Health Level Seven International (HL7) has strongly recommended that health IT other than EHR systems be certified in its comments to the Office of the National Coordinator for Health IT (ONC) supporting forward movement on the development of programs for the voluntary certification of health IT.
“HL7 recommends that interoperability of EHR systems across the continuum of care be certified,” wrote Robert H. Dolin, MD, chair of HL7, and Charles Jaffe, MD, PhD, chair, CEO of HL7, based in Ann Arbor, Mich.
HL7 believes the proposed rule on certification programs for health IT marks an "important step" forward in the nation’s efforts to improve healthcare by putting highly functional EHRs at the fingertips of medical professionals and consumers alike, according to the organization.
Dolin and Jaffe wrote that a first step is ensuring that eligible professionals and hospitals can achieve adoption and meaningful use of qualified, certified EHR technology. “HL7 believes that these programs, once established, can test and certify other types and aspects of health IT in the future,” the authors wrote.
According to HL7, the Centers for Medicare & Medicaid Services (CMS) and Health and Human Services (HHS) approached HL7 in 2003 to develop functional requirements for EHR systems, so that such requirements could be used to certify EHR systems and support EHR adoption incentives resulting with HL7 producing the EHRs Functional Model (FM) as well as deriving functional profiles.
The Certification Commission for Health IT (CCHIT) has already used the EHRs FM and its profiles to develop certification criteria thus establishing the value for these standards for certification purposes, stated HL7. Dolin and Jaffe wrote that ONC should continue to include functional requirements as part of the certification program.
HL7 also pointed out that The National Institute of Standards and Technology (NIST) was involved in the development of the EHRs FM and the methodology to conform to the profiles. “Since NIST is already familiar with the EHRs FM and its profiles, HL7 recommends that it include the criteria that certifying bodies such as CCHIT have derived from these standards in the NIST criteria for test labs,” wrote the authors.
Finally, HL7 commented that the proposed rule does not make any provision for consultation with authoritative bodies with respect to interpretation of standards and implementation guides when such questions arise.
These expert organizations can provide NIST with vital input and review of its testing criteria, according to HL7. The organization recommended that NIST and the National Voluntary Laboratory Accreditation Program (NVLAP) be required to consult with the bodies, including HL7.
HL7 also proposed the addition of a requirement that test scripts based on standards and implementation specifications be reviewed by the publisher of the standards and/or implementation specifications, and that NIST or NVLAP be required to consider comments from the standards developing organization resulting from this review, prior to publication of final test scripts.
To read the letter to ONC in its entirety, click here.