Introduction and Objective: No specific legislation in the United States and various EU Member States explicitly recognizes ownership rights of medical data generated from wearable diabetes devices. Clear medical data ownership laws are needed to define the rights of patients as well as those who wish to use patient-generated data.Methods: We performed a PubMed literature to identify stakeholders with a claim to ownership of data generated by wearable diabetes devices, such as continuous glucose monitors, insulin pumps, and exercise trackers, as well as legal bodies in the United States and Europe with jurisdiction over ownership of medical data.Results: We identified three legal bodies with jurisdiction over ownership of patient generated diabetes data: 1) the United States Health Insurance Portability and Accountability Act 2) The United States Federal Trade Commission, and the European General Data Protection Regulation. We identified five stakeholders (patients, clinicians, researchers, public health professionals, and companies), each with unique claims and reasons (See Table).Conclusion: For solutions, increased authority by patients have to block data sharing, could make their data less available for will be for research and product development and vice versa. Clear ownership laws are needed for patient generated diabetes data so that this rapidly accumulating data can be ethically shared to maximally benefit all stakeholders in medical data ownership.
D.C. Klonoff: Consultant; Synchneuro, Thirdwayv, Tingo, Afon, embecta, Glucotrack, Lifecare, Novo Nordisk, Samsung.
Source link
Leave a Reply