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  • Webinar: Precision Medicine and the proposed EU Regulation of Artificial Intelligence - the AI Act


Date: 29th March

Venue: Zoom

Price: Free

Time: 12:00 - 14:00 CET

How to register:

Please email post@nordicpermedlaw.org to register by 27th March. You will be sent a zoom link shortly before the event.


The proposed EU regulation on artificial intelligence – the AI Act – will likely soon be enacted.  Precision medicine is being developed often with the use of AI systems. In this webinar organised by Nordic PerMed Law and AICARE – AI and Automated systems in Healthcare, a WASP-HS funded project, we will debate some of the potential implications for precision medicine of this future legislative instrument.


Welcome and introduction on behalf of organizers

Oda Bakken, Associate, Legal department, Oslo University Hospital, Norway.

Data biases and the AI: a harmonised approach?

Katharina Ó Cathaoir, Associate Professor, Faculty of Law, University of Copenhagen and Pro Futura Scientia Fellow at the Swedish Collegium for Advanced Study


Statistical biases can occur where datasets are not representative of actual populations. One answer to this problem may be gathering more representative health data, upon which algorithms can be trained to develop diagnostic tools and treatments. This presentation will describe how EU law – from the AIA to GDPR - contributes or undermines this goal.

Risk classification and risk assessment of medical AI devices

Mathias Hauglid, Doctoral Research Fellow, Faculty of Law, UiT The Arctic University of Norway.


The majority of requirements in the proposed AIA are applicable only to ‘high-risk’ AI systems and their providers. Given the legislative aims of the AIA, the provisions that apply to high-risk AI systems are meant to address AI systems’ potential impact on health, safety and fundamental rights. However, AI systems that constitute medical devices shall be classified in accordance with the Medical Device Regulation (MDR), which is not oriented towards fundamental rights. The presentation discusses the risk classification scheme for medical AI devices as proposed in the AIA and asks to what extent it is coherent with the AIA’s legislative aims. Implications for risk assessments in research and development projects are also addressed. 

The AI Act from the perspective of a health research project

Speaker from the AI Mind project TBA



Respondent: Katja de Vries, Assistant professor, Faculty of Law, Uppsala University, Sweden

Moderator: Ana Nordberg, Associate Professor, Faculty of Law, Lund University, Sweden