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S. 3097IntroducedSenate · nowHousePresidentLawIn committee
Sec. 3 · S. 3097

Rights and requirements regarding access to certain protected health information

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Introduced → Committee version · Sec. 3

(a) Time and manner of access In applying section 13405(e) of the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. 17935(e)) or section 164.524(c)(3)(ii) of title 45, Code of Federal Regulations (or any successor regulations), in the case that an individual requests that a covered entity or any business associate of a covered entity transmit, produce, or provide access to a copy of the individual’s protected health information to a person, including an entity, designated by the individual, and except where permitted without authorization under section 164.506(c) of title 45, Code of Federal Regulations (or any successor regulations)— (1) the individual’s request shall meet all requirements of a valid authorization under section 164.508(b) of title 45, Code of Federal Regulations (or any successor regulations); and (2) the covered entity or business associate may condition the transmittal, production, or provision of access upon the person to whom the information is to be transmitted or produced or to whom access is to be provided— (A) paying fees, in accordance with applicable State law and consistent with subsection (b), in advance of such transmittal, production, or access; and (B) acknowledging and accepting the terms, limitations, and conditions of use and disclosure contained in the request made by the individual as the legally binding obligation of the person receiving the information. (b) Fees (1) In general In applying section 13405(e)(3) of the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. 17935(e)(3)) or section 164.524(c)(4) of title 45, Code of Federal Regulations (or any successor regulations), each such section shall apply only— (A) to the provision of access to, or the production, copying, or transmittal of, protected health information directly to— (i) the individual, or the individual’s personal representative for health care purposes as described in section 164.502(g) of title 45, Code of Federal Regulations (or any successor regulations); (ii) subject to paragraph (2) and section 164.510(b) of title 45, Code of Federal Regulations (or any successor regulation), any other person identified in, and subject to the limitations of, such section; or (iii) the individual’s health care provider or the business associates of such provider; and (B) as directed by the individual, to the electronic transmittal of the individual’s electronic health record to the patient portal or mobile medical application used and maintained by the individual’s health care provider or for the health care provider by its business associate. (2) Additional limitations In the case of the provision of access to, or the production, copying, or transmittal of, protected health information under paragraph (1)(A) directly to a person described in clause (ii) of such paragraph, such protected health information shall, in accordance with section 164.510(b) of title 45, Code of Federal Regulations (or any successor regulations), be limited to only such information that is— (A) directly relevant to the person’s involvement with the care of the individual or with the payment relevant to the care of the individual; or (B) needed for notification purposes described in such section. (c) Definitions In this section, the terms business associate, covered entity, health care provider, individual, person, and protected health information have the meanings given such terms in section 160.103 of title 45, Code of Federal Regulations (or any successor regulations). (d) Guidance Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services shall amend existing guidance as necessary to implement subsections (a) and (b).

•S 3097 RSSEC. 3

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