Could the rules governing the privacy of substance abuse records be loosening up? Earlier this month, the US Department of Health and Human Services’ Substance Abuse and Mental Health Services Administration issued a proposed rule to amend the Confidentiality of Alcohol and Drug Abuse Patient Records regulations, more commonly known by the citation 42 CFR Part 2. Promulgated in 1975, long before HIPAA and electronic medical records, and last updated in 1987, 42 CFR Part 2 is arguably ripe for an update. HHS explained that its goals in updating the regulations are to facilitate the exchange of substance use information, particularly within new integrated health care delivery systems, while protecting the privacy of patients seeking treatment for substance abuse.
42 CFR Part 2 governs the confidentiality of patients’ substance abuse treatment records. Currently, the general rule is that a federally assisted substance abuse program may only release identifiable information related to substance abuse diagnosis or treatment with the patient’s express consent. The privacy protections in 42 CFR Part 2 are more stringent than those found in HIPAA. For instance, HIPAA allows patient records to be exchanged among covered entities and business associates, without patient consent, for treatment, payment and other healthcare operations. But if the patient records contain information related to alcohol or drug use, 42 CFR Part 2 requires that the patient specifically consent to those exchanges. This additional layer of consent poses special challenges for health care providers; for example, it can be difficult for substance abuse patients to participate in health information exchanges.
The proposed rule would still require patient consent prior to disclosing or exchanging medical records that would identify, directly or indirectly, an individual who has been diagnosed or treated for a substance-abuse disorder. But it would allow patients to give a general consent to the disclosure of other health-related information; for example, they could consent to disclosure to a specified health information exchange or to all of their health care providers.
Another noteworthy change in the proposed rule relates to research. Recognizing the need for more research into substance use disorders, the proposed rule would allow disclosure of patient-identifying data for research purposes under defined circumstances.
The competing interests at stake will undoubtedly generate some heated debate over the next few months. Supporters argue that the changes will improve patient outcomes by allowing health care providers to better coordinate and modernize patient care. Opponents warn that substance abuse information is so sensitive that any loosening of the rules might discourage patients from receiving treatment.
The entire 144-page proposed rule can be found here. The proposed rule is open for public comment until April 1.