SAMHSA and ONC publish two new guidance documents clarifying 42 CFR Part 2

May 24, 2018 – New official guidance documents are now available for substance use disorder patients and treatment providers to better understand the confidentiality protections for substance use disorder information, 42 CFR Part 2 (Part 2). The Substance Abuse and Mental Health Services Administrative (SAMHSA) and the Office of the National Coordinator for Health Information Technology (ONC) published two factsheets in May 2018 regarding the application of Part 2 to common healthcare and health information technology settings, and SAMHSA updated existing guidance with new information about the rights of same-sex couples to access treatment information about a spouse.

The two new factsheets are the first sub-regulatory guidance published by SAMHSA after the 2017 and 2018 amendments to the Part 2 regulations. For more information about the recent changes to the Part 2 regulations, and what it means for substance use disorder treatment providers, please visit LAC’s confidentiality resources.

The first guidance document, “Disclosure of Substance Use Disorder Patient Records: Does Part 2 Apply to Me?,” illustrates the applications of Part 2’s confidentiality protections to various treatment settings, including:

  • Opioid treatment programs;
  • Primary care practices;
  • Community mental health centers;
  • Participants in an accountable care organization (ACO); and
  • Integrated care settings.

The second guidance document, “Disclosure of Substance Use Disorder Patient Records: How Do I Exchange Part 2 Data?,” clarifies the way that substance use disorder treatment information can be shared and protected in electronic health records (EHRs) and health information exchanges (HIEs) pursuant to the terms of patient consent. The factsheet explains the variety of ways that information can be disclosed to and through HIEs, including whether the record-holder has a Qualified Service Organization Agreement with the HIE or not.

In addition to the new guidance, SAMHSA also updated its 2011 guidance, “Applying the Substance Abuse Confidentiality Regulations,” to reflect changes after the U.S. Supreme Court decision in United States v. Windsor, which struck down as unconstitutional the federal prohibition on recognizing same-sex marriage. The newly updated guidance clarifies that wherever the Part 2 regulations refer to a patient’s “spouse,” the regulations must be interpreted to include a same-sex spouse, even if the couple now lives in a jurisdiction that does not recognize same-sex marriage.

Questions about the new SAMHSA guidance on Part 2? Substance use disorder treatment programs in states that subscribe to the Legal Action Center’s Actionline can call a Legal Action Center attorney with questions regarding this guidance or other questions regarding Part 2 and the confidentiality of substance use disorder records.


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