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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.
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27
Feb
2013
Available languages: German, English, French
8
Feb
2013
In vitro diagnostic medical devices
Opinion on the Commission proposals for a Regulation on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and a Regulation on in vitro diagnostic medical devices
Available languages: German, English, French
Executive Summary
Available languages: Bulgarian, Czech, Danish, German, Estonian, Greek, English, Spanish, French, Croatian, Italian, Latvian, Lithuanian, Hungarian, Maltese, Dutch, Polish, Portuguese, Romanian, Slovak, Slovenian, Finnish, Swedish
Topics
19
Dec
2012
Clinical trials on medicinal products
Opinion on the Commission proposal for a Regulation on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
Available languages: English, French
Topics
29
Jun
2012
Newsletter Nr. 33
Available languages: German, English, French
28
Mar
2012
Cross-border threats to health
Opinion on the proposal for a decision of the European Parliament and of the Council on serious cross-border threats to health
Available languages: German, English, French
Executive summary of the EDPS Opinion
Available languages: Bulgarian, Czech, Danish, German, Estonian, Greek, English, Spanish, French, Italian, Latvian, Lithuanian, Hungarian, Maltese, Dutch, Polish, Portuguese, Romanian, Slovak, Slovenian, Finnish, Swedish
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