A Clearer Path Forward for Health IT Certification

Although the stated intent of the American Recovery and Reinvestment Act (ARRA) was economic stimulus, we’ve seen a paradoxical deceleration in health IT investment since then. Why the slowdown? In a word, uncertainty—uncertainty about the definition of meaningful use, about how EHR technology will be certified, and about how eligible providers and hospitals will qualify for the ARRA incentive payments. But now there’s good news: some of the fog surrounding certification was lifted last week.

On August 11, we supplied ONC and the Advisory Committees the results of an intensive effort by CCHIT staff and many volunteers: a set of Candidate HHS Certification Criteria structured around the Meaningful Use matrix, with detailed cross-mapping against current CCHIT criteria. Although the material is preliminary, we think it will increase your understanding about the direction of HHS Certification. The materials responding to the HSS recommendations are available on the CCHIT website (Note: Zip file).

On August 14, the HIT Policy Committee met and approved a number of recommendations (Note: PowerPoint file) from the Certification and Adoption Workgroup regarding certification. We have been working collaboratively with the Committee, we concur with their recommendations, and our plans are consistent with them. But those plans include substantial changes from our work prior to ARRA’s passage, which you need to understand:

• There will be a new form of certification. The Policy Committee recommended the term HHS Certified. (The labeling could change if there are issues.)
• The criteria for HHS Certification are recommended by the Standards Committee to ONC, then submitted for a formal approval process at HHS. As an experienced certifying body, CCHIT is offering suggestions and advice during the comment process, just as other stakeholders are.
• The Policy Committee recommended that ONC work with NIST to develop an accreditation process for certifying bodies and not place a formal limit on the number of entities that can be accredited. CCHIT agrees with this recommendation and looks forward to complying with a rigorous process that validates the independence and capabilities of health IT certifying bodies.
• The Committee recognized the importance of leveraging work to date and maintaining momentum. For the near future—until the accreditation process is developed and operational — the Policy Committee recommended that CCHIT continue as the certifying body, granting Preliminary HHS Certified status for EHR technologies.
• The Policy Committee recommended that HHS Certification be offered to modular products and that there be flexible approaches for non-vendor software. To address this, we’ve already announced new policies to accommodate open source software as well as site certification. Regarding modular products, you’ll find the Candidate HHS Certification Criteria are divided into components that correspond to the Meaningful Use objectives. Although all vendors must comply with Security and Privacy requirements, they may decide which components of Meaningful Use they support – one, several, or all of them. We’ll include a certification facts label to clearly indicate which components are supported by every product or service.

There is one Policy Committee recommendation that might create a misperception. The Committee suggested that CCHIT 2008 Certified products could gain Preliminary 2011 HHS Certification by testing against the “Gap Criteria”. While we may be able to reduce the amount of testing and the corresponding fee for products that were 2008 Certified, it would be unfair to constrain access to certification to only those products. When we open in early October, we will accept applications from all technology vendors—whether previously certified or new to the process—and give them equal priority within our well established first-come, first-served process.

When we launch our new programs in October, we will be offering both Preliminary 2011 HHS Certification as well as 2011 CCHIT Certification. We know EHR technology developers and vendors will have many questions about those two programs, the differences between them, and the changes that have taken place since last year. To learn more, stay tuned for announcements about upcoming communications events—teleconferences as well as in-person educational sessions.