,,ii #aadth ,,congress #b;d ,session ,s4 #beaa ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,february #h1 #bjaf ,mr4 ,alexander 7for himself1 ,mrs4 ,murray1 ,mr4 ,cassidy1 ,mr4 ,whitehouse1 ,mr4 ,hatch1 and ,mr4 ,bennet7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to improve ,federal requirements relating to the development and use of electronic health records technology4 #a4 ,short title ,this ,act may be cited as the ,improving ,health ,information ,technology ,act4 #b4 ,assisting doctors and hospitals in improving the quality of care for patients 7a7 ,in general ,part #a of subtitle ,a of title ,,xiii of the ,health ,information ,technology for ,economic and ,clinical ,health ,act 7,public ,law #aaa-e7 is amended by adding at the end the following3 #acajc4 ,assisting doctors and hospitals in improving the quality of care for patients 7a7 ,reduction in burdens goal ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary71 in consultation with providers of health services1 health care suppliers of services1 health care payers1 health professional societies1 health information technology developers1 health care quality organizations1 health care accreditation organizations1 public health entities1 ,states1 and other appropriate entities1 shall1 in accordance with subsection 7b7-- 7#a7 establish a goal with respect to the reduction of regulatory or administrative burdens 7such as documentation requirements7 relating to the use of electronic health records2 7#b7 develop a strategy for meeting the goal established under paragraph 7#a72 and 7#c7 develop recommendations for meeting the goal established under paragraph 7#a74 7b7 ,strategy and recommendations 7#a7 ,in general ,to achieve the goals established under subsection 7a77#a71 the ,secretary1 in consultation with the entities described in such subsection1 shall1 not later than #ab months after the date of enactment of this section1 develop a strategy and recommendations to meet the goals in accordance with this subsection4 7#b7 ,strategy ,the strategy developed under paragraph 7#a7 shall address the regulatory and administration burdens 7such as documentation requirements7 relating to the use of electronic health records4 ,such strategy shall include broad public comment and shall prioritize burdens related to-- 7,a7 the ,medicare and ,medicaid ,,ehr ,meaningful ,use ,incentive programs or the ,merit-based ,incentive ,payment ,system1 the ,alternative ,payment ,models1 the ,hospital ,value-,based ,purchasing ,program1 and other value-based payment programs determined appropriate by the ,secretary2 7,b7 health information technology certification programs2 7,c7 standards1 and implementation specifications1 as appropriate2 7,d7 activities that provide individuals access to their electronic health information2 7,e7 activities related to protecting the privacy of electronic health information2 7,f7 activities related to protecting the security of electronic health information2 7,g7 activities related to facilitating health and clinical research2 7,h7 activities related to public health2 7,i7 activities related to aligning and simplifying quality measures across ,federal programs and other payers2 7,j7 activities related to reporting clinical data for administrative purposes2 and 7,k7 other areas determined appropriate by the ,secretary4 7#c7 ,recommendations ,the recommendations developed under paragraph 7#a7 shall address-- 7,a7 actions that improve the clinical documentation experience2 7,b7 actions that improve patient care2 7,c7 actions to be taken by the ,secretary and by other entities2 and 7,d7 other areas determined appropriate by the ,secretary to reduce the reporting burden required of health care providers4 7#d7 ,,faca ,the ,federal ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app47 shall not apply to the development of the goal1 strategies1 or recommendations described in this section4 7c7 ,application of certain regulatory requirements ,a physician 7as defined in section #ahfa7r77#a7 of the ,social ,security ,act7 may delegate electronic medical record documentation requirements specified in regulations promulgated by the ,department of ,health and ,human ,services to a person who is not such physician if such physician has signed and verified the documentation4 4 7b7 ,certification of health information technology for medical specialties and sites of service ,section #cjja7;c77#e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj-#aa7;c77#e77 is amended by adding at the end the following3 7,c7 ,health information technology for medical specialties and sites of service 7i7 ,in general ,the ,national ,coordinator shall encourage1 keep1 or recognize1 through existing authorities1 the voluntary certification of health information technology under the program developed under subparagraph 7,a7 for use in medical specialties and sites of service for which no such technology is available or where more technological advancement or integration is needed4 7ii7 ,specific medical specialties ,the ,,hit ,policy and ,standards ,committees shall make recommendations on specific medical specialties and sites of service1 in addition to those described in clause 7iii71 applicable under this paragraph4 7iii7 ,certified health information technology for pediatrics ,not later than #ah months after the date of enactment of this subparagraph1 the ,,hit ,policy and ,standards ,committees1 in consultation with relevant stakeholders1 shall make recommendations for the voluntary certification of health information technology for use by pediatric health providers to support the health care of children4 ,not later than #bd months after the date of enactment of this subparagraph1 the ,secretary shall adopt certification criteria 7under section #cjjd7 to support the voluntary certification of health information technology for use by pediatric health providers to support the health care of children4 4 7c7 ,meaningful use statistics 7#a7 ,in general ,not later than #f months after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall submit to the ,,hit ,policy ,committee of the ,office of the ,national ,coordinator for ,health ,information ,technology1 a report concerning attestation statistics for the ,medicare and ,medicaid ,,ehr ,meaningful ,use ,incentive programs to assist in informing standards adoption and related practices4 ,such statistics shall include attestation information delineated by ,state1 including the number of providers who did not meet the minimum criteria necessary to attest for the ,medicare and ,medicaid ,,ehr ,meaningful ,use ,incentive programs for a calendar year1 and shall be made publicly available on the ,internet website of the ,secretary on at least a quarterly basis4 7#b7 ,authority to alter format ,the ,secretary of ,health and ,human ,services may alter the format of the reports on the attestation of eligible health care professionals following the first performance year of the ,merit-based ,incentive ,payment ,system to account for changes arising from the implementation of such payment system4 #c4 ,transparent ratings on usability and security to transform information technology 7a7 ,enhancements to certification ,section #cjja7;c77#e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj-#aa71 as amended by section #b7;b71 is further amended-- 7#a7 in subparagraph 7,a7-- 7,a7 by striking ,the ,national ,coordinator and inserting the following3 7i7 ,voluntary certification program ,the ,national ,coordinator 2 and 7,b7 by adding at the end the following3 7ii7 ,transparency of program 7,i7 ,in general ,to enhance transparency in the compliance of health information technology with certification criteria and other requirements adopted under this subtitle1 the ,national ,coordinator1 in coordination with authorized certification bodies1 may make information demonstrating how health information technology meets such certification criteria or other requirements publicly available4 ,such information may include summaries1 screenshots1 video demonstrations1 or any other information the ,national ,coordinator determines appropriate4 7,,ii7 ,protection of proprietary information ,the ,national ,coordinator shall take appropriate measures to ensure that there are in effect effective procedures to prevent the unauthorized disclosure of any trade secret or confidential information that is obtained by the ,secretary pursuant to this section4 2 7#b7 in subparagraph 7,b71 by adding at the end the following3 ,beginning #ah months after reporting criteria are finalized under section #cjji;,a1 certification criteria shall include1 in addition to criteria to establish that the technology meets such standards and implementation specifications1 criteria consistent with section #cjji;,a7b7 to establish that technology meets applicable security requirements1 incorporates user-centered design1 and achieves interoperability42 and 7#c7 by adding at the end the following3 7,d7 ,conditions of certification ,beginning #a year after the date of enactment of the ,improving ,health ,information ,technology ,act1 the ,secretary shall require1 as a condition of certification and maintenance of certification for programs maintained or recognized under this paragraph1 that-- 7i7 the health information technology developer or entity does not take any action that constitutes information blocking with respect to health information technology2 7ii7 the health information technology developer or entity permits unimpeded communication among and between health information technology users1 and for the purposes of health information technology users communicating with an authorized certification body1 the ,office of the ,national ,coordinator1 and the ,office of the ,inspector ,general1 the health information technology developer or entity permits unimpeded communication regarding the usability1 interoperability1 security1 business practices1 or other relevant information about the health information technology or users' experience with the health information technology2 7iii7 health information from such technology may be exchanged1 accessed1 and used through the use of application programming interfaces or successor technology or standard as provided for under applicable law2 7iv7 the health information technology developer or entity provides to the ,secretary an attestation that the developer or entity-- 7,i7 has not engaged in any of the conduct described in clause 7i72 7,,ii7 allows for communication as described in clause 7ii72 and 7,,iii7 ensures that its technology allows for health information to be exchanged1 accessed1 and used1 in the manner described in clause 7iii72 and 7v7 the health information technology developer or entity submits reporting criteria in accordance with section #cjji;,a7f74 4 7b7 ,health information technology rating program ,subtitle ,a of title ,,xxx of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj-#aa et seq47 is amended by adding at the end the following3 #cjji;,a4 ,health information technology rating program 7a7 ,establishment ,not later than #ahj days after the date of enactment of the ,improving ,health ,information ,technology ,act1 the ,secretary shall recognize a development council made up of one representative from each of the certification bodies authorized by the ,office of the ,national ,coordinator and the testing laboratories accredited under section #acbja7;b7 of the ,health ,information ,technology for ,economic and ,clinical ,health ,act 7#db ,u4,s4,c4 #agiaa7;b771 one representative from the ,national ,institute of ,standards and ,technology1 and one representative from the ,office of the ,national ,coordinator4 ,the development council shall meet as needed for the purposes of carrying out its activities in accordance with this section4 7b7 ,reporting criteria 7#a7 ,in general ,the ,secretary shall1 using the procedures prescribed in this subsection1 issue rules establishing reporting criteria for health information technology products4 7#b7 ,convening of stakeholders ,not later than #a year after the date of enactment of the ,improving ,health ,information ,technology ,act1 the ,secretary1 in consultation with the development council described in subsection 7a71 shall convene stakeholders as described in paragraph 7#c7 for the purpose of developing the reporting criteria in accordance with paragraph 7#d74 7#c7 ,development of reporting criteria ,the reporting criteria under this subsection shall be developed through a public1 transparent process that reflects input from relevant stakeholders1 including-- 7,a7 health care providers1 including primary care and specialty care health care professionals2 7,b7 hospitals and hospital systems2 7,c7 health information technology developers2 7,d7 patients1 consumers1 and their advocates2 7,e7 data sharing networks1 such as health information exchanges2 7,f7 authorized certification bodies and testing laboratories2 7,g7 security experts2 7,h7 relevant manufacturers of medical devices2 7,i7 experts in health information technology market economics2 7,j7 public and private entities engaged in the evaluation of health information technology performance2 7,k7 quality organizations1 including the consensus based entity described in section #ahij of the ,social ,security ,act2 7,l7 experts in human factors engineering and the measurement of user-centered design2 and 7,m7 other entities or persons1 as the ,secretary1 in consultation with the development council1 determines appropriate4 7#d7 ,considerations for reporting criteria ,the reporting criteria developed under this subsection-- 7,a7 shall include measures that reflect categories including1 with respect to the technology-- 7i7 security2 7ii7 usability and user-centered design2 7iii7 interoperability2 7iv7 conformance to certification testing2 and 7v7 other categories as appropriate to measure the performance of health information technology2 7,b7 may include measures such as-- 7i7 enabling the user to order and view the results of laboratory tests1 imaging tests1 and other diagnostic tests2 7ii7 submitting1 editing1 and retrieving data from registries such as clinician-led clinical data registries2 7iii7 accessing and exchanging information and data from and through ,health ,information ,exchanges2 7iv7 accessing and exchanging information and data from medical devices2 7v7 accessing and exchanging information and data held by ,federal1 ,state1 and local agencies and other applicable entities useful to a health care provider or other applicable user in the furtherance of patient care2 7vi7 accessing and exchanging information from other health care providers or applicable users2 7vii7 accessing and exchanging patient generated information2 7viii7 providing the patient or an authorized designee with a complete copy of their health information from an electronic record in a computable format2 7ix7 providing accurate patient information for the correct patient1 including exchanging such information1 and avoiding the duplication of patients records2 and 7x7 other appropriate functionalities2 and 7,c7 shall be designed to ensure that small and start-up health information technology developers are not unduly disadvantaged by the reporting criteria or rating scale methodology4 7#e7 ,consideration of development council recommendations ,in promulgating proposed rules under this subsection1 including modifications to such rules under subsection 7e71 the ,secretary may accept1 reject1 or modify the recommendations of the development council1 but may not promulgate a proposed rule that does not represent a complete recommendation of such council4 7#f7 ,public comment ,in promulgating proposed rules under this subsection1 the ,secretary shall conduct a public comment period of not less than #fj days during which any member of the public may provide comments on the proposed reporting criteria and the methodology for the rating body 7defined in subsection 7g77 to use in determining the star ratings4 7#g7 ,final rules ,the final rule promulgated under this subsection shall be accompanied by timely responses to the public comments described in paragraph 7#f74 7#h7 ,,faca ,the ,federal ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app47 shall not apply to the development council described in this section4 7c7 ,feedback 7#a7 ,in general ,the ,secretary1 in consultation with the development council1 shall establish a process for the rating body 7described in subsection 7g77 to collect and verify confidential feedback from-- 7,a7 health care providers1 patients1 and other users of certified health information technology on the usability1 security1 and interoperability of health information technology products2 and 7,b7 developers of certified health information technology on practices of health information technology users that may inhibit interoperability4 7#b7 ,paperwork ,reduction ,act ,the ,paperwork ,reduction ,act 7#dd ,u4,s4,c4 #ceja et seq47 shall not apply to the collection of feedback described in this subsection4 7d7 ,methodology ,the ,secretary1 in consultation with the development council1 shall develop a methodology to be used by the rating body described in subsection 7g7 to calculate the star ratings for certified health information technology described in subsection 7a74 ,the methodology shall use the reporting criteria developed in subsection 7b71 and the confidential feedback collected under subsection 7c74 ,in developing such methodology1 the ,secretary1 in consultation with the development council1 shall-- 7#a7 provide for appropriate weighting of user feedback submitted under subsection 7c7 and reporting criteria submitted under subsection 7f71 including consideration of the number of users who submitted such feedback2 7#b7 consider the impact of customization or adaptation by users of certified health information technology on performance2 7#c7 account for the intended function1 scope1 and type of certified health information technology2 7#d7 in consultation with the development council and after seeking comment from developers of health information technology in a manner that ensures appropriate industry feedback1 establish a timeframe1 but in no case less frequent than once every #c years1 for the submission of reporting criteria under subsection 7f72 and 7#e7 establish a timeframe for incorporating user feedback submitted under subsection 7c7 and reporting criteria submitted under subsection 7f7 into the star ratings for certified health information technology that accounts for updates to such technology in order to encourage innovation and maximize the utility of the star ratings4 7e7 ,modifications 7#a7 ,to the number of stars in the rating program ,the development council may modify the number of star ratings employed by the system1 but not more frequently than every #d years4 ,in no case shall the rating system employ fewer than #c stars4 7#b7 ,to the reporting criteria ,after the final reporting criteria have been established under this section1 the ,secretary1 in consultation with the development council1 may convene stakeholders and conduct a public reporting period for the purpose of modifying the reporting criteria developed under subsection 7b7 and methodology for determining the star ratings proposed under subsection 7e74 7#c7 ,to the methodology ,after the final methodology to be used by the rating body is established under subsection 7e71 the ,secretary1 in consultation with the development council1 may modify the methodology used to calculate the star ratings for certified health information technology using the reporting criteria developed under subsection 7b7 and the confidential feedback collected under subsection 7c74 7#d7 ,consideration of ,,gao report ,the ,secretary and the development council shall take into account the recommendations from the ,comptroller ,general under subsection 7k71 where available1 for the purposes of this paragraph4 7f7 ,participation ,as a condition of maintaining their certification under section #cjja7;c77#e77;,d71 a developer of certified health information technology shall report on the criteria developed under subsection 7b7 for all such certified technology offered by such developer pursuant to the timeframe established under subsection 7d74 7g7 ,rating body 7#a7 ,in general ,the ,national ,coordinator shall recognize an independent entity with appropriate expertise to carry out the rating program established by the development council under subsection 7a7 and shall redetermine such recognition at least every #d years4 7#b7 ,consultation ,the entity recognized under paragraph 7#a7 may consult with organizations with expertise in the measurement of interoperability1 usability1 and security of health information technology in carrying out activities under this section4 7h7 ,one star rating ,each health information technology developer1 or entity offering health information technology for certification1 that receives a #a star rating shall take action1 through an improvement plan developed with the rating body and approved by the ,secretary1 to improve the health information technology rating within a timeframe that the ,secretary determines appropriate4 7i7 ,decertification 7#a7 ,mandatory ,the ,secretary shall decertify health information technology if the developer or entity offering health information technology does not submit reporting criteria in accordance with subsection 7f7 within #ij days of the timeline established under subsection 7d74 7#b7 ,other decertification ,the ,secretary may decertify health information technology if-- 7,a7 the health information technology does not improve from a one star rating within the timeframe established under subsection 7h72 or 7,b7 in other circumstances1 as the ,secretary determines appropriate4 7j7 ,,gao reports ,during the #ab-year period beginning on the date of enactment of the ,improving ,health ,information ,technology ,act1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a report every #d years on the rating scale methodology developed pursuant to subsection 7d71 providing observations on the appropriateness of the current methodology and recommendations for changes to the methodology4 ,the ,development ,council shall recommend to ,congress and the ,secretary if additional reports are needed after the expiration of such #ab-year period4 7k7 ,internet ,website ,on the ,internet website of the ,office of the ,national ,coordinator1 the ,secretary shall publish the criteria and methodology used to determine the star ratings1 and1 for each certified health information technology1 the final star rating1 and a report outlining such technology's performance with regard to the reporting criteria developed under subsection 7b71 and if an improvement plan has been administered4 ,following the reporting described in subsection 7f71 the rating body shall have #cj days to calculate and submit updated ratings to the ,secretary and each developer of health information technology1 and updated ratings shall be published on such ,internet website not later than #cj days following such submission1 notwithstanding an appeal of a rating by a developer or entity through the process developed under subsection 7m74 7l7 ,hardship exemption ,decertification of an adopted health information technology product under subsection 7i7 shall be considered a significant hardship resulting in a blanket exemption from the payment adjustment pursuant to section #ahdh7;a77#g77;,b7 of the ,social ,security ,act for eligible professionals1 section #ahhf7;b77#c77;ix77,,ii7 of such ,act for eligible hospitals1 and #ahad7l77#d77;,c7 of such ,act for critical access hospitals4 7m7 ,notification and ,appeals ,the ,secretary shall establish a process whereby any health information technology developer1 or entity offering health information technology1 is notified not less than #cj days before being made public and can appeal-- 7#a7 the health information technology product's star rating2 or 7#b7 the ,secretary's decision to decertify a product1 as applicable4 4 #d4 ,information blocking ,subtitle ,c of title ,,xxx of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj-#ea et seq47 is amended by adding at the end the following3 #cjbb4 ,information blocking 7a7 ,definition 7#a7 ,in general ,the term information blocking means-- 7,a7 with respect to a health information technology developer1 exchange1 or network1 business1 technical1 or organizational practices that-- 7i7 except as required by law or specified by the ,secretary1 interferes with1 prevents1 or materially discourages access1 exchange1 or use of electronic health information2 and 7ii7 the developer1 exchange1 or network knows1 or should know1 are likely to interfere with or prevent or materially discourage the access1 exchange1 or use of electronic health information2 and 7,b7 with respect to a health care provider1 the person or entity knowingly and unreasonably restricts electronic health information exchange for patient care or other priorities as determined appropriate by the ,secretary4 7#b7 ,rulemaking ,the ,secretary shall1 through rulemaking-- 7,a7 identify reasonable and necessary activities that do not constitute information blocking for purposes of paragraph 7#a77;,a72 and 7,b7 identify actions that meet the definition of information blocking with respect to health care providers for purposes of paragraph 7#a77;,b74 7b7 ,inspector general authority 7#a7 ,in general ,the ,inspector ,general of the ,department of ,health and ,human ,services may investigate any claim that-- 7,a7 a health information technology developer of1 or other entity offering certified health information technology-- 7i7 submits a false attestation made under section #cjja7;c77#e77;,d72 or 7ii7 engaged in information blocking with respect to the use of such health information technology by a health care provider1 unless for a legitimate purpose specified by the ,secretary2 7,b7 a health care provider engaged in information blocking with respect to access or exchange of certified health information technology1 unless for a legitimate purpose specified by the ,secretary2 and 7,c7 a health information network or exchange provider engaged in information blocking with respect to the access1 exchange1 or use of such certified health information technology1 unless for a legitimate purpose specified by the ,secretary4 7#b7 ,jurisdiction of the ,inspector ,general ,for purposes of this section1 the ,office of the ,inspector ,general shall have jurisdiction with respect to exchanges and networks1 as well as any developer or entity offering health information technology for certification under a program or programs kept or recognized by the ,national ,coordinator under section #cjja7;c77#e74 ,the ,national ,coordinator shall notify developers of health information technology as appropriate regarding the jurisdiction of the ,inspector ,general under this paragraph4 7#c7 ,penalty 7,a7 ,developers1 networks1 and exchanges ,with respect to a health information technology developer1 exchange1 or network1 a person or entity determined by the ,inspector ,general to have committed information blocking as described in subparagraph 7,a7 or 7,c7 of paragraph 7#a7 shall be subject to a civil monetary penalty in an amount determined1 through notice-and-comment rulemaking1 by the ,secretary which may take into account factors such as the extent and duration of the information blocking and the number of patients and providers potentially affected4 7,b7 ,providers ,with respect to health care providers1 any person or entity determined by the ,inspector ,general to have committed information blocking as described in subparagraph 7,b7 of paragraph 7#a7 shall be subject to appropriate incentives and disincentives using authorities under applicable ,federal law1 as determined appropriate by the ,secretary through notice and comment rulemaking4 7,c7 ,procedure ,the provisions of section #aabh;,a of the ,social ,security ,act 7other than subsections 7a7 and 7b77 shall apply to a civil money penalty applied under this subsection in the same manner as such provisions apply to a civil money penalty or proceeding under section #aabh;,a7a74 7,d7 ,recovery of funds ,notwithstanding section #ccjb of title #ca1 ,united ,states ,code1 or any other provision of law affecting the crediting of collections1 the ,inspector ,general of the ,department of ,health and ,human ,services may receive and retain for current use any amounts recovered under subparagraphs 7,a7 and 7,c74 ,in addition to amounts otherwise available to the ,inspector ,general1 funds received by the ,inspector ,general under this paragraph shall be deposited1 as an offsetting collection1 to the credit of any appropriation available for purposes of carrying out this subsection and shall be available without fiscal year limitation and without further appropriation4 7#d7 ,resolution of claims 7,a7 ,in general ,the ,office of the ,inspector ,general1 if such ,office determines that a simple consultation regarding the health privacy and security rules promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7#db ,u4,s4,c4 #acbj;d-#b note7 will resolve the claim at issue1 may refer instances of information blocking to the ,office for ,civil ,rights of the ,department of ,health and ,human ,services for resolution4 7,b7 ,limitation on liability ,if a health information technology developer makes information available based on a good faith reliance on consultations with the ,office for ,civil ,rights of the ,department of ,health and ,human ,services with respect to such information1 the developer shall not be liable for such disclosure4 7c7 ,identifying barriers to exchange of certified health information technology 7#a7 ,trusted exchange defined ,in this section1 the term trusted exchange with respect to certified health information technology means that the certified health information technology has the technical capability to enable secure health information exchange between users and multiple certified health information technology systems4 7#b7 ,guidance ,the ,national ,coordinator1 in consultation with the ,office for ,civil ,rights of the ,department of ,health and ,human ,services1 shall issue guidance on common legal1 governance1 and security barriers that prevent the trusted exchange of electronic health information4 7#c7 ,referral ,the ,national ,coordinator and the ,office for ,civil ,rights of the ,department of ,health and ,human ,services may refer to the ,inspector ,general instances or patterns of refusal to exchange health information with an individual or entity using certified health information technology that is technically capable of trusted exchange and under conditions when exchange is legally permissible4 7#d7 ,,hit standards committee consideration ,not later than #a year after the date of enactment of the ,improving ,health ,information ,technology ,act1 the ,,hit ,standards ,committee shall begin consideration of issues related to trusted exchange4 4 #e4 ,interoperability 7a7 ,definition ,section #cjjj of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj7 is amended-- 7#a7 by redesignating paragraphs 7#aj7 through 7#ad71 as paragraphs 7#aa7 through 7#ae71 respectively2 and 7#b7 by inserting after paragraph 7#i7 the following3 7#aj7 ,interoperability ,the term interoperability with respect to health information technology means such health information technology that has the ability to securely exchange electronic health information with and use electronic health information from other health information technology without special effort on the part of the user4 4 7b7 ,support for interoperable network exchange ,section #cjja7;c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj-#aa7;c77 is amended by adding at the end the following3 7#i7 ,support for interoperable networks exchange 7,a7 ,in general ,the ,national ,coordinator shall1 in collaboration with the ,national ,institute of ,standards and ,technology and other relevant agencies within the ,department of ,health and ,human ,services1 for the purpose of ensuring full network-to-network exchange of health information1 convene public-private and public-public partnerships to build consensus and develop a trusted exchange framework1 including a common agreement among health information networks nationally4 ,such convention may occur at a frequency determined appropriate by the ,secretary4 7,b7 ,establishing a trusted exchange framework 7i7 ,in general ,not later than six months after the date of enactment of this paragraph1 the ,national ,coordinator shall convene appropriate public and private stakeholders to develop a trusted exchange framework for trust policies and practices and for a common agreement for exchange between health information networks4 ,the common agreement may include-- 7,i7 a common method for authenticating trusted health information network participants2 7,,ii7 a common set of rules for trusted exchange2 7,,iii7 organizational and operational policies to enable the exchange of health information among networks1 including minimum conditions for such exchange to occur2 and 7,,iv7 a process for filing and adjudicating noncompliance with the terms of the common agreement4 7ii7 ,technical assistance ,the ,national ,coordinator1 in conjunction with the ,national ,institute of ,standards and ,technology1 shall provide technical assistance on how to implement the trusted exchange framework and common agreement under this paragraph4 7iii7 ,pilot testing ,the ,national ,coordinator1 in collaboration with the ,national ,institute of ,standards and ,technology1 shall provide for the pilot testing of the trusted exchange framework and common agreement established under this subsection 7as authorized under section #acbja of the ,health ,information ,technology for ,economic and ,clinical ,health ,act74 ,the ,national ,coordinator1 in collaboration with the ,national ,institute of ,standards and ,technology1 may delegate pilot testing activities under this clause to independent entities with appropriate expertise4 7,c7 ,publication of a trusted exchange framework and common agreement ,not later than one year after convening stakeholders under subparagraph 7,a71 the ,national ,coordinator shall publish on its public ,internet website1 and in the ,federal register1 the trusted exchange framework and common agreement developed under subparagraph 7,b74 ,such trusted exchange framework and common agreement shall be published in a manner that protects proprietary and security information1 including trade secrets and any other protected intellectual property4 7,d7 ,directory of participating health information networks 7i7 ,in general ,not later than two years after convening stakeholders under subparagraph 7,a71 and annually thereafter1 the ,national ,coordinator shall publish on its public ,internet website a list of those health information networks that have adopted the common agreement and are capable of trusted exchange pursuant to the common agreement developed under paragraph 7,b74 7ii7 ,process ,the ,secretary shall1 through notice-and-comment rulemaking1 establish a process for health information networks that voluntarily elect to adopt the trusted exchange framework and common agreement to attest to such adoption of the framework and agreement4 7,e7 ,application of the trusted exchange framework and common agreement ,as appropriate1 ,federal agencies contracting or entering into agreements with health information exchange networks may require that as each such network upgrades health information technology or trust and operational practices1 it may adopt1 where available1 the trusted exchange framework and common agreement published under subparagraph 7,c74 7,f7 ,rule of construction 7i7 ,general adoption ,nothing in this paragraph shall be construed to require a health information network to adopt the trusted exchange framework or common agreement4 7ii7 ,adoption when exchange of information is within network ,nothing in this paragraph shall be construed to require a health information network to adopt the trusted exchange framework or common agreement for the exchange of electronic health information between participants of the same network4 7iii7 ,existing frameworks and agreements ,the trusted exchange framework and common agreement published under subparagraph 7,c7 shall take into account existing trusted exchange frameworks and agreements used by health information networks to avoid the disruption of existing exchanges between participants of health information networks4 7iv7 ,application by ,federal agencies ,notwithstanding clauses 7i71 7ii71 and 7iii71 ,federal agencies may require the adoption of the trusted exchange framework and common agreement published under subparagraph 7,c7 for health information exchanges contracting with or entering into agreements pursuant to subparagraph 7,e74 7v7 ,consideration of ongoing work ,in carrying out this paragraph1 the ,secretary shall ensure the consideration of activities carried out by public and private organizations related to exchange between health information exchanges to avoid duplication of efforts4 4 7c7 ,provider digital contact information index 7#a7 ,in general ,not later than #cf months after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall either directly1 or through a partnership with a private entity1 establish a provider digital contact information index to provide digital contact information for health professionals1 health facilities1 and other individuals or organizations4 7#b7 ,use of existing index ,in establishing the initial index under paragraph 7#a71 the ,secretary of ,health and ,human ,services may utilize an existing provider directory to make such digital contact information available4 7#c7 ,contact information ,an index established under this subsection shall ensure that contact information is available at the individual health care provider level and at the health facility or practice level4 7#d7 ,rule of construction 7,a7 ,in general ,the purpose of this subsection is to encourage the exchange of electronic health information by providing the most useful1 reliable1 and comprehensive index of providers possible4 ,in furthering such purpose1 the ,secretary of ,health and ,human ,services shall include all health professionals1 health facilities1 and other individuals or organizations applicable to provide a useful1 reliable1 and comprehensive index for use in the exchange of health information4 7,b7 ,limitation ,in no case shall exclusion from the index of providers be used as a measure to achieve objectives other those described in subparagraph 7,a74 7d7 ,standards development organizations ,section #cjjd of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj-#ad7 is amended by adding at the end the following3 7c7 ,deference to standards development organizations ,in adopting and implementing standards under this section1 the ,secretary shall give deference to standards published by ,standards ,development ,organizations and voluntary consensus-based standards bodies4 4 #f4 ,leveraging health information technology to improve patient care 7a7 ,requirement relating to registries 7#a7 ,in general ,to be certified in accordance with title ,,xxx of the ,public ,health ,service ,act1 health information technology 7as defined by section #cjjj7e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj7#e777 shall be capable of transmitting to1 and where applicable1 receiving and accepting data from registries in accordance with standards recognized by the ,office of the ,national ,coordinator for ,health ,information ,technology1 including clinician-led clinical data registries1 that are also certified to be technically capable of receiving and accepting from1 and where applicable1 transmitting data to certified health information technology in accordance with such standards4 7#b7 ,rule of construction ,nothing in this subsection shall be construed to require the certification of registries beyond the technical capability to exchange data in accordance with applicable endorsed standards4 7b7 ,definition ,for purposes of this ,act 7including amendments made to title ,,xxx of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj et seq4771 the term clinician-led clinical data registry means a clinical data repository-- 7#a7 that is established and operated by a clinician-led or controlled1 tax-exempt 7pursuant to section #eja7;c7 of the ,internal ,revenue ,code of #aihf71 professional society or other similar clinician-led or -controlled organization1 or such organization's controlled affiliate1 devoted to the care of a population defined by a particular disease1 condition1 exposure or therapy2 7#b7 that is designed to collect detailed1 standardized data on an ongoing basis for medical procedures1 services1 or therapies for particular diseases1 conditions1 or exposures2 7#c7 that provides feedback to participants who submit reports to the repository2 7#d7 that meets standards for data quality including-- 7,a7 systematically collecting clinical and other health care data1 using standardized data elements and has procedures in place to verify the completeness and validity of those data2 and 7,b7 being subject to regular data checks or audits to verify completeness and validity2 and 7#e7 that provides ongoing participant training and support4 7c7 ,treatment of health information technology developers with respect to patient safety organizations 7#a7 ,in general ,in applying part ,c of title ,,ix of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bii;b-#ba et seq471 a health information technology developer shall be treated as a provider 7as defined in section #iba of such ,act7 for purposes of reporting and conducting patient safety activities concerning improving clinical care through the use of health information technology that could result in improved patient safety1 health care quality1 or health care outcomes4 7#b7 ,report ,not later than #dh months after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 a report concerning best practices and current trends voluntarily provided1 and without identifying individual providers or disclosing or using protected health information or individually identifiable information1 by ,patient ,safety ,organizations to improve the integration of health information technology into clinical practice4 #g4 ,empowering patients and improving patient access to their electronic health information 7a7 ,use of health information exchanges for patient access ,section #cjji of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj-#ai7 is amended by adding at the end the following3 7c7 ,promoting patient access to electronic health information through health information exchanges 7#a7 ,in general ,the ,national ,coordinator1 in coordination with the ,office for ,civil ,rights of the ,department of ,health and ,human ,services1 shall use existing authorities to encourage partnerships between health information exchange organizations and networks and health care providers1 health plans1 and other appropriate entities to offer patients access to their electronic health information in a single1 longitudinal format that is easy to understand1 secure1 and may update such information automatically4 7#b7 ,education of providers ,the ,national ,coordinator1 in coordination with the ,office for ,civil ,rights of the ,department of ,health and ,human ,services1 shall-- 7,a7 educate health care providers on ways in which to leverage the capabilities of health information exchanges 7or other relevant platforms7 to provide patients with access to their electronic health information2 7,b7 clarify misunderstandings by health care providers about using health information exchanges 7or other relevant platforms7 for patient access to electronic health information2 and 7,c7 to the extent practicable1 educate providers about health information exchanges 7or other relevant platforms7 that employ some or all of the capabilities described in paragraph 7#a74 7#c7 ,requirements ,in carrying out paragraph 7#a71 the ,national ,coordinator1 in coordination with the ,office for ,civil ,rights1 shall issue guidance to health information exchanges related to best practices to ensure that the electronic health information provided to patients is-- 7,a7 private and secure2 7,b7 accurate2 7,c7 verifiable2 and 7,d7 where a patient's authorization to exchange is required by law1 easily exchanged pursuant to such authorization4 7#d7 ,rule of construction ,nothing in this subsection shall be construed to preempt ,state laws applicable to patient consent for the access of information through a ,health ,information ,exchange 7or other relevant platforms7 that provide protections to patients that are greater than the protections otherwise provided for under applicable ,federal law4 7d7 ,efforts ,to promote access to health information ,the ,national ,coordinator and the ,office for ,civil ,rights of the ,department of ,health and ,human ,services shall jointly1 through the development of policies that support dynamic technology solutions1 promote patient access to health information in a manner that would ensure that such information is available in a form convenient for the patient1 in a reasonable manner1 and without burdening the health care provider involved4 7e7 ,accessibility of ,patient ,records 7#a7 ,accessibility and updating of information 7,a7 ,in general ,the ,secretary1 in consultation with the ,national ,coordinator1 shall promote policies that ensure that a patient's electronic health information is accessible to that patient1 and their designees1 in a manner that facilitates communication with the patient's health care providers and such patient's consent1 including with respect to research4 7,b7 ,updating education on accessing and exchanging personal health information ,to promote awareness that an individual has a right of access to inspect1 obtain a copy of1 and transmit to a third party a copy of protected health information pursuant to the ,health ,information ,portability and ,accountability ,act ,privacy ,rule 7#de ,c4,f4,r4 #afd4ebd et seq471 the ,director of the ,office for ,civil ,rights1 in consultation with the ,national ,coordinator1 shall assist individuals and health care providers in understanding a patient's rights to access and protect their personal health information under the ,health ,insurance ,portability and ,accountability ,act of #aiif 7,public ,law #ajd-aia71 including providing best practices for requesting personal health information in a computable format1 including using patient portals or third-party applications and common cases when a provider is permitted to exchange and provide access to health information4 7#b7 ,certifying usability for patients ,in carrying out certification programs under section #cjja7;c77#e71 the ,national ,coordinator shall require1 where applicable1 that such program or programs require the following3 7,a7 ,that certification criteria support patient access to their electronic health information1 including in a single longitudinal format that is easy to understand1 secure1 and may be updated automatically4 7,b7 ,that developers of health information technology support patient access to an electronic health record in a longitudinal format that is easy to understand1 secure1 and may be updated automatically4 7,c7 ,that certification criteria support patient access to their personal electronic health information for research at the option of the patient4 7,d7 ,that certification criteria support patient and health care provider communication1 including-- 7i7 the ability for the patient to electronically communicate patient reported information 7such as family history and medical history72 and 7ii7 the ability for the patient to electronically share patient health information1 at the option of the patient4 7,e7 ,that certified health information technology used for health programs where certified health information technology is required1 include the function for patient access to their own health information1 including-- 7i7 ensuring that1 as a condition of certification1 health care providers have options for making such information accessible for patients2 7ii7 ensuring that patients have options for accessing such information2 and 7iii7 ensuring that patients have access to information regarding their legal rights and responsibilities1 as well the options available to them for accessing their electronic health information4 7,f7 ,that the ,,hit ,standards ,committee develop and prioritize standards1 implementation specifications1 and certification criteria required to help support patient access to electronic health information1 patient usability1 and support for technologies that offer patients access to their electronic health information in a single1 longitudinal format that is easy to understand1 secure1 and may be updated automatically4 4 7b7 ,access to information in an electronic format ,section #acdje7;e7 of the ,health ,information ,technology for ,economic and ,clinical ,health ,act 7#db ,u4,s4,c4 #agice7 is amended-- 7#a7 in paragraph 7#a71 by striking and at the end2 7#b7 by redesignating paragraph 7#b7 as paragraph 7#c72 and 7#c7 by inserting after paragraph 7#a71 the following3 7#b7 if the individual makes a request to a business associate for access to1 or a copy of1 protected health information about the individual1 or if an individual makes a request to a business associate to grant such access to1 or transmit such copy directly to1 a person or entity designated by the individual1 a business associate may provide the individual with such access or copy1 which may be in an electronic form1 or grant or transmit such access or copy to such person or entity designated by the individual2 and 4 #h4 ,,gao study on patient matching 7a7 ,in general ,not later than #a year after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall conduct a study to review the policies and activities of the ,office of the ,national ,coordinator for ,health ,information ,technology and other relevant stakeholders to ensure appropriate patient matching to protect patient privacy and security with respect to electronic health records and the exchange of electronic health information4 7b7 ,areas of concentration ,in conducting the study under subsection 7a71 the ,comptroller ,general shall-- 7#a7 evaluate current methods used in certified electronic health records for patient matching based on performance related to factors such as-- 7,a7 the privacy of patient information2 7,b7 the security of patient information2 7,c7 improving matching rates2 7,d7 reducing matching errors2 and 7,e7 reducing duplicate records2 and 7#b7 determine whether the ,office of the ,national ,coordinator for ,health ,information ,technology could improve patient matching by taking steps including-- 7,a7 defining additional data elements to assist in patient data matching2 7,b7 agreeing on a required minimum set of elements that need to be collected and exchanged2 7,c7 requiring electronic health records to have the ability to make certain fields required and use specific standards2 or 7,d7 other options recommended by the relevant stakeholders consulted pursuant to subsection 7a74 7c7 ,report ,not later than #b years after the date of enactment of this ,act1 the ,comptroller ,general shall submit to the appropriate committees of ,congress a report concerning the findings of the study conducted under subsection 7a74