Part 57

58

59

59a

61

63

64

Fellowships.

71 Foreign quarantine.

Interstate quarantine.

74 Clinical laboratories.

75 Prepaid medical service plans.

78

PART 1-AVAILABILITY OF RECORDS AND INFORMATION

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., unless otherwise directed in published organizational, procedural, or regulatory statements pertaining to specific records or classes of records. Such requests shall set forth the interest of the applicant in the subject matter of the records sought to be inspected.

(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.

(2) "Clinical information" shall 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 Service 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 preclude the officer in charge of any facility of the Service from disclosing (i) 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

(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) Information in the records or in the possession of the Service concerning (1) the discussions of any councils or other bodies advisory to the Service or to the Surgeon General, or of any committees or panels of such councils or bodies, (2) reports made by such committees or panels to such councils or bodies, and (3) action taken or opinions expressed by individual members of such councils, bodies, committees or panels shall not be disclosed except as may be authorized by the Surgeon General with the assent of the council or advisory body involved. In addition, if the council or other advisory body so recommends, disclosure of its final conclusions on any subject considered by it may be prohibited by the Surgeon General.

(c) The following types of information in the records or possession of the Service are confidential and, subject to the provisions of paragraphs (a) and (b) 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.

(3) Information obtained in connection with applications for employment, fellowships, traineeships or commissions or for research or other grants and information obtained for similar purposes may be disclosed upon consent of the person concerned.

§ 1.104

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 (b) 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 or copying at such place as may be designated by him.

§ 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 his estate) is a party to litigation or other proceedings in which any other person or party seeks to require the production of records of the Service or the disclosure of information described in § 1.102 before a court, agency or other body described in § 1.104, the patient (or, in the case of a deceased patient, his next of kin or an authorized representative of his estate) or his attorney shall be notified promptly, by mail or other reasonable means at his last address known to the Service, of the demand for the records or information and the officer or employee shall respond to the compulsory process in accordance with its terms, without prejudice, however, to any claim of the patient or his representative to the protection against the disclosure of clinical information set forth in the proviso to § 1.104.

[21 F.R. 9805, Dec. 12, 1956. Redesignated at 25 F.R. 12292, Dec. 1, 1960]

§ 1.107 Limitations on release of records.

(a) Records of the Service containing inform ticn described or referred to in § 1.102 or § 1.103 shall not be released to or deposited with anyone not an authorized officer or employee of the Service except: (1) As may be temporarily necessary for purposes of examination or copying; (2) for purposes of storage at General Services Administration Federal Records Centers under conditions assuring the continuation of the limitations on disclosure set forth in this part: Provided, That release or disclosure of records so stored shall be made by the Federal Records Centers only to authorized officers or employees of the Public Health Service.

(b) Where official records of the Service other than X-rays are produced in accordance with subpoena or other compulsory process, their release to or deposit with anyone not an officer or employee of the Service is prohibited except as may be temporarily necessary for the purpose of examination during sessions of the court, body, agency, or other au

thority before which such records are produced or unless release or deposit is otherwise authorized by the Surgeon General.

(c) When the production of official records of the Service in response to a subpoena or other compulsory process is authorized by § 1.106, arrangements shall be made for the procurement of certified copies if so requested by a party litigant. Except when the United States is the requesting party, such copies shall be made at the expense of the requesting party. The records may be released for copying for this purpose in accordance with paragraph (a) of this section.

(d) The Chief, Medical Records Library Service at any hospital or station, or any other officer or employee of the Service designated as local custodian of the records by the Medical Officer in Charge of a hospital or station is authorized to certify copies of records. No fee shall be charged for such certification.

(Sec. 501, 65 Stat. 290; 31 U.S.C. 483a) [25 F.R. 12292, Dec. 1, 1960]

The Director of the National Center for Health Statistics will establish a charge for each authorized special statistical service which shall be based on the estimated cost of the service. No services will be undertaken prior to the prepayment of the estimated cost or of such portion of the estimated cost as the Director may require. Adjustments in the prepaid charge resulting in a refund to the requesting party or a further billing by the Center may be made at any time during the progress of the services or upon their completion if necessary to reflect the actual cost of the services.