Section 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 82 FR 6115 , 2/17/2017; 85 FR 43038 , 8/14/2020; 89 FR 12628 , 4/16/2024 Approved by the Office of Management and Budget under control number 0930-0099