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ONC Regulation FAQs

#23 Question [12-10-023-2]

Could an interface that transmits lab results in HL7 message format between a hospital laboratory system and a physician’s EHR (presuming that the transmissions were occurring between two different legal entities) satisfy the certification criteria related to the exchange of key clinical information in 45 CFR 170.304(i) and 45 CFR 170.306(f)? If not, please specify the required data types and exchange characteristics that must be part of the required clinical information exchange.

Answer:

As implied in the question, for certification a Complete EHR or an EHR Module must have the capability to electronically receive and display, and transmit certain key clinical information in accordance with one of two separate certification criteria (45 CFR 170.304(i) or 45 CFR 170.306(f)), depending on the setting for which the EHR technology is designed (ambulatory or inpatient, respectively). Generally speaking, these certification criteria require two types of information exchange capabilities – the capability to:

  1. Electronically receive and display a patient’s summary record, from other providers and organizations including, at a minimum, diagnostic tests results, problem list, medication list, and medication allergy list in accordance with the continuity of care document (CCD) standard (and the HITSP/C321 implementation specifications) or the continuity of care record (CCR) standard and that upon receipt of a patient summary record formatted according to the alternative standard, display it in human readable format.
  2. Electronically transmit a patient summary record to other providers and organizations including, at a minimum, diagnostic test results, problem list, medication list, and medication allergy list using the CCD standard (and the HITSP/C32 implementation specifications) or the CCR standard while also representing specific named data elements (problems, laboratory test results, and medications) according to adopted standards.

Note: The above uses language from 45 CFR 170.304(i). The certification criterion adopted at 45 CFR 170.306(f) also includes “procedures” as a required, standardized data element within these exchange capabilities.

Therefore, an interface that transmits lab results in HL7 message format between a hospital laboratory system and a physician’s EHR (where the transmission is occurring between two different legal entities) would not qualify as an exchange of key clinical information that complies with the requirements of either of these two certification criteria. The interface would not satisfy the required capabilities included within the adopted certification criteria, and more specifically, the ability to transmit a patient summary record in accordance with the CCD standard (and the HITSP/C32 implementation specifications) or the CCR standard.

Note: This answer is only relevant to 2011 Edition EHR certification as the “exchange clinical information and patient summary record” certification criteria were revised and included in the “transition of care” certification criteria at 45 CFR 170.314(b)(1) and (2) as part of the 2014 Edition EHR certification criteria.

  1. HITSP Summary Documents Using HL7 Continuity of Care Document (CCD)

 

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