38 C.F.R. §§ 1.460–1.496

§1.460. Definitions.

38 C.F.R. § 1.460

For purposes of §§ 1.460 through 1.499 of this part, the following definitions apply:

Agreement. The term “agreement” means a document that a VA health care facility develops in collaboration with an Organ Procurement Organization, eye bank or tissue bank with written, detailed responsibilities and obligations of the parties with regard to identifying potential donors and facilitating the donation process.

Alcohol abuse. The term “alcohol abuse” means the use of an alcoholic beverage which impairs the physical, mental, emotional, or social well-being of the user.

Contractor. The term “contractor” means a person who provides services to VA such as data processing, dosage preparation, laboratory analyses or medical or other professional services. Each contractor shall be required to enter into a written agreement subjecting such contractor to the provisions of §§ 1.460 through 1.499 of this part; 38 U.S.C. 5701 and 7332; and 5 U.S.C. 552a and 38 CFR 1.576(g).

Deceased. The term “deceased” means death established by either neurological criteria (brain death) or cardiopulmonary criteria (cardiac death). Brain death is the irreversible cessation of all brain function. Cardiac death is the irreversible cessation of circulatory and respiratory function. In both cases, “irreversible” means that function will not resume spontaneously and will not be restarted artificially.

Decision-making capacity. The term “decision-making capacity” has the same meaning set forth in 38 CFR 17.32(a).

Diagnosis. The term “diagnosis” means any reference to an individual's alcohol or drug abuse or to a condition which is identified as having been caused by that abuse or any reference to sickle cell anemia or infection with the human immunodeficiency virus which is made for the purpose of treatment or referral for treatment. A diagnosis prepared for the purpose of treatment or referral for treatment but which is not so used is covered by §§ 1.460 through 1.499 of this part. These regulations do not apply to 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).

Disclose or disclosure. The term “disclose” or “disclosure” means a communication of patient identifying information, the affirmative verification of another person's communication of patient identifying information, or the communication of any information from the record of a patient who has been identified.

Drug abuse. The term “drug abuse” means the use of a psychoactive substance for other than medicinal purposes which impairs the physical, mental, emotional, or social well-being of the user.

Eye bank and tissue bank. The term “eye bank and tissue bank” means an “establishment” as defined in 21 CFR 1271.3, pursuant to section 361 of the Public Health Service Act (42 U.S.C. 264) that has a valid, current registration with the Federal Food and Drug Administration (FDA) as required under 21 CFR part 1271.

Health care. The term “health care” has the same meaning as provided in 45 CFR 160.103.

Health care-related activities or functions. The term “health care-related activities or functions” means the actions required for the delivery of health care, including hospital care, medical services, and extended care services. Health care-related activities or functions includes: Treatment as defined by 45 CFR 164.501; activities related to reimbursement for care and treatment by a health care provider; activities related to participation in health information exchanges for the delivery of health care; health care operations as defined by 45 CFR 164.501; and activities related to a patient's exercise of privacy rights regarding health information.

Individual. The term “individual” means a veteran, as defined in 38 U.S.C. 101(2), or a dependent of a veteran, as defined in 38 U.S.C. 101(3) and (4)(A).

Infection with the human immunodeficiency virus (HIV). The term “infection with the human immunodeficiency virus (HIV)” means the presence of laboratory evidence for human immunodeficiency virus infection. The term does not include negative results from the testing of an individual for the presence of the virus or antibodies to the virus, or such testing of an individual where the results are negative.

Informant. The term “informant” means an individual who is a patient or employee or who becomes a patient or employee at the request of a law enforcement agency or official and who at the request of a law enforcement agency or official observes one or more patients or employees for the purpose of reporting the information obtained to the law enforcement agency or official.

Near death. The term “near death” means that in the clinical judgment of the patient's health care provider based on defined clinical triggers, the patient's death is imminent.

Organ Procurement Organization. The term “Organ Procurement Organization” (OPO) means an organization that performs or coordinates the procurement, preservation, and transportation of organs and maintains a system of locating prospective recipients for available organs.

Patient. The term “patient” means any individual or subject who has been given a diagnosis or treatment for drug abuse, alcoholism or alcohol abuse, infection with the human immunodeficiency virus, or sickle cell anemia and includes any individual who, after arrest on a criminal charge, is interviewed and/or tested in connection with drug abuse, alcoholism or alcohol abuse, infection with the human immunodeficiency virus, or sickle cell anemia in order to determine that individual's eligibility to participate in a treatment or rehabilitation program if the result of such testing is positive. The term “patient” includes an individual who has been diagnosed or treated for alcoholism, drug abuse, HIV infection, or sickle cell anemia for purposes of participation in a VA program or activity relating to those four conditions, including a program or activity consisting of treatment, rehabilitation, education, training, evaluation, or research. For the purpose of infection with the human immunodeficiency virus or sickle cell anemia, the term “patient” includes one tested positive for the disease even if no treatment is provided, offered, or requested. The term does not include a patient who has tested negative for the disease.

Patient identifying information. The term “patient identifying information” means the name, address, social security number, fingerprints, photograph, or similar information by which the identity of a patient can be determined with reasonable accuracy and speed either directly or by reference to other publicly available information. The term does not include a number assigned to a patient by a treatment program, if that number does not consist of, or contain numbers (such as social security, or driver's license number) which could be used to identify a patient with reasonable accuracy and speed from sources external to the treatment program.

Person. The term “person” means an individual, partnership, corporation, Federal, State or local government agency, or any other legal entity.

Practitioner. The term “practitioner” has the same meaning set forth in 38 CFR 17.32(a).

Procurement organization. The term “procurement organization” means an organ procurement organization, eye bank, and/or tissue bank as defined in this section.

Records. The term “records” means any information received, obtained or maintained, whether recorded or not, by an employee or contractor of VA, for the purpose of seeking or performing VA program or activity functions relating to drug abuse, alcoholism, tests for or infection with the human immunodeficiency virus, or sickle cell anemia regarding an identifiable patient. A program or activity function relating to drug abuse, alcoholism, infection with the human immunodeficiency virus, or sickle cell anemia includes evaluation, treatment, education, training, rehabilitation, research, or referral for one of these conditions. Sections 1.460 through 1.499 of this part apply to a primary or other diagnosis, or other information which identifies, or could reasonably be expected to identify, a patient as having a drug or alcohol abuse condition, infection with the human immunodeficiency virus, or sickle cell anemia (e.g., alcoholic psychosis, drug dependence), but only if such diagnosis or information is received, obtained or maintained for the purpose of seeking or performing one of the above program or activity functions. Sections 1.460 through 1.499 of this part do not apply if such diagnosis or other information is not received, obtained or maintained for the purpose of seeking or performing a function or activity relating to drug abuse, alcoholism, infection with the human immunodeficiency virus, or sickle cell anemia for the patient in question. Whenever such diagnosis or other information, not originally received or obtained for the purpose of obtaining or providing one of the above program or activity functions, is subsequently used in connection with such program or activity functions, those original entries become a “record” and §§ 1.460 through 1.499 of this part thereafter apply to those entries. Segregability: these regulations do not apply to records or information contained therein, the disclosure of which (the circumstances surrounding the disclosure having been considered) could not reasonably be expected to disclose the fact that a patient has been connected with a VA program or activity function relating to drug abuse, alcoholism, infection with the human immunodeficiency virus, or sickle cell anemia.

(1)

The following are examples of instances whereby records or information related to alcoholism or drug abuse are covered by the provisions of §§ 1.460 through 1.499 of this part:

(i)

A patient with alcoholic delirium tremens is admitted for detoxification. The patient is offered treatment in a VA alcohol rehabilitation program which he declines.

(ii)

A patient who is diagnosed as a drug abuser applies for and is provided VA drug rehabilitation treatment.

(iii)

While undergoing treatment for an unrelated medical condition, a patient discusses with the physician his use and abuse of alcohol. The physician offers VA alcohol rehabilitation treatment which is declined by the patient.

(2)

The following are examples of instances whereby records or information related to alcoholism or drug abuse are not covered by the provisions of §§ 1.460 through 1.499 of this part:

(i)

A patient with alcoholic delirium tremens is admitted for detoxification, treated and released with no counseling or treatment for the underlying condition of alcoholism.

(ii)

While undergoing treatment for an unrelated medical condition, a patient informs the physician of a history of drug abuse fifteen years earlier with no ingestion of drugs since. The history and diagnosis of drug abuse is documented in the hospital summary and no treatment is sought by the patient or offered or provided by VA during the current period of treatment.

(iii)

While undergoing treatment for injuries sustained in an accident, a patient's medical record is documented to support the judgment of the physician to prescribe certain alternate medications in order to avoid possible drug interactions in view of the patient's enrollment and treatment in a non-VA methadone maintenance program. The patient states that continued treatment and follow-up will be obtained from private physicians and VA treatment for the drug abuse is not sought by the patient nor provided or offered by the staff.

(iv)

A patient is admitted to the emergency room suffering from a possible drug overdose. The patient is treated and released; a history and diagnosis of drug abuse may be documented in the hospital summary. The patient is not offered treatment for the underlying conditions of drug abuse, nor is treatment sought by the patient for that condition.

Surrogate. The term “surrogate” has the same meaning set forth in 38 CFR 17.32(a).

Third party payer. The term “third party payer” means a person who pays, or agrees to pay, for diagnosis or treatment furnished to a patient on the basis of a contractual relationship with the patient or a member of his or her family or on the basis of the patient's eligibility for Federal, State, or local governmental benefits.

Treatment. The term “treatment” means the management and care of a patient for drug abuse, alcoholism or alcohol abuse, or the diagnosis, management and care of a patient for infection with the human immunodeficiency virus, or sickle cell anemia, or a condition which is identified as having been caused by one or more of these conditions, in order to reduce or eliminate the adverse effects upon the patient. The term does not include negative test results for the human immunodeficiency virus, antibodies to the virus, or sickle cell anemia, or such testing of an individual where the results are negative.

Undercover agent. The term “undercover agent” means an officer of any Federal, State, or local law enforcement agency who becomes a patient or employee for the purpose of investigating a suspected violation of law or who pursues that purpose after becoming a patient or becoming employed for other purposes.

VHA health care facilty. The term “VHA health care facility” means a VA medical center, VA emergency room, VA nursing home or other facility as defined in 38 U.S.C. 1701(3).

Notes, amendments, and revision history

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 72 FR 48241, Aug. 23, 2007; 73 FR 65260, Nov. 3, 2008; 76 FR 6696, Feb. 8, 2011; 82 FR 14822, Mar. 23, 2017; 85 FR 64043, Oct. 9, 2020]

Authority

Authority: 38 U.S.C. 1751-1754 and 7331-7334.

Source

Source: 60 FR 63929, Dec. 13, 1995, unless otherwise noted.

Authority

Authority: 38 U.S.C. 501, and as noted in specific sections.

Source

Source: 40 FR 33944, Aug. 12, 1975, unless otherwise noted.

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 72 FR 48241, Aug. 23, 2007; 73 FR 65260, Nov. 3, 2008; 76 FR 6696, Feb. 8, 2011; 82 FR 14822, Mar. 23, 2017; 85 FR 64043, Oct. 9, 2020]

§1.461. Applicability.

38 C.F.R. § 1.461

(a)

General—

(1)

Restrictions on disclosure. The restrictions on disclosure in these regulations apply to any information whether or not recorded, which:

(i)

Would identify a patient as an alcohol or drug abuser, an individual who tested positive for or is infected with the human immunodeficiency virus (HIV), hereafter referred to as HIV, or an individual who tested positive for or has sickle cell anemia, either directly, by reference to other publicly available information, or through verification of such an identification by another person; and

(ii)

Is provided or obtained for the purpose of treating alcohol or drug abuse, infection with the HIV, or sickle cell anemia, making a diagnosis for that treatment, or making a referral for that treatment as well as for education, training, evaluation, rehabilitation and research program or activity purposes.

(2)

Restriction on use. The restriction on use of information to initiate or substantiate any criminal charges against a patient or to conduct any criminal investigation of a patient applies to any information, whether or not recorded, which is maintained for the purpose of treating drug abuse, alcoholism or alcohol abuse, infection with the HIV, or sickle cell anemia, making a diagnosis for that treatment, or making a referral for that treatment as well as for education, training, evaluation, rehabilitation, and research program or activity purposes.

(b)

Period covered as affecting applicability. The provisions of §§ 1.460 through 1.499 of this part apply to records of identity, diagnosis, prognosis, or treatment pertaining to any given individual maintained over any period of time which, irrespective of when it begins, does not end before March 21, 1972, in the case of diagnosis or treatment for drug abuse; or before May 14, 1974, in the case of diagnosis or treatment for alcoholism or alcohol abuse; or before September 1, 1973, in the case of testing, diagnosis or treatment of sickle cell anemia; or before May 20, 1988, in the case of testing, diagnosis or treatment for an infection with the HIV.

(c)

Exceptions—

(1)

Department of Veterans Affairs and Armed Forces. The restrictions on disclosure in §§ 1.460 through 1.499 of this part do not apply to communications of information between or among those components of VA who have a need for the information in connection with their duties in the provision of health care, adjudication of benefits, or in carrying out administrative responsibilities related to those functions, including personnel of the Office of the Inspector General who are conducting audits, evaluations, healthcare inspections, or non-patient investigations, or between such components and the Armed Forces. Information obtained by VA components under these circumstances may be disclosed outside of VA to prosecute or investigate a non-patient only in accordance with § 1.495 of this part. Similarly, the restrictions on disclosure in §§ 1.460 through 1.499 of this part do not apply to communications of information to the Department of Justice or U.S. Attorneys who are providing support in civil litigation or possible litigation involving VA.

(2)

Contractor. The restrictions on disclosure in §§ 1.460 through 1.499 of this part do not apply to communications between VA and a contractor of information needed by the contractor to provide his or her services.

(3)

Crimes on VA premises or against VA personnel. The restrictions on disclosure and use in §§ 1.460 through 1.499 of this part do not apply to communications from VA personnel to law enforcement officers which:

(i)

Are directly related to a patient's commission of a crime on the premises of the facility or against personnel of VA 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 to the extent authorized by 38 U.S.C. 5701(f)(2), and that individual's last known whereabouts.

(4)

Undercover agents and informants.

(i)

Except as specifically authorized by a court order granted under § 1.495 of this part, VA may not knowingly employ, or admit as a patient, any undercover agent or informant in any VA drug abuse, alcoholism or alcohol abuse, HIV infection, or sickle cell anemia treatment program.

(ii)

No information obtained by an undercover agent or informant, whether or not that undercover agent or informant is placed in a VA drug abuse, alcoholism or alcohol abuse, HIV infection, or sickle cell anemia treatment program pursuant to an authorizing court order, may be used to criminally investigate or prosecute any patient unless authorized pursuant to the provisions of § 1.494 of this part.

(iii)

The enrollment of an undercover agent or informant in a treatment unit shall not be deemed a violation of this section if the enrollment is solely for the purpose of enabling the individual to obtain treatment for drug or alcohol abuse, HIV infection, or sickle cell anemia.

(d)

Applicability to recipients of information—

(1)

Restriction on use of information. In the absence of a proper § 1.494 court order, the restriction on the use of any information subject to §§ 1.460 through 1.499 of this part 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 VA, regardless of the status of the person obtaining the information or of whether the information was obtained in accordance with §§ 1.460 through 1.499 of this part. 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 paragraph (c) of this section) or through patient access (see § 1.469 of this part) is subject to the restriction on use.

(2)

Restrictions on disclosures—third-party payers and others. The restrictions on disclosure in §§ 1.460 through 1.499 of this part apply to third-party payers and persons who, pursuant to a consent, receive patient records directly from VA and who are notified of the restrictions on redisclosure of the records in accordance with § 1.476 of this part.

Notes, amendments, and revision history

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 76 FR 65135, Oct. 20, 2011; 82 FR 14822, Mar. 23, 2017; 85 FR 64043, Oct. 9, 2020]

Authority

Authority: 38 U.S.C. 1751-1754 and 7331-7334.

Source

Source: 60 FR 63929, Dec. 13, 1995, unless otherwise noted.

Authority

Authority: 38 U.S.C. 501, and as noted in specific sections.

Source

Source: 40 FR 33944, Aug. 12, 1975, unless otherwise noted.

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 76 FR 65135, Oct. 20, 2011; 82 FR 14822, Mar. 23, 2017; 85 FR 64043, Oct. 9, 2020]

§1.462. Confidentiality restrictions.

38 C.F.R. § 1.462

(a)

General. The patient records to which §§ 1.460 through 1.499 of this part 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 disclosure 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 §§ 1.460 through 1.499 of this part apply whether 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 §§ 1.460 through 1.499 of this part. These provisions do not prohibit VA from acting accordingly when there is no disclosure of information.

(c)

Acknowledging the presence of patients: responding to requests.

(1)

The presence of an identified patient in a VA facility for the treatment or other VA program activity relating to drug abuse, alcoholism or alcohol abuse, infection with the HIV, or sickle cell anemia may be acknowledged only if the patient's written consent is obtained in accordance with § 1.475 of this part or if an authorizing court order is entered in accordance with §§ 1.490 through 1.499 of this part. Acknowledgment of the presence of an identified patient in a facility is permitted if the acknowledgment does not reveal that the patient is being treated for or is otherwise involved in a VA program or activity concerning drug abuse, alcoholism or alcohol abuse, infection with the HIV, or sickle cell anemia.

(2)

Any answer to a request for a disclosure of patient records which is not permissible under §§ 1.460 through 1.499 of this part must be made in a way that will not affirmatively reveal that an identified individual has been, or is being diagnosed or treated for drug abuse, alcoholism or alcohol abuse, infection with the HIV, or sickle cell anemia. These regulations do not restrict a disclosure that an identified individual is not and never has been a patient.

38 C.F.R. § 1.464

(a)

Definition of minor. As used in §§ 1.460 through 1.499 of this part the term “minor” means a person who has not attained the age of majority specified in the applicable State law, or if no age of majority is specified in the applicable State law, the age of eighteen years.

(b)

State law not requiring parental consent to treatment. If a minor patient acting alone has the legal capacity under the applicable State law to apply for and obtain treatment for drug abuse, alcoholism or alcohol abuse, infection with the HIV, or sickle cell anemia, any written consent for disclosure authorized under § 1.475 of this part may be given only by the minor patient. This restriction includes, but is not limited to, any disclosure of patient identifying information to the parent or guardian of a minor patient for the purpose of obtaining financial reimbursement. Sections 1.460 through 1.499 of this part do not prohibit a VA facility from refusing to provide nonemergent treatment to an otherwise ineligible minor patient until the minor patient consents to the disclosure necessary to obtain reimbursement for services from a third party payer.

(c)

State law requiring parental consent to treatment.

(1)

Where State law requires consent of a parent, guardian, or other person for a minor to obtain treatment for drug abuse, alcoholism or alcohol abuse, infection with the HIV, or sickle cell anemia, any written consent for disclosure authorized under § 1.475 of this part must be given by both the minor and his or her parent, guardian, or other person authorized under State law to act in the minor's behalf.

(2)

Where State law requires parental consent to treatment, the fact of a minor's application for treatment may be communicated to the minor's parent, guardian, or other person authorized under State law to act in the minor's behalf only if:

(i)

The minor has given written consent to the disclosure in accordance with § 1.475 of this part; or

(ii)

The minor lacks the capacity to make a rational choice regarding such consent as judged by the appropriate VA facility director under paragraph (d) of this section.

(d)

Minor applicant for service lacks capacity for rational choice. Facts relevant to reducing a threat to the life or physical well being of the applicant or any other individual may be disclosed to the parent, guardian, or other person authorized under State law to act in the minor's behalf if the appropriate VA facility director judges that:

(1)

A minor applicant for services lacks capacity because of extreme youth or mental or physical condition to make a rational decision on whether to consent to a disclosure under § 1.475 of this part to his or her parent, guardian, or other person authorized under State law to act in the minor's behalf, and

(2)

The applicant's situation poses a substantial threat to the life or physical well-being of the applicant or any other individual which may be reduced by communicating relevant facts to the minor's parent, guardian, or other person authorized under State law to act in the minor's behalf.

Notes, amendments, and revision history

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]

Authority

Authority: 38 U.S.C. 1751-1754 and 7331-7334.

Source

Source: 60 FR 63929, Dec. 13, 1995, unless otherwise noted.

Authority

Authority: 38 U.S.C. 501, and as noted in specific sections.

Source

Source: 40 FR 33944, Aug. 12, 1975, unless otherwise noted.

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]

§1.465. Incompetent and deceased patients.

38 C.F.R. § 1.465

(a)

Incompetent patients other than minors. In the case of a patient who has been adjudicated as lacking the capacity, for any reason other than insufficient age, to manage his or her own affairs, any consent which is required under §§ 1.460 through 1.499 of this part may be given by a court appointed legal guardian.

(b)

Deceased patients—

(1)

Vital statistics. Sec. 1.460 through 1.499 of this part 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 being treated for drug abuse, alcoholism or alcohol abuse, infection with the HIV, or sickle cell anemia is subject to §§ 1.460 through 1.499 of this part. If a written consent to the disclosure is required, the Under Secretary for Health or designee may, upon the prior written request of the next of kin, executor/executrix, administrator/administratrix, or other personal representative of such deceased patient, disclose the contents of such records, only if the Under Secretary for Health or designee determines such disclosure is necessary to obtain survivorship benefits for the deceased patient's survivor. This would include not only VA benefits, but also payments by the Social Security Administration, Worker's Compensation Boards or Commissions, or other Federal, State, or local government agencies, or nongovernment entities, such as life insurance companies.

(3)

Information related to sickle cell anemia. Information related to sickle cell anemia may be released to a blood relative of a deceased veteran for medical follow-up or family planning purposes.

Notes, amendments, and revision history

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]

Authority

Authority: 38 U.S.C. 1751-1754 and 7331-7334.

Source

Source: 60 FR 63929, Dec. 13, 1995, unless otherwise noted.

Authority

Authority: 38 U.S.C. 501, and as noted in specific sections.

Source

Source: 40 FR 33944, Aug. 12, 1975, unless otherwise noted.

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]

§1.466. Security for records.

38 C.F.R. § 1.466

(a)

Written records which are subject to §§ 1.460 through 1.499 of this part must be maintained in a secure room, locked file cabinet, safe or other similar container when not in use. Access to information stored in computers will be limited to authorized VA employees who have a need for the information in performing their duties. These security precautions shall be consistent with the Privacy Act of 1974 (5 U.S.C. 552a).

(b)

Each VA facility shall adopt in writing procedures related to the access to and use of records which are subject to §§ 1.460 through 1.499 of this part.

Notes, amendments, and revision history

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]

Authority

Authority: 38 U.S.C. 1751-1754 and 7331-7334.

Source

Source: 60 FR 63929, Dec. 13, 1995, unless otherwise noted.

Authority

Authority: 38 U.S.C. 501, and as noted in specific sections.

Source

Source: 40 FR 33944, Aug. 12, 1975, unless otherwise noted.

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]

§1.467. Restrictions on the use of identification cards and public signs.

38 C.F.R. § 1.467

(a)

No facility may require any patient to carry on their person while away from the facility premises any card or other object which would identify the patient as a participant in any VA drug abuse, alcoholism or alcohol abuse, HIV infection, or sickle cell anemia treatment program. A facility may require patients to use or carry cards or other identification objects on the premises of a facility. Patients may not be required to wear clothing or colored identification bracelets or display objects openly to all facility staff or others which would identify them as being treated for drug or alcohol abuse, HIV infection, or sickle cell anemia.

(b)

Treatment locations should not be identified by signs that would identify individuals entering or exiting these locations as patients enrolled in a drug or alcohol abuse, HIV infection, or sickle cell anemia program or activity.

Notes, amendments, and revision history

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]

Authority

Authority: 38 U.S.C. 1751-1754 and 7331-7334.

Source

Source: 60 FR 63929, Dec. 13, 1995, unless otherwise noted.

Authority

Authority: 38 U.S.C. 501, and as noted in specific sections.

Source

Source: 40 FR 33944, Aug. 12, 1975, unless otherwise noted.

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]

§1.468. Relationship to Federal statutes protecting research subjects against compulsory disclosure of their identity.

38 C.F.R. § 1.468

(a)

Research privilege description. There may be concurrent coverage of patient identifying information by the provisions of §§ 1.460 through 1.499 of this part and by administrative action taken under Sec. 303(a) of the Public Health Service Act (42 U.S.C. 241(d) and the implementing regulations at 42 CFR Part 2a); or Sec. 502(c) of the Controlled Substances Act (21 U.S.C. 872(c) and the implementing regulations at 21 CFR 1316.21). These “research privilege” statutes confer on the Secretary of Health and Human Services and on the Attorney General, respectively, the power to authorize researchers conducting certain types of research to withhold from all persons not connected with the research the names and other identifying information concerning individuals who are the subjects of the research.

(b)

Effect of concurrent coverage. Sections 1.460 through 1.499 of this part restrict the disclosure and use of information about patients, while administrative action taken under the research privilege statutes and implementing regulations protects a person engaged in applicable research from being compelled to disclose any identifying characteristics of the individuals who are the subjects of that research. The issuance under §§ 1.490 through 1.499 of this part of a court order authorizing a disclosure of information about a patient does not affect an exercise of authority under these research privilege statutes. However, the research privilege granted under 21 CFR 291.505(g) to treatment programs using methadone for maintenance treatment does not protect from compulsory disclosure any information which is permitted to be disclosed under those regulations. Thus, if a court order entered in accordance with §§ 1.490 through 1.499 of this part authorizes a VA facility to disclose certain information about its patients, the facility may not invoke the research privilege under 21 CFR 291.505(g) as a defense to a subpoena for that information.

Notes, amendments, and revision history

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]

Authority

Authority: 38 U.S.C. 1751-1754 and 7331-7334.

Source

Source: 60 FR 63929, Dec. 13, 1995, unless otherwise noted.

Authority

Authority: 38 U.S.C. 501, and as noted in specific sections.

Source

Source: 40 FR 33944, Aug. 12, 1975, unless otherwise noted.

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]

§1.469. Patient access and restrictions on use.

38 C.F.R. § 1.469

(a)

Patient access not prohibited. Sections 1.460 through 1.499 of this part do not prohibit a facility from giving a patient access to his or her own records, including the opportunity to inspect and copy any records that VA maintains about the patient, subject to the provisions of the Privacy Act (5 U.S.C. 552a(d)(1)) and 38 CFR 1.577. If the patient is accompanied, giving access to the patient and the accompanying person will require a written consent by the patient which is provided in accordance with § 1.475 of this part.

(b)

Restrictions on use of information. Information obtained by patient access to patient record is subject to the restriction on use of this information to initiate or substantiate any criminal charges against the patient or to conduct any criminal investigation of the patient as provided for under § 1.461(d)(1) of this part.

Notes, amendments, and revision history

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]

Authority

Authority: 38 U.S.C. 1751-1754 and 7331-7334.

Source

Source: 60 FR 63929, Dec. 13, 1995, unless otherwise noted.

Authority

Authority: 38 U.S.C. 501, and as noted in specific sections.

Source

Source: 40 FR 33944, Aug. 12, 1975, unless otherwise noted.

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]

§1.470-1.474. Reserved

38 C.F.R. § 1.470-1.474

Notes, amendments, and revision history

Authority

Authority: 38 U.S.C. 1751-1754 and 7331-7334.

Source

Source: 60 FR 63929, Dec. 13, 1995, unless otherwise noted.

Authority

Authority: 38 U.S.C. 501, and as noted in specific sections.

Source

Source: 40 FR 33944, Aug. 12, 1975, unless otherwise noted.

§1.475. Form of written consent.

38 C.F.R. § 1.475

(a)

Required elements. A written consent to a disclosure under §§ 1.460 through 1.499 of this part must include:

(1)

The name of the facility permitted to make the disclosure (such a designation does not preclude the release of records from other VA health care facilities unless a restriction is stated on the consent).

(2)

The name or title of the individual or the name of the organization to which disclosure is to be made.

(3)

The name of the patient.

(4)

The purpose of the disclosure.

(5)

How much and what kind of information is to be disclosed.

(6)

The signature of the patient and, when required for a patient who is a minor, the signature of a person authorized to give consent under § 1.464 of this part; or, when required for a patient who is incompetent or deceased, the signature of a person authorized to sign under § 1.465 of this part in lieu of the patient.

(7)

The date on which the consent is signed.

(8)

A statement that the consent is subject to revocation at any time except to the extent that the facility which is to make the disclosure has already acted in reliance on it. Acting in reliance includes the provision of treatment services in reliance on a valid consent to disclose information to a third party payer.

(9)

The date, event, or condition upon which the consent will expire if not revoked before. This date, event, or condition must ensure that the consent will last no longer than reasonably necessary to serve the purpose for which it is given.

(b)

Expired, deficient, or false consent. A disclosure may not be made on the basis of a consent which:

(1)

Has expired;

(2)

On its face substantially fails to conform to any of the requirements set forth in paragraph (a) of this section;

(3)

Is known to have been revoked; or

(4)

Is known, or through a reasonable effort could be known, by responsible personnel of VA to be materially false.

(c)

Notification of deficient consent. Other than the patient, no person or entity may be advised that a special consent is required in order to disclose information relating to an individual participating in a drug abuse, alcoholism or alcohol abuse, HIV, or sickle cell anemia program or activity. Where a person or entity presents VA with an insufficient written consent for information protected by 38 U.S.C. 7332, VA must, in the process of obtaining a legally sufficient consent, correspond only with the patient whose records are involved, or the legal guardian of an incompetent patient or next of kin of a deceased patient, and not with any other person.

38 C.F.R. § 1.478

(a)

Definitions. For purposes of this section:

(1)

Central registry means an organization which obtains from two or more member programs patient identifying information about individuals applying for maintenance treatment or detoxification treatment for the purpose of avoiding an individual's concurrent enrollment in more than one program.

(2)

Detoxification treatment means the dispensing of a narcotic drug in decreasing doses to an individual in order to reduce or eliminate adverse physiological or psychological effects incident to withdrawal from the sustained use of a narcotic drug.

(3)

Maintenance treatment means the dispensing of a narcotic drug in the treatment of an individual for dependence upon heroin or other morphine-like drugs.

(4)

Member program means a non-VA detoxification treatment or maintenance treatment program which reports patient identifying information to a central registry and which is in the same State as that central registry or is not more than 125 miles from any border of the State in which the central registry is located.

(b)

Restrictions on disclosure. VA may disclose patient records to a central registry which is located in the same State or is not more than 125 miles from any border of the State or to any non-VA detoxification or maintenance treatment program not more than 200 miles away for the purpose of preventing the multiple enrollment of a patient only if:

(1)

The disclosure is made when—

(i)

The patient is accepted for treatment;

(ii)

The type or dosage of the drug is changed; or

(iii)

The treatment is interrupted, resumed or terminated.

(2)

The disclosure is limited to—

(i)

Patient identifying information;

(ii)

Type and dosage of the drug; and

(iii)

Relevant dates.

(3)

The disclosure is made with the patient's written consent meeting the requirements of § 1.475 of this part, except that:

(i)

The consent must list the name and address of each central registry and each known non-VA detoxification or maintenance treatment program to which a disclosure will be made; and

(ii)

The consent may authorize a disclosure to any non-VA detoxification or maintenance treatment program established within 200 miles after the consent is given without naming any such program.

(c)

Use of information limited to prevention of multiple enrollments. A central registry and any non-VA detoxification or maintenance treatment program to which information is disclosed to prevent multiple enrollments may not redisclose or use patient identifying information for any purpose other than the prevention of multiple enrollments unless authorized by a court order under §§ 1.490 through 1.499 of this part.

Notes, amendments, and revision history

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]

Authority

Authority: 38 U.S.C. 501, and as noted in specific sections.

Source

Source: 40 FR 33944, Aug. 12, 1975, unless otherwise noted.

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]

§1.479. Disclosures to elements of the criminal justice system which have referred patients.

38 C.F.R. § 1.479

(a)

VA may disclose information about a patient from records covered by §§ 1.460 through 1.499 of this part to those persons within the criminal justice system which have made participation in a VA treatment program a condition of the disposition of any criminal proceedings against the patient or of the patient's parole or other release from custody if:

(1)

The disclosure is made only to those individuals within the criminal justice system who have a need for the information in connection with their duty to monitor the patient's progress (e.g., a prosecuting attorney who is withholding charges against the patient, a court granting pretrial or posttrial release, probation or parole officers responsible for supervision of the patient); and

(2)

The patient has signed a written consent as a condition of admission to the treatment program meeting the requirements of § 1.475 of this part (except paragraph (a)(8) which is inconsistent with the revocation provisions of paragraph (c) of this section) and the requirements of paragraphs (b) and (c) of this section.

(b)

Duration of consent. The written consent must state the period during which it remains in effect. This period must be reasonable, taking into account:

(1)

The anticipated length of the treatment recognizing that revocation of consent may not generally be effected while treatment is ongoing;

(2)

The type of criminal proceeding involved, the need for the information in connection with the final disposition of that proceeding, and when the final disposition will occur; and

(3)

Such other factors as the facility, the patient, and the person(s) who will receive the disclosure consider pertinent.

(c)

Revocation of consent. The written consent must state that it is revocable upon the passage of a specified amount of time or the occurrence of a specified, ascertainable event. The time or occurrence upon which consent becomes revocable may be no earlier than the individual's completion of the treatment program and no later than the final disposition of the conditional release or other action in connection with which consent was given.

(d)

Restrictions on redisclosure and use. A person who receives patient information under this section may redisclose and use it only to carry out that person's official duties with regard to the patient's conditional release or other action in connection with which the consent was given, including parole.

Notes, amendments, and revision history

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]

Authority

Authority: 38 U.S.C. 501, and as noted in specific sections.

Source

Source: 40 FR 33944, Aug. 12, 1975, unless otherwise noted.

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]

§1.480. Reserved

38 C.F.R. § 1.480

Notes, amendments, and revision history

Authority

Authority: 38 U.S.C. 501, and as noted in specific sections.

Source

Source: 40 FR 33944, Aug. 12, 1975, unless otherwise noted.

§1.481. Disclosure of medical records of veterans who receive non-VA health care.

38 C.F.R. § 1.481

(a)

VA may disclose records referred to in 38 U.S.C. 7332(a) to a non-VA entity (including private entities and other Federal agencies) for purposes of providing health care to patients or performing other health care-related activities or functions.

38 C.F.R. § 1.484

A VA medical practitioner may disclose the content of any record of the identity, diagnosis, prognosis, or treatment of a patient that is maintained in connection with the performance of any VA program or activity relating to drug abuse, alcoholism or alcohol abuse, infection with the human immunodeficiency virus, or sickle cell anemia to a surrogate of the patient who is the subject of such record if:

(a)

The patient lacks decision-making capacity; and

(b)

The practitioner deems the content of the given record necessary for the surrogate to make an informed decision regarding the patient's treatment.

Notes, amendments, and revision history

Amendments

[76 FR 6696, Feb. 8, 2011, as amended at 85 FR 64043, Oct. 9, 2020]

Authority

Authority: 38 U.S.C. 501, and as noted in specific sections.

Source

Source: 40 FR 33944, Aug. 12, 1975, unless otherwise noted.

Amendments

[76 FR 6696, Feb. 8, 2011, as amended at 85 FR 64043, Oct. 9, 2020]

§1.485. Medical emergencies.

38 C.F.R. § 1.485

(a)

General rule. Under the procedures required by paragraph (c) of this section, patient identifying information from records covered by §§ 1.460 through 1.499 of this part may be disclosed to medical personnel who have a need for information about a patient for the purpose of treating a condition which poses an immediate threat to the health of any individual and which requires immediate medical intervention.

(b)

Special rule. Patient identifying information may be disclosed to medical personnel of the Food and Drug Administration (FDA) who assert a reason to believe that the health of any individual may be threatened by an error in the manufacture, labeling, or sale of a product under FDA jurisdiction, and that the information will be used for the exclusive purpose of notifying patients or their physicians of potential dangers.

(c)

Procedures. Immediately following disclosure, any VA employee making an oral disclosure under authority of this section shall make an accounting of the disclosure in accordance with the Privacy Act (5 U.S.C. 552a(c) and 38 CFR 1.576(c)) and document the disclosure in the patient's records setting forth in writing:

(1)

The name and address of the medical personnel to whom disclosure was made and their affiliation with any health care facility;

(2)

The name of the individual making the disclosure;

(3)

The date and time of the disclosure;

(4)

The nature of the emergency (or error, if the report was to FDA);

(5)

The information disclosed; and

(6)

The authority for making the disclosure (§ 1.485 of this part).

Notes, amendments, and revision history

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]

Authority

Authority: 38 U.S.C. 501, and as noted in specific sections.

Source

Source: 40 FR 33944, Aug. 12, 1975, unless otherwise noted.

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]

§1.485a. Eye, organ and tissue donation.

38 C.F.R. § 1.485a

A VHA health care facility may disclose the individually-identified medical record information of an individual covered by §§ 1.460 through 1.499 of this part to an authorized representative of a procurement organization for the purpose of facilitating determination of whether the individual is a suitable potential organ, eye, or tissue donor if:

(a)

The individual is currently an inpatient in a VHA health care facility;

(b)

The individual is, in the clinical judgment of the individual's primary health care provider, near death or deceased;

(c)

The VHA health care facility has a signed agreement with the procurement organization in accordance with the applicable requirements of the United States Department of Health and Human Services (HHS); and

(d)

The VHA health care facility has confirmed with HHS that it has certified or recertified the organ procurement organization as provided in the applicable HHS regulations. VA medical centers must verify annually in January of each calendar year with the Food and Drug Administration (FDA) that an eye bank or tissue bank has complied with the FDA registration requirements of 21 CFR part 1271 and that the registration status is active before permitting an eye bank or tissue bank to receive protected health information.

Notes, amendments, and revision history

Amendments

[72 FR 48242, Aug. 23, 2007, as amended at 73 FR 65260, Nov. 3, 2008; 85 FR 64043, Oct. 9, 2020]

Authority

Authority: 38 U.S.C. 501, and as noted in specific sections.

Source

Source: 40 FR 33944, Aug. 12, 1975, unless otherwise noted.

Amendments

[72 FR 48242, Aug. 23, 2007, as amended at 73 FR 65260, Nov. 3, 2008; 85 FR 64043, Oct. 9, 2020]

§1.486. Disclosure of information related to infection with the human immunodeficiency virus to public health authorities.

38 C.F.R. § 1.486

(a)

In the case of any record which is maintained in connection with the performance of any program or activity relating to infection with the HIV, information may be disclosed to a Federal, State, or local public health authority, charged under Federal or State law with the protection of the public health, and to which Federal or State law requires disclosure of such record, if a qualified representative of such authority has made a written request that such record be provided as required pursuant to such law for a purpose authorized by such law. In the case of a State law, such law must, in order for VA to be able to release patient name and address information in accordance with 38 U.S.C. 5701(f)(2), provide for a penalty or fine or other sanction to be assessed against those individuals who are subject to the jurisdiction of the public health authority but fail to comply with the reporting requirements.

(b)

A person to whom a record is disclosed under this section may not redisclose or use such record for a purpose other than that for which the disclosure was made.

Notes, amendments, and revision history

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]

Authority

Authority: 38 U.S.C. 501, and as noted in specific sections.

Source

Source: 40 FR 33944, Aug. 12, 1975, unless otherwise noted.

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]

§1.487. Disclosure of information related to infection with the human immunodeficiency virus to the spouse or sexual partner of the patient.

38 C.F.R. § 1.487

(a)

Subject to paragraph (b) of this section, a physician or a professional counselor may disclose information or records indicating that a patient is infected with the HIV if the disclosure is made to the spouse of the patient, or to an individual whom the patient has, during the process of professional counseling or of testing to determine whether the patient is infected with such virus, identified as being a sexual partner of such patient.

(b)

A disclosure under this section may be made only if the physician or counselor, after making reasonable efforts to counsel and encourage the patient to provide the information to the spouse or sexual partner, reasonably believes that the patient will not provide the information to the spouse or sexual partner and that the disclosure is necessary to protect the health of the spouse or sexual partner.

(c)

A disclosure under this section may be made by a physician or counselor other than the physician or counselor referred to in paragraph (b) of this section if such physician or counselor is unavailable by reason of extended absence or termination of employment to make the disclosure.

Notes, amendments, and revision history

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]

Authority

Authority: 38 U.S.C. 501, and as noted in specific sections.

Source

Source: 40 FR 33944, Aug. 12, 1975, unless otherwise noted.

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]

§1.488. Research activities.

38 C.F.R. § 1.488

Subject to the provisions of 38 U.S.C. 5701, 38 CFR 1.500-1.527, the Privacy Act (5 U.S.C. 552a), 38 CFR 1.575-1.584 and the following paragraphs, patient medical record information covered by §§ 1.460 through 1.499 of this part may be disclosed for the purpose of conducting scientific research.

(a)

Information in individually identifiable form may be disclosed from records covered by §§ 1.460 through 1.499 of this part for the purpose of conducting scientific research if the Under Secretary for Health or designee makes a determination that the recipient of the patient identifying information:

(1)

Is qualified to conduct the research.

(2)

Has a research protocol under which the information—

(i)

Will be maintained in accordance with the security requirements of § 1.466 of this part (or more stringent requirements); and

(ii)

Will not be redisclosed except as permitted under paragraph (b) of this section.

(3)

Has furnished a written statement that the research protocol has been reviewed by an independent group of three or more individuals who found that the rights of patients would be adequately protected and that the potential benefits of the research outweigh any potential risks to patient confidentiality posed by the disclosure of records.

(b)

A person conducting research may disclose information obtained under paragraph (a) of this section only back to VA and may not identify any individual patient in any report of that research or otherwise disclose patient identities.

Notes, amendments, and revision history

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]

Authority

Authority: 38 U.S.C. 501, and as noted in specific sections.

Source

Source: 40 FR 33944, Aug. 12, 1975, unless otherwise noted.

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]

§1.489. Audit and evaluation activities.

38 C.F.R. § 1.489

Subject to the provisions of 38 U.S.C. 5701, 38 CFR 1.500-1.527, the Privacy Act (5 U.S.C. 552a), 38 CFR 1.575-1.584, and the following paragraphs, patient medical records covered by §§ 1.460 through 1.499 of this part may be disclosed outside VA for the purposes of conducting audit and evaluation activities.

(a)

Records not copies. If patient records covered by §§ 1.460 through 1.499 of this part are not copied, patient identifying information may be disclosed in the course of a review of records on VA facility premises to any person who agrees in writing to comply with the limitations on redisclosure and use in paragraph (d) of this section and:

(1)

Where audit or evaluation functions are performed by a State or Federal governmental agency on behalf of VA; or

(2)

Who is determined by the VA facility director to be qualified to conduct the audit or evaluation activities.

(b)

Copying of records. Records containing patient identifying information may be copied by any person who:

(1)

Agrees in writing to—

(i)

Maintain the patient identifying information in accordance with the security requirements provided in § 1.466 of this part (or more stringent requirements);

(ii)

Destroy all the patient identifying information upon completion of the audit or evaluation; and

(iii)

Comply with the limitations on disclosure and use in paragraph (d) of this section.

(2)

The VA medical facility director determines to be qualified to conduct the audit or evaluation activities.

(c)

Congressional oversight. Records subject to §§ 1.460 through 1.499 of this part upon written request may be released to congressional committees or subcommittees for program oversight and evaluation if such records pertain to any matter within the jurisdiction of such committee or subcommittee.

38 C.F.R. § 1.491

(a)

A court order under §§ 1.490 through 1.499 of this part may authorize disclosure of confidential communications made by a patient to a treatment program in the course of diagnosis, treatment, or referral for treatment only if:

(1)

The disclosure is necessary to protect against an existing threat to life or of serious bodily injury, including circumstances which constitute suspected child abuse and neglect and verbal threats against third parties;

(2)

The disclosure is necessary in connection with investigation or prosecution of an extremely serious crime, such as one which directly threatens loss of life or serious bodily injury, including homicide, rape, kidnapping, armed robbery, assault with a deadly weapon, or child abuse and neglect; or

(3)

The disclosure is in connection with litigation or an administrative proceeding in which the patient offers testimony or other evidence pertaining to the content of the confidential communications.

38 C.F.R. § 1.493

(a)

Application. An order authorizing the disclosure of patient records covered by §§ 1.460 through 1.499 of this part for purposes other than criminal investigation or prosecution may be applied for by any person having a legally recognized interest in the disclosure which is sought. The application may be filed separately or as part of a pending civil action in which it appears that the patient records are needed to provide evidence. An application must use a fictitious name, such as John Doe, to refer to any patient and may not contain or otherwise disclose any patient identifying information unless the patient is the applicant or has given a written consent (meeting the requirements of § 1.475 of this part) to disclosure or the court has ordered the record of the proceeding sealed from public scrutiny.

(b)

Notice. The patient and VA facility from whom disclosure is sought must be given:

(1)

Adequate notice in a manner which will not disclose patient identifying information to other persons; and

(2)

An opportunity to file a written response to the application, or to appear in person, for the limited purpose of providing evidence on whether the statutory and regulatory criteria for the issuance of the court order are met.

(c)

Review of evidence: Conduct of hearing. Any oral argument, review of evidence, or hearing on the application must be held in the judge's chambers or in some manner which ensures that patient identifying information is not disclosed to anyone other than a party to the proceeding, the patient, or VA, unless the patient requests an open hearing in a manner which meets the written consent requirements of § 1.475 of this part. The proceeding may include an examination by the judge of the patient records referred to in the application.

(d)

Criteria for entry of order. An order under this section may be entered only if the court determines that good cause exists. To make this determination the court must find that:

(1)

Other ways of obtaining the information are not available or would not be effective; and

(2)

The public interest and need for the disclosure outweigh the potential injury to the patient, the physician-patient relationship and the treatment services.

(e)

Content of order. An order authorizing a disclosure must:

(1)

Limit disclosure to those parts of the patient's record which are essential to fulfill the objective of the order;

(2)

Limit disclosure to those persons whose need for information is the basis for the order; and

(3)

Include such other measures as are necessary to limit disclosure for the protection of the patient, the physician-patient relationship and the treatment services; for example, sealing from public scrutiny the record of any proceeding for which disclosure of a patient's record has been ordered.

Notes, amendments, and revision history

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]

Authority

Authority: 38 U.S.C. 501, and as noted in specific sections.

Source

Source: 40 FR 33944, Aug. 12, 1975, unless otherwise noted.

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]

§1.494. Procedures and criteria for orders authorizing disclosure and use of records to criminally investigate or prosecute patients.

38 C.F.R. § 1.494

(a)

Application. An order authorizing the disclosure or use of patient records covered by §§ 1.460 through 1.499 of this part to criminally investigate or prosecute a patient may be applied for by VA or by any person conducting investigative or prosecutorial activities with respect to the enforcement of criminal laws. The application may be filed separately, as part of an application for a subpoena or other compulsory process, or in a pending criminal action. An application must use a fictitious name such as John Doe, to refer to any patient and may not contain or otherwise disclose patient identifying information unless the court has ordered the record of the proceeding sealed from public scrutiny.

(b)

Notice and hearing. Unless an order under § 1.495 of this part is sought with an order under this section, VA must be given:

(1)

Adequate notice (in a manner which will not disclose patient identifying information to third parties) of an application by a person performing a law enforcement function;

(2)

An opportunity to appear and be heard for the limited purpose of providing evidence on the statutory and regulatory criteria for the issuance of the court order; and

(3)

An opportunity to be represented by counsel.

(c)

Review of evidence: Conduct of hearings. Any oral argument, review of evidence, or hearing on the application shall be held in the judge's chambers or in some other manner which ensures that patient identifying information is not disclosed to anyone other than a party to the proceedings, the patient, or VA. The proceeding may include an examination by the judge of the patient records referred to in the application.

(d)

Criteria. A court may authorize the disclosure and use of patient records for the purpose of conducting a criminal investigation or prosecution of a patient only if the court finds that all of the following criteria are met:

(1)

The crime involved is extremely serious, such as one which causes or directly threatens loss of life or serious bodily injury including, but not limited to, homicide, rape, kidnapping, armed robbery, assault with a deadly weapon, and child abuse and neglect.

(2)

There is a reasonable likelihood that the records will disclose information of substantial value in the investigation or prosecution.

(3)

Other ways of obtaining the information are not available or would not be effective.

(4)

The potential injury to the patient, to the physician-patient relationship and to the ability of VA to provide services to other patients is outweighed by the public interest and the need for the disclosure.

(5)

If the applicant is a person performing a law enforcement function, VA has been represented by counsel independent of the applicant.

(e)

Content of order. Any order authorizing a disclosure or use of patient records under this section must:

(1)

Limit disclosure and use to those parts of the patient's record which are essential to fulfill the objective of the order;

(2)

Limit disclosure to those law enforcement and prosecutorial officials who are responsible for, or are conducting, the investigation or prosecution, and limit their use of the records to investigation and prosecution of extremely serious crime or suspected crime specified in the applications; and

(3)

Include such other measures as are necessary to limit disclosure and use to the fulfillment on only that public interest and need found by the court.

Notes, amendments, and revision history

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]

Authority

Authority: 38 U.S.C. 501, and as noted in specific sections.

Source

Source: 40 FR 33944, Aug. 12, 1975, unless otherwise noted.

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]

§1.495. Procedures and criteria for orders authorizing disclosure and use of records to investigate or prosecute VA or employees of VA.

38 C.F.R. § 1.495

(a)

Application.

(1)

An order authorizing the disclosure or use of patient records covered by §§ 1.460 through 1.499 of this part to criminally or administratively investigate or prosecute VA (or employees or agents of VA) may be applied for by an administrative, regulatory, supervisory, investigative, law enforcement, or prosecutorial agency having jurisdiction over VA activities.

(2)

The application may be filed separately or as part of a pending civil or criminal action against VA (or agents or employees of VA) in which it appears that the patient records are needed to provide material evidence. The application must use a fictitious name, such as John Doe, to refer to any patient and may not contain or otherwise disclose any patient identifying information unless the court has ordered the record of the proceeding sealed from public scrutiny or the patient has given a written consent (meeting the requirements of § 1.475 of this part) to that disclosure.

(b)

Notice not required. An application under this section may, in the discretion of the court, be granted without notice. Although no express notice is required to VA or to any patient whose records are to be disclosed, upon implementation of an order so granted VA or the patient must be afforded an opportunity to seek revocation or amendment of that order, limited to the presentation of evidence on the statutory and regulatory criteria for the issuance of the court order.

(c)

Requirements for order. An order under this section must be entered in accordance with, and comply with the requirements of, § 1.493(d) and (e) of this part.

(d)

Limitations on disclosure and use of patient identifying information.

(1)

An order entered under this section must require the deletion of patient identifying information from any documents made available to the public.

(2)

No information obtained under this section may be used to conduct any investigation or prosecution of a patient, or be used as the basis for an application for an order under § 1.494 of this part.

Notes, amendments, and revision history

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]

Authority

Authority: 38 U.S.C. 501, and as noted in specific sections.

Source

Source: 40 FR 33944, Aug. 12, 1975, unless otherwise noted.

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]

§1.496. Orders authorizing the use of undercover agents and informants to criminally investigate employees or agents of VA.

38 C.F.R. § 1.496

(a)

Application. A court order authorizing the placement of an undercover agent or informant in a VA drug or alcohol abuse, HIV infection, or sickle cell anemia treatment program as an employee or patient may be applied for by any law enforcement or prosecutorial agency which has reason to believe that employees or agents of the VA treatment program are engaged in criminal misconduct.

(b)

Notice. The VA facility director must be given adequate notice of the application and an opportunity to appear and be heard (for the limited purpose of providing evidence on the statutory and regulatory criteria for the issuance of the court order), unless the application asserts a belief that:

(1)

The VA facility director is involved in the criminal activities to be investigated by the undercover agent or informant; or

(2)

The VA facility director will intentionally or unintentionally disclose the proposed placement of an undercover agent or informant to the employees or agents who are suspected of criminal activities.

(c)

Criteria. An order under this section may be entered only if the court determines that good cause exists. To make this determination the court must find:

(1)

There is reason to believe that an employee or agent of a VA treatment program is engaged in criminal activity;

(2)

Other ways of obtaining evidence of this criminal activity are not available or would not be effective; and

(3)

The public interest and need for the placement of an undercover agent or informant in the VA treatment program outweigh the potential injury to patients of the program, physician-patient relationships and the treatment services.

(d)

Content of order. An order authorizing the placement of an undercover agent or informant in a VA treatment program must:

(1)

Specifically authorize the placement of an undercover agent or an informant;

(2)

Limit the total period of the placement to six months;

(3)

Prohibit the undercover agent or informant from disclosing any patient identifying information obtained from the placement except as necessary to criminally investigate or prosecute employees or agents of the VA treatment program; and

(4)

Include any other measures which are appropriate to limit any potential disruption of the program by the placement and any potential for a real or apparent breach of patient confidentiality; for example, sealing from public scrutiny the record of any proceeding for which disclosure of a patient's record has been ordered.

(e)

Limitation on use of information. No information obtained by an undercover agent or informant placed under this section may be used to criminally investigate or prosecute any patient or as the basis for an application for an order under § 1.494 of this part.

Notes, amendments, and revision history

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]

Authority

Authority: 38 U.S.C. 501, and as noted in specific sections.

Source

Source: 40 FR 33944, Aug. 12, 1975, unless otherwise noted.

Amendments

[60 FR 63929, Dec. 13, 1995, as amended at 85 FR 64043, Oct. 9, 2020]