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42 U.S. Code § 300jj–19a - Electronic health record reporting program

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(a) Reporting criteria

(1) Convening of stakeholders

Not later than 1 year after December 13, 2016, the Secretary shall convene stakeholders, as described in paragraph (2), for the purpose of developing the reporting criteria in accordance with paragraph (3).

(2) Development of reporting criteriaThe reporting criteria under this subsection shall be developed through a public, transparent process that reflects input from relevant stakeholders, including—

(A)

health care providers, including primary care and specialty care health care professionals;

(B)

hospitals and hospital systems;

(C)

health information technology developers;

(D)

patients, consumers, and their advocates;

(E)

data sharing networks, such as health information exchanges;

(F)

authorized certification bodies and testing laboratories;

(G)

security experts;

(H)

relevant manufacturers of medical devices;

(I)

experts in health information technology market economics;

(J)

public and private entities engaged in the evaluation of health information technology performance;

(K)

quality organizations, including the consensus based entity described in section 1395aaa of this title;

(L)

experts in human factors engineering and the measurement of user-centered design; and

(M)

other entities or individuals, as the Secretary determines appropriate.

(3) Considerations for reporting criteriaThe reporting criteria developed under this subsection—

(A) shall include measures that reflect categories including—

(i)

security;

(ii)

usability and user-centered design;

(iii)

interoperability;

(iv)

conformance to certification testing; and

(v)

other categories, as appropriate to measure the performance of electronic health record technology;

(B) may include categories such as—

(i)

enabling the user to order and view the results of laboratory tests, imaging tests, and other diagnostic tests;

(ii)

submitting, editing, and retrieving data from registries such as clinician-led clinical data registries;

(iii)

accessing and exchanging information and data from and through health information exchanges;

(iv)

accessing and exchanging information and data from medical devices;

(v)

accessing and exchanging information and data held by Federal, State, and local agencies and other applicable entities useful to a health care provider or other applicable user in the furtherance of patient care;

(vi)

accessing and exchanging information from other health care providers or applicable users;

(vii)

accessing and exchanging patient generated information;

(viii)

providing the patient or an authorized designee with a complete copy of their health information from an electronic record in a computable format;

(ix)

providing accurate patient information for the correct patient, including exchanging such information, and avoiding the duplication of patients records; and

(x)

other categories regarding performance, accessibility,[1] as the Secretary determines appropriate; and

(C)

shall be designed to ensure that small and startup health information technology developers are not unduly disadvantaged by the reporting criteria.

(4) Modifications

After the reporting criteria have been developed under paragraph (3), the Secretary may convene stakeholders and conduct a public comment period for the purpose of modifying the reporting criteria developed under such paragraph.

(b) Participation

As a condition of maintaining certification under section 300jj–11(c)(5)(D) of this title, a developer of certified electronic health records shall submit to an appropriate recipient of a grant, contract, or agreement under subsection (c)(1) responses to the criteria developed under subsection (a), with respect to all certified technology offered by such developer.

(1) In general

Not later than 1 year after December 13, 2016, the Secretary shall award grants, contracts, or agreements to independent entities on a competitive basis to support the convening of stakeholders as described in subsection (a)(2), collect the information required to be reported in accordance with the criteria established as described subsection (a)(3), and develop and implement a process in accordance with paragraph (5) and report such information to the Secretary.

(2) ApplicationsAn independent entity that seeks a grant, contract, or agreement under this subsection shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require, including a description of—

(A)

the proposed method for reviewing and summarizing information gathered based on reporting criteria established under subsection (a);

(B)

if applicable, the intended focus on a specific subset of certified electronic health record technology users, such as health care providers, including primary care, specialty care, and care provided in rural settings; hospitals and hospital systems; and patients, consumers, and patients and consumer advocates;

(C)

the plan for widely distributing reports described in paragraph (6);

(D)

the period for which the grant, contract, or agreement is requested, which may be up to 2 years; and

(E)

the budget for reporting program participation, and whether the eligible independent entity intends to continue participation after the period of the grant, contract, or agreement.

(3) Considerations for independent entitiesIn awarding grants, contracts, and agreements under paragraph (1), the Secretary shall give priority to independent entities with appropriate expertise in health information technology usability, interoperability, and security (especially entities with such expertise in electronic health records) with respect to—

(A)

health care providers, including primary care, specialty care, and care provided in rural settings;

(B)

hospitals and hospital systems; and

(C)

patients, consumers, and patient and consumer advocates.

(4) Limitations

(A) Assessment and redeterminationNot later than 4 years after December 13, 2016, and every 2 years thereafter, the Secretary, in consultation with stakeholders, shall—

(i)

assess performance of the recipients of the grants, contracts, and agreements under paragraph (1) based on quality and usability of reports described in paragraph (6); and

(ii)

re-determine grants, contracts, and agreements as necessary.

(B) Prohibitions on participationThe Secretary may not award a grant, contract, or cooperative agreement under paragraph (1) to—

(i)

a proprietor of certified health information technology or a business affiliate of such a proprietor;

(ii)

a developer of certified health information technology; or

(iii)

a State or local government agency.

(5) FeedbackBased on reporting criteria established under subsection (a), the recipients of grants, contracts, and agreements under paragraph (1) shall develop and implement a process to collect and verify confidential feedback on such criteria from—

(A)

health care providers, patients, and other users of certified electronic health record technology; and

(B)

developers of certified electronic health record technology.

(6) Reports

(A) Development of reports

Each recipient of a grant, contract, or agreement under paragraph (1) shall report on the information reported to such recipient pursuant to subsection (a) and the user feedback collected under paragraph (5) by preparing summary reports and detailed reports of such information.

(B) Distribution of reports

Each recipient of a grant, contract, or agreement under paragraph (1) shall submit the reports prepared under subparagraph (A) to the Secretary for public distribution in accordance with subsection (d).

(d) PublicationThe Secretary shall distribute widely, as appropriate, and publish, on the Internet website of the Office of the National Coordinator—

(1)

the reporting criteria developed under subsection (a); and

(2)

the summary and detailed reports under subsection (c)(6).

(e) Review

Each recipient of a grant, contract, or agreement under paragraph (1) shall develop and implement a process through which participating electronic health record technology developers may review and recommend changes to the reports created under subsection (c)(6) for products developed by such developer prior to the publication of such report under subsection (d).

(f) Additional resources

The Secretary may provide additional resources on the Internet website of the Office of the National Coordinator to better inform consumers of health information technology. Such reports may be carried out through partnerships with private organizations with appropriate expertise.

(July 1, 1944, ch. 373, title XXX, § 3009A, as added Pub. L. 114–255, div. A, title IV, § 4002(c), Dec. 13, 2016, 130 Stat. 1161.)