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The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and Substance Abuse and Mental Health Services Administration (SAMHSA) released its anticipated Final Rule last week. The Final Rule revises...more
On July 15, 2020, the Substance Abuse and Mental Health Services Administration (SAMHSA), a branch of the U.S. Department of Health and Human Services (HHS), published its much-anticipated final rule to revise 42 C.F.R. Part...more
On 23 January 2019, the European Data Protection Board (“EDPB”) issued an opinion on the interplay between the EU General Data Protection Regulation (“GDPR”) and the EU Clinical Trials Regulation (“CTR”). The CTR is not yet...more
New federal regulations published on January 3, 2018, clarify when lawful holders of substance-use disorder records may use and disclose patient identifying information for payment, health care operations, and audits and...more
The Department of Health and Human Services’ Substance Abuse and Mental Health Services Administration (SAMHSA) is considering significant changes to the “Part 2” regulations (the Confidentiality of Alcohol and Drug Abuse...more