,i #aadth ,,congress #ast ,session ,h4 ,r4 #bedi ,,in ,,the ,,house ,,of ,,representatives ,may #ba1 #bjae ,mrs4 ,mc,morris ,rodgers introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend the ,,hitech ,act with respect to accessing1 sharing1 and using health data for research purposes4 #a4 ,accessing1 sharing1 and using health data for research purposes 7a7 ,in general ,the ,,hitech ,act 7title ,,xiii of division ,a of ,public ,law #aaa-e7 is amended by adding at the end of subtitle ,d of such ,act 7#db ,u4,s4,c4 #agiba et seq47 the following3 #d ,accessing1 sharing1 and using health data for research purposes #acdda4 ,references ,in this part3 7a7 ,the ,rule ,references to the ,rule refer to part #afj or part #afd1 as appropriate1 of title #de1 ,code of ,federal ,regulations 7or any successor regulation74 7b7 ,part #afd ,references to a specified section of part #afd1 refer to such specified section of part #afd of title #de1 ,code of ,federal ,regulations 7or any successor section74 #acddb4 ,defining health data research as part of health care operations 7a7 ,in general ,subject to subsection 7b71 the ,secretary shall revise or clarify the rule to allow the use and disclosure of protected health information by a covered entity for research purposes1 including studies whose purpose is to obtain generalizable knowledge1 to be treated as the use and disclosure of such information for health care operations described in subparagraph 7#a7 of the definition of health care operations in section #afd4eja of part #afd4 7b7 ,modifications to rules for disclosures for health care operations ,in applying section #afd4ejf of part #afd to the disclosure of protected health information described in subsection 7a7-- 7#a7 the ,secretary shall revise or clarify the ,rule so that the disclosure may be made by the covered entity to only-- 7,a7 another covered entity for health care operations 7as defined in such section #afd4eja of part #afd72 7,b7 a business associate that has entered into a contract under section #afd4ejd7;e7 of part #afd with a disclosing covered entity to perform health care operations2 or 7,c7 a business associate that has entered into a contract under section #afd4ejd7;e7 of part #afd for the purpose of data aggregation 7as defined in such section #afd4eja of part #afd72 and 7#b7 the ,secretary shall further revise or clarify the ,rule so that the limitation specified by section #afd4ejf7;c77#d7 of part #afd does not apply to disclosures that are described by subsection 7a74 7c7 ,rule of construction ,this section shall not be construed as prohibiting or restricting a use or disclosure of protected health information for research purposes that is otherwise permitted under part #afd4 #acddc4 ,treating disclosures of protected health information for research similarly to disclosures of such information for public health purposes 7a7 ,remuneration ,the ,secretary shall revise or clarify the ,rule so that disclosures of protected health information for research purposes are not subject to the limitation on remuneration described in section #afd4ejb7;a77#e77;ii77,b77#b77;ii7 of part #afd4 7b7 ,permitted uses and disclosures ,the ,secretary shall revise or clarify the ,rule so that research activities1 including comparative research activities1 related to the quality1 safety1 or effectiveness of a product or activity that is regulated by the ,food and ,drug ,administration are included as public health activities for purposes of which a covered entity may disclose protected health information to a person described in section #afd4eab7;b77#a77;iii7 of part #afd4 #acddd4 ,permitting remote access to protected health information by researchers ,the ,secretary shall revise or clarify the ,rule so that subparagraph 7,b7 of section #afd4eab7;i77#a77;ii7 of part #afd 7prohibiting the removal of protected health information by a researcher7 shall not prohibit remote access to health information by a researcher so long as-- 7#a7 appropriate security and privacy safeguards are maintained by the covered entity and the researcher2 and 7#b7 the protected health information is not copied or otherwise retained by the researcher4 #acdde4 ,allowing one-time authorization of use and disclosure of protected health information for research purposes 7a7 ,in general ,the ,secretary shall revise or clarify the ,rule to specify that an authorization for the use or disclosure of protected health information1 with respect to an individual1 for future research purposes shall be deemed to contain a sufficient description of the purpose of the use or disclosure if the authorization-- 7#a7 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 research2 7#b7 either-- 7,a7 states that the authorization will expire on a particular date or on the occurrence of a particular event2 or 7,b7 states that the authorization will remain valid unless and until it is revoked by the individual2 and 7#c7 provides instruction to the individual on how to revoke such authorization at any time4 7b7 ,revocation of authorization ,the ,secretary shall revise or clarify the ,rule to specify that1 if an individual revokes an authorization for future research purposes such as is described by subsection 7a71 the covered entity may not make any further uses or disclosures based on that authorization1 except1 as provided in paragraph 7b77#e7 of section #afd4ejh of part #afd1 to the extent that the covered entity has taken action in reliance on the authorization4 4 7b7 ,revision of regulations ,not later than #ab months after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall revise and clarify the provisions of title #de1 ,code of ,federal ,regulations1 for consistency with part #d of subtitle ,d of the ,,hitech ,act1 as added by subsection 7a74