In the case that an individual requests under paragraph (a)(1)(i)(A) of section 164.522 of title 45, Code of Federal Regulations, that a covered entity restrict the disclosure of the protected health information of the individual, notwithstanding paragraph (a)(1)(ii) of such section, the covered entity must comply with the requested restriction if-
Subject to subparagraph (B), a covered entity shall be treated as being in compliance with section 164.502(b)(1) of title 45, Code of Federal Regulations, with respect to the use, disclosure, or request of protected health information described in such section, only if the covered entity limits such protected health information, to the extent practicable, to the limited data set (as defined in section 164.514(e)(2) of such title) or, if needed by such entity, to the minimum necessary to accomplish the intended purpose of such use, disclosure, or request, respectively.
Not later than 18 months after February 17, 2009, the Secretary shall issue guidance on what constitutes "minimum necessary" for purposes of subpart E of part 164 of title 45, Code of Federal Regulation.1 In issuing such guidance the Secretary shall take into consideration the guidance under section of this title and the information necessary to improve patient outcomes and to detect, prevent, and manage chronic disease.
Subparagraph (A) shall not apply on and after the effective date on which the Secretary issues the guidance under subparagraph (B).
For purposes of paragraph (1), in the case of the disclosure of protected health information, the covered entity or business associate disclosing such information shall determine what constitutes the minimum necessary to accomplish the intended purpose of such disclosure.
The exceptions described in section 164.502(b)(2) of title 45, Code of Federal Regulations, shall apply to the requirement under paragraph (1) as of the effective date described in section 13423 2 in the same manner that such exceptions apply to section 164.502(b)(1) of such title before such date.
Nothing in this subsection shall be construed as affecting the use, disclosure, or request of protected health information that has been de-identified.
In applying section 164.528 of title 45, Code of Federal Regulations, in the case that a covered entity uses or maintains an electronic health record with respect to protected health information-
The Secretary shall promulgate regulations on what information shall be collected about each disclosure referred to in paragraph (1), not later than 6 months after the date on which the Secretary adopts standards on accounting for disclosure described in the 3 section of this title, as added by section 13101.2 Such regulations shall only require such information to be collected through an electronic health record in a manner that takes into account the interests of the individuals in learning the circumstances under which their protected health information is being disclosed and takes into account the administrative burden of accounting for such disclosures.
In response to an 4 request from an individual for an accounting, a covered entity shall elect to provide either an-
A business associate included on a list under subparagraph (B) shall provide an accounting of disclosures (as required under paragraph (1) for a covered entity) made by the business associate upon a request made by an individual directly to the business associate for such an accounting.
In the case of a covered entity insofar as it acquired an electronic health record as of January 1, 2009, paragraph (1) shall apply to disclosures, with respect to protected health information, made by the covered entity from such a record on and after January 1, 2014.
In the case of a covered entity insofar as it acquires an electronic health record after January 1, 2009, paragraph (1) shall apply to disclosures, with respect to protected health information, made by the covered entity from such record on and after the later of the following:
The Secretary may set an effective date that is later that 5 the date specified under subparagraph (A) or (B) if the Secretary determines that such later date is necessary, but in no case may the date specified under-
Except as provided in paragraph (2), a covered entity or business associate shall not directly or indirectly receive remuneration in exchange for any protected health information of an individual unless the covered entity obtained from the individual, in accordance with section 164.508 of title 45, Code of Federal Regulations, a valid authorization that includes, in accordance with such section, a specification of whether the protected health information can be further exchanged for remuneration by the entity receiving protected health information of that individual.
Paragraph (1) shall not apply in the following cases:
Paragraph (1) shall apply to exchanges occurring on or after the date that is 6 months after the date of the promulgation of final regulations implementing this subsection.
In applying section 164.524 of title 45, Code of Federal Regulations, in the case that a covered entity uses or maintains an electronic health record with respect to protected health information of an individual-
1 So in original. Probably should be "Regulations."
2 See References in Text note below.
3 So in original.
4 So in original. Probably should be "a".
5 So in original. Probably should be "than".
42 U.S.C. § 17935
REFERENCES IN TEXTSection 13423, referred to in subsec. (b)(3), means section 13423 of div. A of Pub. L. 111-5 which is set out as an Effective Date note under section Advisory Committee are contained in section of this title as enacted by Pub. L. 114-255.of this title.Section of this title, as added by section 13101, referred to in subsec. (c)(2), means section of this title as added by section 13101 of div. A of Pub. L. 111-5. Section of this title was repealed by Pub. L. 114-255, div. A, title IV, §4003(e)(1), Dec. 13, 2016, 130 Stat. 1168. Similar provisions as pertaining to the HIT
AMENDMENTS2016-Subsec. (e)(2), (3). Pub. L. 114-255 added par. (2) and redesignated former par. (2) as (3).
EFFECTIVE DATESection effective 12 months after Feb. 17, 2009, except as otherwise specifically provided, see section 13423 of Pub. L. 111-5 set out as a note under sectionof this title.
- Advisory Committee
- The term "Advisory Committee" means the Green Building Advisory Committee established under section 484.1
- The term "Secretary" means the Secretary of Housing and Urban Development.1 See References in Text note below.