The rules applicable to data protection are in the midst of change throughout Europe with the implementation of the General Data Protection Regulation, this is opportunity to take stock on the situation of data processing for scientific research purpose.
As part of the AEGLE Consortium, time.lex team prepared a legal assessment to establish the legal issues that arise by the use of big data in health, resulting to multi-lingual and cross-border applications in Europe.
In the frame of the AEGLE project data have been collected from four different Member States of the European Union, the initial question was to know whether it was permitted to process personal data, and in particular health data for research purpose. The answer was different for each of the countries, despite the Directive on the protection of individuals with regard to the processing of personal data and on the free movement of such data (Directive 95/46/EC). While this instrument provided for a certain degree of harmonisation of the data protection legal frameworks throughout the European Union, divergent legal rules remained in particular concerning the re-use of personal data without the informed consent of the data subjects. Another issue was to know whether the implementation of the GDPR would affect this state of play and harmonise the rules applicable to data processing for scientific research in the European Union. The legal assessment by time.lex addressing these issues was prepared for the AEGLE project based on country reports from all the countries of the European Union, plus Norway and Switzerland, comparing the situation under the previous regime and the GDPR, while applying the new rules specifically to the AEGLE platform.
While these country reports are primarily focused on the framework applicable to the AEGLE Platform, they will prove a valuable source of information to anyone interested in learning more about on the data protection aspect of scientific research in the field of health care and the changes it is undergoing. These reports explain the rules applicable to the collect and the processing of health data.