42 CFR § 2.51

§ 2.51 Medical emergencies.

This federal regulation permits Part 2 programs (substance use disorder treatment programs subject to 42 CFR Part 2) to disclose patient identifying information to medical personnel during bona fide medical emergencies or to FDA personnel investigating product safety threats, without prior written patient consent. Immediately following any such disclosure, the program must document in the patient's record the recipient's name and affiliation, the disclosing staff member's name, the date and time, and the nature of the emergency or error. This rule governs recordkeeping and disclosure procedures for all Part 2-covered programs.

§ 2.51 Medical emergencies.

(a) 
General rule.
 Under the procedures required by paragraph (c) of this section, patient identifying information may be disclosed to medical personnel to the extent necessary to:

(1) Meet a bona fide medical emergency in which the patient's prior written consent cannot be obtained; or

(2) Meet a bona fide medical emergency in which a part 2 program is closed and unable to provide services or obtain the prior written consent of the patient, during a temporary state of emergency declared by a state or federal authority as the result of a natural or major disaster, until such time that the part 2 program resumes operations.

(b) 
Special rule.
 Patient identifying information may be disclosed to medical personnel of the Food and Drug Administration (FDA) who assert a reason to believe that the health of any individual may be threatened by an error in the manufacture, labeling, or sale of a product under FDA jurisdiction, and that the information will be used for the exclusive purpose of notifying patients or their physicians of potential dangers.

(c) 
Procedures.
 Immediately following disclosure, the part 2 program shall document, in writing, the disclosure in the patient's records, including:

(1) The name of the medical personnel to whom disclosure was made and their affiliation with any health care facility;

(2) The name of the person making the disclosure;

(3) The date and time of the disclosure; and

(4) The nature of the emergency (or error, if the report was to FDA).

[82 FR 6115, Jan. 18, 2017, as amended at 85 FR 43038, July 15, 2020; 89 FR 12628, Feb. 16, 2024]