- The Office of the National Coordinator for Health Information Technology published a proposed rule Tuesday aimed at enhancing the safety, reliability, transparency, and accountability of certified health IT.
- The proposal updates the ONC Health IT Certification program to reflect advances in health IT innovations, and the adoption of certified electronic health records.
- Stakeholders may submit comments on the proposal through May 2.
The proposal would allow ONC to directly review certified EHRs and other health IT products and address potential safety risks and other problems that arise.
ONC could initiate a direct review anytime it learns of information that suggests certified health it “may not conform to the requirements of its certification or is, for example, leading to medical errors, breaches in the security of a patient’s health information, or other outcomes that are in direct opposition to the National Coordinator’s responsibilities,” the proposed rule says.
In addition, the proposal would boost ONC’s oversight of health IT testing entities and align it with the office’s current oversight of ONC-Authorized Certification Bodies. To increase transparency and accountability, ONC would make public “identifiable surveillance results” of certified health IT, the proposed rule says.
“Today’s proposed rule will help us ensure that health IT products and the health IT marketplace are continuing to meet the needs of the health care system,” ONC Coordinator Karen DeSalvo said in a statement.
ONC issued a final rule last October identifying how health IT certification can support the establishment of an interoperable nationwide health information infrastructure through certification, and use of adopted vocabulary and content standards.