FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

AdvaMed Calls for Clarity of Privacy Rules for Informed Consent Waivers

March 1, 2019
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AdvaMed urged the FDA to clarify whether or not patients in low-risk clinical trials involving devices will have to sign privacy waivers even if they don’t have to sign informed consent documents.

Late last year, the agency issued a rulemaking notice, implementing provisions in the 21st Century Cures Act, allowing the FDA to waive informed consent requirements for some low-risk trials.

In a written comment to the agency, AdvaMed said it’s worried that sponsors, sites or researchers may still be on the hook for privacy waivers under the Health Insurance Portability and Accountability Act.

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