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HL Chronicle of Data Protection Privacy & Information Security News & Trends
Posted in Health Privacy/HIPAA

HHS extends comment period on human subjects research proposals

The U.S. Department of Health and Human Services (HHS) today extended the public comment period for its new proposed requirements for human subjects research under the Common Rule. HHS’ proposal includes significant new data privacy and security obligations on research entities, including the creation of mandatory data security and information protection standards for all studies involving identifiable or potentially identifiable data, as well as potential new standards for de-identified data.  HHS also proposes to categorize biospecimen research as identifiable information.  HHS has extended the comment period by one month, making comments due by October 26, 2011. Read the notice of the extension here. For more information about the privacy and security components of the proposal, view our Health Privacy archive.