Confidentiality of Substance Use Disorder Patient Records

Statutory authority for confidentiality of substance use disorder patient records.

This provision identifies the statutory authority for the Secretary to prescribe regulations regarding the confidentiality of substance use disorder patient records.

Definitions.

For purposes of the regulations in this part:

Applicability.

This provision defines the scope, applicability, and exceptions for federal confidentiality requirements regarding substance use disorder patient records.

Confidentiality restrictions and safeguards.

This provision mandates strict confidentiality for substance use disorder patient records and limits disclosures to those necessary for the intended purpose.

Minor patients.

This provision defines the requirements for obtaining consent for the disclosure of substance use disorder records for minor patients based on state law.

Patients who lack capacity and deceased patients.

This provision outlines the procedures for obtaining consent for the disclosure of substance use disorder records for patients who lack capacity or are deceased.

Security for records and notification of breaches.

This provision requires programs to implement formal policies to protect substance use disorder patient records and mandates compliance with breach notification requirements.

Undercover agents and informants.

This provision restricts the employment or enrollment of undercover agents and informants in substance use disorder programs to protect patient confidentiality.

Restrictions on the use of identification cards.

This provision prohibits requiring patients to carry identification cards that disclose their substance use disorder status while away from the program premises.

Disposition of records by discontinued programs.

This provision establishes requirements for the secure retention, transfer, or destruction of patient records when a substance use disorder program discontinues operations.

Purpose and effect.

This provision outlines the purpose and scope of federal regulations governing the confidentiality and disclosure of substance use disorder patient records.

Relationship to state laws.

This provision clarifies the preemption relationship between federal substance use disorder record confidentiality regulations and state laws.

Relationship to federal statutes protecting research subjects against compulsory disclosure of their identity.

This provision describes the interaction between substance use disorder record confidentiality rules and federal research privilege statutes regarding compulsory disclosure.

Notice to patients of Federal confidentiality requirements.

This provision mandates that substance use disorder treatment programs provide patients with a formal notice of their privacy practices, legal duties, and patient rights regarding the confidentiality of their records.

Patient access and restrictions on use and disclosure.

This provision outlines the patient's right to access their own substance use disorder records and the limitations on using such information for criminal investigations.

Requirements for intermediaries.

Upon request, an intermediary must provide to patients who have consented to the disclosure of their records using a general designation, pursuant to § 2.31(a)(4)(ii)(B), a list of persons to which their records have been disclosed pursu...

Accounting of disclosures.

This provision mandates that part 2 programs provide patients with an accounting of disclosures of their substance use disorder records upon request.

Right to request privacy protection for records.

This provision establishes the patient's right to request restrictions on the use and disclosure of their substance use disorder records for treatment, payment, or health care operations.

Civil and criminal penalties for violations.

This provision details the civil and criminal penalties for violating federal confidentiality rules regarding substance use disorder patient records.

Consent requirements.

This provision specifies the required elements for written consent for the use or disclosure of substance use disorder patient records.

Notice and copy of consent to accompany disclosure.

This provision requires that any disclosure of substance use disorder records made with patient consent must be accompanied by a specific written notice and a copy of the consent.

Uses and disclosures permitted with written consent.

This provision outlines the requirements for using and disclosing substance use disorder patient records when valid written consent is obtained.

Uses and Disclosures to prevent multiple enrollments.

This provision specifies the conditions under which patient records may be disclosed to central registries or treatment programs to prevent multiple enrollments in substance use disorder programs.

Disclosures to elements of the criminal justice system which have referred patients.

This provision establishes the requirements for disclosing substance use disorder patient records to criminal justice entities that have mandated treatment as a condition of release.

Disclosures to prescription drug monitoring programs.

This provision permits the reporting of substance use disorder medication data to state prescription drug monitoring programs when required by state law, provided patient consent is obtained.

Complaints of noncompliance.

This provision mandates that programs establish a process for receiving complaints regarding privacy noncompliance and prohibits retaliation against patients for exercising their rights.

Medical emergencies.

This provision allows for the disclosure of patient identifying information to medical personnel during bona fide medical emergencies when prior consent cannot be obtained.

Scientific research.

This provision establishes the requirements for the use and disclosure of patient identifying information for scientific research, including researcher obligations, IRB approval for data linkages, and data security and retention standards.

Management audits, financial audits, and program evaluation.

This provision establishes the requirements for disclosing patient identifying information from substance use disorder records for the purpose of conducting management audits, financial audits, and program evaluations.

Disclosures for public health.

Part 2 programs may disclose de-identified patient records to public health authorities without patient consent.

Legal effect of order.

Court orders under Part 2 authorize but do not compel the disclosure of patient records, which requires a separate subpoena or legal mandate.

Order not applicable to records disclosed without consent to researchers, auditors, and evaluators.

Court orders cannot authorize the use of records disclosed to researchers or auditors for criminal investigation or prosecution of patients.

Confidential communications.

Court orders may only authorize disclosure of confidential communications in specific cases involving threats to life, serious crimes, or patient-initiated testimony.

Procedures and criteria for orders authorizing uses and disclosures for noncriminal purposes.

Court orders for noncriminal disclosures require good cause, notice, and specific measures to protect patient identity and confidentiality.

Procedures and criteria for orders authorizing use and disclosure of records to criminally investigate or prosecute patients.

Court orders for criminal investigation of patients require strict criteria, including evidence of serious crime and the exhaustion of other investigative methods.

Procedures and criteria for orders authorizing use and disclosure of records to investigate or prosecute a part 2 program or the person holding the records.

This provision establishes the legal procedures, criteria, and limitations for investigative agencies to obtain court orders for the disclosure of substance use disorder patient records in criminal or administrative investigations.

Orders authorizing the use of undercover agents and informants to investigate employees or agents of a part 2 program in connection with a criminal matter.

This provision outlines the criteria and procedural requirements for obtaining a court order to place undercover agents or informants within a substance use disorder program to investigate suspected criminal activity.

Report to the Secretary.

This provision requires investigative agencies to report annually to the Secretary on the number of court order applications, denials, and instances of record handling related to substance use disorder programs.