Read the entire interview starting with part 1 and continuing with part 2.

As the long and winding river that is EHR certification rolls along, CCHIT recently opened up its latest iteration of testing to the public. The two new offerings are “CCHIT 2011 Comprehensive” Certification and, in line with what is known today about “meaningful use,” Preliminary ARRA 2011 Certification. To drill down on the distinction between these two programs, and to learn more about CCHIT’s progress overall, HCI Editor-in-Chief Anthony Guerra talked with CCHIT Chair Mark Leavitt.

For more, take a few minutes to read the interview.

About 700 attended the call. We focused the Town Call on vendors and developers, and as expected they were the predominant group. Of note, two thirds of the vendors/developers are ‘new’ to CCHIT and do not have a currently certified product. Our new programs are clearly gaining interest beyond the current base of EHR vendors.

As we described during the call, we will be launching two programs October 7: a CCHIT Certified® 2011 program that is an updated version of our previous offerings; and a new, modular certification program called Preliminary ARRA 2011, focusing only on the Meaningful Use objectives and accompanying standards. We asked the vendors and developers about their interest in applying for these programs and received the following responses:

We recognize that these figures are only approximations – for example, there could be more than one attendee on the call from any given vendor – but the results appear to show a high level of interest in both programs. We emitted a collective ‘gulp’ when we saw how many vendors/developers intended to apply in October as soon as the programs are launched, but we’ve handled large volumes before so we know how to handle that drill. A couple of hundred more may come along in the months that follow. Only a small fraction intend to wait until final ARRA certification is available. This appears to support our contention that we can’t afford to wait – products must be available, and providers must get started right away in order to have a chance of achieving meaningful use in 2011-2012.

We received over 100 questions before, during, and after the call. We were able to answer some during the session, but we’ll answer the rest and publish that document soon.

What’s the bottom line? Well, it looks like these new programs have a good chance of delivering what is needed from certification to support an accelerated adoption of health IT in the ARRA environment. We’re expecting lots of activity in both of our certification programs starting in October. Finally, we’re gratified to see that the tremendous work our hundreds of volunteers and our dedicated staff have invested in creating and refining CCHIT’s health IT certification knowhow these past four years will serve as a strong foundation as we build for the future.

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.

One of the strong voices with that community is Fred Trotter, a staunch supporter of the FOSS for health care. He was a vocal and forthright critic of CCHIT’s previous certification scope, especially as it applied to the open source community.

CCHIT listened and then worked to incorporate the open source community’s feedback. And now, we are pleased that these changes are being well received.

Recently, Trotter offered his feedback on the efforts in a post entitled “Embracing the new CCHIT certifications“:

I am happy to say that Mark, Dennis and the other members of the CCHIT team have won my respect and appreciation with how they have taken a 90 degree turn from being an organization that was largely ignorant regarding the health FOSS movement to one that listened and engaged carefully, and has now come back with a plan for certification that I personally, and from what I can tell the FOSS community generally, can embrace.

This post is me doing that. At this stage I am comfortable recommending (to whoever is making the decision) that CCHIT be allowed to be one organization allowed to certify for ARRA funding, under their new EHR-C/EHR-M/EHR-S certification model.

For more, read Fred Trotter’s thoughts on the new CCHIT certifications.

While the funds associated with ARRA are garnering the attention, he states, it is the message the investment sends to the health care industry that is even more important:

But more important than the money itself is the message implicitly conveyed along with it. Will incentives be perceived as an intrusive, carrot-and-stick manipulation of health care providers’ business decisions? Or will health care providers interpret ARRA as the correction of a reimbursement anomaly, welcoming the opportunity to modernize their information management and transform the care they deliver.

So how should the health IT community respond? Leavitt calls for trusted leadership and creative solutions to address the issues. He also outlines how CCHIT is changing its certifications to better support the ARRA-fueled transitions in the HIT environment. Finally, he calls upon the HIT community to join the effort:

How ARRA will play out is not up to ONC alone, nor will it be determined by the choice of interoperability standards. The choice lies within the larger health IT community because collectively we set the standards that matter.

For more of Leavitt’s insights on the dynamically changing HIT enviroment, read “Health IT Under ARRA: It’s Not the Money, It’s the Message.”

We unveiled this thinking to the public in our recent Town Calls.

The initial reaction to our proposed “new paths” to CCHIT certification has been positive. For example, Modern Healthcare asked FOSS proponent Fred Trotter for his opinion on the changes to certification. His response?

Fred Trotter, a co-founder of the new Liberty Medical Software Foundation and open-source advocate, said CCHIT had done a good job in developing the new certification pathways. “The new structure is far more compatible with FOSS (free and open-source software) and effectively answered the vast majority of community complaints,” he said in an e-mailed statement.

Stay tuned for more feedback from the call, as well as answers to the questions that arose during the session.

To attend the town calls:

Tuesday, Jun 16, 2009 1:00 PM (EDT)
“New Paths to Certification: Dialog with the Open Source Community” (LiveMeeting link)
Dial-In Number: (866) 900-5706
Conference ID: 15249954

Wednesday, Jun 17, 2009 11:00 AM (EDT)
“New Paths to Certification” (LiveMeeting link)
Dial-In Number: (866) 900-5706
Conference ID: 15316708

For more information on the calls and instructions on using LiveMeeting (clients available for Windows/Mac/Linux), please see the CCHIT Town Call page.

First, I do not believe this is an appropriate use of health IT certification. Our goal, stated in almost every presentation I’ve given, and to which I’ve adhered in my leadership of the Commission, has always been to unlock positive incentives for health IT adoption. Bridges to Excellence provides a role model for integrating health IT into outcome-based, pay for performance incentives. Successfully executed, ARRA might too. But the New Jersey bill is nowhere near that. Making software purchases illegal, like dangerous substances? Let’s “just say no” to that idea.

Second, neither I personally, nor CCHIT as an organization, have lobbied, advocated, sponsored, or had anything to do with that bill. We were unaware of it until it started showing up on listserves Friday. The bill has never been mentioned in any of our Trustee, Commission, or staff meetings.

Third, our Trustees, Commissioners, and Work Group members all serve in a volunteer capacity. They have full-time careers, volunteer for other organizations, and are members of various professional associations like AAFP, AAP, ACP, AHIMA, AMDIS, AMIA, HIMSS, etc. Beyond those connections—which are inherent in any profession or industry—there is no affiliation of CCHIT with any other organization. All volunteers and staff must disclose their conflicts of interest. In the case of staff and volunteer jurors, no connection to any vendor is allowed.

This controversy nicely depicts how the health IT stakes have changed upon entering the political and legislative arena. We’ve been observing, reflecting, and recognizing we need to make some major changes ourselves. Now we’re ready to share our thoughts and plans for your feedback. Watch for a press release soon, and Town Calls to be set up for next week.

The Certification Commission for Healthcare Information Technology, Chicago, has now certified more than 50 ambulatory electronic health record applications under its 2008 criteria. Since mid-May, CCHIT has certified 10 more applications.

For more, see “More CCHIT Certifications Announced.”