Confidentiality of Substance Use Disorder Patient Records, (42 CFR Part 2)
**Part 2 amendments went into effect on March 21, 2017. The updates to the regulations are reflected in 42 CFR Part 2 and the Final Rule with public comments is at 82 FR 6052. **
The Confidentiality of Substance Use Disorder Patient Records (commonly known as “Part 2”) is a federal regulation enacted to encourage substance abusers to seek treatment without the fear of stigmatization or criminal prosecution. The regulations were updated and modernized in 2017 to reflect a need to better align Part 2 with the U.S. health care delivery system while retaining important privacy protections.
How does Part 2 interact with Minnesota state law?
The Part 2 regulations preempt Minnesota state law. The regulations expressly say that “no State law may either authorize or compel a disclosure prohibited by these regulations.”
What kinds of records are covered under Part 2?Any information, recorded or not, which:
- Identifies a patient as having, or having had, a substance use disorder either directly, by reference to publically available information, or through verification by another person; and
- Is drug or alcohol abuse information obtained by a federally assisted drug or alcohol abuse program after certain dates, or if obtained after the certain dates, is maintained as part of ongoing treatment.
Additional definitions are found in 42 CFR 2.11.
Does everyone have to comply with Part 2?
Part 2 applies if a program is federally assisted and one of the following applies:
- Individual or entity (other than a general medical facility) holds itself out as providing, and provides, substance use disorder diagnosis, treatment, or referral for treatment; or
- Individual unit within a general medical facility holds itself out as providing, and provides, substance use disorder diagnosis, treatment, or referral for treatment; or
- Medical personnel or other staff in a general medical facility whose primary function is substance use disorder diagnosis, treatment, or referral for treatment and are identified as such providers.
A program is considered federally assisted if any of the following apply:
- Conducted in whole or part, directly or under contract, by the federal government
- Authorized, licensed, certified, or registered by the federal government
- Supported by federal funds
- Assisted by the IRS through a grant of tax exempt status or allowance of tax deductions
Are there any times when Part 2 confidentiality doesn't apply?
Yes, there are six instances that Part 2 does not apply to substance use disorder information.
- Department of Veterans Affairs’ records
- Armed Forces records
- Communication within a Part 2 program and between a Part 2 program and an entity with direct administrative control over that program
- Communications between a Part 2 program and a Qualified Service Organization
- Patient commits a crime on the premises or against treatment staff
- Reporting suspected child abuse or neglect
When can records under Part 2 be disclosed?
Consent. A treatment facility may ask a patient to provide written consent for a disclosure. The following elements are required in all electronic or paper Part 2 consent forms:
- Name of patient
- Specific name or general designation of the Part 2 program(s), entity(ies), or individual(s) permitted to make the disclosure
- How much and what kind of information to disclose, including explicit description of the substance use disorder information
- Name(s) of individual(s) (or entity, in certain situations) to whom disclosures are made, which can be a general designation under certain situations
- Purpose of disclosure, which must be limited to information necessary to carry out stated purpose
- Date on which consent is signed
- Statement that consent is subject to revocation at any time (except to the extent that the consent has already been relied upon)
- Date, event, or condition upon which the consent will expire if not revoked (patient is allowed to revoke the consent at any time)
- Signature of patient (or patient’s representative), electronic signatures are permitted
- Date consent is signed
Permitted disclosures. There are certain circumstances when a facility is permitted to disclose patient information:
- To medical personnel to the extent necessary to meet a "bona fide medical emergency" when informed consent cannot be obtained
- To conduct research if certain conditions are met
- For audit and evaluation, if certain conditions are met
- In response to a court order. If the requestor has a court order authorizing disclosure and a subpoena compelling disclosure, the disclosure is mandatory. If the requester only has a subpoena or arrest warrant, the disclosure is not allowed.
What is a Qualified Service Organization Agreement?
A Qualified Service Organization Agreement (QSOA) is an agreement between a Part 2 program and a Qualified Service Organization (QSO) that permits the exchange of patient identifying information when the QSO acknowledges that it is fully bound by Part 2.
Where can I find additional guidance on Part 2 confidentiality requirements?
The federal Substance Abuse and Mental Health Services Administration (SAMHSA) advises on Part 2 and provides a number of FAQs on its related guidance.