[Code of Federal Regulations]

[Title 42, Volume 1]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR2.1]



[Page 7-8]

 

                         TITLE 42--PUBLIC HEALTH

 

    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 2_CONFIDENTIALITY OF ALCOHOL AND DRUG ABUSE PATIENT RECORDS--Table 

of Contents

 

                         Subpart A_Introduction

 

Sec. 2.1  Statutory authority for confidentiality of drug abuse patient 

records.









                         Subpart A_Introduction



Sec.

2.1 Statutory authority for confidentiality of drug abuse patient 

          records.

2.2 Statutory authority for confidentiality of alcohol abuse patient 

          records.

2.3 Purpose and effect.

2.4 Criminal penalty for violation.

2.5 Reports of violations.



                      Subpart B_General Provisions



2.11 Definitions.

2.12 Applicability.

2.13 Confidentiality restrictions.

2.14 Minor patients.

2.15 Incompetent and deceased patients.

2.16 Security for written records.

2.17 Undercover agents and informants.

2.18 Restrictions on the use of identification cards.

2.19 Disposition of records by discontinued programs.

2.20 Relationship to State laws.

2.21 Relationship to Federal statutes protecting research subjects 

          against compulsory disclosure of their identity.

2.22 Notice to patients of Federal confidentiality requirements.

2.23 Patient access and restrictions on use.



              Subpart C_Disclosures With Patient's Consent



2.31 Form of written consent.

2.32 Prohibition on redisclosure.

2.33 Disclosures permitted with written consent.

2.34 Disclosures to prevent multiple enrollments in detoxification and 

          maintenance treatment programs.

2.35 Disclosures to elements of the criminal justice system which have 

          referred patients.



              Subpart D_Disclosures Without Patient Consent



2.51 Medical emergencies.

2.52 Research activities.

2.53 Audit and evaluation activities.



          Subpart E_Court Orders Authorizing Disclosure and Use



2.61 Legal effect of order.

2.62 Order not applicable to records disclosed without consent to 

          researchers, auditors and evaluators.

2.63 Confidential communications.

2.64 Procedures and criteria for orders authorizing disclosures for 

          noncriminal purposes.

2.65 Procedures and criteria for orders authorizing disclosure and use 

          of records to criminally investigate or prosecute patients.

2.66 Procedures and criteria for orders authorizing disclosure and use 

          of records to investigate or prosecute a program or the person 

          holding the records.

2.67 Orders authorizing the use of undercover agents and informants to 

          criminally investigate employees or agents of a program.



    Authority: Sec. 408 of Pub. L. 92-255, 86 Stat. 79, as amended by 

sec. 303 (a), (b) of Pub L. 93-282, 83 Stat. 137, 138; sec. 4(c)(5)(A) 

of Pub. L. 94-237, 90 Stat. 244; sec. 111(c)(3) of Pub. L. 94-581, 90 

Stat. 2852; sec. 509 of Pub. L. 96-88, 93 Stat. 695; sec. 973(d) of Pub. 

L. 97-35, 95 Stat. 598; and transferred to sec. 527 of the Public Health 

Service Act by sec. 2(b)(16)(B) of Pub. L. 98-24, 97 Stat. 182 and as 

amended by sec. 106 of Pub. L. 99-401, 100 Stat. 907 (42 U.S.C. 290ee-3) 

and sec. 333 of Pub. L. 91-616, 84 Stat. 1853, as amended by sec. 122(a) 

of Pub. L. 93-282, 88 Stat. 131; and sec. 111(c)(4) of Pub. L. 94-581, 

90 Stat. 2852 and transferred to sec. 523 of the Public Health Service 

Act by sec. 2(b)(13) of Pub. L. 98-24, 97 Stat. 181 and as amended by 

sec. 106 of Pub. L. 99-401, 100 Stat. 907 (42 U.S.C. 290dd-3), as 

amended by sec. 131 of Pub. L. 102-321, 106 Stat. 368, (42 U.S.C. 290dd-

2).



    Source: 52 FR 21809, June 9, 1987, unless otherwise noted.







    The restrictions of these regulations upon the disclosure and use of 

drug abuse patient records were initially authorized by section 408 of 

the Drug Abuse Prevention, Treatment, and Rehabilitation Act (21 U.S.C. 

1175). That section as amended was transferred by Pub. L. 98-24 to 

section 527 of the Public Health Service Act which is codified



[[Page 8]]



at 42 U.S.C. 290ee-3. The amended statutory authority is set forth 

below:



           Sec. 290ee-3. Confidentiality of patient records.



    (a) Disclosure authorization

    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 (e) of this section, be 

confidential and be disclosed only for the purposes and under the 

circumstances expressly authorized under subsection (b) of this section.

    (b) Purposes and circumstances of disclosure affecting consenting 

patient and patient regardless of consent

    (1) The content of any record referred to in subsection (a) of this 

section 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) of this 

section.

    (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) Prohibition against use of record in making criminal charges or 

investigation of patient

    Except as authorized by a court order granted under subsection 

(b)(2)(C) of this section, no record referred to in subsection (a) of 

this section may be used to initiate or substantiate any criminal 

charges against a patient or to conduct any investigation of a patient.

    (d) Continuing prohibition against disclosure irrespective of status 

as patient

    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) Armed Forces and Veterans' Administration; interchange of 

records; report of suspected child abuse and neglect to State or local 

authorities

    The prohibitions of this section do not apply to any interchange of 

records--

    (1) within the Armed Forces or witrhin those components of the 

Veterans' Administration furnishing health care to veterans, or

    (2) between such components and the Armed Forces.

    The prohibitions of this section do not apply to the reporting under 

State law of incidents of suspected child abuse and neglect to the 

appropriate State or local authorities.

    (f) Penalty for first and subsequent offenses

    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 nore than $5,000 in the 

case of each subsequent offense.

    (g) Regulations; interagency consultations; definitions, safeguards, 

and procedures, including procedures and criteria for issuance and scope 

of orders

    Except as provided in subsection (h) of this section, the Secretary, 

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) of this 

section, 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.



(Subsection (h) was superseded by section 111(c)(3) of Pub. L. 94-581. 

The responsibility of the Administrator of Veterans' Affairs to write 

regulations to provide for confidentiality of drug abuse patient records 

under Title 38 was moved from 21 U.S.C. 1175 to 38 U.S.C. 4134.)