Surveillance and oversight activities have a significant role in the ONC Health IT Certification Program (Certification Program) as they are critical to providing assurance that Certified Health IT Modules function as intended in a production environment and do not present safety and/or public health risks. As a requirement of certification, Certified Health IT Modules 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 Health IT Module they certified continues to function as required by its certification. In certain situations where a Certified Health IT Module has a potential or known non-conformity (i.e., does not meet the Certification 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 Certification Program requirements; this process is called Direct Review. ONC’s Direct Review complements ONC-ACB surveillance and is aimed at promoting developer accountability for the performance, reliability, and safety of health IT. ONC may also initiate Direct Review if it has a reasonable belief that a Certified Health IT Developer has not complied with a Condition or Maintenance of Certification requirement.
Certified Health IT Developer Responsibilities
Certified Health IT Developers have a responsibility to cooperate with ONC-ACB surveillance and ONC Direct Review. The goal of surveillance, Direct Review, and corrective action plans is to help developers identify and address non-conformities in the certified health IT and noncompliance to Conditions and Maintenance of Certification requirements that providers use to support patient care. ONC and ONC-ACBs will work with Certified 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 and health IT developer actions.