§1.101 Public inspection of official records.

Except as is otherwise provided in this part, the official records of the Public Health Service are available upon request for inspection by persons properly and directly concerned. Requests for permission to inspect official records of the Service are required to be addressed to the Surgeon General of the Public Health Service, Washington 25, D.C. [20852], unless other.. wise directed in published organizational, procedural, or regulatory statements pertaining to specific records or classes of records. Such request shall set forth the interest of the applicant in the subject matter of the records sought to be inspected.

81.102 Clinical information; disclosure.

(a) For the purposes of this section: (1) "Patient" shall mean any person who is receiving or has received medical care or treatment or an examination at facilities of the Public Health Service or at other facilities by, or under the direction of, personnel of the Service or at its expense.

shall

(2) "Clinical information" mean any information received by personnel of the Service from patients or regarding patients and related to their examination, care, or treatment.

(b) Clinical information in the records or in the possession of the Ser

vice is confidential and shall be disclosed only as necessary for the performance of the functions of the Service, or as follows:

(1) Upon a reasonable showing of the need therefor, the officer in charge of a hospital, station or other facility of the Service may authorize disclosure to a patient or a person designated by a patient (or, in the case of a deceased patient, to his next of kin or an authorized representative of his estate) of such clinical information as such officer determines to be medically appropriate for disclosure. The information shall not be disclosed to a person other than the patient except on the condition that it shall not be further disclosed for any purpose other than that for which it was shown to be needed. If the patient's examination, treatment or care was requested or arranged for by a governmental agency, the information shall not in any event be disclosed without the consent of that agency.

(2) Any governmental agency which, in accordance with applicable statutes, has requested or arranged for the examination, treatment, or care of a patient by the Service may upon request be furnished clinical information regarding such examination, treatment,

or care.

(3) At the direction of the Surgeon General or his designee, clinical information may be furnished State or other public health agencies engaged in collecting data regarding disease.

(4) Nothing in this section shall preIclude the officer in charge of any facility of the Service from disclosing (1) information as to the presence of a patient in the facility, or as to his general condition and progress, or (ii) such information regarding the commission of crimes or the occurrence of communicable disease as may be required to be disclosed by hospitals generally by the law of the State in which the facility is located.

§1.103 Nonclinical information; disclo

sure.

(a) Information in the records or possession of the Service obtained by

the Service under an assurance of confidentiality which the Surgeon General or his authorized representative determines to be necessary for the purpose of any research, survey, investigation, or collection of statistical data may be disclosed only with the consent of the person, association, or agency to which such assurance was given, or whenever the Surgeon General specifically determines disclosure to be necessary (1) to prevent an epidemic or other grave danger to the public health or (2) to oppose any legal action related to the activities of the Service and brought against the United States or any of its officers or employees.

(b) [Reserved]

(c) The following types of information in the records or possession of the Service are confidential and, subject to the provisions of paragraph (a) of this section, shall be disclosed only as necessary for the performance of the functions of the Service, or as follows:

(1) Information concerning individuals, business enterprises, or public or private agencies obtained by the Service in connection with communicable disease control, water pollution control, licensing of biological products or the manufacture of such products, or with other regulatory functions of the Service may be disclosed to Federal, State or local authorities carrying on related governmental functions to the extent necessary to carry out such related functions.

(2) Information and data obtained and tentative and final conclusions reached in course of or in connection with the conduct of research projects, surveys and investigations may be disclosed at such times and to such extent as the Surgeon General or his designee may determine to be in the public interest.

81.104 Disclosure upon court or other official order.

Notwithstanding any other provisions of this part, information in the records or in the possession of the Service, except information described in §1.103(a) and information the disclosure of which the Surgeon General determines would impair national security, shall be disclosed upon the order of a judge of a court of competent jurisdiction or of a responsible officer of any agency or body having power to compel appearances before it: Provided, however, That (a) clinical information shall be disclosed only in accord with applicable local law regarding the confidentiality of communications to physicians as expressly determined by the court, agency or body, and (b) in the case of an order requiring production of records other than to the court, agency or body involved, the Surgeon General or his designee may determine, in the light of the need to assure the integrity and safety of the records or the efficient administration of the Service, that the records shall be made available for examination of copying at such place as may be designated by him.

[21 FR 9805, Dec. 12, 1956, as amended at 38 FR 34118, Dec. 11, 1973]

§1.105 Disclosure to officers and employees of the Service.

No provision of this part shall be deemed to forbid any officer or employee of the Service to disclose any information to any other officer or employee of the Service in the course of official business.

§1.106 Response to subpoena or other compulsory process.

If any officer or employee of the Service is sought to be required, by subpoena or other compulsory process, to produce records of the Service or to disclose any information described in § 1.102 or § 1.103, he shall respond, call attention to the provisions of this part, and respectfully decline to produce records or disclose information inconsistent with such provisions: Provided, That where a patient (or, in the case of a deceased patient, his next of kin or an authorized representative of

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