HL7 calls for changes to ONC's plan for health IT certification

By Bernie Monegain
09:21 AM

Standards organization Health Level Seven International is urging the United Sates to move full speed ahead with its programs for the voluntary certification of health information technology – with what the group calls "reasonable and important modifications."

Health Level Seven International (HL7) is a not-for-profit, ANSI-accredited standards developing organization (SDO), with more than 2,300 members representing about 500 organizations which comprise more than 90 percent of the healthcare information systems vendors in the United States.

In a formal comment to the Office of the National Coordinator for Health Information Technology regarding the government's proposed rule for certification programs, Robert H. Dolin, MD, chairman of HL7 International, and Charles Jaffe, MD, its CEO, wrote that "the Proposed Rule on establishment of certification programs for health information technology (HIT) marks an important step forward in the nation's efforts to improve health care by putting highly functional electronic health record systems (EHR-S) at the fingertips of medical professionals and consumers alike."

In comments to ONC, they note that HL7 has a history of working with the federal government. In 2003, the Centers for Medicare & Medicaid Services and the Department of Health and Human Services approached HL7 to develop functional requirements for EHR systems, so that such requirements could be used to certify EHR systems and support EHR adoption incentives. As a result of this relationship, HL7 produced the EHR-S Functional Model (EHR-S FM) as well as derived functional profiles such as Emergency Health, Child Health, Behavioral Health and Long Term and Post Acute Care that specify a number of conformance criteria.

The Certification Commission for Health Information Technology (CCHIT) has already used the EHR-S FM and its profiles to develop certification criteria. Therefore, the value of these standards for certification purposes has already been established.

HL7 made these recommendations:

  • That ONC continue to include functional requirements as part of the certification program.
  • Since NIST is already familiar with the HL7 EHR-S FM and its profiles, HL7 recommends that it include the criteria that certifying bodies such as CCHIT have derived from them in the NIST criteria for test labs.
  • That HIT other than EHR systems be certified. To support and accelerate the certification of other HIT, HL7 has developed the PHR System Functional Model (PHR-S FM), which can be used in a manner similar to that in which the EHR-S FM has been used for certification purposes. Moreover, HL7 recommends that interoperability of EHR systems across the continuum of care be certified. To support that effort, the current profiles for the Emergency Department, Long Term and Post Acute Care, Behavioral Health, and Child Health can be used.
  • HL7 notes 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. HL7 recommends that NIST and the National Voluntary Laboratory Accreditation Program (NVLAP) be required to consult with these bodies, and that a formal relationship between NIST and NVLAP and the developers of standards selected under 170 CFR Part 45 be established under this rule.
  • That existing and off-the-shelf tools, where and when they exist, be used to automate testing. HL7, for example, has developed and approved as an ANSI standard, a set of Conformance Profiles that are used with the Messaging Workbench to directly support automated conformance testing in Version 2. Similar tools available through HL7 and other SDOs should be used when possible.

Click here for the full document detailing HL7 International's comments.