Recommendations to Inform Substance Use Disorder Data Sharing Research: Scoping Review and Thematic Analysis.

OBJECTIVES Title 42 Code of Federal Regulations Part 2 (42 CFR Part 2 or Part 2) was enacted in 1975 to protect patients receiving treatment for substance use disorders. A scoping review on Part 2 characterized published work. METHODS Seven databases were searched. Studies were categorized based on date of publication, primary objectives, methods, and findings. A thematic analysis was conducted using article titles and abstracts. RESULTS Of the 36 studies identified, the majority (78%) were opinions or legal reviews, (22%) employed quantitative and/or qualitative methods to study the impact of Part 2, and over half (58%) were published in the past 5 years. Only 8% of studies reported stakeholder involvement in Part 2 studies and no study included patients or patient advocates. No study discussed the efforts to align Part 2 with Health Insurance Portability and Accountability Act or provided evidence of the benefit of this alignment. Three main themes emerged from the review: care delivery (46.6%), law and ethics (27.6%), and technology (25.9%). There were no studies focusing on stigma and its effect on substance use treatment and Part 2. CONCLUSIONS Despite the significance of Part 2, the literature is sparse. It is time to initiate a new era of scholarly research that focuses on the impact of statutes and policies that govern substance use disorder data sharing. Specifically, we recommend research on Part 2 and Health Insurance Portability and Accountability Act alignment, the effects of Part 2 on patients, as well as providers and other stakeholder perceptions on the regulation.