CTN-0070-Ot: Interpretation and Implementation of Title 42 CFR Part 2 for Confidentiality of Patient Drug and Alcohol Use Records: NIDA CTN Stakeholder Snapshot

Principal Investigator
Gavin Bart, MD, PhD, FACP, FASAM
Minneapolis Medical Research Foundation, Hennepin County Medical Center

The research project will explore institutional variability in the interpretation and implementation of 42 CFR Part 2 regulations related to health systems data privacy practices, policies and information technology architecture. Specific aims include describing the range of interpretations of 42 CFR Part 2 across health systems participating in the Clinical Trials Network and describing the range of current information technology implementation practices for 42 CFR Part 2 regulations (e.g., EHR operationalization; workflow strategies; workarounds).

Primary Findings

Participants voiced concern over balancing patient safety with 42 CFR Part 2 privacy protections. Although similar standards of protection regarding release of information outside of the health system was described, numerous workarounds were used to manage intra-institutional communication and care coordination. To align 42 CFR Part 2 restrictions with electronic health records, health systems used sensitive note designation, “break the glass” technology, limited role-based access for providers, and ad hoc solutions (e.g., provider messaging).

In contemporary integrated care systems, substance-related EHR records (e.g., patient visit history, medication logs) are often accessible internally without specific consent for sharing despite the intent of 42 CFR Part 2. Recent amendments to 42 CFR Part 2 have not addressed information sharing needs within integrated care settings.

Primary Outcomes Article: Campbell ANC, et al. Interpretation and Integration of the Federal Substance Use Privacy Protection Rule in Integrated Health Systems: A Qualitative Analysis. Journal of Substance Abuse Treatment 2019;97:41-46. [get article]

    Node Involvement

    Lead Node(s):

  • Northstar Node

  • All Participating Nodes:

  • Northstar Node