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The commentary argues that patients with chronic diseases may hold data ownership rights, while clinicians, researchers, public health professionals, and medical device manufacturers may also claim ownership. Four areas are examined: relevant US/EU laws, stakeholder claims, how ownership laws enable translational research, and emerging controversies.",{"@graph":69,"@context":123},[70,84,106],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/the-need-for-clear-medical-data-ownership-laws-commentary-open-access/419977/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/the-need-for-clear-medical-data-ownership-laws-commentary-open-access/419977.png","ImageObject",300,407,{"name":92,"@type":93},"Muffet","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-11-03","2026-09-28",true,{"@type":102,"interactionType":103,"userInteractionCount":105},"InteractionCounter",{"@type":104},"ViewAction",14,{"@type":107,"mainEntity":108},"FAQPage",[109,115,119],{"name":110,"@type":111,"acceptedAnswer":112},"Do US and EU regulations explicitly recognize medical data ownership rights?","Question",{"text":113,"@type":114},"No. The article states that existing frameworks protect privacy but do not explicitly establish ownership rights for medical data.","Answer",{"name":116,"@type":111,"acceptedAnswer":117},"Why are clear medical data ownership laws needed for translational research?",{"text":118,"@type":114},"Translational research depends on secure and legal access to data streams. Clear ownership policies help enable research while protecting patients’ rights.",{"name":120,"@type":111,"acceptedAnswer":121},"Which stakeholders may claim ownership of patient-generated medical data?",{"text":122,"@type":114},"Beyond patients with chronic diseases, the article notes that clinicians, researchers, public health professionals, and medical device manufacturers can also stake claims.","https://schema.org",{"og:url":83,"og:type":125,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":127,"canonical":83},"index,follow",{"doc_id":129,"site_id":62},419977,1790935890,{"code":4,"msg":5,"data":132},{"doc_id":129,"user_id":133,"nickname":92,"user_avatar":134,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":135,"file_id":136,"file_url":137,"file_type":138,"file_size":139,"view_count":105,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":44,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":144,"read_time":145,"preview_page_count":4},962090768927,"https://ap-avatar.wpscdn.com/davatar_085a072bc5b1113ac321206ff7593b45","Klonoff et al. Journal of Translational Medicine (2026) 24:5  \n[https://doi.org/10.1186/s12967-025-07486-z](https://doi.org/10.1186/s12967-025-07486-z)  \nJournal of Translational Medicine  \nCOMMENTARY Open Access  \nThe need for clear medical data ownership laws  \nDavid C. Klonoff1, Agatha F. Scheideman2*, Mandy M. Shao2, Cindy N. Ho2, Alessandra T. Ayers2, Johan Jendle3,4, Henry G. Wykowski5 and Lutz Heinemann6  \nAbstract  \nCurrent 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  \nrights 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.  \nKeywords Data sharing, Health data governance, Medical data, Ownership laws, Data ownership  \n*Correspondence:  \nAgatha F. Scheideman  \n[scheideman@diabetestechnology.org](scheideman@diabetestechnology.org)  \n1Diabetes Research Institute, Mills-Peninsula Medical Center (Sutter Health), San Mateo, CA, USA  \n2Diabetes Technology Society, 845 Malcolm Road, Suite 5, Burlingame, CA 94010, USA  \n3Working Group on Continuous Glucose Monitoring, Scientific Division, The International Federation of Clinical Chemistry and Laboratory Medicine, Milano, Italy  \n4School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Örebro, Sweden  \n5Wykowski & Wood, LLP, San Francisco, CA, USA  \n6Science-Consulting in Diabetes GmbH, Schwerinstr 36,  \n40477 Düsseldorf, Germany  \nIntroduction  \nThe term“big data” in healthcare includes information from electronic health records (EHR), laboratory results, diagnostic images, and recent data from wearable devices, such as systems for continuous glucose monitoring (CGM) and automated insulin delivery for persons living with diabetes (PLwD). Today, the global big data in healthcare market size is estimated to be worth 61.3 billion United States Dollars (USD) and is expected to grow to 145.4 billion USD by 2033 [1]. No specific legislation in the United States (US) and various European Union (EU) Member States explicitly recognizes ownership rights of medical data. There is a need for clear medical data  \n© The Author(s) 2025. Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and","cbCaiohwgNsX6WRs","https://ap.wps.com/l/cbCaiohwgNsX6WRs","pdf",2137687,"English","# Abstract\n# Introduction\n# Current status of ownership of medical data","[{\"question\":\"Do US and EU regulations explicitly recognize medical data ownership rights?\",\"answer\":\"No. The article states that existing frameworks protect privacy but do not explicitly establish ownership rights for medical data.\"},{\"question\":\"Why are clear medical data ownership laws needed for translational research?\",\"answer\":\"Translational research depends on secure and legal access to data streams. Clear ownership policies help enable research while protecting patients’ rights.\"},{\"question\":\"Which stakeholders may claim ownership of patient-generated medical data?\",\"answer\":\"Beyond patients with chronic diseases, the article notes that clinicians, researchers, public health professionals, and medical device manufacturers can also stake claims.\"}]","The need for clear medical data ownership laws - Commentary - Open Access | PDF",1790619040,23]