The General Data Protection Regulation (GDPR) recognises data concerning health as a special category of data and provides a definition for health data for data protection purposes. Though the innovative principles introduced by the GDPR (privacy by design or the prohibition of discriminatory profiling) remain relevant and applicable to health data as well, specific safeguards for personal health data and for a definitive interpretation of the rules that allows an effective and comprehensive protection of such data have now been addressed by the GDPR. Processes that foster innovation and better quality healthcare, such as clinical trials or mobile health, need robust data protection safeguards in order to maintain the trust and confidence of individuals in the rules designed to protect their data.
Opinion on the Commission proposal for a Regulation on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
Opinion on the proposal for a decision of the European Parliament and of the Council on serious cross-border threats to health
The report shows that 2009 was of major importance for the fundamental right to data protection.
This is due to a number of key developments: the entering into force of the Lisbon Treaty, ensuring a strong legal basis for comprehensive data protection in all areas of EU policy; the start of a public consultation on the future of the EU legal framework for data protection; and the adoption of a new five-year policy programme for the area of freedom, security and justice ("Stockholm Programme") with the emphasis on the importance of data protection in this area.
The EDPS has been highly involved in these fields and is determined to pursue this course in the near future.
You can obtain a paper version of this Annual Report on EU Bookshop.
Opinion of 26 April 2010 on a notification for prior checking on the Early Warning Response System ("EWRS") (Case 2009-0137)