Commenters to ONC: Proposed rule for direct review of certification over the top

The overarching theme of comments on the Office of the National Coordinator for Health IT's proposed rule giving it the power to conduct direct reviews of certified health IT products is that the agency needs to scale it back.

For instance, a representative sample of the approximately 47 comments submitted by the May 2 deadline found many concerned that ONC was trying to increase its authority beyond what is allowed by statute. The College of Healthcare Information Management Executives (CHIME) said that the expanded authority would exceed ONC's resources, and that the agency could view "nonconformities" in certified health IT so broadly that it would put virtually all vendors' certifications at risk.

McKesson and Health IT Now both said that the proposal to directly oversee the non-certified capabilities of health IT is beyond ONC's regulatory authority; Health IT Now also noted that the rule could cause the agency to compete or overlap with regulations from other agencies, such as the Federal Trade Commission or the Food and Drug Administration.

HIMSS, meanwhile, worried that the rule creates a "duplication of effort" given the enormity of the work that needs to be accomplished in the health IT community.

Many healthcare organizations focused on the downstream impact on providers should their certified EHR lose their certification. The American Medical Association (AMA) and CHIME both said that termination of certified health IT should be a "last resort." The AMA asked ONC to develop a process with the Centers for Medicare & Medicaid Services to protect patients and physicians from the effects of such termination. CHIME was a bit more specific, asking ONC and CMS to provide safe harbors for providers with such products decertified or under appeal and not to penalize providers who are trying to meet Medicare requirements.  

To learn more:
- read all the comments