Health Information Management

HHS releases proposed rule for EHR certification: Certification to ensure functionality, security necessary to meet meaningful use criteria

HIM-HIPAA Insider, March 9, 2010

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Is your EHR meaningful use–compliant? Healthcare providers may soon be able to find out for sure.
 
HHS released a proposed rule March 2 for establishing certification programs for health information technology. The proposed rule describes the creation of a certification program for EHRs, as mandated by the HITECH Act.
 
EHR certification is designed to “give purchasers and users of EHR technology assurances that the technology and products have the necessary functionality and security to help meet meaningful use criteria,” according to a press release from the Office of the National Coordinator (ONC) for Health Information Technology.
 
When writing the interim final rule on standards and certification criteria for EHRs, the ONC strived to balance competing agendas, said David Blumenthal, MD, MPP, the National Coordinator for Health Information Technology, March 3 at the Healthcare Information and Management Systems Society (HIMSS) 2010 Annual Conference and Exhibition in Atlanta. For example, it tried to balance the need for uniform standards against the need for interoperability and innovation and the need for an efficient way to exchange information versus patients’ rights to privacy. The agency tried to allow for flexibility, to meet providers “where they are,” and not inhibit "critical innovation," he said.
 
Similar to the multi-stage approach proposed for the EHR meaningful use incentive program, the proposed establishment of an EHR certification process would also occur in various phases.
 
The first phase would be a temporary certification process whereby the national coordinator would approve organizations to test and certify EHRs.
 
The eventual permanent program would transfer testing and certification fully to private sector organizations and separate the two functions.
 
The separation of those two functions is an important aspect, Blumenthal said. It allows certification of not only completed EHRs, but also of individual modules, a move designed to allow architectural innovation.
 
The proposed permanent program also contains requirements for accreditation and addresses the potential certification of health information technology (HIT) other than complete EHRs and EHR modules.
 
HHS anticipates issuing separate final rules for each of the two programs, according to the proposed rule. CMS has indicated it expects the final rules late this spring.
 
The multi-phase system is designed to enable eligible professionals and hospitals to implement certified EHRs in time to qualify for the initial set of meaningful use incentives, which are set to begin as early as October 2010 for hospitals, and January 1, 2011 for eligible professionals.
 
The phased method is a sound way for HHS to work within the regulatory timelines put in place by the HITECH Act, says Frank Ruelas, director of compliance and risk management at Maryvale Hospital and principal of HIPAA Boot Camp in Casa Grande, AZ. “It’s an ambitious program, so this approach works well.”
 
Because HHS made a conscious effort to solicit input from many different parties and a wide variety of stakeholders, it injected an element of practicality into the rule, according to Ruelas. In addition, HHS took care to consider the evolving meaningful use criteria and how the adoption of future criteria may affect the certification status of EHR systems or modules, he says.
 
One element of the program the healthcare community is likely to find particularly helpful is the proposed master “certified HIT products list” the ONC plans to have publicly available on its Web site.
 
“This ONC master list will help folks accurately identify genuinely certified products that may help meet their needs such as in achieving meaningful use,” says Ruelas.
 
The ONC expects to add additional features to the Web site over time, such as interactive functions that would allow providers to review combinations of certified EHR modules to verify that they would comprise a certified EHR technology.
 
Interested parties will have 30 days after the proposed rule’s publication in the Federal Register to comment on the proposed temporary program, and 60 days to comment on the proposed permanent program. You can submit comments electronically at www.regulations.gov.
 
Blumenthal made it clear that HIT leaders must step forward to provide feedback for the proposed rules; the document includes questions directed at HIT leaders and requests for feedback. “We want you to continue to be leaders and we will follow your lead,” he said.
 
With the release of the proposed rule, the focus now shifts from policy to the process of implementation, said Blumenthal, who expects the release of the three related EHR meaningful use final rules later this spring. His soon-to-be expanded office will now begin working on the next iteration of meaningful use. “That is a huge job. We are going to have to grow considerably to make that happen.” But as long as we keep patients as the North Star, he added, “we will not go astray.”
 
Editor’s note: For more information, visit the HHS Web site. Several helpful documents are available, including a list of FAQs and a Fact Sheet regarding the proposed rule.



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