[Federal Register Volume 60, Number 239 (Wednesday, December 13, 1995)]
[Rules and Regulations]
[Pages 63926-63938]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-30138]
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DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 1
RIN 2900-AE28
Confidentiality of Certain Medical Records
AGENCY: Department of Veterans Affairs.
[[Page 63927]]
ACTION: Final rule.
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SUMMARY: This document establishes Department of Veterans Affairs (VA)
regulations to implement specific provisions of the Veterans Omnibus
Health Care Act of 1976 and the Veterans' Benefits and Services Act of
1988 concerning the confidentiality of certain medical records. These
regulations protect the confidentiality of VA records pertaining to
drug abuse, alcoholism or alcohol abuse, infection with the human
immunodeficiency virus (HIV), and sickle cell anemia.
EFFECTIVE DATE: January 12, 1996.
FOR FURTHER INFORMATION CONTACT: Celia Winter, Program Specialist,
Veterans Health Administration (161F), Department of Veterans Affairs,
810 Vermont Avenue, NW, Washington, DC 20420, (202) 273-6274.
SUPPLEMENTARY INFORMATION: On July 26, 1993, at 58 FR 39703, VA
published a notice of proposed rulemaking (NPRM) concerning the
confidentiality of VA records pertaining to drug abuse, alcoholism or
alcohol abuse, infection with the human immunodeficiency virus (HIV)
and sickle cell anemia treatment, rehabilitation, education, training,
evaluation and research information. Interested parties were invited to
submit written comments on or before August 25, 1993. Two comments were
received.
Background
VA was mandated by the Veterans Omnibus Health Care Act of 1976 and
the Veterans' Benefits and Services Act of 1988 to publish its own
regulations relative to the confidentiality of medical records relating
to drug abuse, alcoholism or alcohol abuse, infection with the HIV, and
sickle cell anemia. VA, generally, has been following the Department of
Health and Human Services' regulations on drug and alcohol abuse which
were published in the Federal Register, July 1, 1975. The Department of
Health and Human Services (HHS) regulations (42 CFR Secs. 2.1-2.67)
were promulgated with the enactment of legislation specific to alcohol
and drug abuse programs and confidentiality of records. The regulations
take into consideration the existing HHS regulations in implementing
the confidentiality section of the Veterans Omnibus Health Care Act of
1976. Editorial and substantive changes were made to the HHS
regulations which were published in the Federal Register, June 9, 1987.
The historical development of the regulations begins with Pub. L.
93-282, ``Comprehensive Alcohol Abuse and Alcoholism Prevention,
Treatment, and Rehabilitation Act Amendments of 1974,'' which provided
that the then Administrator of Veterans Affairs, through the then Chief
Medical Director, consistent with responsibilities under Title 38,
United States Code, prescribe regulations applicable to the
confidentiality of medical records maintained in connection with the
provision of hospital care, nursing home care, domiciliary care and
medical services under Title 38 to patients suffering from alcohol
abuse, alcoholism, and drug abuse. In prescribing and implementing
these regulations, the Secretary of Veterans Affairs was required to
consult with the Secretary of HHS in order to achieve the maximum
possible coordination of the regulations.
Congress, recognizing that the particular problems of
confidentiality of records in the VA health care system would best be
handled by placing applicable provisions in Title 38, United States
Code, added a new Sec. 4132, now Sec. 7332, to Title 38, United States
Code, with the enactment of Pub. L. 94-581, Veterans Omnibus Health
Care Act of 1976. The intent of this legislation was to ensure
confidentiality of certain medical records by establishing sanctions
for unauthorized disclosure of information, while at the same time,
meeting the legitimate needs for disclosure under certain conditions.
As part of this legislation, Congress imposed upon VA requirements
similar to those of Pub. L. 93-282 noted above (38 U.S.C. Sec. 7334,
formerly Sec. 4134).
Section 111 of Pub. L. 94-581 replaced, for VA purposes, the
provisions of Sections 122(a) and 303 of Pub. L. 93-282 (21
U.S.C.Sec. 1175, for drug records; 42 U.S.C. Sec. 4582, for alcohol
records) as the statutory base for confidentiality of drug and alcohol
abuse records for those patients treated by VA medical facilities.
Additionally, it replaced Section 109 of Pub. L. 93-82 (38 U.S.C.
Sec. 1753(b), formerly Sec. 653(b)) which provided for confidentiality
of sickle cell anemia records and required VA to promulgate
regulations. Pub. L. 94-581, Veterans Omnibus Health Care Act of 1976,
addressed all three subjects--drug abuse, alcoholism and sickle cell
anemia records--in its confidentiality mandate. Section 121 of Pub. L.
100-322 provided for the confidentiality of records relating to
infection with the HIV. Accordingly, drug and alcohol abuse, infection
with the HIV, and sickle cell anemia records are included in these
regulations.
VA has followed regulations on the confidentiality of patients'
records related to drug and alcohol abuse as prescribed in 1975 by the
Secretary of HHS. Certain provisions of the HHS regulations are
inconsistent with VA requirements and these new VA regulations address
those inconsistencies. Staff at HHS reviewed a draft of the regulations
prior to publication and changes were made based on the comments where
there was statutory authority for the change.
The HHS regulations as revised in 1987 and further amended on May
5, 1995, cover only alcohol and drug abuse information that is obtained
by a specialized program or specific provider whose primary function is
the provision of alcohol or drug abuse diagnosis, treatment, or
referral for treatment. The 1987 regulations do not cover alcohol and
drug abuse information obtained by health care facilities which provide
alcohol and drug abuse care only as an incident to the provision of
general medical care. The VA regulations include all records which are
maintained in connection with the performance of any VA program or
activity (including education, training, evaluation, treatment,
rehabilitation or research) relating to drug abuse, alcoholism,
infection with the HIV, or sickle cell anemia in order to provide
greater confidentiality for patients who are provided care for these
conditions. On May 5, 1995, HHS published a final rule in 60 FR 22296,
amending its confidentiality regulations with regard to the definition
of ``program.'' HHS's final rule was in direct response to the holding
made by the Ninth Circuit in a case involving the VA, United States v.
Eide, 875 F.2d 1429, 1438 (9th Cir. 1989). There the court held the
VAMC's (VA medical center) general emergency room to be a ``program''
as defined by the HHS regulations, upon which VA's policy is based. In
its final rule, HHS limited the definition of ``program'' to: (1) an
individual or entity, or an identified unit within a medical care
facility, who holds itself out as providing, and provides, alcohol or
drug abuse diagnosis, treatment or referral for treatment, or (2)
medical personnel or other staff in a general medical care facility,
whose primary function is the provision of alcohol or drug abuse
diagnosis, treatment or referral for treatment and who are identified
as such providers. VA's final regulations DO NOT reflect the same
regulatory language concerning the definition of a ``program'' as the
HHS regulations due to the VA's treatment of the encompassed conditions
as an integral part of the VA medical health care system and not a
separate program
[[Page 63928]]
isolated from other Department functions. VA believes, as does HHS,
that clarification of this point is necessary to help prevent other
courts from ruling as the Ninth Circuit did in Eide, even as to the VA
version of these regulations. Therefore, a specific example has been
added to Sec. 1.460(k)(2) to reflect that one-time emergency room care,
where neither treatment or referral for treatment of the underlying
drug or alcohol abuse condition is offered or sought, does not fall
within the purview of these regulations. It was determined that a
specific example was necessary to distinguish between those instances
where an individual is brought into an emergency room for a potential
drug overdose, receives one-time treatment and is released, from those
instances where an individual enters an emergency room with, or
acquires while there, the purpose of seeking treatment for his or her
drug addiction, or VA offers treatment for such condition.
Discussion of Comments
A total of two comments were received--one from a national medical
specialty society and the other from a not-for-profit public interest
law firm that specializes in legal and policy issues related to
substance abuse and HIV/AIDS. One of the commenters suggested that the
regulations be revised to include a requirement that patients be given
written notice and summary of the confidentiality protections of the
subject records by Secs. 1.460 through 1.499. This provision is
included in the HHS regulations at 42 CFR 2.22. The HHS regulations
provide confidentiality protections for drug or alcohol abuse
information that is obtained by a specialized program or specific
provider whose primary function is the provision of alcohol or drug
abuse diagnosis, treatment, or referral for treatment. Consequently,
the patients are easily identified at the initiation of treatment and
can be provided the written notice and summary. The VA regulations,
however, provide for the confidentiality of all records which are
maintained in connection with the performance of any VA program or
activity. Consequently, medical care may be given for drug or alcohol
abuse, sickle cell anemia, or infection with the HIV in conjunction
with, and after the initiation of medical care for other conditions.
These patients are not as readily recognized as an individual who
should be provided with the written notice and summary of the
confidentiality protections. While VA will take efforts to notify
patients of these provisions through notices in patient information
handouts, handbooks, etc., it would not be possible to positively
assure every patient will receive the notification as would be required
if provided for in the regulations. Thus, we have not adopted this
suggestion.
The same commenter suggested the addition of a provision that would
provide for limitations on court-ordered disclosure of confidential
communications. They suggested that disclosure of confidential
communications that a patient provides to a treatment service be
limited to those situations where a serious crime is reported or
threatened, or where the patient has already testified about
confidential communications in a formal proceeding, such as is provided
for by HHS at 42 CFR 2.63. The final regulations have been revised to
include the suggested provision. This is consistent with 38 U.S.C. 7334
which requires that the VA regulations follow the HHS regulations as
far as possible. Accordingly, it has been added at Sec. 1.491. The
provisions previously published at Sec. 1.491 and following have been
renumbered following the newly inserted provision.
Another commenter addressed Sec. 1.489(c) which provides for the
release of identifiable patient records 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.'' The commenter did not understand the necessity for a
broad based authorization for the release of individually identifiable
patient records for program oversight and evaluation and assumed that
Congressional committees would not have a need for individual records,
but rather a compilation of information without patient identifiers. It
was further stated that the standards of disclosure to Congress of
individually identifiable patient records for these diagnoses should be
the same as for other Federal and State entities. We do not agree with
this suggestion. As part of their oversight responsibilities,
Congressional committees do review individual patient treatment issues
as well as overall program issues. In order to carry out this function,
they need access to treatment information concerning directly affected
individuals. These responsibilities are not shared nor are they the
responsibility of other Federal and State entities. For these reasons,
the provision was not revised.
The same commenter recommended a revision of section 1.487 which
provides for the notification of information related to infection with
the human immunodeficiency virus to the spouse or sexual partner of a
patient. Disclosure may be made only after the patient's 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
and that the disclosure is necessary to protect the health of the
spouse or sexual partner. The commenter recommended that the provision
be refined to include a focus on risk behavior modification. No changes
were made based on the comment. The regulation addresses the issue of
confidentiality and the disclosure, under certain conditions, of the
information to individuals who are at risk. The issue of risk behavior
modification is best addressed in treatment and therapeutic
publications, policies, guidelines, etc.
These regulations are not intended to direct the manner in which
substantive functions, such as research, treatment, and evaluation
should be carried out, but rather to define the minimum requirements
for the protection of confidentiality of patient records which must be
satisfied in connection with the conduct of those functions in order to
carry out the purposes of the authorizing legislation.
An additional, clarifying change to the regulations has been made
concerning internal non-patient investigations and healthcare
inspections conducted by the Office of Inspector General (OIG). During
the internal review process, a question was raised by the VA's OIG as
to whether OIG would be prohibited access to records protected by the
regulations in cases involving healthcare inspections or criminal
investigations of non-patients. Because the statute prohibits access to
such records only where the patient is the subject of an investigation,
and because the OIG would have a need for the information in connection
with their duties, we have included language in Sec. 1.461(c) that
explicitly extends the exception of coverage of the regulations to
healthcare inspections and non-patient investigations conducted by OIG.
We have also added language clarifying that confidential information
obtained by VA components, including OIG, who have a need for the
information in connection with their duties, may not be redisclosed
except in accordance with the regulations. These clarifications from
the proposed rule merely reflect our interpretation of statutory
authority.
Other nonsubstantive changes have been added for purposes of
clarity.
[[Page 63929]]
Executive Order 12866
This regulatory action has been reviewed by the Office of
Management and Budget under Executive Order 12866.
Regulatory Flexibility Act
The Secretary hereby certifies that this final rule will not have a
significant economic impact on a substantial number of small entities
as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 600-
612. This rule will affect VA beneficiaries and will not affect small
businesses. Therefore, pursuant to 5 U.S.C. 605(b), this final rule is
exempt from the initial and final regulatory flexibility analyses
requirements of Secs. 603 and 604.
The Paperwork Reduction Act
Section 1.475 of this regulation contains an information collection
requirement that has been approved by the Office of Management and
Budget (OMB) in accordance with the requirements of the Paperwork
Reduction Act and has been assigned OMB Control No. 2900-0544
(expiration date is October 31, 1996). The Department of Veterans
Affairs estimates that it will take an average of five minutes per
respondent to provide the required information for the consent form and
there will be approximately 20,640 such requests made per year.
List of Subjects in 38 CFR Part 1
Administrative procedures, Privacy Act, Recordkeeping.
Approved: August 24, 1995.
Jesse Brown,
Secretary of Veterans Affairs.
In consideration of the foregoing, the Department of Veterans
Affairs amends 38 CFR part 1, General Provisions, as follows:
PART 1--GENERAL
1. The authority citation for part 1 is revised to read as follows:
Authority: 38 U.S.C. 501(a), unless otherwise noted.
2. Sections 1.460 through 1.499, an undesignated center heading,
note, and authority citation preceding Sec. 1.460, and undesignated
center headings preceding Secs. 1,475, 1,475 and 1,485 and 1,490 are
added to read as follows:
Release of Information from Department of Veterans Affairs (VA) Records
Relating to Drug Abuse, Alcoholism or Alcohol Abuse, Infection with the
Human Immunodeficiency Virus (HIV), or Sickle Cell Anemia
Sec.
1.460 Definitions.
1.461 Applicability.
1.462 Confidentiality restrictions.
1.463 Criminal penalty for violations.
1.464 Minor patients.
1.465 Incompetent and deceased patients.
1.466 Security for records.
1.467 Restrictions on the use of identification cards and public
signs.
1.468 Relationship to Federal statutes protecting research subjects
against compulsory disclosure of their identity.
1.469 Patient access and restrictions on use.
1.470-1.474 [Reserved]
Disclosures With Patient's Consent
1.475 Form of written consent.
1.476 Prohibition on redisclosure.
1.477 Disclosures permitted with written consent.
1.478 Disclosures to prevent multiple enrollments in detoxification
and maintenance treatment programs; not applicable to records
relating to sickle cell anemia or infection with the human
immunodeficiency virus.
1.479 Disclosures to elements of the criminal justice system which
have referred patients.
1.480-1.484 [Reserved]
Disclosures Without Patient Consent
1.485 Medical emergencies.
1.486 Disclosure of information related to infection with the human
immunodeficiency virus to public health authorities.
1.487 Disclosure of information related to infection with the human
immunodeficiency virus to the spouse or sexual partner of the
patient.
1.488 Research activities.
1.489 Audit and evaluation activities.
Court Orders Authorizing Disclosures and Use
1.490 Legal effect of order.
1.491 Confidential communications.
1.492 Order not applicable to records disclosed without consent to
researchers, auditors and evaluators.
1.493 Procedures and criteria for orders authorizing disclosures
for noncriminal purposes.
1.494 Procedures and criteria for orders authorizing disclosure and
use of records to criminally investigate or prosecute patients.
1.495 Procedures and criteria for orders authorizing disclosure and
use of records to investigate or prosecute VA or employees of VA.
1.496 Orders authorizing the use of undercover agents and
informants to criminally investigate employees or agents of VA.
1.497-1.499 [Reserved]
Release of Information From Department of Veterans Affairs Records
Relating to Drug Abuse, Alcoholism or Alcohol Abuse, Infection With the
Human Immunodeficiency Virus (HIV), or Sickle Cell Anemia
Note: Sections 1.460 through 1.499 of this part concern the
confidentiality of information relating to drug abuse, alcoholism or
alcohol abuse, infection with the human immunodeficiency virus, or
sickle cell anemia in VA records and are applicable in combination
with other regulations pertaining to the release of information from
VA records. Sections 1.500 through 1.527, Title 38, Code of Federal
Regulations, implement the provisions of 38 U.S.C. Secs. 5701 and
5702. Sections 1.550 through 1.559 implement the provisions of 5
U.S.C. Sec. 552 (The Freedom of Information Act). Sections 1.575
through 1.584 implement the provisions of 5 U.S.C. Sec. 552a (The
Privacy Act of 1974).
The provisions of Secs. 1.460 through 1.499 of this part pertain
to any program or activity, including education, treatment,
rehabilitation or research, which relates to drug abuse, alcoholism
or alcohol abuse, infection with the human immunodeficiency virus,
or sickle cell anemia. The statutory authority for the drug abuse
provisions and alcoholism or alcohol abuse provisions of Secs. 1.460
through 1.499 is Sec. 111 of Pub. L. 94-581, the Veterans Omnibus
Health Care Act of 1976 (38 U.S.C. Secs. 7331 through 7334), the
authority for the human immunodeficiency virus provisions is Sec.
121 of Pub. L. 100-322, the Veterans' Benefits and Services Act of
1988 (38 U.S.C. Sec. 7332); the authority for the sickle cell anemia
provisions is Sec. 109 of Pub. L. 93-82, the Veterans Health Care
Expansion Act of 1973 (38 U.S.C. Secs. 1751-1754).
Authority: 38 USC 1751-1754 and 7331-7334.
Sec. 1.460 Definitions.
For purposes of Secs. 1.460 through 1.499 of this part, the
following definitions apply:
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 Secs. 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).
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
[[Page 63930]]
referral for treatment. A diagnosis prepared for the purpose of
treatment or referral for treatment but which is not so used is covered
by Secs. 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.
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. For the purposes of Secs. 1.460 through 1.499 of this part,
the term includes the testing of an individual for the presence of the
virus or antibodies to the virus and information related to such
testing (including tests with negative results).
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.
Patient. The term ``patient'' means any individual or subject who
has applied for or 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. 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. The term ``patient'' for the purpose of
infection with the human immunodeficiency virus or sickle cell anemia,
includes one tested 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.
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 Secs. 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 Secs. 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 Secs. 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
[[Page 63931]]
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.
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, 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 includes testing for the human immunodeficiency
virus or sickle cell anemia.
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.
(Authority: 38 U.S.C. 7334)
Sec. 1.461 Applicability.
(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 tested for or infected with the human immunodeficiency virus
(HIV), hereafter referred to as HIV, or an individual with 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
Secs. 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 Secs. 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, of information pertaining to a person relating to a period when
such person is or was subject to the Uniform Code of Military Justice.
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 Sec. 1.495 of this part. Similarly, the restrictions
on disclosure in Secs. 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 Secs. 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 Secs. 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 Sec. 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 Sec. 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
Sec. 1.494 court order, the restriction on the use of any information
subject to Secs. 1.460 through 1.499 of this part to initiate or
[[Page 63932]]
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 Secs. 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 Sec. 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 Secs. 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
Sec. 1.476 of this part.
(Authority: 38 U.S.C. 7332(e) and 7334)
Sec. 1.462 Confidentiality restrictions.
(a) General. The patient records to which Secs. 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 Secs. 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 Secs. 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 Sec. 1.475 of this part or if an
authorizing court order is entered in accordance with Secs. 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 Secs. 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.
(Authority: 38 U.S.C. 7334)
Sec. 1.463 Criminal penalty for violations.
Under 38 U.S.C. 7332(g), any person who violates any provision of
this statute or Secs. 1.460 through 1.499 of this part shall be fined
not more than $5,000 in the case of a first offense, and not more than
$20,000 for a subsequent offense.
(Authority: 38 U.S.C. 7332(g))
Sec. 1.464 Minor patients.
(a) Definition of minor. As used in Secs. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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.
(Authority: 38 U.S.C. 7334)
Sec. 1.465 Incompetent and deceased patients.
(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 Secs. 1.460 through 1.499 of this
part may be given by a court appointed legal guardian.
[[Page 63933]]
(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 Secs. 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.
(Authority: 38 U.S.C. 7332(b)(3))
Sec. 1.466 Security for records.
(a) Written records which are subject to Secs. 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 Secs. 1.460
through 1.499 of this part.
(Authority: 38 U.S.C. 7334)
Sec. 1.467 Restrictions on the use of identification cards and public
signs.
(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.
(Authority: 38 U.S.C. 7334)
Sec. 1.468 Relationship to Federal statutes protecting research
subjects against compulsory disclosure of their identity.
(a) Research privilege description. There may be concurrent
coverage of patient identifying information by the provisions of
Secs. 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 Secs. 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 Secs. 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.
(Authority: 38 U.S.C. 7334)
Sec. 1.469 Patient access and restrictions on use.
(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 Sec. 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 Sec. 1.461(d)(1) of this part.
(Authority: 38 U.S.C. 7334)
Secs. 1.470-1.474 [Reserved]
Disclosures With Patient's Consent
Sec. 1.475 Form of written consent.
(a) Required elements. A written consent to a disclosure under
Secs. 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 Sec. 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 Sec. 1.465 of this part in lieu of the patient.
(7) The date on which the consent is signed.
[[Page 63934]]
(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.
(d) It is not necessary to use any particular form to establish a
consent referred to in paragraph (a) of this section, however, VA Form
10-5345, titled Request for and Consent to Release of Medical Records
Protected by 38 U.S.C. 7332, may be used for such purpose.
(Authority: 38 U.S.C. 7332(a)(2) and (b)(1))
Sec. 1.476 Prohibition on redisclosure.
Each disclosure under Secs. 1.460 through 1.499 of this part made
with the patient's written consent must be accompanied by a written
statement similar to the following:
This information has been disclosed to you from records
protected by Federal confidentiality rules (38 CFR Part 1). The
Federal rules prohibit you from making any further disclosure of
this information unless further disclosure is expressly permitted by
the written consent of the person to whom it pertains or as
otherwise permitted by 38 CFR Part 1. A general authorization for
the release of medical or other information is NOT sufficient for
this purpose. The Federal rules restrict any use of the information
to criminally investigate or prosecute any alcohol or drug abuse
patient or patient with sickle cell anemia or HIV infection.
(Authority: 38 U.S.C. 7334)
Sec. 1.477 Disclosures permitted with written consent.
If a patient consents to a disclosure of his or her records under
Sec. 1.475 of this part, a facility may disclose those records in
accordance with that consent to any individual or organization named in
the consent, except that disclosures to central registries and in
connection with criminal justice referrals must meet the requirements
of Secs. 1.478 and 1.479 of this part, respectively.
(Authority: 38 U.S.C. 7332(b)(1))
Sec. 1.478 Disclosures to prevent multiple enrollments in
detoxification and maintenance treatment programs; not applicable to
records relating to sickle cell anemia or infection with the HIV.
(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 Sec. 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
Secs. 1.490 through 1.499 of this part.
(Authority: 38 U.S.C. 7334)
Sec. 1.479 Disclosures to elements of the criminal justice system
which have referred patients.
(a) VA may disclose information about a patient from records
covered by Secs. 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
Sec. 1.475 of this part (except paragraph (a)(8) which is
[[Page 63935]]
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.
(Authority: 38 U.S.C. 7334)
Secs. 1.480-1.484 [Reserved]
Disclosures Without Patient Consent
Sec. 1.485 Medical emergencies.
(a) General rule. Under the procedures required by paragraph (c) of
this section, patient identifying information from records covered by
Secs. 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 (Sec. 1.485 of this
part).
(Authority: 38 U.S.C. 7332(b)(2)(A))
Sec. 1.486 Disclosure of information related to infection with the
human immunodeficiency virus to public health authorities.
(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.
(Authority: 38 U.S.C. 7332(b)(2)(C))
Sec. 1.487 Disclosure of information related to infection with the
human immunodeficiency virus to the spouse or sexual partner of the
patient.
(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.
(Authority: 38 U.S.C. 7332(b))
Sec. 1.488 Research activities.
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 Secs. 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 Secs. 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 Sec. 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.
[[Page 63936]]
(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.
(Authority: 38 U.S.C. 7332(b)(2)(B))
Sec. 1.489 Audit and evaluation activities.
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 Secs. 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 Secs. 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 Sec. 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 Secs. 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.
(d) Limitation on disclosure and use. Records containing patient
identifying information disclosed under this section may be disclosed
only back to VA and used only to carry out an audit or evaluation
purpose, or, to investigate or prosecute criminal or other activities
as authorized by a court order entered under Sec. 1.494 of this part.
(Authority: 38 U.S.C. 7332(b)(2)(B))
Court Orders Authorizing Disclosures and Use
Sec. 1.490 Legal effect of order.
The records to which Secs. 1.460 through 1.499 of this part apply
may be disclosed if authorized by an appropriate order of a court of
competent jurisdiction granted after application showing good cause
therefore. In assessing good cause the court is statutorily required to
weigh the public interest and the need for disclosure against the
injury to the patient or subject, to the physician-patient
relationship, and to the treatment services. Upon the granting of such
order, the court, in determining the extent to which any disclosure of
all or any part of any record is necessary, is required by statute to
impose appropriate safeguards against unauthorized disclosure. An order
of a court of competent jurisdiction to produce records subject to
Secs. 1.460 through 1.499 of this part will not be sufficient unless
the order reflects that the court has complied with the requirements of
38 U.S.C. 7332(b)(2)(D). Such an order from a Federal court compels
disclosure. However, such an order from a State court only acts to
authorize the Secretary to exercise discretion pursuant to 38 U.S.C.
5701(b)(5) and 38 CFR 1.511 to disclose such records. It does not
compel disclosure.
(Authority: 38 U.S.C. 7332(b)(2)(D))
Sec. 1.491 Confidential communications.
(a) A court order under Secs. 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.
(Authority: 38 U.S.C. 7334)
Sec. 1.492 Order not applicable to records disclosed without consent
to researchers, auditors and evaluators.
A court order under Secs. 1.460 through 1.499 of this part may not
authorize qualified personnel, who have received patient identifying
information from VA without consent for the purpose of conducting
research, audit or evaluation, to disclose that information or use it
to conduct any criminal investigation or prosecution of a patient.
However, a court order under Sec. 1.495 of this part may authorize
disclosure and use of records to investigate or prosecute VA personnel.
(Authority: 38 U.S.C. 7334)
Sec. 1.493 Procedures and criteria for orders authorizing disclosures
for noncriminal purposes.
(a) Application. An order authorizing the disclosure of patient
records covered by Secs. 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 Sec. 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
[[Page 63937]]
to the proceeding, the patient, or VA, unless the patient requests an
open hearing in a manner which meets the written consent requirements
of Sec. 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.
(Authority: 38 U.S.C. 7334)
Sec. 1.494 Procedures and criteria for orders authorizing disclosure
and use of records to criminally investigate or prosecute patients.
(a) Application. An order authorizing the disclosure or use of
patient records covered by Secs. 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 Sec. 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.
(Authority: 38 U.S.C. 7332(c))
Sec. 1.495 Procedures and criteria for orders authorizing disclosure
and use of records to investigate or prosecute VA or employees of VA.
(a) Application.
(1) An order authorizing the disclosure or use of patient records
covered by Secs. 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 Sec.
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,
Sec. 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 Sec. 1.494 of this
part.
(Authority: 38 U.S.C. 7334)
[[Page 63938]]
Sec. 1.496 Orders authorizing the use of undercover agents and
informants to criminally investigate employees or agents of VA.
(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 Sec. 1.494 of this part.
(Authority: 38 U.S.C. 7334)
Sec. 1.497-1.499 [Reserved]
Sec. 1.513 [Amended]
3. In Sec. 1.513(b)(2) remove the words ``Post Office Department''
and add in their place, ``U.S. Postal Service''.
Sec. 1.513a [Removed]
4. Section Sec. 1.513a is removed.
[FR Doc. 95-30138 Filed 12-12-95; 8:45 am]
BILLING CODE 8320-01-P