Evidence map›Paper›PMID 41484623›Full record

ArticleJournal of translational medicine2026

The need for clear medical data ownership laws.

David C Klonoff, Agatha F Scheideman, Mandy M Shao, Cindy N Ho, Alessandra T Ayers, Johan Jendle, Henry G Wykowski, Lutz Heinemann

Abstract read
In one paragraph

Article in Journal of translational medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

David C KlonoffDiabetes Research Institute, Mills-Peninsula Medical Center (Sutter Health), San Mateo, CA, USA.ORCID 0000-0001-6394-6862
Agatha F ScheidemanDiabetes Technology Society, 845 Malcolm Road, Suite 5, Burlingame, CA, 94010, USA. scheideman@diabetestechnology.org.ORCID 0009-0008-4211-4934
Mandy M ShaoDiabetes Technology Society, 845 Malcolm Road, Suite 5, Burlingame, CA, 94010, USA.ORCID 0009-0004-9550-9965
Cindy N HoDiabetes Technology Society, 845 Malcolm Road, Suite 5, Burlingame, CA, 94010, USA.ORCID 0009-0008-3067-1004
Alessandra T AyersDiabetes Technology Society, 845 Malcolm Road, Suite 5, Burlingame, CA, 94010, USA.ORCID 0009-0000-3054-3207
Johan JendleWorking Group on Continuous Glucose Monitoring, Scientific Division, The International Federation of Clinical Chemistry and Laboratory Medicine, Milano, Italy.ORCID 0000-0003-1025-1682
Henry G WykowskiWykowski & Wood, LLP, San Francisco, CA, USA.ORCID 0009-0002-6557-7348
Lutz HeinemannScience-Consulting in Diabetes GmbH, Schwerinstr 36, 40477, Düsseldorf, Germany.ORCID 0000-0003-2493-1304

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

OwnershipEuropean UnionHumansTranslational Research, BiomedicalUnited StatesData ownershipData sharingHealth data governanceMedical dataOwnership laws

Identifiers

PMID41484623
PMCPMC12763853

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.