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
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 U.S.C. 1751-1754 and 7331-7334.
Source: Sections 1.460 through 1.499 issued
at 60 FR 63929, Dec. 13,
1995, unless otherwise noted.
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 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 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 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 [[Page 25]] 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 non-emergent 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 [[Page
26]] 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. (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 non-government 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 [[Page 27]] 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. (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. [[Page 28]] (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 human immunodeficiency
virus. (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. [[Page 29]] (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
post trial 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