Sec. 3001. Ensuring interoperability of health information technology
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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 the entirety of a patient’s data from any and all health information technology for authorized use under applicable law. The technology allows access to the entirety of a patient’s available data for authorized use under applicable law without special effort, as defined by recommendations adopted in accordance with this section, by the requestor of such data unless such data is not disclosable under applicable law.
The technology is not configured, set up, or implemented to engage in information blocking, as defined in section 3010A(f). The categories described in this subsection, with respect to standards for determining if health information technology is interoperable, consistent with the criteria described in subsection (a), include the following categories of standards: Standards with respect to vocabulary and terminology. Standards with respect to content and structure. Standards with respect to transport of information.
Security standards. Service standards. . Not later than January 1, 2017, the Secretary of Health and Human Services, through 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 of health information technology, as described in such section.
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 under section 3010 are needed for the electronic 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 contracts with health care standards development organizations accredited by the American National Standards Institute to carry out 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 contract 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 organizations described in paragraph
(1)are selected for each contract under paragraph (1). Under the initial contract under subsection (a)(1), the standards development organizations— shall provide to the Secretary, in consultation with the National Coordinator, for adoption under section 3004, recommendations, in accordance with section 3010, for interoperability standards consistent with the criteria described in subsection
(a)of such section and with respect to the categories described in subsection (b)(1) of such section; and may provide to the Secretary, in consultation with the National Coordinator, recommendations described in paragraph (2). Under each subsequent contract, the organizations shall provide to the Secretary, in consultation with the National Coordinator, for adoption under section 3004 recommendations for any standards (including interoperability criteria), implementation specifications, and certification criteria (and modifications, including additions to such standards, specifications, and criteria), which are in accordance with the policies and priorities developed by the Secretary, in consultation with the National Coordinator. The Secretary, in consultation with the National Coordinator, shall periodically conduct hearings to evaluate and review the standards, implementation specification, 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, in consultation with the National Coordinator, the Secretary shall, as needed, enter into contracts under subsection
(a)in addition to the initial contract. 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, 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), by striking and the HIT Standards Committee ; in subsection (b), by adding at the end the following new paragraph: The Secretary may not adopt any standards, implementation specifications, or certification criteria under this subsection or subsection
(a)that are inconsistent with or duplicative of an interoperability standard adopted under this section, in accordance with section 3010. 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 that is subsequently adopted under this section, such interoperability standard 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 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 recommended under section 3003A: Not later than 90 days after the date of receipt of recommendations for such interoperability standards, the Secretary, in consultation with the National Coordinator and representatives of other relevant Federal agencies, shall jointly review such standards and shall determine whether or not to propose adoption of such standards. If the Secretary determines— to propose adoption of such standards, the Secretary shall, by regulation under section 553 of title 5, United States Code, determine whether or not to adopt such standards; or not to propose adoption of such standards, the Secretary shall notify the National Coordinator and the standards development organizations under section 3003A in writing of such determination and the reasons for not proposing the adoption of the recommendation for such standards. The Secretary shall provide for publication in the Federal Register of all determinations made by the Secretary under paragraph (1). Any standard adopted under this subsection shall be effective 12 months after the date of publication of the determination to adopt such standard. In the case of a standard (including interoperability standard), implementation specification, or certification criteria 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 paragraph (2), any such standard (including interoperability standard), implementation specification, or certification criteria shall be a standard, specification, or criterion that has been recommended by the standards development organizations with which the Secretary has entered into a contract under section 3003A. If no standard is recommended under paragraph (1)— in the case of interoperability 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 certification criteria, 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. Any standard, implementation specification, or certification criterion adopted under this section shall be effective 12 months after the date of publication of the final rule to adopt such standard, implementation specification, or certification criteria. In complying with the requirements of this subsection, the Secretary shall rely on the 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. . 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 of a report on the following: The initial set of interoperability standards adopted under section 3004(c). The strategies for achieving widespread interoperability. An overview of the extent to which electronic health records and health information technology offered as of such date satisfy such initial set. Any barriers that are preventing widespread interoperability. The plan and milestones, including specific steps, to achieve widespread interoperability. Not later than December 31, 2019, 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 the following: A determination by the Secretary whether the goal of widespread interoperability has been achieved. A list identifying the vendors of, or other entities offering, qualified electronic health records, which categorizes such entities, with respect to such records, as in compliance or not in compliance with the certification criteria described in section 3001(c)(5)(B)(ii) and with the requirements under clause
(i)of section 3001(c)(5)(C) (including with the terms of the attestation and other requirements under such clause). Actions that may be taken by entities identified under subparagraph
(B)as not being in compliance with such criteria and requirements in order for such entities to become in compliance with such criteria and requirements. Penalties described in section 3010A(d) to which entities, with respect to such qualified electronic health records, beginning January 1, 2019, are subject if such technology and entities are not in compliance with the certification criteria described in section 3001(c)(5)(B)(ii) and with the requirements under clause
(i)of section 3001(c)(5)(C), respectively. 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, including by being 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— by amending subparagraph
(B)of such section to read as follows: In this title, the term certification criteria means, with respect to qualified electronic health records— for certifications made before January 1, 2018, criteria to establish that the records meet standards and implementation specifications adopted under subsections
(a)and
(b)of section 3004 for qualified electronic health records; and for certifications made on or after January 1, 2018, criteria described in clause
(i)and criteria to establish that the records are interoperable, in accordance with section 3010, including by being in compliance with interoperability standards adopted under section 3004. ; and by adding at the end the following new subparagraph: Under any program kept or recognized under subparagraph (A), the Secretary shall ensure that any vendor of or other entity offering 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— that the entity, unless for a legitimate purpose specified by the Secretary, has not taken any action, including through any financial, administrative, or technological barrier, which the entity knows or should know (as defined in section 1128A(i)(7) of the Social Security Act), is to limit or restrict the exchange of information or to prevent or disincentivize widespread interoperability between any providers using such records or other health information technology in connection with such record; on the pricing information described in clause
(v)for purposes of the portal created under paragraph (9), that such information will be available on a public Web site of such entity and in marketing materials, communications statements, and other assertions of such entity related to such record, and that the entity will voluntarily provide such information to customers prior to providing 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, estimate, or other similar marketing or promotional material), and other persons who request such information; that the software with respect to such records have published application programming interfaces for medical records data, search and indexing, semantic harmonization and vocabulary translation, and user interface applications; that the entity has successfully tested the use of the record in the type of setting in which it would be marketed; the entity has in place implementation guidelines for such record that support interoperability, consistent with section 3010; and that the entity has in place data sharing programs or capabilities based on common data elements through application programming interfaces without the requirement for vendor-specific interfaces; publish application programming interfaces and associated documentation, with respect to such records, for medical records data, search and indexing, semantic harmonization and vocabulary translation, and user interface applications; and demonstrate to the satisfaction of the Secretary that data from such records is able to be exchanged through the use of application programming interfaces and used in a manner that allows for exchange and everyday use, as authorized under applicable law, of such record. 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 section 3001(c)(5)(B)(ii) 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 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 vendors of or other entities offering qualified electronic health records with respect to which certification has been withdrawn under clause
(ii)during such year. The Secretary shall periodically review and confirm that vendors of and other entities offering qualified electronic health records have publicly published application programming interfaces and associated documentation as required by clause (i)(II) for purposes of certification and maintaining certification under any program kept or recognized under subparagraph (A). For purposes of clause (i)(I)(bb), 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 data 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 data 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 use, exchange, or portability of any data generated in the course of using any capability to which the record is to be so certified. . Subtitle A of title XXX of the Public Health Service Act ( 42 U.S.C. 300jj–11 et seq. ), as amended by subsection (a)(1), 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, qualified electronic health records— being in violation of an attestation made under section 3001(c)(5)(C)(i)(I), with respect to the use of such records by a health care provider under a specified meaningful use incentive program; and having engaged in information blocking (as defined in subsection (f)), unless for a legitimate purpose specified by the Secretary, with respect to the use of such records by a health care provider under such a program; health care providers, with respect to the use of such records under a specified meaningful use incentive program, having, unless for a legitimate purpose specified by the Secretary, engaged in information blocking (as so defined); health information system providers described in subsection
(b)having engaged in information blocking (as so defined), unless for a legitimate purpose specified by the Secretary, with respect to the use of such records under a specified meaningful use incentive program; and vendors of, or other entities offering, health information technology (other than technology described in paragraph (1)), health care providers, with respect to the use of such technology, and health information system providers, with respect to such technology, unless for a legitimate purpose specified by the Secretary, having engaged in information blocking (as so defined). The Inspector General of the Department of Health and Human Services shall, in coordination with the Federal Trade Commission, ensure that health information system providers (such as operators of health information exchanges and other systems that facilitate the exchange of information) investigate claims of information blocking, with respect to the use of such records under a specified meaningful use incentive 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)or
(b)with the Inspector General and Federal Trade Commission for purposes of such investigations. Any information shared by the National Coordinator under paragraph
(1)shall not be subject to the provisions of section 552 of title 5, United States Code (commonly referred to as the Freedom of Information Act). Any information acquired pursuant to paragraph
(1)shall be held in confidence and shall not be disclosed to any person except as may be necessary to carry out the purposes of subsection (a). 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). Any person or entity determined to have committed an act described in paragraph (1), (2), or
(3)of subsection (a), in connection with a specified meaningful use incentive program, shall be subject to a civil monetary penalty of not more than $10,000 for each such act. The provisions of section 1128A (other than subsections
(a)and (b)) 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 section 1128A(a). For purposes of this section, the term specified meaningful use incentive program includes the following: The incentive payments under subsection
(o)of section 1848 of the Social Security Act ( 42 U.S.C. 1395w–4 ) and adjustments under subsection (a)(7) of such section. The incentive payments under subsection
(n)of section 1848 of such Act ( 42 U.S.C. 1395ww ) and adjustments under subsection (b)(3)(B) of such section. The incentive payments and adjustments made under subsections
(l)and
(m)of section 1853 of such Act ( 42 U.S.C. 1395w–23 ). The incentive payment under paragraph
(3)of section 1814(l) of such Act ( 42 U.S.C. 1395f(l) ) and adjustment under paragraph
(4)of such section. The shared savings program under section 1899 of such Act ( 42 U.S.C. 1395jjj ). The payments to Medicaid providers described in section 1903(t) of such Act ( 42 U.S.C. 1396b(t) ). For purposes of this section and section 3010, the term information blocking means, with respect to the use of qualified electronic health records or other health information technology under a specified meaningful use incentive program, business, technical, and organizational practices, including practices described in paragraph (2), that— prevent or materially discourage the exchange of electronic health information; the actor knows or should know (as defined in section 1128A(i)(7) of the Social Security Act) is likely to interfere with the exchange or use of electronic health information; and do not serve to protect patient safety, maintain the privacy and security of individuals’ health information or promote competition and consumer welfare. For purposes of paragraph (1), the practices described in this paragraph are the following: Contract terms, policies, or other business or organizational practices that restrict individuals’ access to their electronic health information or restrict the exchange or use of that information for treatment and other permitted purposes. Charging prices or fees (such as for data exchange, portability, and interfaces) that make exchanging and using electronic health information cost prohibitive. Developing or implementing health information technology in non-standard 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 data; lead to fraud, waste, or abuse; or impede innovations and advancements in health information exchange and health information technology-enabled care delivery. 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). . Section 3001(c) of the Public Health Service Act ( 42 U.S.C. 300jj–11(c) ) is amended by adding at the end the following new paragraph: Not later than January 1, 2019, the National Coordinator shall create a portal to make the information described in paragraph (5)(C)(I)(i)(bb) available to the public in a manner that allows for comparison of price information among health information technology products and that aids in making informed decisions for purchasing such a product. . Not later than 12 months after the date of the enactment of this Act, the National Coordinator shall, through rulemaking, implement the provisions of this section, and amendments made by this section, relating to information blocking. Not later than January 1, 2017, the National Coordinator shall publish guidance to clarify the relationship of the HIPAA privacy and security law, as defined in section 3009(a)(2) of the Public Health Service Act ( 42 U.S.C. 300jj–19(a)(2) ) as such provisions relate to information blocking (as defined in section 3010A(f) of such Act, as added by paragraph (2), including examples of how such provisions may result in information blocking. Section 1848(o)(2)(C) of the Social Security Act ( 42 U.S.C. 1395w–4(o)(2)(C) ) is amended by adding at the end the following new clause: With respect to EHR reporting periods for payment years beginning with 2018, the means described in clause
(i)specified by the Secretary shall include a demonstration, through means such as an attestation, that the professional has not taken any action described in subsection (a)(2) of section 3010A of the Public Health Service Act with respect to which the professional, 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)(B) ) 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 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 that such professional was determined to not be a meaningful EHR user because the qualified electronic health record used by such professional was 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 subclause (II), during the first payment year with respect to the first EHR reporting period to which such decertification applies. In no case shall an exemption by reason of this clause be for a period of less than 12 months. An exemption under this clause may be extended for a period of an additional 12 months subject to the limitation described in clause (ii). Subject to clause (ii)(II)(aa), in no case may an eligible professional be granted an exemption under this subparagraph for more than 5 years. . Section 1886(o)(1) of the Social Security Act ( 42 U.S.C. 1395ww(o)(1) ) is amended— in subparagraph (A), by inserting before the period at the end the following: and, for performance periods for fiscal year 2018 or a subsequent fiscal year, that provide a demonstration described in subparagraph
(D)to the Secretary ; and by adding at the end the following new subparagraph: The demonstration described in this subparagraph is a demonstration, through means such as an attestation, that the hospital has not taken any action described in subsection (a)(2) of section 3010A of the Public Health Service Act with respect to which the hospital, 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 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 such hospital was determined to not be a meaningful EHR user because the qualified electronic health record used by such hospital was 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. 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 be extended for a period of an additional 12 months subject to the limitation described in item (ee). Subject to item (cc), in no case may a hospital be granted an exemption under this subclause for more than 5 years. . 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 2018, 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 which the provider knows or should know (as defined in section 1128A(i)(7) of the Social Security Act) about, with respect to the use of any certified EHR technology. . 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 are interoperable, in accordance with section 3010, including as measured by the methods adopted under such section; and such records are employed by meaningful EHR users under the specified meaningful use incentive programs (as defined in section 3010A(e)) and 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 adopted under section 3004 after section 3004 . in subsection (b), by inserting including the interoperability standards adopted under section 3004 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, including by being in compliance with 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 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, including by being in compliance with interoperability standards adopted under section 3004 of such Act) . 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— patients have the right to the entirety of the health information of such patient, including such information contained in an electronic health record of such patient; such right extends to both structured and unstructured data; and to further facilitate patient ownership over health information of such patient— health care providers should not have the ability to deny a patient’s request for access to the entirety of such health information of such patient; and health care providers do not need the consent of their patients to share personal health information of such patients 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 patient.
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- 42 USC 300jj–11
- 42 USC 300jj–12
- 42 USC 300jj–13
- 42 USC 300jj–11(c)(1)(A)
- 42 USC 300jj–14
- 42 USC 300jj–17(b)
- 42 USC 300jj–11(c)(5)
- 42 USC 1395w–4
- 42 USC 1395w–23
- 42 USC 300jj–11(c)
- 42 USC 300jj–19(a)(2)
- 42 USC 1395w–4(o)(2)(C)
- 42 USC 1395w–4(a)(7)(B)
- 42 USC 300jj–16
- 42 USC 300jj–19(a)(2)(A)
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cites case law
Sec. 3001
Ensuring interoperability of health information technology
Cite42 USC 300jj–11
Cite42 USC 300jj–12
Cite42 USC 300jj–13
Cite42 USC 300jj–11(c)(1)(A)
Cite42 USC 300jj–14
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