The need for clear medical data ownership laws

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.