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www.fdanews.com/articles/159888-data-protection-rules-would-give-patients-new-data-erasing-powers

Data Protection Rules Would Give Patients New Data ‘Erasing’ Powers

November 6, 2013
A proposal moving through the European Parliament to centralize data protection across member states would grant clinical trial participants the ability to demand that their trial data — including data shared between regulators and other entities — be effectively “erased.” The proposal, overwhelmingly adopted by the Committee for Civil Liberties, Justice and Home Affairs (LIBE) earlier this month, has sparked a backlash from critics who say it will make managing clinical trial data unduly burdensome for devicemakers.
International Medical Device Regulatory Monitor