The following reference(s) are associated with this entry:
| Policy |
Standards Version Advancement Process
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ONC |
The Standards Version Advancement Process (SVAP) permits health IT developers to voluntarily update health IT products certified under the ONC Health IT Certification Program (Certification Program) to newer versions of adopted standards as part of the “Real World Testing” Condition and Maintenance of Certification requirement (§ 170.405) of the 21st Century Cures Act.
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All the standards in this guidance are currently available for voluntary certification under the Certification Program. The authorized SVAP versions for 2020 went into effect in the Certification Program beginning March 12, 2021. The 2022 authorized SVAP versions were announced June 28, 2022 and went into effect on August 29, 2022. Once effective, any newer versions of authorized standards replaced existing authorized standards from previous years. |
| Best Practice |
US Core Profile for USCDI
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Health Level Seven (HL7) |
The US Core Profiles were originally designed to meet the 2015 Edition certification criterion for Patient Selection 170.315(g)(7), and Application Access – Data Category Request 170.315(g)(8). They were created for each item in the 2015 Edition Common Clinical Data Set (CCDS). The Location, Organization, and Practitioner Profiles are not called out specifically in the certification criteria but are included because they are directly referenced by other profiles. The US Core Profiles are informed by the prior Data Access Framework and the Argonaut Data Query Implementation Guides. However, the profiles here are stand alone and include requirements from the U.S. Core Data for Interoperability (USCDI) v2.
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Review for information on US Core Profile and FHIR Resources used for the corresponding USCDI Data Elements. |
| Policy |
170.213 United States Core Data for Interoperability
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Code of Federal Regulations |
Standard. United States Core Data for Interoperability (USCDI), July 2020 Errata, Version 1 (v1) (incorporated by reference in § 170.299). |
| Requirement |
170.315(b)(1) - Transitions of care
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ONC |
This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product development. The CCG is not a substitute for the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule (ONC Cures Act Final Rule). It extracts key portions of the rule’s preamble and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the ONC Cures Act Final Rule, 2015 Edition final rule or other included regulatory reference. The CCG is for public use and should not be sold or redistributed. |
| Requirement |
170.315(b)(2) Clinical information reconciliation and incorporation
|
ONC |
This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product development. The CCG is not a substitute for the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule (ONC Cures Act Final Rule). It extracts key portions of the rule’s preamble and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the ONC Cures Act Final Rule or other included regulatory reference. The CCG is for public use and should not be sold or redistributed. |
| Requirement |
170.315(e)(1) - View, download, and transmit to 3rd party
|
ONC |
This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product development. The CCG is not a substitute for the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program (ONC Cures Act Final Rule). It extracts key portions of the rule’s preamble and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the ONC Cures Act Final Rule or other included regulatory reference. The CCG is for public use and should not be sold or redistributed. |
| Requirement |
170.315(f)(5) - Transmission to public health agencies - electronic case reporting
|
ONC |
This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product development. The CCG is not a substitute for the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule (ONC Cures Act Final Rule). It extracts key portions of the rule’s preamble and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the ONC Cures Act Final Rule or other included regulatory reference. The CCG is for public use and should not be sold or redistributed. |
| Requirement |
170.315(g)(9) - Application access - all data request
|
ONC |
This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product development. The CCG is not a substitute for the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule (ONC Cures Act Final Rule). It extracts key portions of the rule’s preamble and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the ONC Cures Act Final Rule or other included regulatory reference. The CCG is for public use and should not be sold or redistributed. |
| Requirement |
170.315(g)(10) - Standardized API for patient and population services
|
ONC |
This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product development. The CCG is not a substitute for the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule (ONC Cures Act Final Rule). It includes extracts of preamble and regulation text from the ONC Cures Act Final Rule with accompanying clarifying interpretations. To access the full context of regulatory intent please consult the ONC Cures Act Final Rule or other included regulatory reference. This CCG is for public use and should not be sold or redistributed. |
| Policy |
Information Blocking (21st Century Cures Act)
|
ONC |
Most clinical information is digitized, accessible, and shareable thanks to several technology and policy advances making interoperable, electronic health record systems widely available. In 2016, the 21st Century Cures Act (Cures Act) made sharing electronic health information the expected norm in health care by authorizing the Secretary of Health and Human Services (HHS) to identify `reasonable and necessary activities that do not constitute information blocking.` ONC``s 2020 Cures Act Final Rule established information blocking exceptions to implement the law. |
| Policy |
Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1)
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Federal Register |
Register This final rule implements the Electronic Health Record (EHR) Reporting Program provision of the 21st Century Cures Act by establishing new Conditions and Maintenance of Certification requirements for health information technology (health IT) developers under the ONC Health IT Certification Program (Program). This final rule also makes several updates to certification criteria and standards recognized by the Program. The Program updates include revised certification criteria for “decision support interventions,” “patient demographics and observations,” and “electronic case reporting,” as well as a new baseline version of the United States Core Data for Interoperability (USCDI) standard to Version 3. Additionally, this final rule provides enhancements to support information sharing under the information blocking regulations. The implementation of these provisions advances interoperability, improves algorithm transparency, and supports the access, exchange, and use of electronic health information (EHI). This final rule also updates numerous technical standards in the Program in additional ways to advance interoperability, enhance health IT certification, and reduce burden and costs for health IT developers and users of health IT. |
