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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 FR 9805, Dec. 12, 1956. Redesignated at 25 FR 12292, Dec. 1, 1960]

§ 1.107 Limitations on release of records. (a) Records of the Service containing information 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 authority 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 FR 12292, Dec. 1, 1960]

§ 1.108 Relation to other provisions of law.

The provisions of this part are in addition to other applicable provisions of law or regulation and shall not be deemed to authorize or compel disclosure of information inconsistently with such other provisions.

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

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for.-Rules.

not otherwise provided

2.40-1 Situations not otherwise provided for.-Basis and purpose.

Subpart D-Disclosures Without Patient Consent

2.51 Medical emergencies.-Rules. 2.51-1 Medical emergencies.-Basis

purpose.

and

2.52 Research, audit, and evaluation.— Rules.

2.52-1 Research, audit, and evaluation.Basis and purpose.

2.53 Government agencies.-Rules. 2.53-1 Governmental agencies.-Basis and

purpose.

2.54 Patient identifying information in connection with examinations.-Rules. 2.54-1 Patient identifying information in connection with examinations.-Basis and purpose.

2.55 Supervision and regulation of narcotic maintenance and detoxification programs.-Rules. 2.55-1 Supervision and regulation of narcotic maintenance and detoxification programs.-Basis and purpose.

2.56 Prohibition on disclosure of patient identities from research, audit, or evaluation records.-Rules.

2.56-1 Prohibition on disclosure of patient identities from research, audit, or evaluation records.-Basis and purpose.

Subpart E-Court Orders

2.61 Legal effect of order.-Rules. 2.61-1 Legal effect of order.-Basis and purpose.

2.62 Inapplicability to secondary records.—

Rules.

2.62-1 Inapplicability to secondary records.-Basis and purpose.

2.63 Limitation to objective data.-Rules. 2.63-1 Limitation to objective data.-Basis and purpose.

2.64 Procedures and criteria in general.

Rules.

Sec.

2.64-1 Procedures and criteria in general.

Basis and purpose.

2.65 Investigation and prosecution of patients.-Rules.

2.65-1 Investigation and prosecution of patients.-Basis and purpose.

2.66 Investigation and prosecution of programs.-Rules.

2.66-1 Investigation and prosecution of programs.-Basis and purpose.

2.67 Undercover agents and informants.—

Rules.

2.67-1 Undercover agents and informants.-Basis and purpose.

Subpart A-Introductory Statement

AUTHORITY: Sec. 408, Pub. L. 92-255, 21 U.S.C. 1175, as amended by sec. 303, Pub. L. 93-282; 88 Stat. 137.

SOURCE: 40 FR 27802, July 1, 1975, unless otherwise noted.

§ 2.1 Statutory authority-drug abuse.

(a) Statutory provisions effective May 14, 1974. Insofar as the provisions of this part pertain to any program or activity relating to drug abuse education, training, treatment, rehabilitation, or research, such provisions are authorized under section 403 of Pub. L. 92-255, the Drug Abuse Office and Treatment Act of 1972 (21 U.S.C. 1175) as amended by section 303 of Pub. L. 93-282 (88 Stat. 137). That section reads as follows:

CONFIDENTIALITY OF PATIENT RECORDS

Sec. 408. (a) Records of the identity, diagnosis, prognosis, or treatment of any patient which are maintained in connection with the performance of any drug abuse prevention function conducted, regulated, or directly or indirectly assisted by any department or agency of the United States shall, except as provided in subsection (c), be confidential and be disclosed only for the purposes and under the circumstances expressly authorized under subsection (b) of this section.

(b)(1) The content of any record referred to in subsection (a) may be disclosed in accordance with the prior written consent of the patient with respect to whom such record is maintained, but only to such extent, under such circumstances, and for such purposes as may be allowed under regulations prescribed pursuant to subsection (g).

(2) Whether or not the patient, with respect to whom any given record referred to

in subsection (a) of this section is maintained, gives his written consent, the content of such record may be disclosed as follows:

(A) To medical personnel to the extent necessary to meet a bona fide medical emergency.

(B) To qualified personnel for the purpose of conducting scientific research, management audits, financial audits, or program evaluation, but such personnel may not identify, directly or indirectly, any individual patient in any report of such research, audit, or evaluation, or otherwise disclose patient identities in any manner.

(C) If authorized by an appropriate order of a court of competent jurisdiction granted after application showing good cause therefor. In assessing good cause the court shall weigh the public interest and the need for disclosure against the injury to the patient, to the physician-patient relationship, and to the treatment services. Upon the granting of such order, the court, in determining the extent to which any disclosure of all or any part of any record is necessary, shall impose appropriate safeguards against unauthorized disclosure.

(c) Except as authorized by a court order granted under subsection (b)(2)(C) of this section, no record referred to in subsection (a) may be used to initiate or substantiate any criminal charges against a patient or to conduct any investigation of a patient.

(d) The prohibitions of this section continue to apply to records concerning any individual who has been a patient, irrespective of whether or when he ceases to be a patient.

(e) The prohibitions of this section do not apply to any interchange of records

(1) within the Armed Forces or within those components of the Veterans' Administration furnishing health care to veterans,

or

(2) between such components and the Armed Forces.

(f) Any person who violates any provision of this section or any regulation issued pursuant to this section shall be fined not more than $500 in the case of a first offense, and not more than $5,000 in the case of each subsequent offense.

(g) The Director of the Special Action Office for Drug Abuse Prevention, after consultation with the Administrator of Veterans' Affairs and the heads of other Federal departments and agencies substantially affected thereby, shall prescribe regulations to carry out the purposes of this section. These regulations may contain such definitions, and may provide for such safeguards and procedures, including procedures and criteria for the issuance and scope of orders under subsection (b)(2)(C), as in the judgment of the Director are necessary or proper to effectuate the purposes of this

section, to prevent circumvention or evasion thereof, or to facilitate compliance therewith.

(b) Amendments effective June 30, 1975. Effective on the date specified in section 104 of the Drug Abuse Office and Treatment Act of 1972 (June 30, 1975), the first sentence of section 408(g) above, will be amended by striking "Director of the Special Action Office for Drug Abuse Prevention" and inserting in lieu thereof "Secretary of Health, Education, and Welfare”, and the second sentence of such section will be amended by striking "Director" and inserting "Secretary" in lieu thereof. Also effective on that date, section 408, above, will be further amended by (1) striking out “The” and inserting in lieu thereof "Except as provided in subsection (h) of this section, the" in the first sentence of subsection (g) of such section; and (2) adding at the end of such section the following new subsection:

(h) The Administrator of Veterans' Affairs, through the Chief Medical Director, shall, to the maximum feasible extent consistent with their responsibilities under title 38, United States Code, prescribe regulations making applicable the regulations established by the Secretary under subsection (g) of this section to records maintained in connection with the provision of hospital care, nursing home care, domiciliary care, and medical services under such title 38 to veterans suffering from drug abuse. In prescribing and implementing regulations pursuant to this subsection, the Administrator shall, from time to time, consult with the Secretary in order to achieve the maximum possible coordination of the regulations, and the implementation thereof, which they each prescribe.

§ 2.2 Statutory authority-alcohol abuse.

Insofar as the provisions of this part pertain to any program or activity relating to alcoholism or alcohol abuse education, training, treatment, rehabilitation, or research, such provisions are authorized under section 333 of Pub. L. 91-616, the Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment and Rehabilitation Act of 1970 (42 U.S.C. 4582), as amended by section 122(a) of Pub. L. 93-282, the Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and Rehabilitation Act Amendments

of 1974 (88 Stat. 131). As so amended, that section reads as follows:

CONFIDENTIALITY OF RECORDS

Sec. 333. (a) Records of the identity, diagnosis, prognosis, or treatment of any patient which are maintained in connection with the performance of any program or activity relating to alcoholism or alcohol abuse education, training, treatment, rehabilitation, or research, which is conducted, regulated, or directly or indirectly assisted by any department or agency of the United States shall, except as provided in subsection (e), be confidential and be disclosed only for the purposes and under the circumstances expressly authorized under subsection (b) of this section.

(b)(1) The content of any record referred to in subsection (a) may be disclosed in accordance with the prior written consent of the patient with respect to whom such record is maintained, but only to such extent, under such circumstances, and for such purposes as may be allowed under regulations prescribed pursuant to subsection (g).

(2) Whether or not the patient, with respect to whom any given record refered to in subsection (a) of this section is maintained, gives his written consent, the content of such record may be disclosed as follows:

(A) To medical personnel to the extent necessary to meet a bona fide medical emergency.

(B) To qualified personnel for the purpose of conducting scientific research, management audits, financial audits, or program evaluation, but such personnel may not identify, directly or indirectly, any individual patient in any report of such research, audit, or evaluation, or otherwise disclose patient identities in any manner.

(C) If authorized by an appropriate order of a court of competent jurisdiction granted after application showing good cause therefor. In assessing good cause the court shall weigh the public interest and the need for disclosure against the injury to the patient, to the physician-patient relationship, and to the treatment services. Upon the granting of such order, the court, in determining the extent to which any disclosure of all or any part of any record is necessary, shall impose appropriate safeguards against unauthorized disclosure.

(c) Except as authorized by a court order granted under subsection (b)(2)(C) of this section, no record referred to in subsection (a) may be used to initiate or substantiate any criminal charges against a patient or to conduct any investigation of a patient.

(d) The prohibitions of this section continue to apply to records concerning any individual who has been a patient, irrespective

of whether or when he ceases to be a patient.

(e) The prohibitions of this section do not apply to any interchange of records

(1) within the Armed Forces or within those components of the Veterans' Administration furnishing health care to veterans,

or

(2) between such components and the Armed Forces.

(f) Any person who violates any provision of this section or any regulation issued pursuant to this section shall be fined not more than $500 in the case of a first offense, and not more than $5,000 in the case of each subsequent offense.

(g) Except as provided in subsection (h) of this section, the Secretary shall prescribe regulations to carry out the purposes of this section. These regulations may contain such definitions, and may provide for such safeguards and procedures, including procedures and criteria for the issuance and scope of orders under subsection (b)(2)(C), as in the judgment of the Secretary are necessary or proper to effectuate the purposes of this section, to prevent circumvention or evasion thereof, or to facilitate compliance therewith.

(h) The Administrator of Veterans' Affairs, through the Chief Medical Director, shall, to the maximum feasible extent consistent with their responsibilities under title 38, United States Code, prescribe regulations making applicable the regulations prescribed by the Secretary under subsection (g) of this section to records maintained in connection with the provision of hospital care, nursing home care, domiciliary care, and medical services under such title 38 to veterans suffering from alcohol abuse or alcoholism. In prescribing and implementing regulations pursuant to this subsection, the Administrator shall, from time to time, consult with the Secretary in order to achieve the maximum possible coordination of the regulations, and the implementation thereof, which they each prescribe.

§ 2.3 Previous regulations as controlling authority.

Attention is called to the interpretative regulations, issued by the Special Action Office for Drug Abuse Prevention (37 FR 24636, November 17, 1972, as revised 38 FR 33744, December 6, 1973, referred to hereinafter in this part as the "previous regulations"). Those regulations have been given a special status as controlling authority by the provisions of section 303(d) of Pub. L. 93-282, as well as the references in the legislative history of that act to the precedents established under section 408 of Pub. L. 92-255.

Such references appear at page 11 of House Committee Report No. 93-759 and at page H3563 of the Congressional Record for May 6, 1974. The latter citation is to a detailed analysis of the bill in its final form which was submitted for the Record by its floor manager, Chairman Staggers of the Interstate and Foreign Commerce Committee, when the bill was up for final action by the House of Representatives.

§ 2.4 General purposes.

(a) Policy objectives. The purpose of the regulations set forth in this part is to implement the authorizing legislation in a manner that, to the extent practicable, takes into account two streams of legal thought and social policy. One has to do with enhancing the quality and attractiveness of treatment systems. The other is concerned with the interests of patients as citizens, most particularly in regard to protecting their rights of privacy. Within each stream there are crosscurrents, and it should come as no surprise that areas of turbulence are to be found at their confluence.

(b) Limited purpose. The regulations contained in this part are not intended to direct the manner in which substantive functions, such as research, treatment, and evaluation, should be carried out, but rather to define the minimum requirements for the protection of confidentiality of patient records which must be satisfied in connection with the conduct of those functions in order to carry out the purposes of the authorizing legislation. This does not mean that observance of only the minimum legal requirements is always the wisest course, but in framing these regulations, allowance has necessarily been made for a diversity of emphasis and approach in the many different jurisdictions and by the great variety of public and private agencies which must find a way to function within the limits here prescribed.

§2.5 Format.

(a) Basis and purpose sections. Each section setting forth rules on any given topic in Subparts B through E of this part is followed by a section setting forth their basis and purpose. In

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