Responsibility needed for medical device manufacturers for the protection of personal dataThe European Regulation 2016/679 of 27 April 2016[1] introduces a new regulation on the processing and circulation of personal data. It repeals Directive 95/46 / EC of 24 October 1995 which is the European reference text with regards to protection of personal data.
If most major principles remain unchanged from the 1995 Directive (notably concerning the rights of those affected by treatment and regulation of data transfers outside the European Union) while at the same time strengthening them, then this regulation takes a new approach: it is to give greater responsibility of both data controllers and subcontractors (notably the obligation to keep an internal register and appoint a data protection delegate when processing sensitive data).
The regulation (EU) 2016/679 will be applicable from 25 May 2018 and will largely replace the French Data Protection Act of 6 January 1978. It is therefore important that the medical device sector, which deals in particular with the purposes of clinical investigations and monitoring sensitive health data, immediately understands these major changes.Written by Thomas ROCHE, partner
DELSOL Avocats troche@delsolavocats.com
[1] Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regards to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation).
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On June 29th 2016, there is a free webinar on Clinical Evaluation Requirements for In Vitro Diagnostic Devices (IVDs) in the upcoming IVD Regulation Sign up !
