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Health research is essential for better public health and health care. However, the use of personal data in research could be put under threat by amendments recently adopted by the European Parliament.Individual patient records provide a vital resource for health research for the benefit of society. These records form the basis for observational studies of the factors influencing health and disease and help researchers identify suitable participants to invite them to take part in clinical trials concerning their condition. It is equally essential to make most use of the research that has already been completed. By re-using patient research data where appropriate, participants in trials are then assured that the data they contribute help to further knowledge without unnecessary duplication of research.1In the European Union (EU), the use of patient data in research in Member States is governed by the Data Protection Directive, which has been criticized as overly complex, sometimes ambiguous and presenting an obstacle to epidemiological and other research. Furthermore, variability in the implementation of the EU Directive in different countries has impeded the collection and use of complete, accurate and homogenous data in multi-centre studies, for example using diabetes registries.2 The Directive is now being revised as a General Data Protection Regulation (DPR) with the objectives to harmonize data protection within the EU, facilitate the flow of data across borders and enhance privacy protection. Although reservations had again been expressed at the potential for jeopardizing the use of personal data in health research,3 the proposed reforms did initially offer new opportunities to researchers, enabling international collaboration by streamlining the currently complex data protection rules. The European Commission’s draft DPR acknowledges that research generates valuable knowledge for society and includes an important exception …

Data protection regulation and the promotion of health research: getting the balance right