Proposed EU data protection regulation is a threat to medical research

A suggested amendment would make most epidemiological and health research impossible Legislation going through the European Parliament this summer could prohibit most epidemiological and other medical research if amendments proposed by one committee are accepted. The main goals of the legislation will be to strengthen the digital privacy rights of European citizens, improve Europe’s online economy, strengthen the free market, and end the divergence between national data protection laws of the 27 member states of the European Union. This is all well and good, as long as data protection is balanced fairly against adequate provision for legitimate data processing. The European Commission proposed last year that the EU’s 1995 Data Protection Directive 95/46/EC should be replaced by the General Data Protection Regulation.1 In line with the current directive, the draft regulation prohibits the processing of sensitive personal data, including “data concerning health.” However, the draft allows exceptions, including data processing for research and statistics. Research deserves a special position within the normative framework, not only because its focus is not on the individual, but also because it serves an important public interest—the generation of valuable knowledge for society. So far, so good. But, in December 2012, the European parliament’s Committee on Civil Liberties, Justice and Home Affairs (LIBE …