PART 1-[RESERVED]

PART 2-CONFIDENTIALITY OF ALCOHOL AND DRUG ABUSE PATIENT RECORDS

Sec.

Subpart A-Introductory Statement

Sec.

2.23-1 Relationship to State laws-Basis and purpose.

2.24 Relationship to section 303(a) of Public Health Service Act and section 502(c) of Controlled Substances ActRules.

2.24-1 Relationship to section 303(a) of Public Health Service Act and section 502(c) of Controlled Substances ActBasis and purpose.

Subpart C-Disclosures With Patient's Consent

2.31 Written consent required-Rules. 2.31-1 Written consent required-Basis and

purpose.

2.32 Prohibition on redisclosure-Rules. 2.32-1 Prohibition on redisclosure-Basis and purpose.

2.33 Diagnosis, treatment, and rehabilitation-Rules.

2.33-1 Diagnosis, treatment, and rehabilitation-Basis and purpose.

2.34 Prevention of certain multiple enrollments-Rules.

2.34-1 Prevention of certain multiple enrollments-Basis and purpose.

2.35 Legal counsel for patient-Rules. 2.35-1 Legal counsel for patient-Basis and purpose.

2.36 Patient's family and others-Rules. 2.36-1 Patient's family and others-Basis and purpose.

2.37 Third party payers and funding sources-Rules.

2.37-1 Third party payers and funding sources-Basis and purpose.

2.38 Employers and employment agencies-Rules.

2.38-1 Employers and employment agencies-Basis and purpose.

2.39 Criminal justice system referrals— Rules.

2.39-1 Criminal justice system referrals— Basis and purpose.

precautions-Basis

and

purpose.

2.18-1 Extent of disclosure-Basis and pur

pose.

2.40 Situations

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 evaluationRules.

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

2.53 Government agencies-Rules.

Sec.

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.

2.64-1 Procedures and criteria in generalBasis 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.

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.

Subpart A-Introductory Statement

§ 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 408 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 and Human Services", 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 regula

tions 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:

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