Health IT Certification

Citation

45 CFR § 170.100

Statutory basis and purpose.

This provision identifies the statutory authority under the Public Health Service Act for the health information technology regulations.

Citation

45 CFR § 170.101

Applicability.

This provision defines the scope of health IT standards and certification criteria and includes a severability clause.

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45 CFR § 170.102

Definitions.

This provision provides definitions for key terms used in health information technology standards, including base EHR, interoperability, and common clinical data sets.

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45 CFR § 170.200

Applicability.

This provision states that the standards and implementation specifications adopted in the part apply to health information technology.

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45 CFR § 170.300

Applicability.

This provision establishes the applicability of certification criteria for Health IT Modules and clarifies the use of alternative standards and optional capabilities.

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45 CFR § 170.315

ONC certification criteria for Health IT.

The Secretary adopts the following certification criteria for health IT.

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45 CFR § 170.400

Basis and scope.

This provision outlines the basis and scope for Conditions and Maintenance of Certification requirements for health IT developers participating in the ONC Health IT Certification Program.

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45 CFR § 170.401

Information blocking.

This provision prohibits health IT developers from engaging in actions that constitute information blocking as defined by federal law.

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45 CFR § 170.402

Assurances.

This provision mandates that health IT developers provide assurances regarding information blocking, certification criteria conformance, and record retention for compliance demonstration.

Citation

45 CFR § 170.403

Communications.

This provision restricts health IT developers from prohibiting or restricting communications regarding the usability, interoperability, security, and business practices of their health IT products.

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45 CFR § 170.405

Real world testing.

Health IT developers must conduct and report real-world testing for interoperability of certified Health IT Modules in the settings where they are marketed.

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45 CFR § 170.406

Attestations.

Health IT developers must provide semiannual attestations of compliance with specific conditions and maintenance of certification requirements.

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45 CFR § 170.407

Insights Condition and Maintenance of Certification.

Health IT developers must submit annual reports on specific measures regarding the use and performance of their certified health IT products.

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45 CFR § 170.500

Basis and scope.

This section defines the legal basis and scope of the ONC Health IT Certification Program for health information technology.

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45 CFR § 170.501

Applicability.

This section establishes the processes and requirements for ONC-ACB and ONC-ATL status and the direct review of certified health IT.

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45 CFR § 170.502

Definitions.

Defines key terms such as applicant, deployment site, gap certification, and ONC-authorized entities for the health IT certification program.

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45 CFR § 170.505

Correspondence.

Establishes requirements for official communication between ONC and applicants or certified entities, including email and mail protocols.

Citation

45 CFR § 170.510

Authorization scope for ONC-ACB status.

Defines the scope of certification activities that an ONC-Authorized Certification Body is permitted to perform.

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45 CFR § 170.511

Authorization scope for ONC-ATL status.

Defines the scope of testing activities that an ONC-Authorized Testing Laboratory is permitted to perform.

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45 CFR § 170.520

Application.

Specifies the information and documentation required for organizations to apply for ONC-ACB or ONC-ATL status.

Citation

45 CFR § 170.523

Principles of proper conduct for ONC-ACBs.

This provision establishes the operational, reporting, surveillance, and certification requirements for ONC-Authorized Certification Bodies (ONC-ACBs) under the ONC Health IT Certification Program.

Citation

45 CFR § 170.524

Principles of proper conduct for ONC-ATLs.

This provision outlines the mandatory conduct, reporting, and record retention requirements for ONC-Authorized Testing Laboratories.

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45 CFR § 170.525

Application submission.

This provision specifies the submission methods and timing for entities applying for ONC-ACB or ONC-ATL status.

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45 CFR § 170.530

Review of application.

This provision establishes the timeline and process for the National Coordinator to review applications for ONC-ACB or ONC-ATL status, including deficiency notices.

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45 CFR § 170.535

ONC-ACB and ONC-ATL application reconsideration.

This provision defines the process for applicants to request reconsideration of a denial of ONC-ACB or ONC-ATL status based on factual errors.

Citation

45 CFR § 170.540

ONC-ACB and ONC-ATL status.

This provision outlines the requirements for public representation, renewal, and expiration of ONC-ACB and ONC-ATL status.

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45 CFR § 170.550

Health IT Module certification.

This provision establishes the requirements for certifying Health IT Modules, including scope, privacy and security criteria, and inherited certification status.

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45 CFR § 170.555

Certification to newer versions of certain standards.

This provision outlines the requirements and conditions under which ONC-ACBs may certify Health IT Modules to newer versions of established standards.

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45 CFR § 170.556

In-the-field surveillance and maintenance of certification for Health IT.

This provision establishes the requirements for ONC-ACBs to conduct in-the-field surveillance of certified Health IT Modules and manage corrective action plans for non-conformities.

Citation

45 CFR § 170.557

Authorized testing and certification methods.

This provision mandates that ONC-ATLs and ONC-ACBs must provide remote testing and certification capabilities for development and deployment sites.

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45 CFR § 170.560

Good standing as an ONC-ACB or ONC-ATL.

This provision defines the requirements for ONC-ACBs and ONC-ATLs to maintain good standing, including adherence to principles of conduct and compliance with applicable laws.

Citation

45 CFR § 170.565

Revocation of ONC-ACB or ONC-ATL status.

This provision outlines the procedures and criteria for the National Coordinator to suspend or revoke the status of ONC-Authorized Certification Bodies and ONC-Authorized Testing Labs.

Citation

45 CFR § 170.570

Effect of revocation on the certifications issued to Complete EHRs and EHR Module(s).

This provision defines the impact of an ONC-ACB or ONC-ATL status revocation on the certification status of previously certified health IT modules.

Citation

45 CFR § 170.580

ONC review of certified health IT.

This provision establishes the authority and procedures for the Office of the National Coordinator for Health Information Technology (ONC) to review, suspend, or terminate the certification of health IT modules, including requirements for corrective action plans and developer appeals.

Citation

45 CFR § 170.581

Certification ban.

This provision outlines the circumstances under which a health IT developer's certification may be banned and the process for reinstatement into the ONC Health IT Certification Program.

Citation

45 CFR § 170.599

Incorporation by reference.

This provision lists the technical standards and conformity assessment guides incorporated by reference into the ONC health IT certification regulations.