ONC Publishes Three ONC-ACB Post-Certification Educational Resources
ONC has published three post-certification educational resources that reinforce and clarify ONC’s expectations for ONC-Authorized Certification Bodies’ (ONC-ACBs’) performance of the following responsibilities: (1) post-certification assessment of certified health IT against ONC Health IT Certification Program (Program) requirements; (2) enforcement of health IT developers’ compliance with material information disclosure requirements; and (3) surveillance of certified health IT.
Post-certification Assessment of Program Requirements. This document describes the approach that should be taken by ONC-ACBs to assess whether health IT certified under the Program conforms to the requirements of its certification when it is implemented and used in the field. In particular, it clarifies the responsibilities of ONC-ACBs for evaluating how certified health IT performs in real-world environments, such as hospitals and health care practices. It also explains how Program requirements are applied in these post-certification settings.
Post-certification Assessment of Program Requirements [PDF-481 KB]
Disclosure of Material Information. This document is intended to assist ONC-ACBs with their surveillance activities and assessment of health IT developers’ product disclosures required by 45 CFR 170.523(k)(1), which establishes the mandatory disclosure of any limitations or additional types of costs related to the use of the certified health IT. It provides ONC-ACBs with information and practical tips on how to assess whether a health IT developer has complied with these “mandatory disclosure” requirements.
Surveillance. This document provides information about the surveillance obligations for ONC-ACBs and identifies the requirements for the surveillance plans prepared by ONC-ACBs for the CY19 surveillance period.
Surveillance Resource [PDF – 362 KB]