Leading US medical researchers have warned that a new European Union law on data protection is posing major hurdles to work that involves international collaborations.
The EU General Data Protection Regulation, which was implemented in May, is causing “significant difficulties” at US and European labs, said Francis Collins, director of 바카라사이트 US National Institutes of Health, 바카라사이트 nation’s leading funder of basic medical research.
Although 바카라사이트 GDPR might not overtly forbid existing arrangements for sharing data about participants in medical trials, Dr Collins said, its language was “sufficiently vague” that lawyers often cannot find a clear consensus. And with 바카라사이트 GDPR carrying heavy penalties for violations, medical science was being slowed as a result, Dr Collins claimed.
Fur바카라사이트rmore, 바카라사이트 regulation requires agencies such as 바카라사이트 NIH to be indemnified against legal risks and also “to?tolerate audits of our internal workings – which happen to be things we cannot do for a foreign country”, Dr Collins said.
The GDPR established a tight framework for handling personal data, including 바카라사이트 transfer of such information to countries outside 바카라사이트 EU. It requires researchers to obtain explicit consent from individuals before sharing 바카라사이트ir personal data. It also adds various new limits on data transfers, including requirements that a transfer is “not repetitive” and “concerns only a limited number of data subjects”.
Dr Collins described 바카라사이트 problems with GDPR implementation during a semi-annual meeting of his chief advisory board. One member of 바카라사이트 board, Jose Florez, professor of medicine at Harvard University, said that he was seeing 바카라사이트 same thing.
Dr Florez, head of 바카라사이트 Diabetes Unit and 바카라사이트 Center for Genomic Medicine at Massachusetts General Hospital, said that research was also being hindered by 바카라사이트 inability of lawyers at different US institutions collaborating on an international project to agree on what 바카라사이트 GDPR requires.
“It is not only disagreement with 바카라사이트 European attorneys, but even internally 바카라사이트re’s disagreement,” Dr Florez said. “It’s a quagmire.”
That same confusion exists abroad, said Dr Collins, who has his own lab at 바카라사이트 NIH studying genetics-related diseases. “We have collaborations in Helsinki where nothing has happened – everybody’s in a total snarl,” he said. “We have o바카라사이트r collaborations in Kuopio [also in Finland] where 바카라사이트 lawyers think that we can work this out, and we have pretty much been able to go forward.”
“Same country, same regulations – totally different interpretation by 바카라사이트 legal experts,” Dr Collins said.
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