On February 9, 2016, the Substance Abuse and Mental Health Services Administration (SAMHSA) published a proposed rule (Proposed Rule) to modernize the Confidentiality of Alcohol and Drug Abuse Patient Records regulations, 42 CFR Part 2 (Part 2). Generally, Part 2 protects the confidentiality of patient records and requires patient consent for the disclosure of information regarding substance use disorder treatment by a federally funded entity.

When SAMHSA promulgated Part 2 in 1987, electronic health records and health information exchanges were a product of the future. Given the developments in the use of electronic information, the Proposed Rule modernizes Part 2 by seeking to facilitate information sharing within new health care models, such as Accountable Care Organizations. Consistent with the initial purpose of Part 2, the Proposed Rule strives to address patient privacy concerns and encourage patients with substance use disorders to fully participate in coordinated health care models without fear of adverse consequences, such as loss of employment or incarceration.

While SAMHSA has included numerous revisions to Part 2 in the Proposed Rule, some of the more notable revisions are summarized below.

Change to Definitions and Terminology

With the goal of clarifying the regulations and promoting consistency throughout the regulations and statute, SAMHSA proposes several changes to the definitions and terminology used in Part 2. Because the current regulations include four separate definitions sections, the Proposed Rule consolidates all definitions (except for the term “Federally assisted”) into a single section to ensure they are applied consistently throughout Part 2.

New Consent Requirements and Confidentiality Safeguards

SAMHSA proposes to make changes to the consent form requirements and permit a patient to give general consent, such that a patient can authorize his or her Part 2 information to be shared with treating providers or a health information exchange.  The purpose of these changes is to improve access to information for care coordination and integrated health models and improve the quality of care for patients who receive care from multiple providers. SAMHSA also wants to ensure that patients are aware of the information they are authorizing to disclose when signing the consent form, as well as who is sending and receiving their identifying information.

Security of Electronic Records                                   

Currently, Part 2 does not contain rules for the security of electronic records. The Proposed Rule addresses both paper and electronic health records by clarifying that Part 2 programs and other lawful holders of patient identifying information must have formal policies and procedures in place for both paper and electronic records. The goal of this modification is to ensure protection of patient identifying information when records are exchanged electronically.

Research Disclosures

Under the current regulations, only the Part 2 program director may authorize the disclosure of patient identifying information for scientific research purposes to qualified personnel.  SAMHSA proposes to allow any individual or entity in lawful possession of Part 2 data to disclose information to qualified personnel for the purpose of conducting scientific research. The Proposed Rule also attempts to improve data linkages to open up new research opportunities. By expanding the research exception, SAMHSA will promote more scientific research that will encourage quality improvement of Part 2 programs.

The public comment period for the Proposed Rule closes on April 11, 2016 at 5 p.m. Eastern.

If you would like additional information about the potential impacts of any of the changes described in this blog post, please contact our Health Care practice group at Feldesman Tucker Leifer Fidell LLP, www.ftlf.com or 202-466-8960.