United States · regulation · 42 CFR · 7,228 active provisions
Title 42, United States Code, section 290dd-2(g) authorizes the Secretary to prescribe regulations to carry out the purposes of section 290dd-2. Such regulations may contain such definitions, and may provide for such safeguards and procedures, including procedures and criteria for the issuance and scope of orders under…
(a) Purpose. Pursuant to 42 U.S.C. 290dd-2(g), the regulations in this part impose restrictions upon the use and disclosure of substance use disorder patient records (“records,” as defined in this part) which are maintained in connection with the performance of any part 2 program. The regulations in this part include t…
(a) Penalties. Any person who violates any provision of 42 U.S.C. 290dd-2(a)-(d), shall be subject to the applicable penalties under sections 1176 and 1177 of the Social Security Act, 42 U.S.C. 1320d-5 and 1320d-6. (b) Limitation on criminal or civil liability. A person who is acting on behalf of an investigative agenc…
(a) Receipt of complaints. A part 2 program must provide a process to receive complaints concerning the program's compliance with the requirements of this part. (b) Right to file a complaint. A person may file a complaint to the Secretary for a violation of this part by a part 2 program, covered entity, business associ…
For purposes of the regulations in this part: Breach has the same meaning given that term in 45 CFR 164.402. Business associate has the same meaning given that term in 45 CFR 160.103. Central registry means an organization which obtains from two or more member programs patient identifying information about individuals…
(a) General— (1) Restrictions on use and disclosure. The restrictions on use and disclosure in the regulations in this part apply to any records which: (i) Would identify a patient as having or having had a substance use disorder either directly, by reference to publicly available information, or through verification o…
(a) General. The patient records subject to the regulations in this part may be used or disclosed only as permitted by the regulations in this part and may not otherwise be used or disclosed in any civil, criminal, administrative, or legislative proceedings conducted by any Federal, state, or local authority. Any use o…
(a) State law not requiring parental consent to treatment. If a minor patient acting alone has the legal capacity under the applicable state law to apply for and obtain substance use disorder treatment, any written consent for use or disclosure authorized under subpart C of this part may be given only by the minor pati…
(a) Adult patients who lack capacity to make health care decisions—(1) Adjudication by a court. In the case of a patient who has been adjudicated as lacking the capacity, for any reason other than insufficient age, to make their own health care decisions, any consent which is required under the regulations in this part…
(a) The part 2 program or other lawful holder of patient identifying information must have in place formal policies and procedures to reasonably protect against unauthorized uses and disclosures of patient identifying information and to protect against reasonably anticipated threats or hazards to the security of patien…
(a) Restrictions on placement. Except as specifically authorized by a court order granted under § 2.67, no part 2 program may knowingly employ, or enroll as a patient, any undercover agent or informant. (b) Restriction on use and disclosure of information. No information obtained by an undercover agent or informant, wh…
No person may require any patient to carry in their immediate possession while away from the part 2 program premises any card or other object which would identify the patient as having a substance use disorder. This section does not prohibit a person from requiring patients to use or carry cards or other identification…
(a) General. If a part 2 program discontinues operations or is taken over or acquired by another program, it must remove patient identifying information from its records or destroy its records, including sanitizing any associated hard copy or electronic media, to render the patient identifying information non-retrievab…
The statute authorizing the regulations in this part (42 U.S.C. 290dd-2) does not preempt the field of law which they cover to the exclusion of all state laws in that field. If a use or disclosure permitted under the regulations in this part is prohibited under state law, neither the regulations in this part nor the au…
(a) Research privilege description. There may be concurrent coverage of patient identifying information by the regulations in this part and by administrative action taken under section 502(c) of the Controlled Substances Act (21 U.S.C. 872(c) and the implementing regulations at 21 CFR part 1316); or section 301(d) of t…
(a) Notice required. At the time of admission to a part 2 program or, in the case that a patient does not have capacity upon admission to understand their medical status, as soon thereafter as the patient attains such capacity, each part 2 program shall inform the patient that Federal law protects the confidentiality o…
(a) Patient access not prohibited. These regulations do not prohibit a part 2 program from giving a patient access to their own records, including the opportunity to inspect and copy any records that the part 2 program maintains about the patient. The part 2 program is not required to obtain a patient's written consent…
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 pursuant to the general designation. (a) Under this section, patient requests: (1) Must…
(a) General rule. Subject to the limitations in paragraph (b) of this section, a part 2 program must provide to a patient, upon request, an accounting of all disclosures made with consent under § 2.31 in the 3 years prior to the date of the request (or a shorter time period chosen by the patient). The accounting of dis…
(a)(1) A part 2 program must permit a patient to request that the part 2 program restrict uses or disclosures of records about the patient to carry out treatment, payment, or health care operations, including when the patient has signed written consent for such disclosures. (2) Except as provided in paragraph (a)(6) of…
(a) Required elements for written consent. A written consent to a use or disclosure under the regulations in this part may be paper or electronic and must include: (1) The name of the patient. (2) The name or other specific identification of the person(s), or class of persons, authorized to make the requested use or di…
(a) Each disclosure made with the patient's written consent must be accompanied by one of the following written statements (i.e., paragraph (a)(1) or (2) of this section): (1) Statement 1. This record which has been disclosed to you is protected by Federal confidentiality rules (42 CFR part 2). These rules prohibit you…
(a) If a patient consents to a use or disclosure of their records consistent with § 2.31, the following uses and disclosures are permitted, as applicable: (1) A part 2 program may use and disclose those records in accordance with that consent to any person or category of persons identified or generally designated in th…
(a) Restrictions on disclosure. A part 2 program, as defined in § 2.11, may disclose patient records to a central registry or to any withdrawal management or maintenance treatment program not more than 200 miles away for the purpose of preventing the multiple enrollment of a patient only if: (1) The disclosure is made…
(a) Consent for criminal justice referrals. A part 2 program may disclose information from a record about a patient to those persons within the criminal justice system who have made participation in the part 2 program a condition of the disposition of any criminal proceedings against the patient or of the patient's par…