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

31 October 2024 | 14.00 - 16.00

Current and Upcoming Challenges of the Medical Devices Regulations of the European Union

The Medical Devices Regulation (MDR) and In Vitro Medical Devices Regulation (IVDR) have been in force since May 2021 and May 2022 respectively, adopted to modernise the rules on medical devices, including IVDs, to ensure the smooth functioning of the single market for these products and to ensure a high level of health protection for patients and users. However, it is argued that in practice the regulations have had the effect of eroding these objectives and contributing to a decline in innovation. Their interplay with other legislative pieces such as the General Data Protection Regulation, Artificial Intelligence Act, Cybersecurity Act, and Battery Regulation also raise new questions on full legal compliance of med-tech companies. This talk will focus on challenges faced by industry stakeholders in the health and medical domain from a legal practitioner’s perspective and explore potential solutions to clarify regulatory uncertainties. We will have the opportunity to hear from our guest speaker Erik Vollebregt, regulatory expert in the domain of life sciences and medical technologies.

Speaker

Erik Vollebregt

Partner at Axon Lawyers - Sciences and IP lawyer

Erik specialises in EU and national legal and regulatory issues relating to medical devices, including AI, batteries, REACH and protection of personal data. He is an expert in life sciences regulation at EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at national and EU level via membership of specialized committees at branch associations and the European Commission.