Regulators Seek More Authority on Electronic Health Records

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By Alex Ruoff

March 1 — Federal regulators want more authority to deal with safety issues involving electronic health records, HHS officials said March 1.

The Office of the National Coordinator for Health IT wants the ability to directly review federally certified EHRs and other health information technologies, the agency said in a proposed rule released March 1. Currently, the agency relies on a few designated organizations in the private sector that ensure certified EHRs are working properly.

The agency wants to respond directly to complaints that certified EHRs aren’t working as advertised, particularly when used with other health IT tools, Elise Sweeney Anthony, acting director of the ONC's Office of Policy, told reporters March 1.

“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,” Karen DeSalvo, the national coordinator for health IT, said in a statement.

The ONC's proposed rule (RIN 0955-AA00) would also boost agency oversight of health IT testing bodies and make identifiable surveillance results of certified health IT publicly available.

The proposed rule will be published in the Federal Register March 2. The ONC will accept comments on the proposed rule until May 2.

Oversight Changes

The ONC currently authorizes several certified bodies, known at ONC-authorized certification bodies (ONC-ACBs), to certify EHRs for use by providers and hospitals in the meaningful use program. These ONC-ACBs are also responsible for ensuring that federally certified EHRs continue to meet certification requirements after they're certified.

However, the ONC-ACBs have limited resources and authority to address problems that arise when EHRs are connected to other health IT tools, such as other EHRs and clinical decisions support software, the ONC said in the proposed rule. Changes in EHR performance can cause serious safety issues, the ONC said.

Anthony told reporters the ONC has received complaints about certified EHRs not working properly and hopes to investigate them. If safety issues are found, the agency will first work with developers of the technologies to resolve them, but reserves the authority to decertify EHRs that fail to come back into compliance, she said.

ONC reviews would be done independently of the oversight work the ONC-ACBs are already doing. The agency expects to do its own reviews “relatively infrequently” and focus only on those situations that pose a risk to public health or safety, the ONC said in the proposed rule.

To contact the reporter on this story: Alex Ruoff in Washington at aruoff@bna.com

To contact the editor responsible for this story: Kendra Casey Plank at kcasey@bna.com

For More Information

The proposed rule is at http://src.bna.com/cXQ.