts of the European Health Data Space (EHDS), a framework that will determine how omics researchers can access, link, and reuse data across borders. With the TEHDAS 2 public consultation now open for 11 new Guidelines, this is a critical moment for the research community to contribute to evidence-based governance. The session will also focus on guidance for Health Data Access Bodies (HDABs) under the European Health Data Space (EHDS), with particular attention to implementing Opt-Out mechanisms and managing the Return of Significant Findings in secondary use of data, two pivotal benchmarks in balancing individual autonomy, societal benefit, and research integrity.

Speakers

Dr. Roxana Albu

Scientific Researcher at Sciensano

Dr. Roxana Albu is a Scientific Researcher at Sciensano, Belgium’s national public health institute, specializing in the ethical, legal, and societal implications of omics technologies. With a background in pharmaceutical sciences, GDPR, and EU health data policy, she contributes to projects like TEHDAS2 and Genome of Europe, bridging science and regulation to ensure responsible reuse of health data for biomedical innovation.