The 21st Century Cures Act (Section 4002) requires the Secretary of Health and Human Services (HHS) to establish Conditions and Maintenance of Certification requirements for the ONC Health IT Certification Program. ONC has finalized the Conditions and Maintenance of Certification requirements to express initial requirements and ongoing requirements for health IT developers and their Certified Health IT Module(s). There are seven Conditions of Certification with accompanying Maintenance of Certification Requirements. ONC has not yet established an EHR Reporting Program for the seventh Conditions and Maintenance of Certification requirement; the EHR reporting criteria submission. Once ONC establishes such program, we will undertake rulemaking to propose and implement the associated Condition and Maintenance of Certification requirements for health IT developers.
The Conditions and Maintenance of Certification requirements, except for the Information Blocking and Assurances Conditions and Maintenance of Certification requirements, apply only to actions and behaviors of health IT developers related to their certified health IT as well as to the certified health IT itself. The Information Blocking and Assurances Conditions and Maintenance of Certification require that a health IT developer is responsible to ensure that all of its health IT and related actions and behaviors do not constitute information blocking or inhibit the appropriate access, exchange, and use of electronic health information (EHI).
The Conditions and Maintenance of Certification requirements are defined in Subpart D of the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule (ONC Cures Act Final Rule). Furthermore, compliance dates have been updated per the Interim Final Rule (IFR), Information Blocking and the ONC Health IT Certification Program: Extension of Compliance Dates and Timeframes in Response to the COVID-19 Public Health Emergency.
Regulation |
Condition of Certification |
Maintenance of Certification |
Certification Companion Guide (CCG)
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Information Blocking |
A health IT developer may not take any actions that constitutes “information blocking” as defined in Section 3022(a) of the Public Health Service Act (PHSA) and § 171.103 on or after April 5, 2021. |
There are no accompanying MoC requirements beyond compliance with the Condition. |
11-02-2020 |
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Assurances |
A health IT developer must:
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A health IT developer must:
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11-02-2020 |
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Communications |
A health IT developer may not prohibit or restrict communication regarding the following subjects for Certified Health IT Modules:
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A health IT developer must:
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11-02-2020 |
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Application Programming Interfaces (APIs) |
A health IT developer of a Health IT Module certified to any certification criteria adopted in § 170.315(g)(7) through (g)(10) must:
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A health IT developer of a Health IT Module that meets the requirements outlined in the Condition of Certification must comply with the following requirements:
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11-02-2020 |
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Real World Testing |
A health IT developer with Health IT Module(s) certified to § 170.315(b), (c)(1) through (3), (e)(1), (f), (g)(7) through (10), and (h) must: successfully test the real world use of the technology for interoperability in the type of setting in which such technology would be marketed. |
A health IT developer that meets the requirements outlined in the Condition of Certification must:
Standards Version Advancement Process
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11-02-2020 |
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Attestation |
A health IT developer must attest, as applicable, to compliance with the Conditions and Maintenance of Certification related to: (1) Information Blocking, (2) Assurances, (3) Communications, (4) API, and (5) Real World Testing. |
A health IT developer must submit their attestations every six months as of the first attestation window beginning on April 1, 2022. |
11-02-2020 |