As they are now, the EU Parliament’s amendments to the Data Protection Regulation (DPR) prohibit the use of identifiable health data without specific consent and set tough limits on the use of pseudonymised data. Learn what this could mean for research!
What is going on?
In January 2012, the European Commission proposed a comprehensive reform of data protection rules in the EU. The current rules from 1995 do not cover the areas of globalisation and technological developments like social networks and cloud computing sufficiently.
The EU aims to complete the new version of the policy by the end of 2015 meaning that at this very moment representatives from the three EU institutions – the European Parliament, European Commission and the Council of Ministers – are working together to agree on a final text of the draft law.
Read here in more detail why the reform of the data protection rules from 1995 is needed.
Although the idea to control what is going on with your personal data is good, one can go really far and overprotect things beyond decent levels. For example,
What consequences could it have for research?
This new regulation as it is now will make the process of data collection, access and usage much more difficult than it is today. It would strictly regulate the use of consent and many current studies would be put at risk because they would not satisfy these new strict criteria.
For the most part, scientific research (especially in life sciences) relies on the availability of data from external sources. Researchers use personal data to change people’s lives for the better. It is vital that the Data Protection Regulation does not limit the use of this data for research.
Whether it is clinical and/or genomic data from patients, or other types of personal data, it is important to make sure that 1) people who really need access to the data (researchers) and 2) people who want their data to work for the benefit of the community (data donors) will continue to be able to do it.
If the changes to the original European Commission text that the European Parliament has proposed are included in the new law, it will make it much harder for researchers to use individuals’ health data in research and will put our progress towards understanding disease and developing new treatments at risk.
In response to the EU negotiations about DPR, the Data Saves Lives campaign was initiated by the European Data in Health Research Alliance that gathers together patient groups and academic and research organisations. The initiative calls on the EU institutions to work together to ensure that the final text of the Data Protection Regulation means people’s data will be kept safe and secure while allowing vital research to continue to take place in Europe.
The original draft Regulation set out a proportionate mechanism for protecting privacy, while enabling health and scientific research to continue. It included a requirement for specific and explicit consent for the use and storage of personal data, but provided an exemption for research, subject to certain safeguards in Article 83. This recognised that individuals’ interests can be protected through strong ethical and governance safeguards, such as approval by a research ethics committee. The European Parliament’s amendments to Articles 81 and 83 very significantly reduce the scope of this research exemption.The use of personal data in research without specific consent would be prohibited or become impossible in practice. The requirement for specific consent fails to take account of the fact that this research is subject to ethical approval and strict confidentiality safeguards, and the identity of individuals is often masked.This would put at risk significant European investments in genetics, cohort studies, biobanks, disease registries and the use of routinely collected data, and associated progress towards understanding society, health, and disease that delivers real patient benefit.
You can learn more about the concerns of the researchers and check which current projects will be affected by the new DPR.
If you agree with these concerns and want your voice to be heard, you can sign this petition.