Integrating artificial intelligence (AI) medical devices into healthcare systems is rapidly advancing across the European Union. However, individual Member states face significant challenges in ensuring these technologies' safe, efficient, and effective adoption. This workshop aims to critically examine the legal, technical, and procedural obstacles hindering the full utilisation of AI medical devices in healthcare of Member states.
The workshop adopts a multidisciplinary approach, focusing on the perspectives of four key stakeholders: patients, healthcare professionals, developers, and legislators.
Workshop Structure:
- Introduction: Overview of legislation and implementation of AI medical devices in healthcare.
- Stakeholder Sessions: Participants work in groups to identify obstacles and develop potential solutions from their assigned perspective.
- Presentation of Findings: Stakeholder groups present their conclusions, followed by an open discussion.
- Synthesis: Consolidation of insights and agreement on actionable solutions.
The session will begin with a structured overview of the topic by facilitators representing each group of stakeholders in the adoption process. Participants will then be invited to join one of these stakeholder groups, choosing either a familiar role to act as a contributor or an unfamiliar one to gain new insights as an observer. An expert facilitator will lead each group with in-depth knowledge of their assigned stakeholder role. These facilitators will guide discussions, synthesise participants' suggestions, and prepare a summary of findings for the concluding plenary session. The final segment will include a moderated discussion, allowing for cross-group engagement and a holistic evaluation of proposed solutions.
This workshop seeks to foster a comprehensive understanding of the interplay between different stakeholders in the regulatory and practical implementation of AI medical devices. It is an initial step in a broader effort to address the challenges faced by patients, healthcare professionals, developers, and legislators alike. By integrating diverse perspectives, the workshop aims to generate innovative strategies for overcoming barriers and advancing the deployment of AI medical devices to enhance healthcare efficiency and accessibility across the EU.
The project benefits from the contributions of the two workshop organizers, a representative from the healthcare technology industry, and a medical professional affiliated with the AIR Lund research group. Their expertise will ensure a robust and balanced dialogue, enriching participants’ understanding of this pressing issue and paving the way for future collaborations. The names of the two remaining representatives will be specified before future registration.