ESR Connect

    ESR eHealth and Informatics Subcommittee Session

    ESR eHealth 4 - What the radiologist needs to know about EU regulations: AI Act, EHDS and more

    • ECR 2025
    • 6 Lectures
    • 90 Minutes
    • 5 Speakers

    Lectures

    1
    Chairperson's introduction

    Chairperson's introduction

    05:00Daniel Pinto Dos Santos, Frankfurt / DE

    2
    The EU AI Act: helpful protection or the end of innovation?

    The EU AI Act: helpful protection or the end of innovation?

    15:00Kicky Gerhilde Van Leeuwen, De Bilt / NL

    3
    The EHDS: what can we expect of it and when?

    The EHDS: what can we expect of it and when?

    15:00Carla Meeuwis, Arnhem / NL

    4
    Post-market surveillance: how is it done and what needs to change?

    Post-market surveillance: how is it done and what needs to change?

    15:00Nilaykumar Patel, Vienna / AT

    5
    The business of data: who can share which data and at what price?

    The business of data: who can share which data and at what price?

    15:00Martin J. Willemink, San Diego / US

    6
    Panel discussion: Regulations: are they a benefit or only a challenge?

    Panel discussion: Regulations: are they a benefit or only a challenge?

    25:00Panel discussion: Regulations: are they a benefit or only a challenge?

    Description

    5 min
    Chairperson's introduction
    Daniel Pinto Dos Santos, Frankfurt / Germany
    15 min
    The EU AI Act: helpful protection or the end of innovation?
    Kicky Gerhilde Van Leeuwen, De Bilt / Netherlands
    1. To learn about how medical AI software is classified by the AI Act.
    2. To appreciate the requirements for datasets and generalisability as defined in the AI Act.
    3. To understand how the regulations of the AI Act will impact the AI software market in the EU.
    15 min
    The EHDS: what can we expect of it and when?
    Carla Meeuwis, Arnhem / Netherlands
    1. To learn about the general envisioned structure of the European Health Data Space.
    2. To appreciate the potential benefits of the EHDS for primary and secondary use of healthcare data.
    3. To discuss the future timeline of EHDS rollout and implementation throughout Europe.
    15 min
    Post-market surveillance: how is it done and what needs to change?
    Nilaykumar Patel, Vienna / Austria
    1. To learn about the general concepts of post-market surveillance with regard to medical devices.
    2. To appreciate the particularities of post-market surveillance for medical AI software.
    3. To discuss what radiologists can do to facilitate post-market surveillance in their institutions.
    15 min
    The business of data: who can share which data and at what price?
    Martin J. Willemink, San Diego / United States
    1. To learn about the need for data and where data is currently being sourced from for medical AI software.
    2. To appreciate how EU regulations (EHDS, GDPR, etc.) affect which data can be shared for AI development.
    3. To understand if and how institutions can contribute their data to EU projects or share it with industry.
    25 min
    Panel discussion: Regulations: are they a benefit or only a challenge?

    This session offers AI-generated subtitles.

    Categories and Tags

    Moderators

    • Daniel Pinto Dos Santos

      Frankfurt / Germany

    Speakers

    • Daniel Pinto Dos Santos

      Frankfurt / Germany

    • Kicky Gerhilde Van Leeuwen

      De Bilt / Netherlands

    • Carla Meeuwis

      Arnhem / Netherlands

    • Nilaykumar Patel

      Vienna / Austria

    • Martin J. Willemink

      San Diego / United States