Proposed Changes to Regulations Governing the Confidentiality of Substance Abuse Disorder Treatment Records Reflects Concerns About Opioid Crisis

November 2019

The U.S. Department of Health and Human Services has released proposed amendments to the regulations governing the Confidentiality of Substance Abuse Disorder Treatment Records. The amendments are intended to improve continuity of care for patients, reduce risk of patient injury, and promote research about the use of opioids and the effectiveness of responses to the opioid crisis. Final regulations are expected to be released in early 2020.


The confidentiality of medical records maintained by substance use disorder (SUD) programs is regulated by provisions of the Public Health Services Act, enacted long before the advent of the HIPAA privacy regulations. Providers that operate SUD programs are often referred to as “Part 2 Programs” or simply as “Programs.” The regulations, which are codified at 42 C.F.R. Part 2, are administered by the Substance Abuse and Mental Health Services Administration (“SAMHSA”), a unit of the Department of Health and Human Services. The regulations are often referred to as the “Part 2 Rules.” The Part 2 Rules are more strict than HIPAA, and require the written consent of the patient for most kinds of disclosures. Notably, if a Part 2 Program discloses treatment records that identify an individual to a third party, the records continue to be protected by the confidentiality regulations. The regulations apply only to healthcare providers that both (i) receive federal assistance and (ii) hold themselves out to the public as SUD-related services. General medical providers, such as hospitals and medical practices, are generally not subject to the regulations, although a specialized sub-unit or department devoted to SUD treatment within a larger health care facility would be subject to the Part 2 Rules.

Key Proposals

SAMHSA made several clarifications and proposals in the notice of proposed rulemaking. These included:

  • SAMHSA clarified that if a general medical facility or medical group itself collects and records information from its patients about substance abuse disorders, that information, and the resulting records, are not subject to the Part 2 Rules. By way of contrast, records received by a general medical facility from a Part 2 Program remain subject to the protections of the Part 2 Rules, and should be segregated from the general medical record to prevent improper use or disclosure.
  • SAMHSA noted that general medical providers are not permitted to transcribe or copy information contained in a record received from a Part 2 Program into their own medical records.
  • SAMHSA proposed amendments to the consent rules that would make it easier for patients to consent to having their SUD records sent to social services programs or to government agencies for the purpose of obtaining benefits.
  • SAMHSA proposed amendments to the consent rules to make it easier for patients to consent to sharing their records of SUD treatment with their other treating healthcare providers, such as their primary care physician or their hospital.
  • SAMHSA proposed clarifications regarding the disclosures of SUD information that Part 2 Programs can make for their own administrative purposes.
  • SAMHSA proposed that Part 2 Programs have greater authority to disclose information to other treatment programs and to central registries to prevent duplicate enrollment in medication assisted treatment programs and to coordinate care with general medical providers.
  • SAMHSA proposed to amend the rules to permit disclosures to state-operated prescription drug monitoring programs, but only with the patient’s written consent.
  • SAMHSA proposed amending the scope of “medical emergencies” to include natural and other disasters, so that SUD treatment information could be disclosed to protect patient welfare in those circumstances.
  • SAMHSA proposed amendments to make it easier for state agencies and other entities to conduct research on the incidence of substance abuse disorders and the effectiveness of treatment, subject to HIPAA research rules and the federal Common Rule governing human subject protection.
  • SAMHSA proposed to modify the rules governing audits and evaluations to more readily permit disclosure of patient information to state agencies that regulate the health care system and for programs that are part of larger organizations to share information for planning and monitoring purposes.
  • SAMHSA proposed amendments to the rules governing the use of undercover investigators and informants when prosecutors investigate alleged wrongdoing, such as drug diversion, at Part 2 Programs.

Many health care providers would like to see further modification of the confidentiality rules governing the treatment records of Part 2 Programs to allow disclosure among health care providers without a specific patient consent. Others feel that the high level of confidentiality imposed by current law remains necessary. While these regulations address some concerns related to sharing of medical information to improve care, further changes may require Congressional action.