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. 2026 Jan 3;24(1):5.
doi: 10.1186/s12967-025-07486-z.

The need for clear medical data ownership laws

David C Klonoff  1 , Agatha F Scheideman  2 , Mandy M Shao  3 , Cindy N Ho  3 , Alessandra T Ayers  3 , Johan Jendle  4   5 , Henry G Wykowski  6 , Lutz Heinemann  7
Affiliations

The need for clear medical data ownership laws

David C Klonoff et al. J Transl Med. .

Abstract

Current regulatory frameworks in the United States (US) and the European Union (EU) provide medical data privacy protections, but do not explicitly establish ownership rights. Legislation increasingly recognizes the rights of persons with chronic diseases for data ownership, but clinicians, researchers, public health professionals, and medical device manufacturers can also stake claims to ownership. Effective translational medical research requires policies for using patient-generated data to help society while still protecting the rights of patients from whom the data was obtained. Four increasingly important areas related to the ownership of patient-generated research data are discussed in this article, including (1) US and European laws relating to medical data ownership, (2) stakeholders claiming ownership of medical data, (3) the need for ownership laws to support translational medicine research, and (4) emerging controversies in medical data ownership. Translational research requires secure and legal acquisition of data streams. Technological and policy strategies for data ownership are increasingly needed that respect the rights of all involved stakeholders. No specific legislation in the US and various EU Member States explicitly recognizes ownership rights of medical data. Recent regulatory initiatives like the Trusted Exchange Framework and Common Agreement (TEFCA) in the US and the European Health Data Space Regulation (EHDS) in European Union Member States have strengthened patients’ access to and control of their medical data, but they do not establish medical data ownership rights. The absence of clear ownership rules continues to raise ethical, technical, and legal challenges as medical data sharing expands across international borders.

Keywords: Data ownership; Data sharing; Health data governance; Medical data; Ownership laws.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: Not applicable. Consent for publication: Not applicable. Competing interests: D.C.K. is a consultant for Afon, Embecta, Glooko, Glucotrack, Lifecare, Synchneuro, and Thirdwayv. C.N.H. is a consultant for Liom. A.T.A. is a consultant for Liom. J.J. has been a lecturer/member of the scientific advisory boards at the following companies: Abbott, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Medtronic, Nordic InfuCare, Novo Nordisk, and Sanofi. L.H. is a consultant for Abbott, Lifecare (also a member of the Board of Directors), Medtronic EU Advisory Board, Dexcom Germany, Roche Diagnostics, Liom, and Perfood. He is a shareholder of the Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany, Science Consulting in Diabetes GmbH, Düsseldorf, Germany, and diateam GmbH, Bad Mergentheim, Germany. A.F.S., M.M.S., and H.G.W. have nothing to disclose.

Figures

Fig. 1
Fig. 1
Potential benefits of implementing clear medical data ownership laws for the five key stakeholders. Adapted from https://www.european-health-data-space.com/ [12]
Fig. 2
Fig. 2
Timeline of the European data regulations and frameworks shaping the European Health Data Space Regulation. Adapted from Hussein et al.[13]
See this image and copyright information in PMC

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