Title 42 — The Public Health and WelfareRelease 119-73

§300jj–19a Electronic health record reporting program

Title 42 › Chapter CHAPTER 6A— - PUBLIC HEALTH SERVICE › Subchapter SUBCHAPTER XXVIII— - HEALTH INFORMATION TECHNOLOGY AND QUALITY › Part Part A— - Promotion of Health Information Technology › § 300jj–19a

Last updated Apr 6, 2026|Official source

Summary

Within 1 year after December 13, 2016, the Secretary must bring together doctors, hospitals, health IT makers, patients and advocates, data-sharing groups, testing and certification groups, security experts, medical device makers, market and quality experts, human-factors specialists, and others to create public reporting rules for electronic health record (EHR) technology. The rules must measure things like security, usability, interoperability, and whether products meet certification tests. They may also cover things such as ordering and viewing lab or imaging results, sending and getting registry data, exchanging data with health information exchanges, devices, government agencies, other providers, and patients, giving patients a computable copy of their records, correct patient matching, and other performance or access issues. The rules must be fair to small and startup technology developers. Also within 1 year after December 13, 2016, the Secretary must fund independent groups, chosen competitively, to gather the required information, get confidential feedback from users and developers, make summary and detailed reports, and send those reports to the Secretary for public posting. Applicants must explain how they will review and summarize information, who they will focus on, how they will share reports, the funding period (up to 2 years), and the budget. Priority goes to groups with expertise in usability, interoperability, and security. The Secretary will review these groups’ performance starting not later than 4 years after December 13, 2016, and every 2 years after that, and may re-award funding as needed. Vendors of certified EHRs, their affiliates, and state or local governments cannot get these grants. The Secretary must publish the reporting rules and the reports on the Office of the National Coordinator’s website, let developers review draft reports about their products before publication, and may add consumer resources on the website.

Full Legal Text

Title 42, §300jj–19a

The Public Health and Welfare — Source: USLM XML via OLRC

(a)(1)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)The 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)The 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,11 So in original. Probably should be “performance or accessibility,”. 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)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)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.

(c)(1)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)An 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)In 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)(A)Not 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)The 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)Based 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)(A)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)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)The 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)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)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.

Reference

Citations & Metadata

Citation

42 U.S.C. § 300jj–19a

Title 42 — The Public Health and Welfare

Last Updated

Apr 6, 2026

Release point: 119-73