Monday, October 4, 2010

Clarifying Certification

NOTE  - this post was extensively revised at 3pm on October 4, 2010 based on new information from authoritative sources.

On October 1, CCHIT announced certification of 33 complete and modular EHRs.  Drummond Group announced 3 certifications.

Meaningful Users must utilize "Certified EHR Technology".   Many folks are asking about the terms "complete EHR certification", "modular EHR certification", and "site certification". Let's start with the regulatory definition of �Certified EHR Technology� and what it takes to meet that definition.  How this certification is achieved - complete, modular, or site does not make a difference.

45 CFR 170.102
Certified EHR Technology means:
(1) A Complete EHR that meets the requirements included in the definition of a Qualified EHR and has been tested and certified in accordance with the certification program established by the National Coordinator as having met all applicable certification criteria adopted by the Secretary; or
(2) A combination of EHR Modules in which each constituent EHR Module of the combination has been tested and certified in accordance with the certification program established by the National Coordinator as having met all applicable certification criteria adopted by the Secretary, and the resultant combination also meets the requirements included in the definition of a Qualified EHR.

Complete EHR means EHR technology that has been developed to meet, at a minimum, all applicable certification criteria adopted by the Secretary.

EHR Module means any service, component, or combination thereof that can meet the requirements of at least one certification criterion adopted by the Secretary.

For example �all applicable certification criteria� for an Certified EHR Technology designed for an ambulatory setting would be to all certification criteria adopted at 45 CFR 170.302 and 170.304 (general certification criteria, and ambulatory specific certification criteria).  For inpatient EHRs it would be 45 CFR 170.302 and 170.306 (general certification criteria, and inpatient specific certification criteria)

Regardless of whether one uses a Complete EHR, a combination of EHR Modules or a Site certification, all certification criteria need to be met in all settings.  In other words, a proper combination of EHR Modules, if seen as a black box, would be a Complete EHR.  In order to meet the definition of Certified EHR Technology, no matter how one achieves it (using a Complete EHR, combination of EHR Modules, or Site Certification) all the boxes need to be checked.   See this FAQ posted by ONC.

It's likely that many existing EHRs will achieve modular certification - having most but not all needed functionality.   It's perfectly reasonable to use your existing EHR for the majority of the functionality you need, then supplement it with a data warehouse or health information exchange to achieve all the certifications necessary.

There will be many interesting lessons learned in this first round of certification.

1.  As I've reported previously, the Syndromic Surveillance implementation guide in the Standards Final rule is incorrect.   However, until it is fixed, vendors must implement the wrong data exchange in order to be certified because that is what the NIST testing site specifies.

2.  Some vendors may opt to be modular EHRs now and evolve to become complete EHRs as data exchange issues are clarified.  

3.  Testing procedures are going to evolve in these early days of certification and that is going to be challenging for vendors to support.   For example, NIST currently offers an e-prescribing validation procedure for NCPDP e-Prescribing formats using EDI but not XML implementations.  The HIT Standards Committee and the Standards Final Rule did not limit the transaction to just the EDI type.   Thus, it's likely NIST will change their testing criteria to support both EDI and XML.

  In the end, it will fall to the purchaser to ensure their goals are aligned with vendor plans.     If purchasers are seeking modules to expand the capabilities of an existing EHR, that should be clear.   If purchasers want a complete EHR and their preferred vendor is currently a module,  purchasers should request an agreement that the vendor will offer a complete EHR in a set period of time.
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