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Full-Text Articles in Health Law and Policy
Big Data: Destroyer Of Informed Consent, A. Michael Froomkin
Big Data: Destroyer Of Informed Consent, A. Michael Froomkin
Articles
The 'Revised Common Rule' took effect on January 21, 2019, marking the first change since 2005 to the federal regulation that governs human subjects research conducted with federal support or in federally supported institutions. The Common Rule had required informed consent before researchers could collect and use identifiable personal health information. While informed consent is far from perfect, it is and was the gold standard for data collection and use policies; the standard in the old Common Rule served an important function as the exemplar for data collection in other contexts. Unfortunately, true informed consent seems incompatible with modern analytics …