Sec. 2063. ACCESSING, SHARING, AND USING HEALTH DATA FOR RESEARCH PURPOSES
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## SEC. 2063 ACCESSING, SHARING, AND USING HEALTH DATA FOR RESEARCH PURPOSES **[**[42 U.S.C. 1320d-2 note](/us/usc/t42/s1320d-2)**]** ###
(a)Guidance Related to Remote Access Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall issue guidance clarifying that subparagraph
(B)of section 164.512(i)(1)(ii) of part 164 of the Rule (prohibiting the removal of protected health information by a researcher) does not prohibit remote access to health information by a researcher for such purposes as described in section 164.512(i)(1)(ii) of part 164 of the Rule so long as— ####
(1)at a minimum, security and privacy safeguards, consistent with the requirements of the Rule, are maintained by the covered entity and the researcher; and ####
(2)the protected health information is not copied or otherwise retained by the researcher. ###
(b)Guidance Related to Streamlining Authorization Not later than 1 year after the date of enactment of this Act, the Secretary shall issue guidance on the following: ####
(1)Authorization for use and disclosure of health information Clarification of the circumstances under which the authorization for the use or disclosure of protected health information, with respect to an individual, for future research purposes contains a sufficient description of the purpose of the use or disclosure, such as if the authorization— #####
(A)sufficiently describes the purposes such that it would be reasonable for the individual to expect that the protected health information could be used or disclosed for such future research; #####
(B)either— ######
(i)states that the authorization will expire on a particular date or on the occurrence of a particular event; or ######
(ii)states that the authorization will remain valid unless and until it is revoked by the individual; and #####
(C)provides instruction to the individual on how to revoke such authorization at any time. ####
(2)Reminder of the right to revoke Clarification of the circumstances under which it is appropriate to provide an individual with an annual notice or reminder that the individual has the right to revoke such authorization. ####
(3)Revocation of authorization Clarification of appropriate mechanisms by which an individual may revoke an authorization for future research purposes, such as described in paragraph (1)(C). ###
(c)Working Group on Protected Health Information for Research ####
(1)Establishment Not later than 1 year after the date of enactment of this Act, the Secretary shall convene a working group to study and report on the uses and disclosures of protected health information for research purposes, under the Health Insurance Portability and Accountability Act of 1996 (Public Law 104-191). ####
(2)Members The working group shall include representatives of— #####
(A)relevant Federal agencies, including the National Institutes of Health, the Centers for Disease Control and Prevention, the Food and Drug Administration, and the Office for Civil Rights; #####
(B)the research community; #####
(C)patients; #####
(D)experts in civil rights, such as privacy rights; #####
(E)developers of health information technology; #####
(F)experts in data privacy and security; #####
(G)health care providers; #####
(H)bioethicists; and #####
(I)other experts and entities, as the Secretary determines appropriate. ####
(3)Report Not later than 1 year after the date on which the working group is convened under paragraph (1), the working group shall conduct a review and submit a report to the Secretary containing recommendations on whether the uses and disclosures of protected health information for research purposes should be modified to allow protected health information to be available, as appropriate, for research purposes, including studies to obtain generalizable knowledge, while protecting individuals’ privacy rights. In conducting the review and making recommendations, the working group shall— #####
(A)address, at a minimum— ######
(i)the appropriate manner and timing of authorization, including whether additional notification to the individual should be required when the individual’s protected health information will be used or disclosed for such research; ######
(ii)opportunities for individuals to set preferences on the manner in which their protected health information is used in research; ######
(iii)opportunities for patients to revoke authorization; ######
(iv)notification to individuals of a breach in privacy; ######
(v)existing gaps in statute, regulation, or policy related to protecting the privacy of individuals, and ######
(vi)existing barriers to research related to the current restrictions on the uses and disclosures of protected health information; and #####
(B)consider, at a minimum— ######
(i)expectations and preferences on how an individual’s protected health information is shared and used; ######
(ii)issues related to specific subgroups of people, such as children, incarcerated individuals, and individuals with a cognitive or intellectual disability impacting capacity to consent; ######
(iii)relevant Federal and State laws; ######
(iv)models of facilitating data access and levels of data access, including data segmentation, where applicable; ######
(v)potential impacts of disclosure and non-disclosure of protected health information on access to health care services; and ######
(vi)the potential uses of such data. ####
(4)Report submission The Secretary shall submit the report under paragraph
(3)to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, and shall post such report on the appropriate Internet website of the Department of Health and Human Services. ####
(5)Termination The working group convened under paragraph
(1)shall terminate the day after the report under paragraph
(3)is submitted to Congress and made public in accordance with paragraph (4). ###
(d)Definitions In this section: ####
(1)The rule References to “the Rule” refer to part 160 or part 164, as appropriate, of title 45, Code of Federal Regulations (or any successor regulation). ####
(2)Part 164 References to a specified section of “part 164”, refer to such specified section of part 164 of title 45, Code of Federal Regulations (or any successor section). ## Subtitle G Promoting Pediatric Research
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- Pub. L. 104-191
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Sec. 2063
ACCESSING, SHARING, AND USING HEALTH DATA FOR RESEARCH PURPOSES
Pub. L.Pub. L. 104-191
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