The Office of the National Coordinator for Health Information Technology (ONC) now can conduct direct surveillance of certified health information technology (IT) under the provisions of a recently issued final rule.
ONC, the federal agency tasked with the development of certification standards for health IT products, previously delegated certification and review responsibilities to ONC-authorized certification bodies (ONC-ACBs). In the final rule, ONC introduces three primary changes to ensure the reliability and safety of health IT:
- enabling ONC to directly review certified health IT to ensure its compliance with certification criteria;
- providing for ONC oversight and authorization of testing laboratories; and
- publishing the results of certified health IT product surveillance.
ONC will conduct direct review of certified health IT in limited cases — when there are risks to public health or safety and when an ONC-ACB is unable to review certified health IT due to practical limitations, such as cases involving a developer’s proprietary business information or other confidential matters. If ONC identifies instances in which certified health IT does not comply with certification criteria, it can take remedial actions, such as suspending or terminating the certification.
The provisions of the rule take effect 60 days from publication in the Federal Register. Publication was schedule for Oct. 19.
Contact Director of Policy Erin O’Malley at email@example.com or 202.585.0127 with questions.