The 21st CenturyCures Act established a set of requirements for health IT developers that define both the initial and ongoing certification requirements for health IT developers and their certified health IT modules.
The Conditions and Maintenance of Certification requirements are divided into these seven distinct areas:
Condition of Certification Requirement: A health IT developer must:
Maintenance of Certification:
Please refer to the Certification Companion Guide: Assurances for additional details on the requirement.
Condition of Certification Requirement: A health IT developer may not prohibit or restrict communication regarding the following subjects for certified Health IT Modules:
Maintenance of Certification: A health IT developer must:
Please refer to the Certification Companion Guide: Communications for additional details on the requirement.
Condition of Certification Requirement: A health IT developer of a Health IT Module certified to any certification criteria adopted in § 170.315(g)(7) through (g)(10) must:
Maintenance of Certification: 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:
Please refer to the Certification Companion Guide: Application Programming Interfaces for additional details on the requirement.
View the API Resource Guide, here.
Condition of Certification Requirement: A health IT developer must attest, as applicable, to compliance with the Conditions and Maintenance of Certification related to:
Maintenance of Certification: A health IT developer must submit their attestations every six months as of the first attestation window beginning on April 1, 2022.
Condition of Certification: A health IT developer with Health IT Module(s) certified to § 170.315(b)(1) through (10), (c)(1) through (3), (e)(1), (f)(1) through (7), (g)(7) through (10), and (h)(1) and (2) must: successfully test the real world use of the technology for interoperability in the type of setting in which such technology would be marketed.
For Maintenance of Certification requirements and additional details, please see the Certification Companion Guide: Real World Testing, the Real World Testing (RWT) Fact Sheet as well as the Real World Testing Resource Guide.
While optional, we strongly encourage developers to use the Real World Testing Plan Template when creating their test plans.
Additional resources can be found here.
Condition of Certification Requirement: A health IT developer of certified health IT does not take any action that constitutes information blocking on or after April 5, 2021. A health IT developer of certified health IT is responsible for ensuring 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).
Maintenance of Certification: There are no accompanying Maintenance of Certification requirements beyond compliance with the Condition.
Please refer to the Certification Companion Guide: Information Blocking for exceptions to the information blocking provisions and additional details on the requirement.
View the Information Blocking Fact Sheet, here and Information Blocking FAQs, here.