Surveillance and oversight activities have a significant role in the ONC Health IT Certification Program (Program) as they are critical to providing assurance that certified Complete EHRs and Health IT Modules function as intended in a production environment and do not present safety and/or public health risks. These aspects of the Program have been built in over time and at multiple stages throughout the evolution of the Program. As a requirement of certification, Complete EHRs and Health IT Modules certified under the Program are subject to surveillance activities. The purpose of surveillance is to ensure that certified products and capabilities meet certification requirements, not just in a controlled testing environment, but also when they are used “in-the-field” (for example, in a clinician’s office or a hospital).
ONC-Authorized Certification Bodies (ONC-ACBs) must conduct surveillance to determine if a Complete EHR or Health IT Module they certified continues to function as required by its certification. In certain situations where a Complete EHR or Health IT Module has a potential or known non-conformity (i.e., does not meet the Program requirements) that may present a serious risk to public health or safety or may pose special challenges for ONC-ACBs’ surveillance, ONC may choose to directly review the product’s conformity to Program requirements; this process is called direct review. ONC’s direct review complements ONC-ACB surveillance and is aimed at promoting health IT developer accountability for the performance, reliability, and safety of health IT.
Health IT Developer Responsibilities
Health IT developers have a responsibility to cooperate with ONC-ACB surveillance and ONC direct review. The goal of surveillance and corrective action plans is to help health IT developers identify and address non-conformities in the certified health IT that providers use to support patient care. ONC and ONC-ACBs will work with health IT developers to remedy any non-conformities in a timely manner and across all customers.
ONC encourages end users of certified health IT to become familiar with the ONC recommended process for filing complaints concerning certified health IT.