§2.51. Medical emergencies.
42 C.F.R. § 2.51
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:
Meet a bona fide medical emergency in which the patient's prior written consent cannot be obtained; or
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.
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.
Procedures. Immediately following disclosure, the part 2 program shall document, in writing, the disclosure in the patient's records, including:
The name of the medical personnel to whom disclosure was made and their affiliation with any health care facility;
The name of the person making the disclosure;
The date and time of the disclosure; and
The nature of the emergency (or error, if the report was to FDA).
Notes, amendments, and revision history
Amendments
[82 FR 6115, Jan. 18, 2017, as amended at 85 FR 43038, July 15, 2020; 89 FR 12628, Feb. 16, 2024]
Authority
Authority: 42 U.S.C. 290dd-2; 42 U.S.C. 290dd-2 note.
Source
Source: 82 FR 6115, Jan. 18, 2017, unless otherwise noted.
Amendments
[82 FR 6115, Jan. 18, 2017, as amended at 85 FR 43038, July 15, 2020; 89 FR 12628, Feb. 16, 2024]