Title 42 of CFR part 2 was first promulgated in 1975 during the Nixon Administration(40 FR 27802) and last substantively updated in 1987 (52 FR 21796). The authorizing statute, Title 42, United States Code (U.S.C.) 290dd-2, protects the confidentiality of the records containing the identity, diagnosis, prognosis, or treatment of any patient that are maintained in connection with the performance of any federally assisted program or activity relating to substance abuse (now referred to as substance use disorder 'SUD') education, prevention, training, treatment, rehabilitation, or research.
The Substance Abuse and Mental Health Services Administration (SAMHSA) is the agency within the U.S. Department of Health and Human Services that leads public health efforts to advance the behavioral health of the nation. SAMHSA's mission is to reduce the impact of substance abuse and mental illness on America's communities.
SAMHSA Key Components
- HIPAA Harmonization (sort of)
SAMSHA monitors the use of illegal drugs, prescription drugs, alcohol, and tobacco as well as mental disorders, treatment, and co-occurring substance use and mental disorders. This data provides estimates of substance use and mental illness at the national, state, and sub-state levels.
Lack of harmonization with HIPAA clearly is a function of the separation of authoritative bodies as shown above for SAMHSA and OCR. Although these organizations are both associated with HHS, the regulations for which they provide guidance are separate and data collected is dissimilar.
(1) Except as provided in paragraph (2) of this definition, that is:
(i) Transmitted by electronic media;
(ii) Maintained in electronic media; or
(iii) Transmitted or maintained in any other form or medium.
(2) Protected health information excludes individually identifiable health information:
(i) In education records covered by the Family Educational Rights and Privacy Act, as amended, 20 U.S.C. 1232g;
(ii) In records described at 20 U.S.C. 1232g(a)(4)(B)(iv);
(iii) In employment records held by a covered entity in its role as employer; and
(iv) Regarding a person who has been deceased for more than 50 years.
SAMSHA data collection includes more than simply health information. The Center for Behavioral Health Statistics and Quality (CBHSQ) is the leading source of behavioral health data in the United States. Behavioral health data collected includes:
- Prevalence of mental illness and substance use disorders
- Behavioral health service provision and use
- Evaluation data
This data helps researchers, public health officials, and policymakers to understand and solve issues.
Individuals are identified for screening with a personal face-to-face interview or via Computer-Based questionnaires. Initial contact with residents of specific SDUs is made through a lead letter that gives a brief explanation of the nature of the interview and its methods.
However; like HIPAA, informed consent is obtained prior to interviews.
A minimum of four visits may be made at different times of day on different days of the week to complete the interview. More often than desired, potential respondents exercised their "right to refuse to participate." Refusals at the screening and interviewing level have historically been a problem for NSDUH (as is common with many other national-level household surveys). Again, another similarity with HIPAA rights for refusal.
Table 7.3 shows the national totals for ineligible and eligible cases, as broken down by population density and screening result code. As part of each NSDUH interview, field interviewers (FIs) were required to assess the respondent's level of cooperation, understanding, and privacy during the interview. One question asked whether respondents revealed to the FI answers entered during the audio computer-assisted self-interviewing (ACASI) section.
This excerpt of Table 7.11 shows the national totals for eligible and ineligible cases and lists results for each state broken down by population density and non-response rate.
Regulations under Part 2 impose restrictions upon the disclosure and use of substance use disorder patient records which are maintained in connection with the performance of any part 2 program. Violations of these may be directed to the United States Attorney for the judicial district in which the violation occurs as well as to the Substance Abuse and Mental Health Services Administration (SAMHSA) office responsible for opioid treatment program oversight.
Like HIPAA's Privacy Rule, Part 2 contains Disclosure rules. A court order under the regulations in Part 2 may authorize the disclosure of confidential communications
made by a patient to a part 2 program in the course of diagnosis, treatment, or referral for treatment only if: (1) The disclosure is necessary to protect against an existing threat to life or of serious bodily injury, including circumstances which constitute suspected child abuse and neglect and verbal threats against third parties; (2) The disclosure is necessary in connection with investigation or prosecution of an extremely serious crime allegedly committed by the patient, such as one which directly threatens loss of life or serious bodily injury, including homicide, rape, kidnapping, armed robbery, assault with a deadly weapon, or child abuse and neglect; or (3) The disclosure is in connection with litigation or an administrative proceeding in which the patient offers testimony or other evidence pertaining to the content of the confidential communications.
The Substance Abuse and Mental Health Services Administration (SAMHSA) is the agency within the U.S. Department of Health and Human Services (HHS) that leads public health efforts to advance the behavioral health of the nation and to improve the lives of individuals living with mental and substance use disorders, and their families.
To provide leadership and resources - programs, policies, information and data, funding, and personnel - advance mental and substance use disorder prevention, treatment, and recovery services in order to improve the individual, community, and public health.
To reduce the impact of substance misuse and mental illness on America's communities.