The rule “will further enhance health services research, integrated treatment, quality assurance, and health information exchange activities while at the same time safeguarding the essential privacy rights of people seeking treatment for substance use disorders,” said Kana Enomoto, deputy assistant secretary of the Department of Health and Human Services. She oversees the Substance Abuse and Mental Health Services Administration (SAMHSA).
The previous regulations governing the confidentiality of substance use disorder records (referred to as "42 CFR Part 2”) were promulgated in 1975 to protect the confidentiality of patients receiving services for alcohol and other substance use disorders through programs that receive federal assistance. In February 2016, SAMHSA issued a notice of proposed rulemaking intended to adjust the regulations to reflect changes in the health care delivery system—especially the development of integrated care networks that depend on shared information—and permit appropriate research and data exchange activities.
Major provisions in the final rule include the following:
- SAMHSA will allow any lawful holder of patient identifying information to disclose Part 2 patient identifying information to qualified personnel for purposes of conducting scientific research if the researcher meets certain regulatory requirements. SAMHSA also permits data linkages to enable researchers to link to datasets from data repositories holding Part 2 data if certain regulatory requirements are met. These will enable more needed research on substance use disorders.
- SAMHSA will allow a patient to consent to disclosing their information using a general designation to individuals and/or entities (such as “my treating providers”) in certain circumstances. This change is intended to allow patients to benefit from integrated health care systems while retaining patient choice, confidentiality, and privacy; patients do not have to agree to such disclosures.
- SAMHSA has added a requirement allowing patients who have agreed to the general disclosure designation the option of receiving a list of entities to whom their information has been disclosed.
- SAMHSA has made changes that outline the audit or evaluation procedures necessary to meet the requirements of a CMS-regulated accountable care organization or similar CMS-regulated organizations. This change will ensure CMS-regulated entities can perform necessary audit and evaluations activities, including financial and quality assurance functions critical to accountable care organizations and other health care organizations.
- The final rule addresses both paper and electronic documentation.