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42 U.S.C. § 300jj — Information blocking
Federal law — U.S. Code and appendices · legal_authorities
**(a) Definition**
(1) **In general** — In this section, the term “information blocking” means a practice that—
(A) except as required by law or specified by the Secretary pursuant to rulemaking under paragraph (3), is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information; and
(B)
(i) if conducted by a health information technology developer, exchange, or network, such developer, exchange, or network knows, or should know, that such practice is likely to interfere with, prevent, or materially discourage the access, exchange, or use of electronic health information; or
(ii) if conducted by a health care provider, such provider knows that such practice is unreasonable and is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information.
(2) **Practices described** — The information blocking practices described in paragraph (1) may include—
(A) practices that restrict authorized access, exchange, or use under applicable State or Federal law of such information for treatment and other permitted purposes under such applicable law, including transitions between certified health information technologies;
(B) implementing health information technology in nonstandard ways that are likely to substantially increase the complexity or burden of accessing, exchanging, or using electronic health information; and
(C) implementing health information technology in ways that are likely to—
(i) restrict the access, exchange, or use of electronic health information with respect to exporting complete information sets or in transitioning between health information technology systems; or
(ii) lead to fraud, waste, or abuse, or impede innov
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Source file: Laws/federal/codes/united-states-code/title-42/section-300jj-information-blocking--839f7d583b.md
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Source location: Title 42, Chapter 6A, § 300jj; chapter-6a-public-health-service.md
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**(a) Definition**
(1) **In general** — In this section, the term “information blocking” means a practice that—
(A) except as required by law or specified by the Secretary pursuant to rulemaking under paragraph (3), is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information; and
(B)
(i) if conducted by a health information technology developer, exchange, or network, such developer, exchange, or network knows, or should know, that such practice is likely to interfere with, prevent, or materially discourage the access, exchange, or use of electronic health information; or
(ii) if conducted by a health care provider, such provider knows that such practice is unreasonable and is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information.
(2) **Practices described** — The information blocking practices described in paragraph (1) may include—
(A) practices that restrict authorized access, exchange, or use under applicable State or Federal law of such information for treatment and other permitted purposes under such applicable law, including transitions between certified health information technologies;
(B) implementing health information technology in nonstandard ways that are likely to substantially increase the complexity or burden of accessing, exchanging, or using electronic health information; and
(C) implementing health information technology in ways that are likely to—
(i) restrict the access, exchange, or use of electronic health information with respect to exporting complete information sets or in transitioning between health information technology systems; or
(ii) lead to fraud, waste, or abuse, or impede innovations and advancements in health information access, exchange, and use, including care delivery enabled by health information technology.
(3) **Rulemaking** — The Secretary, through rulemaking, shall identify reasonable and necessary activities that do not constitute information blocking for purposes of paragraph (1).
(4) **No enforcement before exception identified** — The term “information blocking” does not include any practice or conduct occurring prior to the date that is 30 days after December 13, 2016.
(5) **Consultation** — The Secretary may consult with the Federal Trade Commission in promulgating regulations under this subsection, to the extent that such regulations define practices that are necessary to promote competition and consumer welfare.
(6) **Application** — 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.
(7) **Clarification** — In carrying out this section, the Secretary shall ensure that health care providers are not penalized for the failure of developers of health information technology or other entities offering health information technology to such providers to ensure that such technology meets the requirements to be certified under this subchapter.
**(b) Inspector General authority**
(1) **In general** — The inspector general of the Department of Health and Human Services (referred to in this section as the “Inspector General”) may investigate any claim that—
(A) a health information technology developer of certified health information technology or other entity offering certified health information technology—
(i) submitted a false attestation under [section 300jj–11(c)(5)(D)(vii) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300jj–11/c/5/D/vii&num=0&edition=prelim); or
(ii) engaged in information blocking;
(B) a health care provider engaged in information blocking; or
(C) a health information exchange or network engaged in information blocking.
(2) **Penalties**
(A) *Developers, networks, and exchanges* — Any individual or entity described in subparagraph (A) or (C) of paragraph (1) that the Inspector General, following an investigation conducted under this subsection, determines to have committed information blocking shall be subject to a civil monetary penalty determined by the Secretary for all such violations identified through such investigation, which may not exceed $1,000,000 per violation. Such determination shall take into account factors such as the nature and extent of the information blocking and harm resulting from such information blocking, including, where applicable, the number of patients affected, the number of providers affected, and the number of days the information blocking persisted.
(B) *Providers* — Any individual or entity described in subparagraph (B) of paragraph (1) determined by the Inspector General to have committed information blocking shall be referred to the appropriate agency to be subject to appropriate disincentives using authorities under applicable Federal law, as the Secretary sets forth through notice and comment rulemaking.
(C) *Procedure* — The provisions of [section 1320a–7a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1320a-7a&num=0&edition=prelim) (other than subsections (a) and (b) of such section) shall apply to a civil money penalty applied under this paragraph in the same manner as such provisions apply to a civil money penalty or proceeding under such [section 1320a–7a(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1320a–7a/a&num=0&edition=prelim).
(D) *Recovered penalty funds* — The amounts recovered under this paragraph shall be allocated as follows:
(i) *Annual operating expenses* — Each year following the establishment of the authority under this subsection, the Office of the Inspector General shall provide to the Secretary an estimate of the costs to carry out investigations under this section. Such estimate may include reasonable reserves to account for variance in annual amounts recovered under this paragraph. There is authorized to be appropriated for purposes of carrying out this section an amount equal to the amount specified in such estimate for the fiscal year.
(ii) *Application to other programs* — The amounts recovered under this paragraph and remaining after amounts are made available under clause (i) shall be transferred to the Federal Hospital Insurance Trust Fund under [section 1395i of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395i&num=0&edition=prelim) and the Federal Supplementary Medical Insurance Trust Fund under [section 1395t of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395t&num=0&edition=prelim), in such proportion as the Secretary determines appropriate.
(E) *Authorization of appropriations* — There is authorized to be appropriated to the Office of the Inspector General to carry out this section $10,000,000, to remain available until expended.
(3) **Resolution of claims**
(A) *In general* — The Office of the Inspector General, if such Office determines that a consultation regarding the health privacy and security rules promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 ([42 U.S.C. 1320d–2](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1320d-2&num=0&edition=prelim) note) will resolve an information blocking claim, may refer such instances of information blocking to the Office for Civil Rights of the Department of Health and Human Services for resolution.
(B) *Limitation on liability* — If a health care provider or health information technology developer makes information available based on a good faith reliance on consultations with the Office for Civil Rights of the Department of Health and Human Services pursuant to a referral under subparagraph (A), with respect to such information, the health care provider or developer shall not be liable for such disclosure or disclosures made pursuant to subparagraph (A).
(4) **Application of authorities under Inspector General Act of 1978** — In carrying out this subsection, the Inspector General shall have the same authorities as provided under section 6 of the Inspector General Act of 1978 (5 U.S.C. App.).11 See References in Text note below.
**(c) Identifying barriers to exchange of certified health information technology**
(1) **Trusted exchange defined** — In this section, the term “trusted exchange” with respect to certified electronic health records means that the certified electronic health record technology has the technical capability to enable secure health information exchange between users and multiple certified electronic health record technology systems.
(2) **Guidance** — The National Coordinator, in consultation with the Office for Civil Rights of the Department of Health and Human Services, shall issue guidance on common legal, governance, and security barriers that prevent the trusted exchange of electronic health information.
(3) **Referral** — The National Coordinator and the Office for Civil Rights of the Department of Health and Human Services may refer to the Inspector General instances or patterns of refusal to exchange health information with an individual or entity using certified electronic health record technology that is technically capable of trusted exchange and under conditions when exchange is legally permissible.
**(d) Additional provisions**
(1) **Information sharing provisions** — The National Coordinator may serve as a technical consultant to the Inspector General and the Federal Trade Commission for purposes of carrying out this section. The National Coordinator may, notwithstanding any other provision of law, share information related to claims or investigations under subsection (b) with the Federal Trade Commission for purposes of such investigations and shall share information with the Inspector General, as required by law.
(2) **Protection from disclosure of information** — 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—
(A) shall not be disclosed by the National Coordinator except as may be necessary to carry out the purpose of this section;
(B) shall be exempt from mandatory disclosure under [section 552 of title 5](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552&num=0&edition=prelim), as provided by subsection (b)(3) of such section; and
(C) may be used by the Inspector General 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.
(3) **Standardized process**
(A) *In general* — The National Coordinator shall implement a standardized process for the public to submit reports on claims of—
(i) health information technology products or developers of such products (or other entities offering such products to health care providers) not being interoperable or resulting in information blocking;
(ii) actions described in subsection (b)(1) that result in information blocking as described in subsection (a); and
(iii) any other act described in subsection (a).
(B) *Collection of information* — The standardized process implemented under subparagraph (A) 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.
(4) **Nonduplication of penalty structures** — In carrying out this subsection, the Secretary shall, to the extent possible, ensure that penalties do not duplicate penalty structures that would otherwise apply with respect to information blocking and the type of individual or entity involved as of the day before December 13, 2016.
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In General.—** In addition to the authority otherwise provided by this chapter, each Inspector General, in carrying out the provisions of this chapter, is authorized—
(1)
(A) to have timely access to all records, reports, audits, reviews, documents, papers, recommendations, or other materials available to the applicable establishment which relate to the programs and operations with respect to which that Inspector General has responsibilities under this chapter;
(B) to have access under subparagraph (A) notwithstanding any other provision of law, except pursuant to any provision of law enacted by Congress that expressly—
(i) refers to the Inspector General; and
(ii) limits the right of access of the Inspector General; and
(C) except as provided in subsection (i), with regard to Federal grand jury materials protected from disclosure pursuant to rule 6(e) of the Federal Rules of Criminal Procedure, to have timely access to such information if the Attorney General grants the request in accordance with subsection (h);
(2) to make such investigations and reports relating to the administration of the programs and operations of the applicable establishment as are, in the judgment of the Inspector General, necessary or desirable;
(3) to request such information or assistance as may be necessary for carrying out the duties and responsibilities provided by this chapter from any Federal, State, or local governmental agency or unit thereof;
(4) to require by subpoena the production of all information, documents, reports, answers, records, accounts, papers, and other data in any medium (including electronically stored information), as well as any tangible thing and documentary evidence necessary in the performance of the functions assigned by this chapter
Source: Supplied U.S. Code snapshot — release unconfirmed · 5 U.S.C. § 406
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Federal law — U.S. Code and appendices · legal_authorities
**(a)** Each agency shall make available to the public information as follows:
(1) Each agency shall separately state and currently publish in the Federal Register for the guidance of the public—
(A) descriptions of its central and field organization and the established places at which, the employees (and in the case of a uniformed service, the members) from whom, and the methods whereby, the public may obtain information, make submittals or requests, or obtain decisions;
(B) statements of the general course and method by which its functions are channeled and determined, including the nature and requirements of all formal and informal procedures available;
(C) rules of procedure, descriptions of forms available or the places at which forms may be obtained, and instructions as to the scope and contents of all papers, reports, or examinations;
(D) substantive rules of general applicability adopted as authorized by law, and statements of general policy or interpretations of general applicability formulated and adopted by the agency; and
(E) each amendment, revision, or repeal of the foregoing.
Except to the extent that a person has actual and timely notice of the terms thereof, a person may not in any manner be required to resort to, or be adversely affected by, a matter required to be published in the Federal Register and not so published. For the purpose of this paragraph, matter reasonably available to the class of persons affected thereby is deemed published in the Federal Register when incorporated by reference therein with the approval of the Director of the Federal Register.
(2) Each agency, in accordance with published rules, shall make available for public inspection in an electronic format—
(A) final opinions, including concurring and dissen
Source: Supplied U.S. Code snapshot — release unconfirmed · 5 U.S.C. § 552
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Grants** The Secretary of Health and Human Services (in this section referred to as the “Secretary”) shall make grants to States, with approved State regulatory programs under [section 1395ss of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395ss&num=0&edition=prelim), that submit applications to the Secretary that meet the requirements of this section for the purpose of providing information, counseling, and assistance relating to the procurement of adequate and appropriate health insurance coverage to individuals who are eligible to receive benefits under this subchapter (in this section referred to as “eligible individuals”). The Secretary shall prescribe regulations to establish a minimum level of funding for a grant issued under this section.
**(b) Grant applications**
(1) In submitting an application under this section, a State may consolidate and coordinate an application that consists of parts prepared by more than one agency or department of such State.
(2) As part of an application for a grant under this section, a State shall submit a plan for a State-wide health insurance information, counseling, and assistance program. Such program shall—
(A) establish or improve upon a health insurance information, counseling, and assistance program that provides counseling and assistance to eligible individuals in need of health insurance information, including—
(i) information that may assist individuals in obtaining benefits and filing claims under this subchapter and subchapter XIX of this chapter;
(ii) policy comparison information for medicare supplemental policies (as described in [section 1395ss(g)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395ss/g/1
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 1395i
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** Subject to subsections (c) and (d), payment under this part may be made for inpatient hospital services or post-hospital extended care services furnished an individual in a religious nonmedical health care institution and for home health services furnished an individual by a religious nonmedical health care institution only if—
(1) the individual has an election in effect for such benefits under subsection (b); and
(2) the individual has a condition such that the individual would qualify for benefits under this part for inpatient hospital services, extended care services, or home health services, respectively, if the individual were an inpatient or resident in a hospital or skilled nursing facility, or receiving services from a home health agency, that was not such an institution.
**(b) Election**
(1) **In general** — An individual may make an election under this subsection in a form and manner specified by the Secretary consistent with this subsection. Unless otherwise provided, such an election shall take effect immediately upon its execution. Such an election, once made, shall continue in effect until revoked.
(2) **Form** — The election form under this subsection shall include the following:
(A) A written statement, signed by the individual (or such individual’s legal representative), that—
(i) the individual is conscientiously opposed to acceptance of nonexcepted medical treatment; and
(ii) the individual’s acceptance of nonexcepted medical treatment would be inconsistent with the individual’s sincere religious beliefs.
(B) A statement that the receipt of nonexcepted medical services shall constitute a revocation of the election and may limit further receipt of services described in subsection (a).
(3) **Revocation** — An el
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 1395t
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Federal law — U.S. Code and appendices · legal_authorities
The Secretary, acting through the Service, may make grants to urban Indian organizations under this subchapter for the development, adoption, and implementation of health information technology (as defined in [section 300jj of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300jj&num=0&edition=prelim)), telemedicine services development, and related infrastructure.
Source: Supplied U.S. Code snapshot — release unconfirmed · 25 U.S.C. § 1662
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Spending on health information technology systems** As each agency (as defined by the Director of the Office of Management and Budget, in consultation with the Secretary of Health and Human Services) implements, acquires, or upgrades health information technology systems used for the direct exchange of individually identifiable health information between agencies and with non-Federal entities, it shall utilize, where available, health information technology systems and products that meet standards and implementation specifications adopted under [section 300jj–14 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300jj-14&num=0&edition=prelim), as added by section 13101.11 See References in Text note below.
**(b) Federal information collection activities** With respect to a standard or implementation specification adopted under [section 300jj–14 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300jj-14&num=0&edition=prelim), as added by section 13101, the President shall take measures to ensure that Federal activities involving the broad collection and submission of health information are consistent with such standard or implementation specification, respectively, within three years after the date of such adoption.
**(c) Application of definitions** The definitions contained in [section 300jj of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300jj&num=0&edition=prelim), as added by section 13101,1 shall apply for purposes of this subchapter.
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 17901
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general**
(1) **Findings** — Congress finds that the Centers for Disease Control and Prevention has an essential role in defending against and combatting public health threats domestically and abroad and requires secure and modern facilities, and expanded, improved, and appropriately maintained capabilities related to bioterrorism and other public health emergencies, sufficient to enable such Centers to conduct this important mission.
(2) **Facilities**
(A) *In general* — The Director of the Centers for Disease Control and Prevention may design, construct, and equip new facilities, renovate existing facilities (including laboratories, laboratory support buildings, scientific communication facilities, transshipment complexes, secured and isolated parking structures, office buildings, and other facilities and infrastructure), and upgrade security of such facilities, in order to better conduct the capacities described in [section 247d–1 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d-1&num=0&edition=prelim), and for supporting public health activities.
(B) *Multiyear contracting authority* — For any project of designing, constructing, equipping, or renovating any facility under subparagraph (A), the Director of the Centers for Disease Control and Prevention may enter into a single contract or related contracts that collectively include the full scope of the project, and the solicitation and contract shall contain the clause “availability of funds” found at section 52.232–18 of title 48, Code of Federal Regulations.
(3) **Improving the capacities of the Centers for Disease Control and Prevention** — The Secretary shall expand, improve, enhance, and appropriately maintain the capabilities of the Centers for Di
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 247d–4
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** The Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall establish a program to provide grants to or enter into contracts with eligible entities to establish community-based interdisciplinary, interprofessional teams (referred to in this section as “health teams”) to support primary care practices, including obstetrics and gynecology practices, within the hospital service areas served by the eligible entities. Grants or contracts shall be used to—
(1) establish health teams to provide support services to primary care providers; and
(2) provide capitated payments to primary care providers as determined by the Secretary.
**(b) Eligible entities** To be eligible to receive a grant or contract under subsection (a), an entity shall—
(1)
(A) be a State or State-designated entity; or
(B) be an Indian tribe or tribal organization, as defined in [section 1603 of title 25](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title25-section1603&num=0&edition=prelim);
(2) submit a plan for achieving long-term financial sustainability within 3 years;
(3) submit a plan for incorporating prevention initiatives and patient education and care management resources into the delivery of health care that is integrated with community-based prevention and treatment resources, where available;
(4) ensure that the health team established by the entity includes an interdisciplinary, interprofessional team of health care providers, as determined by the Secretary; such team may include medical specialists, nurses, pharmacists, nutritionists, dieticians, social workers, behavioral and mental health providers (including substance use disorder prevention and treatment providers), doctors of chiropractic, licensed comple
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 256a–1
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Purpose** The purposes of this section are to—
(1) enable the Director to identify, develop, evaluate, disseminate, and provide training in innovative methodologies and strategies for quality improvement practices in the delivery of health care services that represent best practices (referred to as “best practices”) in health care quality, safety, and value; and
(2) ensure that the Director is accountable for implementing a model to pursue such research in a collaborative manner with other related Federal agencies.
**(b) General functions of the Center** The Center for Quality Improvement and Patient Safety of the Agency for Healthcare Research and Quality (referred to in this section as the “Center”), or any other relevant agency or department designated by the Director, shall—
(1) carry out its functions using research from a variety of disciplines, which may include epidemiology, health services, sociology, psychology, human factors engineering, biostatistics, health economics, clinical research, and health informatics;
(2) conduct or support activities consistent with the purposes described in subsection (a), and for—
(A) best practices for quality improvement practices in the delivery of health care services; and
(B) that include changes in processes of care and the redesign of systems used by providers that will reliably result in intended health outcomes, improve patient safety, and reduce medical errors (such as skill development for health care providers in team-based health care delivery and rapid cycle process improvement) and facilitate adoption of improved workflow;
(3) identify health care providers, including health care systems, single institutions, and individual providers, that—
(A) deliver consistently high-quality, efficient heal
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 299b–33
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Establishment** There is established within the Department of Health and Human Services an Office of the National Coordinator for Health Information Technology (referred to in this section as the “Office”). The Office shall be headed by a National Coordinator who shall be appointed by the Secretary and shall report directly to the Secretary.
**(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)
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 300jj–12
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