Sec. 3001. Ensuring interoperability of health information technology

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A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

Subtitle A of title XXX of the Public Health Service Act ( 42 U.S.C. 300jj–11 et seq. ) is amended by adding at the end the following new section: In order for health information technology to be considered interoperable, such technology must satisfy the following criteria: The technology allows the secure transfer of all electronically accessible health information to and from any and all health information technology for authorized use under applicable State or Federal law.

The technology allows for complete access, exchange, and use of all electronically accessible health information for authorized use under applicable State or Federal law without special effort by the requestor of such health information. The technology is not configured, set up, or implemented to information block, as defined in section 3010A(d). The categories described in this subsection, with respect to standards and the corresponding implementation specifications for determining if health information technology is interoperable, consistent with the criteria described in subsection (a), include at least categories of standards and implementation specifications with respect to the following:

Vocabulary and terminology. Content and structure. Transport. Security. Services. Querying and requesting health information for access, exchange, and use. A standard and implementation specification, with respect to such standard, that is determined under section 3001(c)(5)(D) to be compatible with baseline standards and implementation specifications (as defined in clause

(ii)of such section) shall be treated as in compliance with this section. . Not later than January 1, 2017, the Secretary of Health and Human Services, in consultation with the National Coordinator of the Office of the National Coordinator for Health Information Technology, shall issue guidance with respect to the implementation of section 3010 of the Public Health Service Act, as added by paragraph (1), including with respect to defining and providing examples of authorized use under applicable State or Federal law of health information. Section 3002 of the Public Health Service Act ( 42 U.S.C. 300jj–12 ) is amended— in subsection (a)— by striking National Coordinator and inserting Secretary, in consultation with the National Coordinator, ; and by adding at the end the following new sentence: The HIT Policy Committee is authorized only to provide policy and priority recommendations to the Secretary and not authorized to otherwise affect the development or modification of any standard, implementation specification, or certification criterion under this title. ; and in subsection (b)(2)— in subparagraph (A), in the first sentence— by striking The HIT Policy Committee and inserting Subject to subparagraph (D), the HIT Policy Committee ; and by inserting (including the areas in which modifications and additions to interoperability standards and implementation specifications, with respect to such interoperability standards, under section 3010 are needed for the electronic access, exchange, and use of health information for purposes of adoption of such modifications and additions under section 3004) after section 3004 . by adding at the end the following new subparagraph: Any recommendation made by the HIT Policy Committee on or after the date of the enactment of this subparagraph with respect to interoperability of health information technology shall be consistent with the criteria described in subsection

(a)of section 3010. . Section 3003 of the Public Health Service Act ( 42 U.S.C. 300jj–13 ) is amended by adding at the end the following new subsection: The HIT Standards Committee shall terminate on the date that is 90 days after the date of the enactment of this subsection. . Title XXX of the Public Health Service Act is amended by inserting after section 3003 the following new section: For purposes of activities conducted under this title, the Secretary shall enter into one or more contracts with health care standards development organizations accredited by the American National Standards Institute (or with the American National Standards Institute) to carry out, directly or through contracts with subcontractors, the duties described in subsection (b), as applicable. As soon as practicable after the date of the enactment of this section, the Secretary shall enter into the first contracts under paragraph (1). Each contract under paragraph

(1)shall be for a period determined necessary by the Secretary, in consultation with the National Coordinator, to carry out the applicable duties described in subsection (b). The Secretary shall ensure the most appropriate entities described in paragraph

(1)are selected for each contract under such paragraph. The Secretary shall initially enter into one or more contracts under subsection (a)(1) with entities described in such subsection, under which the entities— shall recommend to the Secretary— for adoption under section 3004, an initial set of interoperability standards and implementation specifications, with respect to such standards, identified or, as appropriate, developed by such entities that are consistent with the criteria described in subsection

(a)of section 3010, and with respect to the categories described in subsection

(b)of such section; and as applicable, for purposes of section 3001(c)(5)(D), methods to test if health information technology is compatible with health information technology that applies baseline standards and implementation specifications (as defined in clause

(ii)of such section); and may provide to the Secretary recommendations described in paragraph (2). Under each subsequent contract entered into under this section with entities described in subsection (a)(1) pursuant to subsection (c), the entities shall recommend to the Secretary— for adoption under section 3004 any standards (including interoperability standards), implementation specifications, and, to the extent necessary, certification criteria (and modifications, including additions, to such standards, specifications, and, to the extent necessary, criteria), which are in accordance with the criteria described in section 3010; and as applicable, for purposes of section 3001(c)(5)(D), methods to test if health information technology is compatible with baseline standards and implementation specifications (as defined in clause

(ii)of such section). Under each contract with an entity under this section, the entity shall submit to the Director of the National Institute of Standards and Technology each recommendation submitted to the Secretary by such entity under this section. For the purposes of developing methods to test interoperability standards and implementation specifications with respect to such standards, the entities with a contract under this section may consult with the Director of the National Institute of Standards and Technology. The Secretary, in consultation with the National Coordinator, shall periodically conduct hearings to evaluate and review the standards, implementation specifications, and certification criteria adopted under section 3004 for purposes of determining if modifications, including any additions, are needed with respect to such standards, specifications, and criteria. Based on the needs for standards, implementation specifications, and certification criteria (and modifications, including additions, to such standards, specifications, and criteria) under this title, as determined by the Secretary, with due consideration to section 3010(b) and in consultation with the National Coordinator, the Secretary shall, as needed, enter into contracts under subsection

(a)to carry out the duties described in subsection (b)(2) in addition to any contract entered into to carry out the duties described in subsection (b)(1). There is authorized to be appropriated $10,000,000 for contracts under subsection (a), to remain available until expended. . Section 3001(c)(1)(A) of the Public Health Service Act ( 42 U.S.C. 300jj–11(c)(1)(A) ) is amended by inserting for recommendations made before the date of the enactment of the 21st Century Cures Act, before review and determine . Section 3004 of the Public Health Service Act ( 42 U.S.C. 300jj–14 ) is amended— in subsection (a)— in paragraph (1), by inserting after section 3001(c) the following: (or, subject to subsection (c), in the case of a standard, implementation specification, or criterion recommended on or after the date of the enactment of the 21st Century Cures Act, after the date of submission of the recommendation to the Secretary under section 3003A) ; and in paragraph (2)(B), by striking and the HIT Standards Committee ; in subsection (b)— in paragraph (3), by striking with the schedule published under section 3003(b)(2) and inserting with subsection

(d); and by adding at the end the following new paragraph: The Secretary may not adopt any policies, priorities, standards, implementation specifications, or certification criteria under this subsection or subsection

(a)that are inconsistent with or duplicative of an interoperability standard or implementation specification with respect to such standard adopted under this section, in accordance with subsections

(c)and (d). In the case of a standard, specification, or criterion that has been adopted under this section and is inconsistent or duplicative of such an interoperability standard or specification that is subsequently adopted under this section, such interoperability standard or specification shall supercede such other standard, specification, or criterion and such other standard, specification, or criterion shall no longer be considered adopted under this section beginning on the date that such interoperability standard or specification becomes effective. ; and by adding at the end the following new subsections: Notwithstanding the previous subsections of this section, the following shall apply in the case of the initial set of interoperability standards and implementation specifications with respect to such standards recommended under section 3003A: Not later than 90 days after the date of receipt of recommendations for such interoperability standards and implementation specifications, the Secretary, in consultation with the National Coordinator and representatives of other relevant Federal agencies, such as the National Institute of Standards and Technology, shall jointly review such standards and implementation specifications and shall determine whether or not to propose adoption of such standards and implementation specifications. If, subject to subsection (d)(3), the Secretary determines— to propose adoption of such standards and implementation specifications, the Secretary shall, by regulation under section 553 of title 5, United States Code, determine whether or not to adopt such standards and implementation specifications; or not to propose adoption of such standards and implementation specifications, the Secretary shall notify the applicable entity with a contract under section 3003A in writing of such determination and the reasons for not proposing the adoption of the recommendation for such standards and implementation specifications. The Secretary shall provide for publication in the Federal Register of all determinations made by the Secretary under paragraph (1). In the case of a standard (including interoperability standard), implementation specification, or certification criterion adopted under this section on or after the date of the enactment of the 21st Century Cures Act, the following shall apply: Except as provided in paragraphs

(2)and (3), any such standard (including interoperability standard), implementation specification, or certification criterion shall be a standard, specification, or criterion that has been recommended by the entities with which the Secretary has entered into a contract under section 3003A. If no standard, implementation specification, or, to the extent necessary, certification criterion is recommended under paragraph (1)— in the case of interoperability standards and implementation specifications with respect to such standards, relating to a category described in section 3010(b)— paragraph

(1)shall not apply; and paragraph

(4)shall apply; or in the case of any other standard, implementation specification, or, to the extent necessary, certification criterion, relating to a policy or priority to carry out this title, as determined by the Secretary, in consultation with the National Coordinator— paragraph

(1)shall not apply; and paragraph

(4)shall apply. If, following public comment pursuant to subsection (c), the Secretary would propose adoption of interoperability standards recommended under section 3003A but for the implementation specifications, with respect to such standards, so recommended, the Secretary may modify such implementation specifications and adopt such standards and specifications in accordance with subsection (c)(2). In the case of a standard, implementation specification, or certification criterion for which there is a determination to adopt such standard, implementation specification, or certification criterion, such standard, implementation specification, or certification criterion shall be considered adopted under this section and shall be effective beginning on the date that is 12 months after the date of publication of the final rule to adopt such standard, implementation specification, or certification criterion. In complying with the requirements of this subsection, the Secretary shall give due consideration to any recommendations of the National Committee on Vital and Health Statistics established under section 306(k), and shall consult with appropriate Federal and State agencies and private organizations. The Secretary shall publish in the Federal Register any recommendation of the National Committee on Vital and Health Statistics regarding the adoption of a standard, implementation specification, or certification criterion under this section. Any standard, implementation specification, or certification criterion adopted pursuant to this paragraph shall be promulgated in accordance with the rulemaking procedures of subchapter III of chapter 5 of title 5, United States Code. For purposes of this title, title XVIII of the Social Security Act, title XIX of such Act, and any other provision of law, a standard and implementation specification, with respect to such standard, that is determined under section 3001(c)(5)(D) to be compatible with baseline standards and implementation specifications (as defined in clause

(ii)of such section) shall be treated as if such standard and specification were an interoperability standard and implementation specification, with respect to such interoperability standard, adopted under this section. . Section 3010 of the Public Health Service Act, as added by subsection (a), is amended by adding at the end the following new subsection: Not later than July 1, 2017, the Secretary, after consultation with relevant stakeholders, shall submit to Congress and provide for publication in the Federal Register and the posting on the Internet website of the Office of the National Coordinator for Health Information Technology a report on the following: The initial set of interoperability standards and implementation specifications adopted under section 3004(c). The strategies for achieving widespread interoperability. Any barriers that are preventing widespread interoperability. The plan and milestones, including specific steps, to achieve widespread interoperability. The Secretary shall provide for publication in the Federal Register, and the posting on the Internet website of the Office of the National Coordinator for Health Information Technology, of all recommendations made under this section. . Section 3007(b) of the Public Health Service Act ( 42 U.S.C. 300jj–17(b) ) is amended by striking under section 3001(c)(3) to be in compliance with and all that follows through the period at the end and inserting under section 3001(c)(3)— for certifications made before January 1, 2018, to be in compliance with applicable standards adopted under subsections

(a)and

(b)of section 3004; and for certifications made on or after January 1, 2018, to be in compliance with applicable standards adopted under subsections

(a)and

(b)of section 3004 and to be interoperable in accordance with section 3010 and in compliance with interoperability standards adopted under section 3004. . Section 3001(c)(5) of the Public Health Service Act ( 42 U.S.C. 300jj–11(c)(5) ) is amended— in subparagraph (B), by inserting before the period at the end the following: and, for certifications made on or after January 1, 2018, with respect to health information technology, additional criteria to establish that the technology is interoperable, in accordance with section 3010, and in compliance with interoperability standards and implementation specifications, with respect to such standards, adopted under section 3004 ; and by adding at the end the following new subparagraphs: Under any program kept or recognized under subparagraph (A), the Secretary shall ensure that any vendor of or other entity offering to health care providers (as defined in section 3010A(g)) qualified electronic health records seeking a certification of such records under such program on or after January 1, 2018, shall, as a condition of certification (and maintenance of certification) of such a record under such program— provide to the Secretary an attestation— the entity has implemented interoperability standards and implementation specifications, with respect to such standards, adopted under section 3004 (including through application of subsection

(e)of such section); that the entity, unless for a legitimate purpose specified by the Secretary, has not taken and will not take any action that constitutes information blocking (as defined in section 3010A(d)), with respect to such qualified electronic health records; that includes the pricing information described in clause

(iii)for purposes of inclusion under subsection

(f)of such information on the Internet website of the Department of Health and Human Services; that such information will be available on a public Internet website of such entity; and that the entity will voluntarily provide such information to customers prior to offering any qualified electronic health records or related product or service (including subsequent updates, add-ons, or additional products or services to be provided during the course of an on-going contract), prospective customers (such as persons who request or receive a quotation or estimate), and other persons who request such information; that the technology with respect to such records has published application programming interfaces, with respect to health information within such records, for search and indexing, semantic harmonization and vocabulary translation, and user interface applications; that the entity has successfully and rigorously tested the real world use of the record in the type of setting in which it would be marketed; and that the entity has in place data sharing programs or capabilities based on common data elements through such mechanisms as application programming interfaces without the requirement for vendor-specific interfaces; publish application programming interfaces and associated documentation, with respect to health information within such records, for search and indexing, semantic harmonization and vocabulary translation, and user interface applications; and demonstrate to the satisfaction of the Secretary that health information from such records are able to be exchanged, accessed, and used through the use of application programming interfaces without special effort, as authorized under applicable law. Under any program kept or recognized under subparagraph (A), the Secretary shall ensure that beginning January 1, 2019, any qualified electronic health records that do not satisfy the certification criteria described in subparagraph

(B)or with respect to which the vendor or other entity described in clause

(i)does not satisfy the requirements under such clause (or is determined to be in violation of the terms of the attestation or other requirements under such clause) shall no longer be considered as certified under such program. For purposes of clause (i)(I)(cc), the pricing information described in this clause, with respect to a vendor of or other entity offering a qualified electronic health record, is the following: Additional types of costs or fees (whether fixed, recurring, transaction based, or otherwise) imposed by the entity (or any third-party from whom the entity purchases, licenses, or obtains any technology, products, or services in connection with the qualified electronic health record) to purchase, license, implement, maintain, upgrade, use, or otherwise enable and support the use of capabilities to which such record is to be certified under this section; or in connection with any health information generated in the course of using any capability to which the record is to be so certified. Limitations, whether by contract or otherwise, on the use of any capability to which the record is to be certified under this section for any purpose within the scope of the record’s certification; or in connection with any health information generated in the course of using any capability to which the record is to be certified under this section. Limitations, including technical or practical limitations of technology or its capabilities, that could prevent or impair the successful implementation, configuration, customization, maintenance, support, or use of any capabilities to which the record is to be certified under this section; or that could prevent or limit the access, use, exchange, or portability of any health information generated in the course of using any capability to which the record is to be so certified. Under any program kept or recognized under subparagraph (A), the Secretary shall provide for a method and process by which a vendor of or other entity offering to health care providers (as defined in section 3010A(g)) qualified electronic health records seeking a certification of such records under such program on or after January 1, 2018, may demonstrate, using such mechanisms as a reference implementation model or other means, that the standards and implementation specifications applied by such entity with respect to such records are compatible with baseline standards and implementation specifications, including by demonstrating such records are able to transmit information that is compatible with qualified electronic health records that would receive such information and that apply the baseline standards and implementation specifications. Such a method and process shall ensure that any such entity using a standard or implementation specification other than a baseline standard or implementation specification demonstrates, through testing, compatibility with the baseline standard and implementation specification with respect to receiving information. For purposes of clause (i), the term baseline standards and implementation specifications means the interoperability standards and implementation specifications, with respect to such standards, adopted under section 3004 (without application of subsection

(e)of such section). . Subtitle A of title XXX of the Public Health Service Act ( 42 U.S.C. 300jj–11 et seq. ), as amended by subsections (a)(1) and (d), is further amended by adding at the end the following new section: The Inspector General of the Department of Health and Human Services shall have the authority to investigate claims of— vendors of, or other entities offering to health care providers (as defined in subsection (g)), qualified electronic health records (as defined in section 3000(13)) being in violation of an attestation (whether providing false information at the time of such attestation or by act or practice conducted after such attestation) made under section 3001(c)(5)(C)(i)(I), with respect to the use of such records by a health care provider with respect to items and services furnished under the Medicare Program under title XVIII of the Social Security Act or Medicaid program under title XIX of such Act; and vendors of, or other entities offering to health care providers (as defined in subsection (g)), health information technology having engaged in information blocking (as defined in subsection (d)), unless for a legitimate purpose specified by the Secretary, with respect to the use of such technology by a health care provider with respect to items and services furnished under such a program; health care providers having engaged in information blocking (as so defined), with respect to the use of health information technology with respect to items and services furnished under such a program, unless for a legitimate purpose specified by the Secretary; and health information system providers (such as operators of health information exchanges, clinical data registries, and other systems that facilitate the exchange of information) having engaged in information blocking (as so defined), unless for a legitimate purpose specified by the Secretary, with respect to the use of health information technology with respect to items and services furnished under such a program. The National Coordinator may serve as a technical consultant to the Inspector General of the Department of Health and Human Services and the Federal Trade Commission for purposes of carrying out this section. As such technical consultant, the National Coordinator may, notwithstanding any other provision of law, share information related to claims or investigations under subsection

(a)with the Federal Trade Commission for purposes of such investigations and shall share information with the Inspector General, as required by law. Any information that is received by the National Coordinator in connection with a claim or suggestion of possible information blocking and that could reasonably be expected to facilitate identification of the source of the information— shall not be disclosed by the National Coordinator except as may be necessary to carry out the purpose of this section; and shall be exempt from mandatory disclosure under section 552 of title 5, United States Code, as provided by subsection (b)(3) of such section. Such information may be used by the Inspector General of the Department of Health and Human Services or Federal Trade Commission for reporting purposes to the extent that such information could not reasonably be expected to facilitate identification of the source of such information. Chapter 35 of title 44, United States Code (commonly referred to as the Paperwork Reduction Act of 1995) shall not apply to the National Coordinator or to the Office of the National Coordinator for Health Information Technology with respect to the collection of complaints relating to claims described in subsection (a). The National Coordinator shall implement a standardized process for the public to submit reports on claims of— health information technology products of vendors (or other entities offering such products to health care providers (as defined in subsection (g))) not being interoperable or resulting in information blocking; or actions by such entities, health care providers, or health information system providers that result in such technology not being interoperable or in information blocking with respect to such technology; and any other act described in subsection (a). The standardized process shall provide for the collection of such information as the originating institution, location, type of transaction, system and version, timestamp, terminating institution, locations, system and version, failure notice, and other related information. Any person or entity described in paragraph (1), (2), or

(3)of subsection

(a)determined to have committed on or after January 1, 2018, an act described in such respective paragraph with respect to the use of a qualified electronic health record or health information technology, as applicable under such respective paragraph, with respect to items and services furnished under the Medicare Program under title XVIII of the Social Security Act or the Medicaid program under title XIX of such Act, shall be subject to a civil monetary penalty in such amount as determined appropriate by the Secretary through rulemaking. Subject to paragraph (3), the provisions of section 1128A (other than subsections

(a)and (b)) of such Act ( 42 U.S.C. 1320a–7a ) shall apply to a civil money penalty applied under this subsection in the same manner as they apply to a civil money penalty or proceeding under subsection

(a)of such section 1128A. Notwithstanding section 3302 of title 31, United States Code, or any other provision of law affecting the crediting of collections, the Inspector General of the Department of Health and Human Services may receive and retain for current use any amounts recovered under this subsection. In addition to amounts otherwise available to the Inspector General, funds received by the Inspector General under this paragraph shall be deposited, as an offsetting collection, to the credit of any appropriation available for purposes of carrying out this subsection and subsection

(a)and shall be available without fiscal year limitation and without further appropriation. For purposes of this section and section 3010, subject to paragraph (3), the term information blocking means, with respect to the access, use, and exchange of qualified electronic health records and other health information technology, business, technical, and organizational practices, including practices described in paragraph (2), that— prevent or materially discourage the access, exchange, or use of electronic health information; and the actor knows or should know (as defined in section 1128A(i)(7) of the Social Security Act) are likely to interfere with the access, exchange, or use of electronic health information. For purposes of paragraph (1), the practices described in this paragraph shall include the following: Contract terms, policies, or business or organizational practices that restrict authorized use under applicable State or Federal law of electronic health information or restrict the authorized exchange under applicable State or Federal law of such information for treatment and other permitted purposes under such applicable law, including transitions between certified EHR technologies. Charging unreasonable prices or fees (such as for health information exchange, portability, interfaces, and full export of health information) that make accessing, exchanging, or using electronic health information cost prohibitive. Developing or implementing health information technology in nonstandard ways that are likely to substantially increase the costs, complexity, or burden of sharing electronic health information, especially in cases in which relevant interoperability standards or methods to measure interoperability have been adopted by the Secretary. Developing or implementing health information technology in ways that are likely to lock in users or electronic health information, such as not allowing for the full export of health information; lead to fraud, waste, or abuse; or impede innovations and advancements in health information access, exchange, and use, including health information technology-enabled care delivery. The term information blocking shall not include practices that— are required by applicable law; or that the Secretary, through regulation, identifies as necessary to protect patient safety, to maintain the privacy or security of individuals’ health information, or to promote competition and consumer welfare. For purposes of subparagraph (A)(ii), not later than 12 months after the date of the enactment of this section, the Secretary shall issue regulations following the notice and comment procedures of section 553 of title 5, United States Code, except that the Secretary may issue the first such regulation as an interim final regulation. The term information blocking shall not include any practice or conduct occurring before the date that is 30 days after the date on which the first regulation (as described in subparagraph (B)) is issued under such subparagraph. To the extent that regulations issued under this paragraph define practices that are necessary to promote competition and consumer welfare, the Secretary may consult with the Federal Trade Commission in issuing such regulations. The term information blocking , with respect to an individual or entity, shall not include an act or practice other than an act or practice committed by such individual or entity. In applying part C of title IX— vendors shall be treated as a provider (as defined in section 921) for purposes of reporting requirements under such part, to the extent that such reports are related to attestation requirements under section 3001(c)(5)(C)(i)(I); claims of information blocking described in subsection

(a)shall be treated as a patient safety activity under such part for purposes of reporting requirements under such part; and health care providers that are not members of patient safety organizations shall be treated in the same manner as health care providers that are such members for purposes of such reporting requirements with respect to claims of information blocking described in subsection (a). Not later than 12 months after the date of the enactment of this section, the Secretary, in consultation with the National Coordinator and the Inspector General of the Department of Health and Human Services, shall, through rulemaking, implement the provisions of section 3001 of the 21st Century Cures Act, including amendments made by such section, relating to information blocking. In carrying out paragraph (1), in determining the scope of penalties, assessments, or exclusions under such section 3001, including amendments made by such section, relating to information blocking, the Secretary shall ensure to the extent possible that such penalties, assessments, and exclusions do not duplicate penalty, assessment, and exclusion structures that would otherwise apply with respect to information blocking and the type of individual or entity involved as of the day before the date of the enactment of this section. In carrying out paragraph (1), the Secretary shall ensure that health care providers are not penalized for actions of vendor of, and other entities offering to such providers, health information technology for the failure of such technology to meet requirements for such technology to be certified under this title. Not later than January 1, 2017, the National Coordinator shall publish guidance to clarify the relationship of the provisions of the HIPAA privacy and security law, as defined in section 3009(a)(2) to information blocking, including— examples of how such provisions may result in information blocking; and clarifying that a health care provider (as defined in subsection (g)) who discloses health information as allowed under applicable State and Federal law is not liable for unlawful actions, including breaches that occur in the custody of the recipient unless the disclosure proximately cause the breach. For purposes of this section, the term health care provider means a provider of services under subsection

(u)of section 1861 of the Social Security Act and a supplier under subsection

(d)of such section. In addition to amounts made available under subsection (c)(3), there is authorized to be appropriated $10,000,000 for fiscal year 2017 to carry out subsection (a), to remain available until expended. . Section 3001 of the Public Health Service Act ( 42 U.S.C. 300jj–11 ) is amended by adding at the end the following new subsection: Not later than January 1, 2019, the National Coordinator shall post the information described in subsection (c)(5)(C)(I)(i)(cc) on the public Internet website of the Office of the National Coordinator for Health Information Technology in a manner that allows for comparison of functionality, price information, and other features among health information technology products that aids in making informed decisions for purchasing such a product. For 2019 and each subsequent year, the Secretary shall post on the public Internet website of the Department of Health and Human Services a list of any qualified electronic health records with respect to which certification has been withdrawn under subsection (c)(5)(C)(ii) during such year and the vendor of or other entity offering to health care providers (as defined in section 3010A(g)) such qualified electronic health records. The Secretary shall periodically review and confirm that vendors of and other entities offering to health care providers (as defined in section 3010A(g)) qualified electronic health records have publicly published application programming interfaces and associated documentation as required by subsection (c)(5)(C)(i)(II) for purposes of certification and maintaining certification under any program kept or recognized under subsection (c)(5)(A). . Section 1848(o)(2)(A) of the Social Security Act ( 42 U.S.C. 1395w–4(o)(2)(A) ) is amended by inserting after clause

(iii)the following new clause: With respect to EHR reporting periods for payment years beginning with 2020, the eligible professional demonstrates to the satisfaction of the Secretary, in accordance with subparagraph (C)(i), that during such period the professional has not taken any action described in subsection (a)(2) of section 3010A of the Public Health Service Act, with respect to the use of any certified EHR technology. . Subparagraph

(B)of section 1848(a)(7) of the Social Security Act ( 42 U.S.C. 1395w–4(a)(7) ) is amended to read as follows: The Secretary may, on a case-by-case basis, exempt an eligible professional from the application of the payment adjustment under subparagraph

(A)if the Secretary determines, subject to annual renewal, that compliance with the requirement for being a meaningful EHR user would result in a significant hardship, such as in the case of an eligible professional who practices in a rural area without sufficient Internet access. The Secretary shall exempt an eligible professional from the application of the payment adjustment under subparagraph

(A)if the Secretary determines that such professional was determined to not be a meaningful EHR user because the certified EHR technology used by such professional is decertified under section 3001(c)(5)(C) of the Public Health Service Act. An exemption under the previous sentence may be applied to an eligible professional only, subject to clause (iii), during the first payment year with respect to the first EHR reporting period to which such decertification applies. Notwithstanding clause (iv)(I), in no case shall an exemption by reason of clause

(ii)be for a period of less than 12 months. An exemption under clause

(ii)may be extended, on a case-by-case basis, for a period of an additional 12 months subject to the limitation described in clause (iv)(I). Subject to subclause (II), in no case may an eligible professional be granted an exemption under this subparagraph for more than 5 years. Subclause

(I)shall not apply to an exemption by reason of clause

(ii)to the extent necessary to satisfy clause (iii)(I). . Section 1848(o)(2) of the Social Security Act ( 42 U.S.C. 1395w–4(o)(2) ) is amended by adding at the end the following new subparagraph: In the case of certified EHR technology used by an eligible professional that is decertified under section 3001(c)(5)(C), during the first payment year with respect to the first EHR reporting period to which such decertification applies, the Secretary shall not treat the professional as not being a meaningful EHR user solely because the technology used by such professional was so decertified. The treatment of a professional under the previous sentence shall be for a period of at least 12 months and may, on a case-by-case basis, be for a period of an additional 12 months. . Section 1886(n)(3)(A) of the Social Security Act ( 42 U.S.C. 1395ww(n)(3)(A) ) is amended by inserting after clause

(iii)the following new clause: With respect to EHR reporting periods for payment years beginning with 2020, the hospital demonstrates to the satisfaction of the Secretary, in accordance with subparagraph (C)(i), that during such period the hospital has not taken any action described in subsection (a)(2) of section 3010A of the Public Health Service Act, with respect to the use of any certified EHR technology. . Subclause

(II)of section 1886(b)(3)(B)(ix) of the Social Security Act ( 42 U.S.C. 1395ww(b)(3)(B)(ix) ) is amended to read as follows: The Secretary may, on a case-by-case basis, exempt a subsection

(d)hospital from the application of subclause

(I)with respect to a fiscal year if the Secretary determines, subject to annual renewal, that requiring such hospital to be a meaningful EHR user during such fiscal year would result in a significant hardship, such as in the case of a hospital in a rural area without sufficient Internet access. The Secretary shall exempt a subsection

(d)hospital from the application of subclause

(I)with respect to a fiscal year if the Secretary determines that such hospital was determined to not be a meaningful EHR user because the certified EHR technology used by such hospital is decertified under section 3001(c)(5)(C) of the Public Health Service Act. An exemption under the previous sentence may be applied to a subsection

(d)hospital only, subject to items

(cc)and (dd), during the first payment year with respect to the first EHR reporting period to which such decertification applies. Notwithstanding item (ee), in no case shall an exemption by reason of item

(bb)be for a period of less than 12 months. An exemption under item

(bb)may, on a case-by-case basis, be extended for a period of an additional 12 months subject to the limitation described in item (ee). Subject to item (ff), in no case may a hospital be granted an exemption under this subclause for more than 5 years. Item

(ee)shall not apply to an exemption by reason of item

(bb)to the extent necessary to satisfy item (cc). . Section 1903(t)(2) of the Social Security Act ( 42 U.S.C. 1396b(t)(2) ) is amended by adding at the end the following: An eligible professional shall not qualify as a Medicaid provider under this subsection, with respect to a year beginning with 2020, unless such provider demonstrates to the Secretary, through means such as an attestation, that the provider has not taken any action described in subsection (a)(2) of section 3010A of the Public Health Service Act, with respect to the use of any certified EHR technology. . Not later than January 1, 2018, the Secretary of Health and Human Services shall issue guidance to further the voluntary transition of health care providers between different certified EHR technology (as defined in section 3000(1) of the Public Health Service Act ( 42 U.S.C. 300jj(1) ) by removing disincentives to such transition, which may include applying to instances of such a transition the hardship exemption authority under section 1848(a)(7) of the Social Security Act ( 42 U.S.C. 1395w–4(a)(7) ), section 1886(b)(3)(B)(ix) of such Act ( 42 U.S.C. 1395ww(b)(3)(B)(ix) ), and other provisions of law in existence as of the date of the enactment of this Act. In developing such guidance, the Secretary may consult with the relevant Federal agencies. Paragraph

(1)of section 3000 of the Public Health Service Act ( 42 U.S.C. 300jj ) is amended to read as follows: The term certified EHR technology means a qualified electronic health record that is certified pursuant to section 3001(c)(5) as meeting the certification criteria defined in subparagraph

(B)of such section that are applicable to the type of record involved (as determined by the Secretary, such as an ambulatory electronic health record for office-based physicians or an inpatient hospital electronic health record for hospitals) including, beginning January 1, 2018, with respect to which the vendor or other entity offering such technology is in compliance with the requirements under section 3001(c)(5)(C)(i). . Section 3000 of the Public Health Service Act ( 42 U.S.C. 300jj ) is amended by adding at the end the following new paragraph: The term widespread interoperability means that, on a nationwide basis— health information technology is interoperable, in accordance with section 3010; and such technology is employed by meaningful EHR users under the Medicare Program under title XVIII of the Social Security Act and the Medicaid program under title XIX of such Act and by other clinicians and health care providers. . Section 3006 of the Public Health Service Act ( 42 U.S.C. 300jj–16 ) is amended— in subsection (a)(1), by inserting , including an interoperability standard or implementation specification, with respect to such interoperability standard, adopted under such section after section 3004 . in subsection (b), by inserting , including the interoperability standards and implementation specifications, with respect to such interoperability standards, adopted under such section after section 3004 . Section 3009(a)(2)(A) of the Public Health Service Act ( 42 U.S.C. 300jj–19(a)(2)(A) ) is amended by striking title IV and inserting title XIII . Section 13111 of the HITECH Act is amended— in subsection (a), by inserting before the period at the end the following: (and, beginning on January 1, 2018, that are also interoperable under section 3010 of such Act and in compliance with interoperability standards and implementation specifications, with respect to such interoperability standards, adopted under section 3004 of such Act ) ; and in subsection (b), by inserting (and, beginning on January 1, 2018, including an interoperability standard or implementation specification, with respect to such interoperability standard, adopted under section 3004 of such Act) before the President . Section 13112 of the HITECH Act is amended by inserting before the period at the end the following: (and, beginning on January 1, 2018, that are also interoperable under section 3010 of such Act and in compliance with interoperability standards and implementation specifications, with respect to such interoperability standards, adopted under section 3004 of such Act) . Section 13201 of the HITECH Act ( 42 U.S.C. 17911 ) is amended— in subsection (a), by inserting (or, beginning January 1, 2018, in coordination with the entities with contracts under section 3003A, with respect to standards, and implementation specifications under section 3004) before , the Director ; in subsection (b), by inserting (or, beginning January 1, 2018, in coordination with the entities with contracts under section 3003A, with respect to standards and implementation specifications under section 3004) before , the Director ; and by adding at the end the following new subsection: For purposes of carrying out this section, in addition to any other funds made available to carry out this section, there is authorized to be appropriated $15,000,000, to remain available until expended. . Section 106 of the Medicare Access and CHIP Reauthorization Act of 2015 ( Public Law 114–10 ) is amended by striking subsection (b). It is the sense of Congress that— if the strategic goals that Congress set forth in the HITECH Act are to be achieved, interoperability is best achieved with individuals and authorized representatives having equal access to the health information of such individuals in electronic format; patients have the right to the entirety of the health information of such individuals, including such information contained in an electronic health record of such individuals; such right extends to both structured and unstructured data; such right extends to authorized representatives of the individual involved, such as caretakers of such individual, family members of such individual, and guardians of such individual; and to further facilitate access of an individual to health information of such individual— health care providers should not have the ability to deny a request of the individual for access to the entirety of such health information of such individual; health care providers do not need the consent of individuals to share personal health information of such individuals with other covered entities, in compliance with the HIPAA privacy regulations promulgated pursuant to section 264(c) of the Health Insurance Portability and Accountability Act of 1996 for the purposes of supporting patient care, except in situations where consent is specifically required under such regulations, such as in cases related to the psychiatric records of the individual involved; mechanisms should be utilized that allow for the bidirectional exchange of information through such mechanisms as web portals, appointments, and prescription refills, for the purpose of patients partnering with providers to assist in managing health and care; mechanisms described in subparagraph

(C)should allow for connecting individuals across the continuum of care; an individual has the right to access the health information of the individual without cost to the individual; mechanisms described in subparagraph

(C)should allow for data of an individual generated by the individual to be integrated into such platforms as electronic health records; such access should be timely, in accordance with the HIPAA privacy regulations described in subparagraph (B), and take into account communications preferences of the individual involved; an individual should have the right to be confident that the data in the electronic health record of the individual pertains to such individual; and the right described in subparagraph

(H)will promote safety and care coordination for individuals.

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