SAMHSA Proposes Rule Modernizing Regulations Regarding Confidentiality of Alcohol and Drug Abuse Patient Records
On February 9, 2016, The Department of Health and Human Services’ Substance Abuse and Mental Health Services Administration (“SAMHSA”) published a proposed rule intended to modernize and update the regulations at 42 C.F.R. Part 2 (“Part 2”).
Part 2, which has not been substantively updated since 1987, generally requires that a federally assisted substance use disorder program may only release identifiable information related to substance use disorder diagnosis, treatment, or referral for treatment with the individual’s express consent. The proposed rule is intended to facilitate the electronic exchange of substance use disorder information with appropriate confidentiality protections. SAMHSA hopes that this will lead to increased opportunities for individuals with substance use disorders to participate in emerging health care models such as health information exchanges and accountable care organizations, leading to increased efficiency and quality.
The major provisions of the proposed rule are:
- Revisions to and addition of certain defined terms. Of particular note, “substance use disorder” is a new term that refers to alcohol abuse and drug abuse collectively. Another new key definition is “treating provider relationship,” which is created regardless of whether there has been an in-person encounter if: (1) a patient agrees to be diagnosed, evaluated, or treated for any condition by an individual or entity; and (2) the individual or entity agrees to undertake diagnosis, evaluation, or treatment of the patient, or consultation with the patient, for any condition.
- Changes to the consent form. In certain circumstances, a patient would be allowed to include a general designation in the “To Whom” section of the consent form (e.g., an ACO, or “my current and future treating providers”), in conjunction with requirements that (1) the consent form include an explicit description of the amount and kind of substance use disorder treatment information that may be disclosed; and (2) the “From Whom” section of the consent specifically must name the Part 2 program or other lawful holder of the patient identifying information permitted to make the disclosure. When using a general designation in the “To Whom” section of the consent form, the patient has a right to obtain, upon request, a list of entities to which their information has been disclosed. The patient’s understanding of this right must be documented on the form.
- Changes to the research exception. Data protected by Part 2 would be permitted to be disclosed to qualified personnel for the purpose of conducting scientific research by a Part 2 program or any other individual or entity that is in lawful possession of Part 2 data if the researcher provides documentation of meeting certain requirements related to other existing protections for human research (e.g., HIPAA Privacy Rule requirements and/or HHS Common Rule informed consent or waiver of consent requirements). In addition, SAMHSA is proposing to enable researchers holding Part 2 data to link to data sets from federal data repositories and is seeking comment on expanding this provision to non-federal data repositories.
In the preamble to the proposed rule, SAMHSA states that signed consent forms in place prior to the effective date of the final rule would be valid until they expire. However, consents obtained after the effective date would need to comply with the final rule, regardless of whether the consents involve patient identifying information obtained prior to or after the effective date of the final rule.
The proposed rule is located here. All comments must be received by April 11, 2016.
Please contact us should you have any questions or concerns regarding the proposed rule.
This News Alert has been prepared for informational purposes only and should not be construed as, and does not constitute, legal advice on any specific matter. For more information, please see the disclaimer.