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HHS/SAMHSA RIN: 0930-AA26 Publication ID: Fall 2017 
Title: Confidentiality of Substance Use Disorder Patient Records 

The action would finalize the proposed additional clarifications to the part 2 regulations which were included in the Supplemental NPRM published on January 18, 2017, ( 82 FR 5485). This proposed to permit lawful holders and their contractors and subcontractors' to, under certain circumstances, use and disclose part 2-covered data for purposes of carrying out payment, healthcare operations, and other healthcare related activities.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
EO 13771 Designation: Regulatory 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 42 U.S.C. 290dd-2   
Legal Deadline:  None

Statement of Need:

This action should improve information sharing for purposes of carrying out payment, healthcare operations, and other healthcare related activities.

Summary of the Legal Basis:

The governing statute, 42 U.S.C. 290dd-2, establishes that records of the identity, diagnosis, prognosis, or treatment of any patient which are maintained in connection with the performance of any program or activity relating to substance abuse education, prevention, training, treatment, rehabilitation, or research, which is conducted, regulated, or directly or indirectly assisted by any department or agency of the United States shall, except as provided in subsection (e) of this section, be confidential. The statute requires that HHS issue regulations, which are codified at 42 CFR Part 2. SAMHSA.  This final rule will adopt changes proposed in the SNPRM.


Based on public comments, SAMHSA anticipates that these modifications will enhance efficiency of such payment and health care operations as claims processing, business management, training and customer service. The alternative would be not to finalize these changes in which case it would remain unclear in some cases as to when and whether part 2 programs could work with contractors or subcontractors on payment and health care operations activities.

Anticipated Costs and Benefits:

The changes proposed will make it easier for part 2 programs to work with contractors, subcontractors, and legal representatives on payment and healthcare operations activities. SAMHSA also will develop an abbreviated notice of redisclosure that may make it easier for some entities to use electronic health records.


None known.

This rule, if finalized, would permit lawful holders of part 2 information to work with contractors, subcontractors and legal representatives to make additional disclosures of part 2 information for certain payment and health care operations purposes when initial patient consent is obtained. The rule includes language which provides that the contractor and any subcontractor or legal representative are or will be fully bound by the provisions of part 2 upon receipt of the patient identifying data, and, as such that each disclosure shall be accompanied by a required redisclosure notice. SAMHSA does not believe the additional disclosures permitted will increase risks of data breaches or other risks to patients.

Action Date FR Cite
Final Action  01/00/2018 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Federalism: Undetermined 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Agency Contact:
Chris Carroll
Director of Health Care Financing and Systems Integration
Department of Health and Human Services
Substance Abuse and Mental Health Services Administration
1 Choke Cherry Road,
Rockville, MD 20857
Phone:240 276-1765