Interpretation and integration of the federal substance use privacy protection rule in integrated health systems: A qualitative analysis.

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BACKGROUND:Federal regulations (42 CFR Part 2) provide special privacy protections for persons seeking treatment for substance use disorders. Primary care providers, hospitals, and health care organizations have struggled to balance best practices for medical care with adherence to 42 CFR Part 2, but little formal research has examined this issue. The aim of this study was to 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. METHODS:This was a cross-sectional qualitative study using purposive sampling to conduct interviews with privacy/legal officers (n = 17) and information technology specialists (n = 10) from 15 integrated healthcare organizations affiliated with three research nodes of the National Institute on Drug Abuse (NIDA) National Drug Abuse Treatment Clinical Trials Network (CTN). Trained staff completed a short survey and digitally recorded semi-structured qualitative interview with each participant. Interviews were transcribed and coded within Atlas.ti. Framework analysis was used to identify and organize key themes across selected codes. RESULTS: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). CONCLUSIONS: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.





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Campbell, Aimee NC, Dennis McCarty, Traci Rieckmann, Jennifer McNeely, John Rotrosen, Li-Tzy Wu and Gavin Bart (2019). Interpretation and integration of the federal substance use privacy protection rule in integrated health systems: A qualitative analysis. Journal of substance abuse treatment, 97. pp. 41–46. 10.1016/j.jsat.2018.11.005 Retrieved from

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Li-Tzy Wu

Professor in Psychiatry and Behavioral Sciences

Education/Training: Pre- and post-doctoral training in mental health service research, psychiatric epidemiology (NIMH T32), and addiction epidemiology (NIDA T32) from Johns Hopkins University School of Public Health (Maryland); Fellow of the NIH Summer Institute on the Design and Conduct of Randomized Clinical Trials.

Director: Duke Community Based Substance Use Disorder Research Program.

Research interests: COVID-19, Opioid misuse, Opioid overdose, Opioid use disorder, Opioid addiction prevention and treatment, Pain and addiction, Chronic diseases and substance use disorders, diabetes, pharmacy-based care models and services, medication treatment for opioid use disorder (MOUD), Drug overdose, Polysubstance use and disorders, cannabis, alcohol, tobacco, hallucinogens, stimulants, e-cigarette, SBIRT (substance use Screening, Brief Intervention, Referral to Treatment), EHR-based research and intervention, data science, psychometric analysis (IRT), epidemiology of addictions and comorbidity, behavioral health care integration, health services research (mental health disorders, substance use disorders, chronic diseases), nosology, research design, HIV risk behavior. 

FUNDED Research projects (Principal Investigator [PI], Site PI, or Sub-award PI): 
R03: Substance use/dependence (PI).
R21: Treatment use for alcohol use disorders (PI).
R21: Inhalant use & disorders (PI).
R01: MDMA/hallucinogen use/disorders (PI).
R01: Prescription pain reliever (opioids) misuse and use disorders (PI).
R01: Substance use disorders in adolescents (PI).
R21: CTN Substance use diagnoses & treatment (PI).
R33: CTN Substance use diagnoses & treatment (PI).
R01: Evolution of Psychopathology in the Population (ECA Duke site PI).
R01: Substance use disorders and treatment use among Asian Americans and Pacific Islanders (PI).
UG1: SBIRT in Primary Care (NIDA, PI).
UG1: TAPS Tool, Substance use screening tool validation in primary care (NIDA, PI).
UG1: NIDA CTN Mid-Southern Node (Clinical Trials Network, PI).
UG1: EHR Data Element Study (NIDA, PI).
UG1: Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder (NIDA, PI).
PCORI: INSPIRE-Integrated Health Services to Reduce Opioid Use While Managing Chronic Pain (Site PI).
CDC R01: Evaluation of state-mandated acute and post-surgical pain-specific CDC opioid prescribing (Site PI).
Pilot: Measuring Opioid Use Disorders in Secondary Electronic Health Records Data (Carolinas Collaborative Grant: Duke PI).
R21: Developing a prevention model of alcohol use disorder for Pacific Islander young adults (Subaward PI, Investigator).
UG1: Subthreshold Opioid Use Disorder Prevention Trial (NIH HEAL Initiative) (NIDA supplement, CTN-0101, Investigator).
NIDA: A Pilot Study to Permit Opioid Treatment Program Physicians to Prescribe Methadone through Community Pharmacies for their Stable Methadone Patients (NIDA/FRI: Study PI).
UG1: Integrating pharmacy-based prevention and treatment of opioid and other substance use disorders: A survey of pharmacists and stakeholder (NIH HEAL Initiative, NIDA, PI).
UG1: NorthStar Node of the Clinical Trials Network (NIDA, Site PI).
R34: Intervention Development and Pilot Study to Reduce Untreated Native Hawaiian and Pacific Islander Opioid Use Disorders (Subaward PI, Investigator).
UG1: Optimal Policies to Improve Methadone Maintenance Adherence Longterm (OPTIMMAL Study) (NIDA, Site PI).
R01: Increasing access to opioid use disorder treatment by opening pharmacy-based medication units of opioid treatment programs (NIDA, PI)

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