A proposed new rule would "further enhance the safety, reliability, transparency and accountability of certified health IT for users," according to the Department of Health and Human Services and the Office of the National Coordinator for Health IT (ONC).
The “ONC Health IT Certification Program: Enhanced Oversight and Accountability” proposed rulemaking would modify the ONC Health IT Certification Program to reflect the widespread adoption of certified EHRs and the rapid pace of innovation in the health IT market.
“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,” said National Coordinator for Health Information Technology Karen B. DeSalvo, MD, MPH, MSc. “We look forward to comments on the proposed rule from health IT developers and other stakeholders as we continue to work together to make health information available where and when it is needed safely and reliably.”
The proposed rule would focus on the following three key areas:
- Direct Review: Enabling ONC to directly review certified health IT products, including certified EHRs and take necessary action to address circumstances such as potential risks to public health and safety. This will complement existing ONC-Authorized Certification Bodies' (ONC-ACBs) responsibilities.
- Enhanced Oversight: Increasing ONC oversight of health IT testing bodies to align with ONC’s existing oversight of ONC-ACBs and provide the means for ONC to quickly, directly and precisely address testing issues.
- Greater Transparency and Accountability: Making identifiable surveillance results of certified health IT publicly available to provide customers and users with valuable information about the overall performance of certified health IT, including illuminating good performance and continued compliance.
"The proposed rule furthers our ability to address and correct non-conformities found in certified health IT products from the initial testing phase through implementation in healthcare settings. The proposed rule empowers health IT consumers by proposing to make more information available about how an individual certified health IT product performs in the field," according to the agencies.
Comment period for the proposed rule ends on May 2.
Read the proposed rule.