§ 2.2 - Purpose and effect.

§ 2.2 Purpose and effect.

Cross Reference

Link to an amendment published at 89 FR 12618, Feb. 16, 2024.

(a) Purpose. Pursuant to 42 U.S.C. 290dd-2(g), the regulations in this part impose restrictions upon the use and disclosure and use 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 the following subparts:

(1) Subpart B of this part: General Provisions, including definitions, applicability, and general restrictions;

(2) Subpart C of this part: Uses and Disclosures with With Patient Consent, including uses and disclosures which that require patient consent and the consent form requirements;

(3) Subpart D of this part: Uses and Disclosures without Without Patient Consent, including uses and disclosures which do not require patient consent or an authorizing court order; and

(4) Subpart E of this part: Court Orders Authorizing Use and Disclosure and Use, including uses and disclosures and uses of patient records which may be made with an authorizing court order and the procedures and criteria for the entry and scope of those orders.

(b) Effect.

(1) The regulations in this part prohibit the use and disclosure and use of patient records unless certain circumstances exist. If any circumstance exists under which use or disclosure is permitted, that circumstance acts to remove the prohibition on use and disclosure but it does not compel the use or disclosure. Thus, the regulations in this part do not require use or disclosure under any circumstances.

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circumstance other than when disclosure is required by the Secretary to investigate or determine a person's compliance with this part pursuant to § 2.3(c).

(2) The regulations in this part are not intended to direct the manner in which substantive functions such as research, treatment, and evaluation are carried out. They are intended to ensure that a patient receiving treatment for a substance use disorder in a part 2 program is not made more vulnerable by reason of the availability of their patient record than an individual with a substance use disorder who does not seek treatment.

(3) Because there is a criminal penalty for violating the regulations, they are to be construed strictly in favor of the potential violator in the same manner as a criminal statute (see M. Kraus & Brothers v. United States, 327 U.S. 614, 621-22, 66 S. Ct. 705, 707-08 (1946)). The regulations in this part shall not be construed to limit:

(i) A patient's right, as described in 45 CFR 164.522, to request a restriction on the use or disclosure of a record for purposes of treatment, payment, or health care operations.

(ii) A covered entity's choice, as described in 45 CFR 164.506, to obtain the consent of the patient to use or disclose a record to carry out treatment, payment, or health care operations.

[89 FR 12618, Feb. 16, 2024]