Certification Recommendations OK'd
HDM Breaking News, August 14, 2009
Multiple entities could provide certification services that attest an electronic health records system meets meaningful use requirements under the American Recovery and Reinvestment Act, according to recommendations adopted today by the HIT Policy Committee.
The recommendations now go to the Department of Health and Human Services for consideration as federal officials write the rules that will implement the Medicare/Medicaid incentive programs for meaningful use of EHRs.
The recommendations also mean that the Certification Commission for Healthcare Information Technology soon could have competition. The workgroup recommends that multiple organizations be accredited to perform "HHS Certification" testing and provide certification. HHS Certification means a certifying process that is limited to the minimum set of criteria necessary to meet functional requirements of ARRA and achieve the law's meaningful use objectives.
Workgroup members believed the CCHIT process is excessively detailed, though the processes are transparent and fair. "There has been criticism that CCHIT is too closely aligned with HIMSS or with vendors," according to the workgroup. "While we did not see any evidence that vendors were exerting undue influence on CCHIT, we also understand that the appearance of a conflict is important to address."
CCHIT and other entities could develop accreditation programs that meet the HHS Certification criteria, and also could offer more advanced certification if there is demand for such a program.
Under the adopted recommendations from the policy committee's Certification/Adoption Workgroup:
* Multiple organizations should be allowed to perform HHS-approved certification testing using identical criteria;
* The process of defining certification criteria should be performed by the Office of the National Coordinator for Health Information Technology and separated from organizations that provide certification testing;
* ONC should develop an accreditation process and select organizations to accredit certifying organizations.
* The National Institute for Standards and Technologies should play a major role in determining who should conduct certification and how the accreditation body should be established.
* Vendors would need to get certification from only one approved certifying entity,
* Certification criteria should occur no more frequently than once a year and certification would last for four years;
* The process for obtaining certification also should enable qualifying for Stark exceptions that enable organizations to subsidize the cost of EHRs for physicians. It would not be necessary to get two certifications;
* "Lock down" requirements of EHR software should be eliminated to address concerns of the open source community; and
* An alternate certification process, based on a site inspection, could be developed for organizations using self-developed software.
In addition, a number of recommendations lay out a short-term transition plan. For instance, certifications obtained during the transition period should be valid at least three 2011. Further, products certified under CCHIT's 2008 criteria could have an optional shorter, expedited meaningful use certification process.
The proposed Definition of HHS Certification in the HIT Policy Committee-adopted recommendations is:
"HHS Certification means that a system is able to achieve the minimum government requirements for security, privacy and interoperability, and that the system is able to support the achievement of Meaningful Use results that the government expects."
The committee emphasizes that HHS Certification is not intended to be viewed as a 'seal of approval' or an indication of the benefits of one system over another.
The committee slightly amended the definition of certification prior to adopting the recommendations. The original definition and complete recommendations are available at http://healthit.hhs.gov/portal/server.pt. Click on Federal Advisory Committee then Health IT Policy Committee, and scroll down to the materials for the Aug. 14 meeting.
--Joseph Goedert
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