Up to 2014, within the scope of the European project "Electronic Health Records for Clinical Research" (EHR4CR), partners from academic research and industry will be jointly establishing a Europe-wide technology platform that aims to allow secondary use of data from electronic health records for the purpose of clinical research.
Today, lawyers, ethics specialists, and data protection experts from various EU member states are discussing in Berlin what legal and ethical issues will have to be addressed. The workshop is being organized by TMF, which – due to its extensive preliminary work on data protection and ethical issues of networked medical research – in this project is leading a work package dealing with the topic of data protection and data security.
Secondary use of data from electronic health records for the purpose of medical research could cut costs, speed up clinical research projects and make them more efficient. In particular, researchers could better identify suitable study patients – hitherto one of the major difficulties in planning and conducting clinical studies. Now a technological platform is to be created which will seamlessly integrate electronic health records into existing research platforms and networks in the health sector.
Legal Regulations in the EU Countries Vary Considerably
However, many legal and ethical issues still have to be clarified on the way. In particular, one of the reasons why the legal framework to which physicians, researchers and patients are exposed in the cross-border use of patient data for clinical research is uncertain is that the legal regulations and implemented legal practice concerning data protection and protection of the private domain vary substantially throughout the individual EU member states. For this reason, one work package in the EHR4CR project has the task of analyzing the current legal situations in the various member states of the EU and comparing them with one another. The aim is to provide recommendations as to how legal certainty can be created for clinical research when using the EU-wide technology platform.
At the workshop in Berlin on January 12 and 13, 2012, the legal situation in selected pilot countries is being presented: France, Great Britain, Scotland, and Germany. European researchers, lawyers and data protectionists will be jointly examining what points on the pathway of data from clinics to research are critical in legal terms.
One of the Largest Public-Private Partnership Projects in Europe
The EHR4CR project is being funded with a total of 17 million euros within the scope of the Innovative Medicines Initiative (IMI) over the period from 2011 to 2014. IMI is one of the largest public-private partnership projects in Europe with the aim of speeding up the development of better and safer medicinal drugs. The initiative is being jointly funded by the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
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