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those components of the Veterans Administration furnishing health care to veterans.

(3) Communication within a program or between a program and an entity having direct administrative control over that program. The restrictions on disclosure in these regulations do not apply to communications of information between or among personnel having a need for the information in connection with their duties that arise out of the provision of diagnosis, treatment, or referral for treatment of alcohol or drug abuse if the communications are

(i) Within a program or

(ii) Between a program and an entity that has direct administrative control over the program.

(4) Qualified Service Organizations. The restrictions on disclosure in these regulations do not apply to communications between a program and a qualified service organization of information needed by the organization to provide services to the program.

(5) Crimes on program premises of against program personnel. The restrictions on disclosure and use in these regulations do not apply to communications from program personnel to law enforcement officers which

(1) Are directly related to a patient's commission of a crime on the premises of the program or against program personnel or to a threat to commit such a crime; and

(ii) Are limited to the circumstances of the incident, including the patient status of the individual committing or threatening to commit the crime, that individual's name and address, and that individual's last known whereabouts.

(6) Reports of suspected child abuse and neglect. The restrictions on disclosure and use in these regulations do not apply to the reporting under State law of incidents of suspected child abuse and neglect to the appropriate State or local authorities. However, the restrictions continue to apply to the original alcohol or drug abuse patient records maintained by the program including their disclosure and use for civil or criminal proceedings which may arise out of the report of suspected child abuse and neglect.

(d) Applicability to recipients of information—(1) Restriction on use of information. The restriction on the use of any information subject to these regulations to initiate or substantiate any criminal charges against a patient or to conduct any criminal investigation of a patient applies to any person who obtains that information from a federally assisted alcohol or drug abuse program, regardless of the status of the person obtaining the information or of whether the information was obtained in accordance with these regulations. This restriction on use bars, among other things, the introduction of that information as evidence in a criminal proceeding and any other use of the information to investigate or prosecute a patient with respect to a suspected crime. Information obtained by undercover agents or informants (see $2.17) or through patient access (see $2.23) is subject to the restriction on use.

(2) Restrictions on disclosures-Third party payers, administrative entities, and others. The restrictions on disclosure in these regulations apply to:

(i) Third party payers with regard to records disclosed to them by federally assisted alcohol or drug abuse programs;

(ii) Entities having direct administrative control over programs with regard to information communicated to them by the program under $2.12(c)(3); and

(iii) Persons who receive patient records directly from a federally assisted alcohol or drug abuse program and who are notified of the restrictions on redisclosure of the records in accordance with $2.32 of these regulations.

(e) Explanation of applicability-(1) Coverage. These regulations cover any information (including information on referral and intake) about alcohol and drug abuse patients obtained by a program (as the terms "patient" and "program" are defined in $2.11) if the program is federally assisted in any manner described in $2.12(b). Coverage includes, but is not limited to, those treatment or rehabilitation programs, employee assistance programs, programs within general hospitals, schoolbased programs, and private practitioners who hold themselves out as of alcohol or drug abuse. A diagnosis prepared for the purpose of treatment or referral for treatment but which is not so used is covered by these regulations. The following are not covered by these regulations:

(i) Diagnosis which is made solely for the purpose of providing evidence for use by law enforcement authorities; or

(ii) A diagnosis of drug overdose or alcohol intoxication which clearly shows that the individual involved is not an alcohol or drug abuser (e.g., involuntary ingestion of alcohol or drugs or reaction to a prescribed dosage of one or more drugs). (52 FR 21809, June 9, 1987; 52 FR 42061, Nov. 2, 1987, as amended at 60 FR 22297, May 5, 1995)

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providing, and provide alcohol or drug abuse diagnosis, treatment, or referral for treatment. However, these regulations would not apply, for example, to emergency room personnel who refer a patient to the intensive care unit for an apparent overdose, unless the primary function of such personnel is the provision of alcohol or drug abuse diagnosis, treatment or referral and they are identified as providing such services or the emergency room has promoted itself to the community as a provider of such services.

(2) Federal assistance to program required. If a patient's alcohol or drug abuse diagnosis, treatment, or referral for treatment is not provided by a program which is federally conducted, regulated or supported in a manner which constitutes Federal assistance under $2.12(b), that patient's record is not covered by these regulations. Thus, it is possible for an individual patient to benefit from Federal support and not be covered by the confidentiality regulations because the program in which the patient is enrolled is not federally assisted as defined in $2.12(b). For example, if a Federal court placed an individual in a private for-profit program and made a payment to the program on behalf of that individual, that patient's record would not be covered by these regulations unless the program itself received Federal assistance as defined by $2.12(b).

(3) Information to which restrictions are applicable. Whether a restriction is on use or disclosure affects the type of information which may be available. The restrictions on disclosure apply to any information which would identify a patient as an alcohol or drug abuser. The restriction on use of information to bring criminal charges against a patient for a crime applies to any information obtained by the program for the purpose of diagnosis, treatment, or referral for treatment of alcohol or drug abuse. (Note that restrictions on use and disclosure apply to recipients of information under $2.12(d).)

(4) How type of diagnosis affects coverage. These regulations cover any record of a diagnosis identifying a patient as an alcohol or drug abuser which is prepared in connection with the treatment or referral for treatment

$2.13 Confidentiality restrictions.

(a) General. The patient records to which these regulations apply may be disclosed or used only as permitted by these regulations and may not otherwise be disclosed or used in any civil, criminal, administrative, or legislative proceedings conducted by any Federal, State, or local authority. Any disclo

made under these regulations must be limited to that information which is necessary to carry out the purpose of the disclosure.

(b) Unconditional compliance required. The restrictions on disclosure and use in these regulations apply whether the holder of the information believes that the person seeking the information already has it, has other means of obtaining it, is a law enforcement or other official, has obtained a subpoena, or asserts any other justification for a disclosure or use which is not permitted by these regulations.

(c) Acknowledging the presence of patients: Responding to requests. (1) The presence of an identified patient in a facility or component of a facility which is publicly identified as a place where only alcohol or drug abuse diagnosis, treatment, or referral is provided may be acknowledged only if the patient's written consent is obtained in accordance with subpart C of these regulations or if an authorizing court order is entered in accordance with subpart E of these regulations. The regulations permit acknowledgement of the presence of an identified patient in a facility or part of a facility if the

facility is not publicy identified as cohol or drug abuse treatment, any only an alcohol or drug abuse diag- written consent for disclosure authornosis, treatment or referral facility, ized under subpart C of these regulaand if the acknowledgement does not tions must be given by both the minor reveal that the patient is an alcohol or and his or her parent, guardian, or drug abuser.

other person authorized under State (2) Any answer to a request for a dis- law to act in the minor's behalf. closure of patient records which is not (2) Where State law requires parental permissible under these regulations consent to treatment the fact of a mimust be made in a way that will not af- nor's application for treatment may be firmatively reveal that an identified communicated to the minor's parent, individual has been, or is being diag- guardian, or other person authorized nosed or treated for alcohol or drug under State law to act in the minor's abuse. An inquiring party may be given behalf only if: a copy of these regulations and advised (i) The minor has given written conthat they restrict the disclosure of al- sent to the disclosure in accordance cohol or drug abuse patient records, with subpart C of these regulations or but may not be told affirmatively that (ii) The minor lacks the capacity to the regulations restrict the disclosure make a rational choice regarding such of the records of an identified patient. consent as judged by the program diThe regulations do not restrict a dis- rector under paragraph (d) of this secclosure that an identified individual is tion. not and never has been a patient.

(d) Minor applicant for services lacks

capacity for rational choice. Facts rel$2.14 Minor patients.

evant to reducing a threat to the life or (a) Definition of minor. As used in physical well being of the applicant or these regulations the term "minor" any other individual may be disclosed means a person who has not attained to the parent, guardian, or other perthe age of majority specified in the ap- son authorized under State law to act plicable State law, or if no age of ma- in the minor's behalf if the program dijority is specified in the applicable rector judges that: State law, the age of eighteen years. (1) A minor applicant for services

(b) State law not requiring parental lacks capacity because of extreme consent to treatment. If a minor patient youth or mental or physical condition acting alone has the legal capacity to make a rational decision on whether under the applicable State law to apply to consent to a disclosure under subfor and obtain alcohol or drug abuse part C of these regulations to his or her treatment, any written consent for dis- parent, guardian, or other person auclosure authorized under subpart C of thorized under State law to act in the these regulations may be given only by minor's behalf, and the minor patient. This restriction in- (2) The applicant's situation poses a cludes, but is not limited to, any dis- substantial threat to the life or physclosure of patient identifying informa- ical well being of the applicant or any tion to the parent or guardian of a other individual which may be reduced minor patient for the purpose of ob- by communicating relevant facts to taining financial reimbursement. the minor's parent, guardian, or other These regulations do not prohibit a person authorized under State law to program from refusing to provide act in the minor's behalf. treatment until the minor patient consents to the disclosure necessary to ob- $2.15 Incompetent and deceased patain reimbursement, but refusal to pro

tients. vide treatment may be prohibited (a) Incompetent patients other than miunder a State or local law requiring nors—(1) Adjudication of incompetence. the program to furnish the service irre- In the case of a patient who has been spective of ability to pay.

adjudicated as lacking the capacity, (c) State law requiring parental consent for any reason other than insufficient to treatment. (1) Where State law re- age, to manage his or her own affairs, quires consent of a parent, guardian, or any consent which is required under other person for a minor to obtain al- these regulations may be given by the

(b) Restriction on use of information. No information obtained by an undercover agent or informant, whether or not that undercover agent or informant is placed in a program pursuant to an authorizing court order, may be used to criminally investigate or prosecute any patient. (52 FR 21809, June 9, 1987; 52 FR 42061, Nov. 2, 1987)

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guardian or other person authorized under State law to act in the patient's behalf.

(2) No adjudication of incompetency. For any period for which the program director determines that a patient, other than a minor or one who has been adjudicated incompetent, suffers from

medical condition that prevents knowing or effective action on his or her own behalf, the program director may exercise the right of the patient to consent to a disclosure under subpart C of these regulations for the sole purpose of obtaining payment for services from a third party payer.

(b) Deceased patients—(1) Vital statistics. These regulations do not restrict the disclosure of patient identifying information relating to the cause of death of a patient under laws requiring the collection of death or other vital statistics or permitting inquiry into the cause of death.

(2) Consent by personal representative. Any other disclosure of information identifying a deceased patient as an alcohol or drug abuser is subject to these regulations. If a written consent to the disclosure is required, that consent may be given by an executor, administrator, or other personal representative appointed under applicable State law. If there is no such appointment the consent may be given by the patient's spouse or, if none, by any responsible member of the patient's family.

$2.18 Restrictions on the use of identi

fication cards. No person may require any patient to carry on his or her person while away from the program premises any card or other object which would identify the patient as an alcohol or drug abuser. This section does not prohibit a person from requiring patients to use or carry cards or other identification objects on the premises of a program. 82.19 Disposition of records by discon

tinued programs. (a) General. If a program discontinues operations or is taken over or acquired by another program, it must purge patient identifying information from its records or destroy the records unless

(1) The patient who is the subject of the records gives written consent (meeting the requirements of $2.31) to a transfer of the records to the acquiring program or to any other program designated in the consent (the manner of obtaining this consent must minimize the likelihood of a disclosure of patient identifying information to a third party); or

(2) There is a legal requirement that the records be kept for a period specified by law which does not expire until after the discontinuation or acquisition of the program.

(b) Procedure where retention period required by law. If paragraph (a)(2) of this section applies, the records must be:

(1) Sealed in envelopes or other containers labeled as follows: "Records of [insert name of program) required to be maintained under [insert citation to statute, regulation, court order other legal authority requiring that records be kept] until a date not later than [insert appropriate date)”; and

(2) Held under the restrictions of these regulations by a responsible person who must, as soon as practicable

$2.16 Security for written records.

(a) Written records which are subject to these regulations must be maintained in a secure room, locked file cabinet, safe or other similar container when not in use; and

(b) Each program shall adopt in writing procedures which regulate and control access to and use of written records which are subject to these regulations.

or

$2.17 Undercover agents and inform

ants. (a) Restrictions on placement. Except as specifically authorized by a court order granted under $2.67 of these regulations, no program may knowingly employ, or enroll as a patient, any undercover agent or informant.

after the end of the retention period privilege statutes. However, the respecified on the label, destroy the search privilage granted under 21 CFR records.

291.505(g) to treatment programs using

methadone for maintenance treatment $ 2.20 Relationship to State laws. does not protect from compulsory dis

The statutes authorizing these regu- closure any imformation which is perlations (42 U.S.C. 290ee-3 and 42 U.S.C.

mitted to be disclosed under those reg290dd-3) do not preempt the field of law ulations. Thus, if a court order entered which they cover to the exclusion of all in accordance with subpart E of these State laws in that field. If a disclosure regulations authorizes a methadone permitted under these regulations is

maintenance treatment program to prohibited under State law, neither

disclose certain information about its these regulations nor the authorizing patients, that program may not invoke statutes may be construed to authorize the research privilege under 21 CFR any violation of that State law. How- 291.505(g) as a defense to a subpoena for ever, no State law may either author- that information. ize or compel any disclosure prohibited by these regulations.

2.22 Notice to patients of Federal

confidentiality requirements. 82.21 Relationship to Federal statutes (a) Notice required. At the time of ad

protecting research subjects mission or as soon threreafter as the against compulsory disclosure of their identity.

patient is capable of rational commu

nication, each program shall: (a) Research privilege description. (1) Communicate to the patient that There may be concurrent coverage of Federal law and regulations protect patient identifying information by the confidentiality of alcohol and drug these regulations and by administra- abuse patient records; and tive action taken under: Section 303(a) (2) Give to the patient a summary in of the Public Health Service Act (42 writing of the Federal law and regulaU.S.C. 242a(a) and the implementing tions. regulations at 42 CFR part 2a); or sec- (b) Required elements of written sumtion 502(c) of the Controlled Substances mary. The written summary of the FedAct (21 U.S.C. 872(c) and the imple- eral law and regulations must include: menting regulations at 21 CFR 1316.21). (1) A general description of the limThese “research privilege" statutes ited circumstances under which a proconfer on the Secretary of Health and gram may acknowledge that an indiHuman Services and on the Attorney vidual is present at a facility or disGeneral, respectively, the power to au- close outside the program information thorize researchers conducting certain identifying a patient as an alcohol or types of research to withhold from all drug abuser. persons not connected with the re- (2) A statement that violation of the search the names and other identifying Federal law and regulations by a proinformation concerning individuals gram is a crime and that suspected viowho are the subjects of the research. lations may be reported to appropriate

(b) Effect of concurrent coverage. These authorities in accordance with these regulations restrict the disclosure and regulations. use of information about patients, (3) A statement that information rewhile administrative action taken lated to a patient's commission of a under the research privilege statutes crime on the premises of the program and implementing regulations protects or against personnel of the program is a person engaged in applicable research not protected. from being compelled to disclose any (4) A statement that reports of susidentifying characteristics of the indi- pected child abuse and neglect made viduals who are the subjects of that re- under State law to appropriate State search. The issuance under subpart E or local authorities are not protected. of these regulations of a court order (5) A citation to the Federal law and authorizing a disclosure of information regulations. about a patient does not affect an exer- (c) Program options. The program may cise of authority under these research devise its own notice or may use the

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