42 USC 300jj-11 - Office of the National Coordinator for Health Information Technology

U.S Code last checked for updates: Nov 22, 2024

§ 300jj–11.

Office of the National Coordinator for Health Information Technology

(a)

Establishment

(b)

Purpose

The National Coordinator shall perform the duties under subsection (c) in a manner consistent with the development of a nationwide health information technology infrastructure that allows for the electronic use and exchange of information and that—

(1)

ensures that each patient’s health information is secure and protected, in accordance with applicable law;

(2)

improves health care quality, reduces medical errors, reduces health disparities, and advances the delivery of patient-centered medical care;

(3)

reduces health care costs resulting from inefficiency, medical errors, inappropriate care, duplicative care, and incomplete information;

(4)

provides appropriate information to help guide medical decisions at the time and place of care;

(5)

ensures the inclusion of meaningful public input in such development of such infrastructure;

(6)

improves the coordination of care and information among hospitals, laboratories, physician offices, and other entities through an effective infrastructure for the secure and authorized exchange of health care information;

(7)

improves public health activities and facilitates the early identification and rapid response to public health threats and emergencies, including bioterror events and infectious disease outbreaks;

(8)

facilitates health and clinical research and health care quality;

(9)

promotes early detection, prevention, and management of chronic diseases;

(10)

promotes a more effective marketplace, greater competition, greater systems analysis, increased consumer choice, and improved outcomes in health care services; and

(11)

improves efforts to reduce health disparities.

(c)

Duties of the National Coordinator

(1)

Standards

The National Coordinator shall—

(A)

review and determine whether to endorse each standard, implementation specification, and certification criterion for the electronic exchange and use of health information that is recommended by the HIT Advisory Committee under section 300jj–12 of this title for purposes of adoption under section 300jj–14 of this title;

(B)

make such determinations under subparagraph (A), and report to the Secretary such determinations, not later than 45 days after the date the recommendation is received by the Coordinator; and

(C)

review Federal health information technology investments to ensure that Federal health information technology programs are meeting the objectives of the strategic plan published under paragraph (3).

(2)

HIT policy coordination

(A)

In general

(B)

HIT Advisory Committee

(3)

Strategic plan

(A)

In general

The National Coordinator shall, in consultation with other appropriate Federal agencies (including the National Institute of Standards and Technology), update the Federal Health IT Strategic Plan (developed as of June 3, 2008) to include specific objectives, milestones, and metrics with respect to the following:

(i)

The electronic exchange and use of health information and the enterprise integration of such information.

(ii)

The utilization of an electronic health record for each person in the United States by 2014.

(iii)

The incorporation of privacy and security protections for the electronic exchange of an individual’s individually identifiable health information.

(iv)

Ensuring security methods to ensure appropriate authorization and electronic authentication of health information and specifying technologies or methodologies for rendering health information unusable, unreadable, or indecipherable.

(v)

Specifying a framework for coordination and flow of recommendations and policies under this part among the Secretary, the National Coordinator, the HIT Advisory Committee, and other health information exchanges and other relevant entities.

(vi)

Methods to foster the public understanding of health information technology.

(vii)

Strategies to enhance the use of health information technology in improving the quality of health care, reducing medical errors, reducing health disparities, improving public health, increasing prevention and coordination with community resources, and improving the continuity of care among health care settings.

(viii)

Specific plans for ensuring that populations with unique needs, such as children, are appropriately addressed in the technology design, as appropriate, which may include technology that automates enrollment and retention for eligible individuals.

(B)

Collaboration

(C)

Measurable outcome goals

(D)

Publication

(4)

Website

(5)

Certification

(A)

In general

(B)

Certification criteria described

(C)

Health information technology for medical specialties and sites of service

(i)

In general

(ii)

Specific medical specialties

(iii)

Health information technology for pediatrics

(D)

Conditions of certification

Not later than 1 year after December 13, 2016, the Secretary, through notice and comment rulemaking, shall require, as a condition of certification and maintenance of certification for programs maintained or recognized under this paragraph, consistent with other conditions and requirements under this subchapter, that the health information technology developer or entity—

(i)

does not take any action that constitutes information blocking as defined in section 300jj–52(a) of this title;

(ii)

provides assurances satisfactory to the Secretary that such developer or entity, unless for legitimate purposes specified by the Secretary, will not take any action described in clause (i) or any other action that may inhibit the appropriate exchange, access, and use of electronic health information;

(iii)

does not prohibit or restrict communication regarding—

(I)

the usability of the health information technology;

(II)

the interoperability of the health information technology;

(III)

the security of the health information technology;

(IV)

relevant information regarding users’ experiences when using the health information technology;

(V)

the business practices of developers of health information technology related to exchanging electronic health information; and

(VI)

the manner in which a user of the health information technology has used such technology;

(iv)

has published application programming interfaces and allows health information from such technology to be accessed, exchanged, and used without special effort through the use of application programming interfaces or successor technology or standards, as provided for under applicable law, including providing access to all data elements of a patient’s electronic health record to the extent permissible under applicable privacy laws;

(v)

has successfully tested the real world use of the technology for interoperability (as defined in section 300jj of this title) in the type of setting in which such technology would be marketed;

(vi)

provides to the Secretary an attestation that the developer or entity—

(I)

has not engaged in any of the conduct described in clause (i);

(II)

has provided assurances satisfactory to the Secretary in accordance with clause (ii);

(III)

does not prohibit or restrict communication as described in clause (iii);

(IV)

has published information in accordance with clause (iv);

(V)

ensures that its technology allows for health information to be exchanged, accessed, and used, in the manner described in clause (iv); and

(VI)

has undertaken real world testing as described in clause (v); and

(vii)

submits reporting criteria in accordance with section 300jj–19a(b) of this title.

(E)

Compliance with conditions of certification

(6)

Reports and publications

(A)

Report on additional funding or authority needed

(B)

Implementation report

(C)

Assessment of impact of HIT on communities with health disparities and uninsured, underinsured, and medically underserved areas

(D)

Evaluation of benefits and costs of the electronic use and exchange of health information

(E)

Resource requirements

The National Coordinator shall estimate and publish resources required annually to reach the goal of utilization of an electronic health record for each person in the United States by 2014, including—

(i)

the required level of Federal funding;

(ii)

expectations for regional, State, and private investment;

(iii)

the expected contributions by volunteers to activities for the utilization of such records; and

(iv)

the resources needed to establish a health information technology workforce sufficient to support this effort (including education programs in medical informatics and health information management).

(7)

Assistance

(8)

Governance for nationwide health information network

(9)

Support for interoperable networks exchange

(A)

In general

(B)

Establishing a trusted exchange framework

(i)

In general

Not later than 6 months after December 13, 2016, the National Coordinator shall convene appropriate public and private stakeholders to develop or support a trusted exchange framework for trust policies and practices and for a common agreement for exchange between health information networks. The common agreement may include—

(I)

a common method for authenticating trusted health information network participants;

(II)

a common set of rules for trusted exchange;

(III)

organizational and operational policies to enable the exchange of health information among networks, including minimum conditions for such exchange to occur; and

(IV)

a process for filing and adjudicating noncompliance with the terms of the common agreement.

(ii)

Technical assistance

(iii)

Pilot testing

(C)

Publication of a trusted exchange framework and common agreement

(D)

Directory of participating health information networks

(i)

In general

(ii)

Process

(E)

Application of the trusted exchange framework and common agreement

(F)

Rule of construction

(i)

General adoption

(ii)

Adoption when exchange of information is within network

(iii)

Existing frameworks and agreements

(iv)

Application by Federal agencies

(v)

Consideration of ongoing work

(d)

Detail of Federal employees

(1)

In general

(2)

Effect of detail

Any detail of personnel under paragraph (1) shall—

(A)

not interrupt or otherwise affect the civil service status or privileges of the Federal employee; and

(B)

be in addition to any other staff of the Department employed by the National Coordinator.

(3)

Acceptance of detailees

(e)

Chief Privacy Officer of the Office of the National Coordinator

(July 1, 1944, ch. 373, title XXX, § 3001, as added Pub. L. 111–5, div. A, title XIII, § 13101, Feb. 17, 2009, 123 Stat. 230; amended Pub. L. 114–255, div. A, title IV, §§ 4001(b), 4002(a), 4003(b), (e)(2)(A)(i), (ii), (C), Dec. 13, 2016, 130 Stat. 1158, 1159, 1165, 1174.)

cite as: 42 USC 300jj-11