Trustworthy reuse of health data: a transnational perspective

Abstract

Background: The widespread adoption of electronic health records (EHRs) is accelerating the collection of sensitive clinical data. The availability of these data raises privacy concerns, yet sharing the data is essential for public health, longitudinal patient care, and clinical research.

Method: Following previous work in the United States [1,2], the International Medical Informatics Association convened the 2012 European Summit on Trustworthy Reuse of Health Data. Over 100 delegates representing national governments, academia, patient groups, industry, and the European Commission participated. In all, 21 countries were represented. The agenda was designed to solicit a wide range of perspectives on trustworthy reuse of health data from the participants.

Results and conclusions: Delegates agreed that the "government" should provide oversight, that the reuse should be "fully regulated," and that the patient should be "fully informed." One important reflection was that doing nothing will have negative implications across the European Union (EU). First, continued fragmented parallel non-standards-based developments in multiple sectors entail a substantial duplication of costs and human effort. Second, a failure to work jointly across the stakeholders on common policy frameworks will forego a crucial opportunity to boost key EU markets (pharmaceuticals, health technology and devices, and eHealth solutions) and counter global competition. Finally, and crucially, the lack of harmonized policy across EU nations for trustworthy reuse of health data risks patient safety. The productive dialog, initiated with multiple stakeholders from government, academia, and industry, will have to continue, in order to address the many remaining issues outlined in this white paper.