.2024 Aug 27;7(1):229.

doi: 10.1038/s41746-024-01221-6.

Mapping the regulatory landscape for artificial intelligence in health within the European Union

Jelena Schmidt¹, Nienke M Schutte², Stefan Buttigieg^{3 4}, David Novillo-Ortiz⁵, Eric Sutherland⁶, Michael Anderson⁷, Bart de Witte⁸, Michael Peolsson⁹, Brigid Unim¹⁰, Milena Pavlova¹¹, Ariel Dora Stern^{12 13 14}, Elias Mossialos^{7 15}, Robin van Kessel^{16 17 18}

Affiliations

¹ Department of International Health, Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands.
² Innovation in Health Information Systems Unit, SD Data Governance, Sciensano, Brussels, Belgium.
³ Ministry for Health and Active Ageing, Valletta, Malta.
⁴ Faculty of Health Sciences, University of Malta, Msida, Malta.
⁵ Division of Country Health Policies and Systems, World Health Organization Regional Office for Europe, Copenhagen, Denmark.
⁶ Independent Researcher, Paris, France.
⁷ LSE Health, Department of Health Policy, London School of Economics and Political Science, London, United Kingdom.
⁸ Hippo AI Foundation, Berlin, Germany.
⁹ Swedish eHealth Agency, Stockholm, Sweden.
¹⁰ Department of Cardiovascular, Endocrine-Metabolic Diseases and Aging, National Institute of Health, Rome, Italy.
¹¹ Department of Health Services Research, Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands.
¹² Harvard Business School Technology and Operations Management, Boston, MS, USA.
¹³ Harvard-MIT Center for Regulatory Science, Boston, MS, USA.
¹⁴ Digital Health Cluster, Hasso-Plattner Institute, University of Potsdam, Potsdam, Germany.
¹⁵ Institute of Global Health Innovation, Imperial College London, London, United Kingdom.
¹⁶ Department of International Health, Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands. r.van-kessel@lse.ac.uk.
¹⁷ LSE Health, Department of Health Policy, London School of Economics and Political Science, London, United Kingdom. r.van-kessel@lse.ac.uk.
¹⁸ Department of Psychiatry, University of Cambridge, Cambridge, United Kingdom. r.van-kessel@lse.ac.uk.

PMID:39191937
PMCID: PMC11350181
DOI: 10.1038/s41746-024-01221-6

Mapping the regulatory landscape for artificial intelligence in health within the European Union

Jelena Schmidt et al. NPJ Digit Med.2024.

.2024 Aug 27;7(1):229.

doi: 10.1038/s41746-024-01221-6.

Authors

Affiliations

¹ Department of International Health, Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands.
² Innovation in Health Information Systems Unit, SD Data Governance, Sciensano, Brussels, Belgium.
³ Ministry for Health and Active Ageing, Valletta, Malta.
⁴ Faculty of Health Sciences, University of Malta, Msida, Malta.
⁵ Division of Country Health Policies and Systems, World Health Organization Regional Office for Europe, Copenhagen, Denmark.
⁶ Independent Researcher, Paris, France.
⁷ LSE Health, Department of Health Policy, London School of Economics and Political Science, London, United Kingdom.
⁸ Hippo AI Foundation, Berlin, Germany.
⁹ Swedish eHealth Agency, Stockholm, Sweden.
¹⁰ Department of Cardiovascular, Endocrine-Metabolic Diseases and Aging, National Institute of Health, Rome, Italy.
¹¹ Department of Health Services Research, Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands.
¹² Harvard Business School Technology and Operations Management, Boston, MS, USA.
¹³ Harvard-MIT Center for Regulatory Science, Boston, MS, USA.
¹⁴ Digital Health Cluster, Hasso-Plattner Institute, University of Potsdam, Potsdam, Germany.
¹⁵ Institute of Global Health Innovation, Imperial College London, London, United Kingdom.
¹⁶ Department of International Health, Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands. r.van-kessel@lse.ac.uk.
¹⁷ LSE Health, Department of Health Policy, London School of Economics and Political Science, London, United Kingdom. r.van-kessel@lse.ac.uk.
¹⁸ Department of Psychiatry, University of Cambridge, Cambridge, United Kingdom. r.van-kessel@lse.ac.uk.

PMID:39191937
PMCID: PMC11350181
DOI: 10.1038/s41746-024-01221-6

Abstract

Regulatory frameworks for artificial intelligence (AI) are needed to mitigate risks while ensuring the ethical, secure, and effective implementation of AI technology in healthcare and population health. In this article, we present a synthesis of 141 binding policies applicable to AI in healthcare and population health in the EU and 10 European countries. The EU AI Act sets the overall regulatory framework for AI, while other legislations set social, health, and human rights standards, address the safety of technologies and the implementation of innovation, and ensure the protection and safe use of data. Regulation specifically pertaining to AI is still nascent and scarce, though a combination of data, technology, innovation, and health and human rights policy has already formed a baseline regulatory framework for AI in health. Future work should explore specific regulatory challenges, especially with respect to AI medical devices, data protection, and data enablement.

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Conflict of interest statement

A.D.S. declares being a Guest Editor ofnpj Digital Medicine. The remaining authors declare no competing interests.

Figures

**Fig. 1. A PRISMA flowchart outlining the data collection process.**
The provided figure shows a PRISMA flowchart depicting a systematic overview of the identification, screening, eligibility, and inclusion processes used to determine the final set of studies included in the qualitative synthesis. Source: flowchart is adapted from Moher et al., which is an open-access article distributed under the terms of the Creative Commons Attribution License (CC-BY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

**Fig. 2. Regulatory framework for artificial intelligence in healthcare and population health.**
The regulatory framework for artificial intelligence in healthcare and population health consists two parts: the technological part and the health and human rights part. The key components of each of the four dimensions in the the technological regulatory landscape for artificial intelligence (AI) in healthcare and population health are outlined as AI Regulation, Processing Data, Technology Appraisal, and Supporting Innovation. The health and human rights part complements the technological regulatory landscape to ensure that the total regulatory framework encompasses the specific needs, norms, and values of the health domain. Source: authors’ own creation.

**Fig. 3. Risk classification process following the EU AI Act and EU Medical Devices Regulation.**
The figure shows a flowchart for the risk classification of artificial intelligence (AI)-enabled medical devices under the Medical Devices Regulation (MDR) and the AI Act. It begins with the question: “Is the technology an artificial intelligence system?” If the answer is “No,” it falls outside the scope of the AI Act. If “Yes,” it proceeds to check if the intended purpose is within the scope of medical devices. A “No” here means it is outside the scope of MDR. If both answers are “Yes,” the flowchart notes that the vast majority of software as a medical device is classified as risk category IIa or higher. Medical devices with risk class IIa or higher are high-risk artificial intelligence systems. This means that these AI-enabled medical device require Conformité Européene (CE) marking through a decentralized notified body. The boxes positioned on the left side indicate the specific section of the MDR or AI Act that informs that specific step. Source: authors’ own creation.

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References

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Mapping the regulatory landscape for artificial intelligence in health within the European Union

Affiliations

Mapping the regulatory landscape for artificial intelligence in health within the European Union

Authors

Affiliations

Abstract

Conflict of interest statement

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