[Code of Federal Regulations]
[Title 45, Volume 1]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 45CFR164.502]

[Page 744-747]
 
                        TITLE 45--PUBLIC WELFARE
 
                    SUBTITLE A--DEPARTMENT OF HEALTH
                         AND HUMAN SERVICES
 
PART 164_SECURITY AND PRIVACY--Table of Contents
 
    Subpart E_Privacy of Individually Identifiable Health Information
 
Sec. 164.502  Uses and disclosures of protected health information: 
general rules.

    (a) Standard. A covered entity may not use or disclose protected 
health information, except as permitted or required by this subpart or 
by subpart C of part 160 of this subchapter.
    (1) Permitted uses and disclosures. A covered entity is permitted to 
use or disclose protected health information as follows:
    (i) To the individual;
    (ii) For treatment, payment, or health care operations, as permitted 
by and in compliance with Sec. 164.506;
    (iii) Incident to a use or disclosure otherwise permitted or 
required by this subpart, provided that the covered entity has complied 
with the applicable requirements of Sec. 164.502(b), Sec. 164.514(d), 
and Sec. 164.530(c) with respect to such otherwise permitted or 
required use or disclosure;
    (iv) Pursuant to and in compliance with a valid authorization under 
Sec. 164.508;
    (v) Pursuant to an agreement under, or as otherwise permitted by, 
Sec. 164.510; and
    (vi) As permitted by and in compliance with this section, Sec. 
164.512, or Sec. 164.514(e), (f), or (g).
    (2) Required disclosures. A covered entity is required to disclose 
protected health information:
    (i) To an individual, when requested under, and required by Sec. 
164.524 or Sec. 164.528; and
    (ii) When required by the Secretary under subpart C of part 160 of 
this subchapter to investigate or determine the covered entity's 
compliance with this subpart.
    (b) Standard: Minimum necessary. (1) Minimum necessary applies. When 
using or disclosing protected health information or when requesting 
protected health information from another covered entity, a covered 
entity must make reasonable efforts to limit protected health 
information to the minimum necessary to accomplish the intended purpose 
of the use, disclosure, or request.
    (2) Minimum necessary does not apply. This requirement does not 
apply to:
    (i) Disclosures to or requests by a health care provider for 
treatment;
    (ii) Uses or disclosures made to the individual, as permitted under 
paragraph (a)(1)(i) of this section or as required by paragraph 
(a)(2)(i) of this section;
    (iii) Uses or disclosures made pursuant to an authorization under 
Sec. 164.508;
    (iv) Disclosures made to the Secretary in accordance with subpart C 
of part 160 of this subchapter;
    (v) Uses or disclosures that are required by law, as described by 
Sec. 164.512(a); and
    (vi) Uses or disclosures that are required for compliance with 
applicable requirements of this subchapter.
    (c) Standard: Uses and disclosures of protected health information 
subject to an agreed upon restriction. A covered entity that has agreed 
to a restriction pursuant to Sec. 164.522(a)(1) may not use or disclose 
the protected health information covered by the restriction in violation 
of such restriction, except as otherwise provided in Sec. 164.522(a).
    (d) Standard: Uses and disclosures of de-identified protected health 
information.(1) Uses and disclosures to create de-identified 
information. A covered entity may use protected health information to 
create information that is not individually identifiable health 
information or disclose protected health information only to a business 
associate for such purpose, whether or not the de-

[[Page 745]]

identified information is to be used by the covered entity.
    (2) Uses and disclosures of de-identified information. Health 
information that meets the standard and implementation specifications 
for de-identification under Sec. 164.514(a) and (b) is considered not 
to be individually identifiable health information, i.e., de-identified. 
The requirements of this subpart do not apply to information that has 
been de-identified in accordance with the applicable requirements of 
Sec. 164.514, provided that:
    (i) Disclosure of a code or other means of record identification 
designed to enable coded or otherwise de-identified information to be 
re-identified constitutes disclosure of protected health information; 
and
    (ii) If de-identified information is re-identified, a covered entity 
may use or disclose such re-identified information only as permitted or 
required by this subpart.
    (e)(1) Standard: Disclosures to business associates. (i) A covered 
entity may disclose protected health information to a business associate 
and may allow a business associate to create or receive protected health 
information on its behalf, if the covered entity obtains satisfactory 
assurance that the business associate will appropriately safeguard the 
information.
    (ii) This standard does not apply:
    (A) With respect to disclosures by a covered entity to a health care 
provider concerning the treatment of the individual;
    (B) With respect to disclosures by a group health plan or a health 
insurance issuer or HMO with respect to a group health plan to the plan 
sponsor, to the extent that the requirements of Sec. 164.504(f) apply 
and are met; or
    (C) With respect to uses or disclosures by a health plan that is a 
government program providing public benefits, if eligibility for, or 
enrollment in, the health plan is determined by an agency other than the 
agency administering the health plan, or if the protected health 
information used to determine enrollment or eligibility in the health 
plan is collected by an agency other than the agency administering the 
health plan, and such activity is authorized by law, with respect to the 
collection and sharing of individually identifiable health information 
for the performance of such functions by the health plan and the agency 
other than the agency administering the health plan.
    (iii) A covered entity that violates the satisfactory assurances it 
provided as a business associate of another covered entity will be in 
noncompliance with the standards, implementation specifications, and 
requirements of this paragraph and Sec. 164.504(e).
    (2) Implementation specification: documentation. A covered entity 
must document the satisfactory assurances required by paragraph (e)(1) 
of this section through a written contract or other written agreement or 
arrangement with the business associate that meets the applicable 
requirements of Sec. 164.504(e).
    (f) Standard: Deceased individuals. A covered entity must comply 
with the requirements of this subpart with respect to the protected 
health information of a deceased individual.
    (g)(1) Standard: Personal representatives. As specified in this 
paragraph, a covered entity must, except as provided in paragraphs 
(g)(3) and (g)(5) of this section, treat a personal representative as 
the individual for purposes of this subchapter.
    (2) Implementation specification: adults and emancipated minors. If 
under applicable law a person has authority to act on behalf of an 
individual who is an adult or an emancipated minor in making decisions 
related to health care, a covered entity must treat such person as a 
personal representative under this subchapter, with respect to protected 
health information relevant to such personal representation.
    (3)(i) Implementation specification: unemancipated minors. If under 
applicable law a parent, guardian, or other person acting in loco 
parentis has authority to act on behalf of an individual who is an 
unemancipated minor in making decisions related to health care, a 
covered entity must treat such person as a personal representative under 
this subchapter, with respect to protected health information relevant 
to such personal representation, except that such person may not be a 
personal representative of an unemancipated

[[Page 746]]

minor, and the minor has the authority to act as an individual, with 
respect to protected health information pertaining to a health care 
service, if:
    (A) The minor consents to such health care service; no other consent 
to such health care service is required by law, regardless of whether 
the consent of another person has also been obtained; and the minor has 
not requested that such person be treated as the personal 
representative;
    (B) The minor may lawfully obtain such health care service without 
the consent of a parent, guardian, or other person acting in loco 
parentis, and the minor, a court, or another person authorized by law 
consents to such health care service; or
    (C) A parent, guardian, or other person acting in loco parentis 
assents to an agreement of confidentiality between a covered health care 
provider and the minor with respect to such health care service.
    (ii) Notwithstanding the provisions of paragraph (g)(3)(i) of this 
section:
    (A) If, and to the extent, permitted or required by an applicable 
provision of State or other law, including applicable case law, a 
covered entity may disclose, or provide access in accordance with Sec. 
164.524 to, protected health information about an unemancipated minor to 
a parent, guardian, or other person acting in loco parentis;
    (B) If, and to the extent, prohibited by an applicable provision of 
State or other law, including applicable case law, a covered entity may 
not disclose, or provide access in accordance with Sec. 164.524 to, 
protected health information about an unemancipated minor to a parent, 
guardian, or other person acting in loco parentis; and
    (C) Where the parent, guardian, or other person acting in loco 
parentis, is not the personal representative under paragraphs 
(g)(3)(i)(A), (B), or (C) of this section and where there is no 
applicable access provision under State or other law, including case 
law, a covered entity may provide or deny access under Sec. 164.524 to 
a parent, guardian, or other person acting in loco parentis, if such 
action is consistent with State or other applicable law, provided that 
such decision must be made by a licensed health care professional, in 
the exercise of professional judgment.
    (4) Implementation specification: Deceased individuals. If under 
applicable law an executor, administrator, or other person has authority 
to act on behalf of a deceased individual or of the individual's estate, 
a covered entity must treat such person as a personal representative 
under this subchapter, with respect to protected health information 
relevant to such personal representation.
    (5) Implementation specification: Abuse, neglect, endangerment 
situations. Notwithstanding a State law or any requirement of this 
paragraph to the contrary, a covered entity may elect not to treat a 
person as the personal representative of an individual if:
    (i) The covered entity has a reasonable belief that:
    (A) The individual has been or may be subjected to domestic 
violence, abuse, or neglect by such person; or
    (B) Treating such person as the personal representative could 
endanger the individual; and
    (ii) The covered entity, in the exercise of professional judgment, 
decides that it is not in the best interest of the individual to treat 
the person as the individual's personal representative.
    (h) Standard: Confidential communications. A covered health care 
provider or health plan must comply with the applicable requirements of 
Sec. 164.522(b) in communicating protected health information.
    (i) Standard: Uses and disclosures consistent with notice. A covered 
entity that is required by Sec. 164.520 to have a notice may not use or 
disclose protected health information in a manner inconsistent with such 
notice. A covered entity that is required by Sec. 164.520(b)(1)(iii) to 
include a specific statement in its notice if it intends to engage in an 
activity listed in Sec. 164.520(b)(1)(iii)(A)-(C), may not use or 
disclose protected health information for such activities, unless the 
required statement is included in the notice.
    (j) Standard: Disclosures by whistleblowers and workforce member 
crime victims. (1) Disclosures by whistleblowers. A covered entity is 
not considered to have violated the requirements of this subpart if a 
member of its workforce or

[[Page 747]]

a business associate discloses protected health information, provided 
that:
    (i) The workforce member or business associate believes in good 
faith that the covered entity has engaged in conduct that is unlawful or 
otherwise violates professional or clinical standards, or that the care, 
services, or conditions provided by the covered entity potentially 
endangers one or more patients, workers, or the public; and
    (ii) The disclosure is to:
    (A) A health oversight agency or public health authority authorized 
by law to investigate or otherwise oversee the relevant conduct or 
conditions of the covered entity or to an appropriate health care 
accreditation organization for the purpose of reporting the allegation 
of failure to meet professional standards or misconduct by the covered 
entity; or
    (B) An attorney retained by or on behalf of the workforce member or 
business associate for the purpose of determining the legal options of 
the workforce member or business associate with regard to the conduct 
described in paragraph (j)(1)(i) of this section.
    (2) Disclosures by workforce members who are victims of a crime. A 
covered entity is not considered to have violated the requirements of 
this subpart if a member of its workforce who is the victim of a 
criminal act discloses protected health information to a law enforcement 
official, provided that:
    (i) The protected health information disclosed is about the 
suspected perpetrator of the criminal act; and
    (ii) The protected health information disclosed is limited to the 
information listed in Sec. 164.512(f)(2)(i).

[65 FR 82802, Dec. 28, 2000, as amended at 67 FR 53267, Aug. 14, 2002]