Responding to stakeholder concerns, the Office of the National Coordinator for Health Information Technology on Tuesday released a proposed rule designed to enhance the safety, reliability, transparency and accountability of certified health IT.

According to ONC, the proposed rule seeks to modify the agency’s Health IT Certification Program to reflect the widespread adoption of certified electronic health records and the rapid pace of innovation in the marketplace. Specifically, the rule would establish processes for ONC to directly review health IT certified under the program and take action when necessary, including requiring the correction of “non-conformities” found in HIT certified under the program as well as suspending/terminating certifications issued to complete EHRs and HIT modules.

Currently, ONC-Authorized Certification Bodies (ONC-ACBs) are not positioned to address situations that involve non-conformities resulting from the interaction of certified and uncertified capabilities within certified health IT or the interaction of a certified health IT’s capabilities with other products. As a result, the agency makes the case in its rule proposal that these non-conformities may pose a risk to public health or safety, including HIT directly contributing to or causing medical errors.

“The proposed rule includes processes for ONC to authorize and oversee accredited testing laboratories under the program,” states the 113-page document. “It also includes a provision for the increased transparency and availability of surveillance results.”

The proposed rule focuses on three 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, complementing existing 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.

“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 healthcare system,” said National Coordinator for HIT Karen DeSalvo, MD. “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.”

However, at an opening keynote address on Monday at a HIMSS16 pre-conference symposium in Las Vegas, John Halamka, MD, CIO of Beth Israel Deaconess Medical Center sharply criticized ONC’s Health IT Certification Program in its current form, arguing that it “paralyzes innovation and does not improve interoperability.” What’s needed, Halamka advised, are a national provider directory, a voluntary national patient identifier, a trust fabric, a governance framework, and consistent privacy policies.

The public comment period for the proposed rule is open until May 2, 2016.

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