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.


Anonymous said...

"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."

Can you please clarify, "all criteria... need to be met"? Does a hospital have to certify for menu items it chooses not to achieve in Stage 1?

John Halamka said...

Yes, a hospital must have software certified for the items it choses not to achieve in Stage 1. I've just added an FAQ from ONC/HHS stating this to my post.

Anonymous said...

One related comment to this is the modular certification. Let me explain with an example - A vendor has, say, 22 of 25 objectives required for certification, which would include the 15 core objectives and 7 of the 10 menu set objectives including the 2 Public Health ones. If a Eligible Provider adopts this solution, will they qualify for MU incentives? In this case, the vendor has modular certification for these 22 modules. The ONC FAQ seems to indicate on page 17 that the vendor should be fully certified on all applicable criteria adopted by the Secretary. If the EP is clear on which 5 menu set objectives they are going to defer and only wants to adopt the 20 modules that make sense to them, why would it be necessary for the vendor to certified on all 25 objectives? Otherwise, standalone solutions, like ePrescribing vendors, will be forced to partner with other modular solutions to offer a complete EHR to customers which is not going to feasible. Can you elaborate your thoughts on this?

John Halamka said...

You've identified the issue precisely. Such a product would NOT quality a clinician for meaningful use. All 25 functions need to be available from modules, even though a clinician only has to attest to using 20 of the them. Stand alone eRx vendors will only achieve modular certification and clinicians will have to use multiple products to achieve "Certified EHR technology" and thus qualify for meaningful use.

Anonymous said...

Thanks for your response. In the eRx example then, would the physician have to "collect" all 25 certified modules from multiple vendors first, then adopt only 20 and qualify for the incentive? Or would they have to only gather the 20 certified modules that they wish to adopt and report on those. What confuses me is if a physician who is integrating certified EHR modules from multiple vendors should not be required to purchase all 25 modules but only adopt 20. Your thoughts on this would be highly appreciated.

John Halamka said...

You are correct. All eligible professionals need to acquire modules with 25 capabilities to achieve the designated "Certified EHR technology". They can then choose which 20 meaningful use criteria to adopt and attest.

Anonymous said...

Specialist EPs with clinical workflows and HIT needs that do not resemble preventive medicine/primary care really need to satisfy the definition of "certified EHR technology" via the EHR Module combination pathway. What I mean is that many EPs do not have a clinical or business use case for Complete EHR products. Instead, they will rely on their specialty IS vendors to get products such as LIS, AIMS, RIS/PACS, etc, certified for as many criteria in 45 CFR 170.302 and 304 as feasible, then must plug in the gaps with "filler" modules certified against any missing criteria.

A better way to define "certified EHR technology" via the modular pathway in the Stage 2 regulations would be to state that combinations of EHR Modules should only need to encompass the certification criteria that directly correspond with CMS meaningful use measures the individual EP needs to satisfy. This removes the requirement that EPs must have access to EHR Modules certified against ONC criteria that correspond with CMS measures for which the EP meets the exclusion criteria (e.g., implementing an eRx module and a CPOE/medications module even though you write <100 prescriptions in an EHR reporting period, and are thus excluded from the CPOE and eRx measures).

Brent Antony said...


After reviewing the initial entries on the CHPL and participating in numerous discussions over the last week on certification and the impact, I appreciate the concise summary. In particular, the clarification on core and menu items is particularly helpful as this seems to be an area of confusion.