Healthcare Innovation and Artificial Intelligence in European Union

Shebanova, O.1, Mesarčík, M., Slosiarová, N.

1 AID s.r.o., Namestie SNP 3, 811 06, Bratislava, Slovakia

In this stance we are presenting our positions on the selected implications of the Artificial Intelligence Act (AI Act), Medical Devices Regulation (MDR), and European Health Data Spaces (EHDS) regulation for healthcare innovation. These are the main points of the stance:

Medical devices using AI are high-risk and must comply with both the MDR and AIA, requiring a conformity assessment for CE marking. The procedures of such assessment vary by device and AI classification, with AI-specific risks needing separate evaluation in healthcare. We recommend the European Commission to provide additional guidance on integrating risk management systems. Additionally, we welcome guidance on implementing data governance requirements stemming from the EHDS regulation in the AI medical sector.

Regarding the regulatory sandboxes introduced by the AI Act, we welcome them as a mechanism to balance fostering innovation in AI and ensuring public safety but we call upon the EU member states to consider the introduction of regulatory sandboxes for healthcare innovation with priority access for SMEs and startups to strengthen the competitive advantage of the EU and foster innovation in healthcare. Furthermore, we argue that support of SMEs and startups shall be connected to tangible financial assistance for regulatory compliance.

We also propose an “anticipatory” CE conformity assessment for continuous learning AI systems. This would involve assessing the AI system’s learning algorithms and data governance practices, rather than the specific outputs of the system at a given point in time. This approach would ensure that the AI system continues to meet the necessary regulatory standards as it evolves and improves, without the need for repeated conformity assessments as foreseen by the MDR.

To ensure the successful implementation of the European Health Data Space (EHDS) and AI Act across all EU countries, it’s crucial to support local engagement and adoption. Local associations and non-political bodies can be officially recognized and approved by the European Commission for aid with EHDS adoption locally, focusing on ensuring the sector gets the necessary tools. Ensuring acts are adopted based on their merits will be vital in realizing their benefits across the EU.

Cite: Shebanova, O., Mesarcik, M., Slosiarova, N. Healthcare Innovation and Artificial Intelligence in European Union: Aligning Goals with Societal Benefits Across Emerging Sectoral Frameworks. Kempelen Institute of Intelligent Technologies. June 2024. DOI: 10.5281/zenodo.12567431


Matúš Mesarčík
Ethics and Law Specialist
Natália Slosiarová
Research Intern