SUBCHAPTER III—PROTECTION OF PATIENT RIGHTS
§7331. Informed consent
The Secretary, upon the recommendation of the Under Secretary for Health and pursuant to the provisions of section 7334 of this title, shall prescribe regulations establishing procedures to ensure that all medical and prosthetic research carried out and, to the maximum extent practicable, all patient care furnished under this title shall be carried out only with the full and informed consent of the patient or subject or, in appropriate cases, a representative thereof.
(Added Pub. L. 94–581, title I, §111(a)(1), Oct. 21, 1976, 90 Stat. 2849, §4131; renumbered §7331 and amended Pub. L. 102–40, title IV, §§401(a)(4)(A), 402(d)(1), 403(a)(1), May 7, 1991, 105 Stat. 221, 239; Pub. L. 102–405, title III, §302(c)(1), Oct. 9, 1992, 106 Stat. 1984.)
Editorial Notes
Amendments
1992—Pub. L. 102–405 substituted "Under Secretary for Health" for "Chief Medical Director".
1991—Pub. L. 102–40, §401(a)(4)(A), renumbered section 4131 of this title as this section.
Pub. L. 102–40, §403(a)(1), substituted "Secretary" for "Administrator".
Pub. L. 102–40, §402(d)(1), substituted "7334" for "4134".
Statutory Notes and Related Subsidiaries
Effective Date
Subchapter effective Oct. 21, 1976, see section 211 of Pub. L. 94–581, set out as an Effective Date of 1976 Amendment note under section 111 of this title.
§7332. Confidentiality of certain medical records
(a)(1) Records of the identity, diagnosis, prognosis, or treatment of any patient or subject which are maintained in connection with the performance of any program or activity (including education, training, treatment, rehabilitation, or research) relating to drug abuse, alcoholism or alcohol abuse, infection with the human immunodeficiency virus, or sickle cell anemia which is carried out by or for the Department under this title shall, except as provided in subsections (e) and (f), be confidential, and (section 5701 of this title to the contrary notwithstanding) such records may be disclosed only for the purposes and under the circumstances expressly authorized under subsection (b).
(2) Paragraph (1) prohibits the disclosure to any person or entity other than the patient or subject concerned of the fact that a special written consent is required in order for such records to be disclosed.
(b)(1) The content of any record referred to in subsection (a) may be disclosed by the Secretary in accordance with the prior written consent of the patient or subject with respect to whom such record is maintained, but only to such extent, under such circumstances, and for such purposes as may be allowed in regulations prescribed by the Secretary.
(2) Whether or not any patient or subject, with respect to whom any given record referred to in subsection (a) is maintained, gives written consent, the content of such record may be disclosed by the Secretary as follows:
(A) To medical personnel to the extent necessary to meet a bona fide medical emergency.
(B) To qualified personnel for the purpose of conducting scientific research, management audits, financial audits, or program evaluation, but such personnel may not identify, directly or indirectly, any individual patient or subject in any report of such research, audit, or evaluation, or otherwise disclose patient or subject identities in any manner.
(C)(i) In the case of any record which is maintained in connection with the performance of any program or activity relating to infection with the human immunodeficiency virus, 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.
(ii) A person to whom a record is disclosed under this paragraph may not redisclose or use such record for a purpose other than that for which the disclosure was made.
(D) If authorized by an appropriate order of a court of competent jurisdiction granted after application showing good cause therefor. In assessing good cause the court shall weigh the public interest and the need for disclosure against the injury to the patient 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, shall impose appropriate safeguards against unauthorized disclosure.
(E) To an entity described in paragraph (1)(B) of section 5701(k) of this title, but only to the extent authorized by such section.
(F)(i) To a representative of a patient who lacks decision-making capacity, when a practitioner deems the content of the given record necessary for that representative to make an informed decision regarding the patient's treatment.
(ii) In this subparagraph, the term "representative" means an individual, organization, or other body authorized under section 7331 of this title and its implementing regulations to give informed consent on behalf of a patient who lacks decision-making capacity.
(G) To a State controlled substance monitoring program, including a program approved by the Secretary of Health and Human Services under section 399O of the Public Health Service Act (42 U.S.C. 280g–3), to the extent necessary to prevent misuse and diversion of prescription medicines.
(H)(i) To a non-Department entity (including private entities and other Federal agencies) for purposes of providing health care, including hospital care, medical services, and extended care services, to patients or performing other health care-related activities or functions.
(ii) An entity to which a record is disclosed under this subparagraph may not disclose or use such record for a purpose other than that for which the disclosure was made or as permitted by law.
(I) To a third party in order to recover or collect reasonable charges for care furnished to, or paid on behalf of, a patient in connection with a non-service connected disability as permitted by section 1729 of this title or for a condition for which recovery is authorized or with respect to which the United States is deemed to be a third party beneficiary under the Act entitled "An Act to provide for the recovery from tortiously liable third persons of the cost of hospital and medical care and treatment furnished by the United States" (Public Law 87–693; 42 U.S.C. 2651 et seq.; commonly known as the "Federal Medical Care Recovery Act").
(3) In the event that the patient or subject who is the subject of any record referred to in subsection (a) is deceased, the content of any such record may be disclosed by the Secretary only upon the prior written request of the next of kin, executor, administrator, or other personal representative of such patient or subject and only if the Secretary determines that such disclosure is necessary for such survivor to obtain benefits to which such survivor may be entitled, including the pursuit of legal action, but then only to the extent, under such circumstances, and for such purposes as may be allowed in regulations prescribed pursuant to section 7334 of this title.
(c) Except as authorized by a court order granted under subsection (b)(2)(D), no record referred to in subsection (a) may be used to initiate or substantiate any criminal charges against, or to conduct any investigation of, a patient or subject.
(d) The prohibitions of this section shall continue to apply to records concerning any person who has been a patient or subject, irrespective of whether or when such person ceases to be a patient.
(e) The prohibitions of this section shall not prevent any interchange of records—
(1) within and among those components of the Department furnishing health care to veterans, or determining eligibility for benefits under this title; or
(2) between such components furnishing health care to veterans and the Armed Forces.
(f)(1) Notwithstanding subsection (a) but subject to paragraph (2), a physician or a professional counselor may disclose information or records indicating that a patient or subject is infected with the human immunodeficiency virus if the disclosure is made to (A) the spouse of the patient or subject, or (B) to an individual whom the patient or subject has, during the process of professional counseling or of testing to determine whether the patient or subject is infected with such virus, identified as being a sexual partner of such patient or subject.
(2)(A) A disclosure under paragraph (1) may be made only if the physician or counselor, after making reasonable efforts to counsel and encourage the patient or subject to provide the information to the spouse or sexual partner, reasonably believes that the patient or subject 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.
(B) A disclosure under such paragraph may be made by a physician or counselor other than the physician or counselor referred to in subparagraph (A) if such physician or counselor is unavailable by reason of absence or termination of employment to make the disclosure.
(g) Any person who violates any provision of this section or any regulation issued pursuant to this section shall be fined, in the case of a first offense, up to the maximum amount provided under section 5701(f) of this title for a first offense under that section and, in the case of a subsequent offense, up to the maximum amount provided under section 5701(f) of this title for a subsequent offense under that section.
(Added Pub. L. 94–581, title I, §111(a)(1), Oct. 21, 1976, 90 Stat. 2849, §4132; amended Pub. L. 100–322, title I, §121, May 20, 1988, 102 Stat. 502; renumbered §7332 and amended Pub. L. 102–40, title IV, §§401(a)(4)(A), 402(d)(1), 403(a)(1), (2), (4), (5), May 7, 1991, 105 Stat. 221, 239; Pub. L. 109–461, title II, §204(b), Dec. 22, 2006, 120 Stat. 3411; Pub. L. 111–163, title V, §504, May 5, 2010, 124 Stat. 1157; Pub. L. 112–74, div. H, title II, §230(b), Dec. 23, 2011, 125 Stat. 1159; Pub. L. 115–26, §3, Apr. 19, 2017, 131 Stat. 130; Pub. L. 115–182, title I, §132, June 6, 2018, 132 Stat. 1427.)
Editorial Notes
References in Text
Public Law 87–693, commonly known as the Federal Medical Care Recovery Act, referred to in subsec. (b)(2)(I), is Pub. L. 87–693, Sept. 25, 1962, 76 Stat. 593, which is classified generally to chapter 32 (§2651 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Tables.
Amendments
2018—Subsec. (b)(2)(H), (I). Pub. L. 115–182 added subpars. (H) and (I) and struck out former subpar. (H), which read as follows:
"(i) To a non-Department entity (including private entities and other Federal agencies) that provides hospital care or medical services to veterans as authorized by the Secretary.
"(ii) An entity to which a record is disclosed under this subparagraph may not redisclose or use such record for a purpose other than that for which the disclosure was made."
2017—Subsec. (b)(2)(H). Pub. L. 115–26 added subpar. (H).
2011—Subsec. (b)(2)(G). Pub. L. 112–74 added subpar. (G).
2010—Subsec. (b)(2)(F). Pub. L. 111–163 added subpar. (F).
2006—Subsec. (b)(2)(E). Pub. L. 109–461 added subpar. (E).
1991—Pub. L. 102–40, §401(a)(4)(A), renumbered section 4132 of this title as this section.
Subsec. (a)(1). Pub. L. 102–40, §403(a)(4), struck out "of this section" after "subsections (e) and (f)" and after "subsection (b)".
Pub. L. 102–40, §403(a)(2), substituted "Department" for "Veterans' Administration".
Pub. L. 102–40, §402(d)(1), substituted "5701" for "3301".
Subsec. (a)(2). Pub. L. 102–40, §403(a)(4), struck out "of this subsection" after "Paragraph (1)".
Subsec. (b)(1). Pub. L. 102–40, §403(a)(4), struck out "of this section" after "subsection (a)".
Pub. L. 102–40, §403(a)(1), substituted "Secretary" for "Administrator" in two places.
Subsec. (b)(2). Pub. L. 102–40, §403(a)(4), struck out "of this section" after "subsection (a)" in introductory provisions.
Pub. L. 102–40, §403(a)(1), substituted "Secretary" for "Administrator" in introductory provisions.
Subsec. (b)(3). Pub. L. 102–40, §403(a)(4), struck out "of this section" after "subsection (a)".
Pub. L. 102–40, §403(a)(1), substituted "Secretary" for "Administrator" in two places.
Pub. L. 102–40, §402(d)(1), substituted "7334" for "4134".
Subsec. (c). Pub. L. 102–40, §403(a)(4), struck out "of this section" after "subsection (b)(2)(D)" and after "subsection (a)".
Subsec. (e)(1). Pub. L. 102–40, §403(a)(2), substituted "Department" for "Veterans' Administration".
Subsec. (f)(1). Pub. L. 102–40, §403(a)(4), struck out "of this section" after "subsection (a)" and "of this subsection" after "paragraph (2)".
Subsec. (f)(2)(A). Pub. L. 102–40, §403(a)(4), struck out "of this subsection" after "paragraph (1)".
Subsec. (f)(2)(B). Pub. L. 102–40, §403(a)(5), struck out "of this paragraph" after "subparagraph (A)".
Subsec. (g). Pub. L. 102–40, §402(d)(1), substituted "5701(f)" for "3301(f)" in two places.
1988—Subsec. (a). Pub. L. 100–322, §121(a), (e)(1), designated existing provisions as par. (1), inserted "infection with the human immunodeficiency virus," after "alcohol abuse,", substituted "subsections (e) and (f)" for "subsection (e)", and added par. (2).
Subsec. (b)(1). Pub. L. 100–322, §121(b)(1), struck out "pursuant to section 4134 of this title" before period at end.
Subsec. (b)(2)(C), (D). Pub. L. 100–322, §121(b)(2), added subpar. (C) and redesignated former subpar. (C) as (D).
Subsec. (c). Pub. L. 100–322, §121(e)(2), substituted "subsection (b)(2)(D)" for "subsection (b)(2)(C)".
Subsec. (f). Pub. L. 100–322, §121(c)(2), added subsec. (f). Former subsec. (f) redesignated (g).
Subsec. (g). Pub. L. 100–322, §121(c)(1), (d), redesignated subsec. (f) as (g) and substituted "shall be fined, in the case of a first offense, up to the maximum amount provided under section 3301(f) of this title for a first offense under that section and, in the case of a subsequent offense, up to the maximum amount provided under section 3301(f) of this title for a subsequent offense under that section." for "shall be fined not more than $500 in the case of a first offense, and not more than $5,000 in the case of each subsequent offense".
§7333. Nondiscrimination against alcohol and drug abusers and persons infected with the human immunodeficiency virus
(a) Veterans eligible for treatment under chapter 17 of this title who are alcohol or drug abusers or who are infected with the human immunodeficiency virus shall not be discriminated against in admission or treatment by any Department health-care facility solely because of their alcohol or drug abuse or dependency or because of their viral infection.
(b) The Secretary shall prescribe regulations for the enforcement of this section. Such regulations, with respect to the admission and treatment of such veterans who are alcohol or drug abusers, shall be prescribed in accordance with section 7334 of this title.
(Added Pub. L. 94–581, title I, §111(a)(1), Oct. 21, 1976, 90 Stat. 2850, §4133; amended Pub. L. 100–322, title I, §122(a), May 20, 1988, 102 Stat. 503; renumbered §7333 and amended Pub. L. 102–40, title IV, §§401(a)(4)(A), 402(d)(1), 403(a)(1), (2), May 7, 1991, 105 Stat. 221, 239.)
Editorial Notes
Amendments
1991—Pub. L. 102–40, §401(a)(4)(A), renumbered section 4133 of this title as this section.
Subsec. (a). Pub. L. 102–40, §403(a)(2), substituted "Department" for "Veterans' Administration".
Subsec. (b). Pub. L. 102–40, §§402(d)(1), 403(a)(1), substituted "Secretary" for "Administrator" and "7334" for "4134".
1988—Pub. L. 100–322 substituted "Nondiscrimination against alcohol and drug abusers and persons infected with the human immunodeficiency virus" for "Nondiscrimination in the admission of alcohol and drug abusers to Veterans' Administration health care facilities" as section catchline, and amended text generally. Prior to amendment, text read as follows: "Veterans eligible for treatment under chapter 17 of this title who are alcohol or drug abusers and who are suffering from medical disabilities shall not be discriminated against in admission or treatment, solely because of their alcohol or drug abuse or dependence, by any Veterans' Administration health care facility. The Administrator, pursuant to the provisions of section 4134 of this title, shall prescribe regulations for the enforcement of this nondiscrimination policy with respect to the admission and treatment of such eligible veterans who are alcohol or drug abusers."
Statutory Notes and Related Subsidiaries
Restriction on Testing for Infection With Human Immunodeficiency Virus
Pub. L. 100–322, title I, §124, May 20, 1988, 102 Stat. 505, as amended by Pub. L. 102–83, §6(j)(3), Aug. 6, 1991, 105 Stat. 409, provided that the Secretary of Veterans Affairs could not conduct a widespread program to test for the human immunodeficiency virus unless funds for the program were appropriated, with an exception for voluntary testing, prior to repeal by Pub. L. 110–387, title IV, §407, Oct. 10, 2008, 122 Stat. 4130.
§7334. Regulations
(a) Regulations prescribed by the Secretary under section 7331 of this title, section 7332 of this title with respect to the confidentiality of alcohol and drug abuse medical records, and section 7333 of this title with respect to alcohol or drug abusers shall, to the maximum extent feasible consistent with other provisions of this title, make applicable the regulations described in subsection (b) to the conduct of research and to the provision of hospital care, nursing home care, domiciliary care, and medical services under this title.
(b) The regulations referred to in subsection (a) are—
(1) regulations governing human experimentation and informed consent prescribed by the Secretary of Health and Human Services, based on the recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, established by section 201 of the National Research Act (Public Law 93–348; 88 Stat. 348); and
(2) regulations governing (A) the confidentiality of drug and alcohol abuse medical records, and (B) the admission of drug and alcohol abusers to private and public hospitals, prescribed pursuant to the Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and Rehabilitation Act of 1970 (42 U.S.C. 4551 et seq.) and the Drug Abuse Office and Treatment Act of 1972 (21 U.S.C. 1101 et seq.).
(c) Regulations prescribed by the Secretary under sections 7331, 7332, and 7333 of this title may contain such definitions, and may provide for such safeguards and procedures (including procedures and criteria for the issuance and scope of court orders under section 7332(b)(2)(C) 1 of this title), as are necessary to prevent circumvention or evasion of such regulations or to facilitate compliance with such regulations.
(d) In prescribing and implementing such regulations, the Secretary shall, from time to time, consult with the Secretary of Health and Human Services and, as appropriate, with the President (or the delegate of the President) in order to achieve the maximum possible coordination of the regulations, and the implementation of the regulations, which they and the Secretary prescribe.
(Added Pub. L. 94–581, title I, §111(a)(1), Oct. 21, 1976, 90 Stat. 2851, §4134; amended Pub. L. 97–295, §4(87), Oct. 12, 1982, 96 Stat. 1312; Pub. L. 100–322, title I, §122(a), May 20, 1988, 102 Stat. 504; renumbered §7334 and amended Pub. L. 102–40, title IV, §§401(a)(4)(A), 402(d)(1), 403(a)(1), (4), May 7, 1991, 105 Stat. 221, 239.)
Editorial Notes
References in Text
Section 201 of the National Research Act, referred to in subsec. (b)(1), is section 201 of Pub. L. 93–348, title II, July 12, 1974, 88 Stat. 348, which was set out as a note under section 289l–1 of Title 42, The Public Health and Welfare, and was repealed by Pub. L. 95–622, title III, §302(b), Nov. 9, 1978, 92 Stat. 3442.
The Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and Rehabilitation Act of 1970 (42 U.S.C. 4551 et seq.), referred to in subsec. (b)(2), is Pub. L. 91–616, Dec. 31, 1970, 84 Stat. 1848, which is classified principally to chapter 60 (§4541 et seq.) of Title 42. For complete classification of this Act to the Code, see Short Title note set out under section 4541 of Title 42 and Tables.
The Drug Abuse Office and Treatment Act of 1972, referred to in subsec. (b)(2), which was redesignated the Drug Abuse Prevention, Treatment, and Rehabilitation Act, is Pub. L. 92–255, Mar. 21, 1972, 86 Stat. 65, which is classified principally to chapter 16 (§1101 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see Short Title note set out under section 1101 of Title 21 and Tables.
Section 7332(b)(2)(C) of this title, referred to in subsec. (c), was formerly a reference to section 4132(b)(2)(C) of this title which was redesignated section 4132(b)(2)(D) by Pub. L. 100–322, title I, §121(b)(2)(A), May 20, 1988, 102 Stat. 502, and subsequently renumbered section 7332(b)(2)(D) by Pub. L. 102–40, title IV, §401(a)(4)(A), May 7, 1991, 105 Stat. 221. The reference to section 4132(b)(2)(C) in subsec. (c) was amended to reflect the renumbering by Pub. L. 102–40 but not the redesignation by Pub. L. 100–322.
Amendments
1991—Pub. L. 102–40, §401(a)(4)(A), renumbered section 4134 of this title as this section.
Subsec. (a). Pub. L. 102–40, §403(a)(4), struck out "of this section" after "subsection (b)".
Pub. L. 102–40, §403(a)(1), substituted "Secretary" for "Administrator".
Pub. L. 102–40, §402(d)(1), substituted "7331" for "4131", "7332" for "4132", and "7333" for "4133".
Subsec. (b). Pub. L. 102–40, §403(a)(4), struck out "of this section" after "subsection (a)" in introductory provisions.
Subsec. (c). Pub. L. 102–40, §403(a)(1), substituted "Secretary" for "Administrator".
Pub. L. 102–40, §402(d)(1), substituted "7331, 7332, and 7333" for "4131, 4132, and 4133" and "7332(b)(2)(C)" for "4132(b)(2)(C)".
Subsec. (d). Pub. L. 102–40, §403(a)(1), substituted "Secretary" for "Administrator" in two places.
1988—Pub. L. 100–322 amended section generally, substituting provisions consisting of subsecs. (a) to (d) for former provisions consisting of subsecs. (a) and (b).
1982—Subsec. (a). Pub. L. 97–295 substituted "Health and Human Services" for "Health, Education, and Welfare" wherever appearing, and substituted "the President (or the delegate of the President)" for "the Director of the Office of Drug Abuse Policy (or any successor authority)".