We have over the years provided comments to rules and regulations for data protection. We have especially provided information on the situation in Europe where new regulations is being negotiated. The rules have crucial importance for our access to use of data for research, especially for use of registers like the cancer Registry or the Death Registry. The main problem is that rules for research are regulated together with use of data from social media, bank business etc.
Under the regulations, all health data are classified as sensitive data and sensitive data cannot be used without informed consent. First principles state that research on data from existing health registers or research data collected for a different purpose without informed consent, or with an informed consent not addressing the current purpose, cannot be used. That eliminates most of our options for using the collective experience in health care to learn about preventable causes of diseases, prognostic factors, side effects of medicine etc.
A backdoor path is, however, open for use of data for statistical and research purposes if personal identifiers are eliminated or kept under lock by a ‘trusted third party’. The full text of the current suggested exemptions to the regulation on data protection in the EU is printed below. The interpretation and governance of these exemptions is being debated and the reassuring fact is that policy makers from some countries now are aware of the importance of these rules for research. Some countries in the EU support research friendly conditions but not all.
The main problem is that a common regulation on data protection has to fit so many different situations and the starting point is wrong. The people (and many do) should demand good research to make sure we identify avoidable causes of diseases and provide the best possible treatment. This important research obligation should not rest on a ‘backdoor’ legislation as presented in article 81 and 83 below – see for example Vandenbroucke JP, Olsen J. Informed consent and the new EU regulation on data protection. Int J Epidemiol 2013; 42: 1891-92.
If we get a set of rules written for research, one should keep in mind the importance of research in a democracy. The idea behind a democracy is that the people have sufficient information to make choices between different options. Research and the free press provide an important part of the information needed to make these choices. Rules for data protection have to take this into consideration and the starting point is not that research is only allowed under some rather strict exemption. Access to data is important for research as well as access to information in general is important for the free press. It would probably be better to have research regulated together with rules for the ‘free press’. Both serve the same purpose.
— Jørn Olsen, Neal Pearce, Cesar Victora, Shah Ebrahim