New data-protection legislation in Europe can be a problem for register-based research

News: 2014-06-11

The European Parliament has proposed a new European General Data Protection Regulation. If this draft is passed it replaces the Swedish Personal Data Act (1998:204). The draft  is supported by a majority in the parliament and according to an article in The European Journal of Epidemiology written by Magnus Stenbeck and Henrik Grönberg it poses several problems for Sweden.

The new General Data Protection Regulation proposed by the European Parliament will replace the national legislations. In other words it will replace the Swedish Personal Data Act.

Even if Sweden opposes the new legislation there is little hope for us to keep our old system in the future. A majority of the EU member states supports the reform on the data-protection legislation, Olof Nyrén, Magnus Stenbeck and Henrik Grönberg write in an article in the European Journal of Epidemiology

The European Parliament will be given the task to negotiate with the Council of the European Union about the exact wording in the proposed regulation.

The article writers points out that it is important for Sweden to safeguard the regulations that enables registered based research, as well as other research using personal data.

This concerns for instant whether amendments to the Swedish regulations can be introduced. These amendments will be proposed by the commission on Register-Data Research, chaired by Bengt Westerberg, the 26 of June 2014.

According to the article authors, there are several alarming parts in the parliament proposal. The most severe is that what one might call the “research exemption” is missing. In the current regulations there is an exemption from the purpose limitations on research. This exemption makes it possible, after an ethics board approval, to use personal data for specific research purposes, even if the data was initially collected for other purposes.

The exemption from the basic principal, that the data may only be used for the purpose given when collected, is absent in the proposal from the parliament. This makes it very difficult for the researchers to use registered epidemiological data as well as register data from the authorities in other research.

Another problem is that the proposal may entail excessive requirements of pseudonymisation of data, which, in turn, may result in a large quantity of the databases used by researchers today must be erased.

In the forthcoming newsletter of the European Epidemiology Federation there is a contribution from the Swedish Epidemiological Society. It provides a detailed account of the problems that need to be eliminated to make the regulations functional for research in the future.  This contribution is based on the article mentioned above.


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