SPOTLIGHT #3


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Regulation (EU) 2016/679
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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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Senate bill looks to streamline CMS pathway for “breakthrough” devicesBY FINK DENSFORD
The U.S. Senate has introduced a bill entitled “Ensuring Patient Access to Critical Breakthrough Product Act” to expedite the CMS’s decision to help “improve patient access to breakthrough medical technologies” READ THE ARTICLE
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Ireland : the unexpected land of medical devices in Europe
BY MATHIEU CHARLEUX
There are still quite a few people in the medical device arena are not fully aware of the vast ecosystem in place in Ireland. And I have to admit, I was one of them. Let’s tell the truth – yes there are many sheep, pubs (with nice music by the way) and churches in Ireland. But that is not all the country has to offer.  READ THE ARTICLE
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