The U.S. government established the Office of the National Coordinator for Health Information Technology (ONC) in 2004 and increased its role significantly in 2009 to promote and certify certain aspects of Health IT, including electronic medical record systems. Although a voluntary program, certification is required to access a number of financial incentives. This is entirely separate from the U.S. FDA. The government website for information on certification is at the link provided. Given the financial incentives involved the ONC has in many ways become a regulatory body for certain HealthIT in the United States. Note that one of the requirements for certification is the manufacturer of the HelathIT establish a quality system. The following is a summary describing the ONC from its webpage.
“The Office of the National Coordinator for Health Information Technology (ONC) operates the ONC Health IT Certification Program (Program) under the authority granted by section 3001(c)(5) of the Public Health Service Act (PHSA), and as defined in the Health Information Technology for Economic and Clinical Health (HITECH) Act. The Program is run as a third-party product conformity assessment scheme for health information technology (health IT) based on the principles of the International Standards Organization (ISO) and International Electrotechnical Commission (IEC) framework. ONC does not perform conformance testing or issue certifications itself. Rather, ONC collaborates with other organizations that it evaluates, approves, and authorizes to perform these functions on its behalf. The Program is a voluntary health IT testing and certification scheme with requirements including, but not limited to, capabilities related to the recording, security, and interoperable sharing of health information. The Program defines the technical requirements for health IT and the process by which health IT may become certified and maintain its certification.”
ONC launched the Program in 2010 to support the Medicare and Medicaid EHR Incentive Programs (EHR Incentive Programs) administered by the Centers for Medicare & Medicaid Services (CMS). While the EHR Incentive Programs continue to require the use of certified health IT, the use of certified health IT has expanded to other government and non-government programs. Similarly, the Program has evolved and now also supports other health IT adoption, interoperability, and care quality improvement initiatives. This evolution has been demonstrated as the Program has released several editions of certification criteria and expanded program requirements. These new editions of certification criteria include more robust functional and interoperability requirements, ONC-ACB in-the-field surveillance expectations, and cost transparency and disclosure requirements for health IT developers’ certified health IT. These additional disclosure requirements have been adopted to ensure users of certified health IT are fully informed about certain types of limitations and additional costs associated with the ability to implement or use certified health IT in a manner consistent with its certification.”
https://www.healthit.gov/topic/certification-ehrs/about-onc-health-it-certification-program