Reading the Tea Leaves in a Disclosure Document: When will ONC and NIST be prepared to accredit health IT certifying bodies?

by Mark Leavitt, MD, PhD on January 15, 2010

A recent article, reporting that NIST awarded a $400,000 contract to Booz Allen Hamilton to develop a framework for electronic health record certification, stirred up lots of questions.

We needed to find out more. It took some time to locate the source document, because the terms “health IT” and “certification” aren’t in the title – instead, it’s entitled “Justification for Other than Free and Open Competition” and it is publicly available by searching fbo.gov for Department of Commerce/NIST documents released January 13, 2010. Or just use this quick link: http://bit.ly/6p2pDD

The NIST document refers to two task areas. First, “develop testing and certification program documents in support of the HHS Health IT Certification Program.” Second, “develop accreditation program documents and a proficiency testing framework to support HHS in authorizing certification and testing organizations.” Note the work product in both cases: documents, not actual programs. We see nothing here to suggest that ONC, NIST, or Booz Allen intend to build and operate a certification program themselves. They do need to develop a well-defined set of policies and processes for accreditation of those programs.

In the Interim Final Rule, ONC said they “decided to proceed with a separate notice and comment rulemaking (which we anticipate publishing shortly after this interim final rule) to establish the policies for the certification of HIT and the process a certification body will need to follow to become an authorized certification body, as determined by the National Coordinator.” [our italics] We think that’s still the most reliable description of what’s underway.

But the NIST document does offer some timing clues. This particular contract, described as a bridge to an upcoming acquisition (i.e. contract) runs 3 months, with a 3 month optional extension. Sounds to us like the soonest the accreditation package would be ready is July 2010, and of course the certifying bodies then have to apply and qualify. By which time, in our opinion, it would be impossible for a provider or hospital to begin shopping for a certified EHR and achieve Stage 1 Meaningful Use in time for the 2011 or 2012 incentives. Let us know if you agree with that assessment.

It appears clearer than ever how crucial our current work is to the health care community and to the practical achievement of the ARRA goals. Next week we’ll release an analysis of the gaps between our current 2011 criteria and the IFR, as well as a plan for promptly closing the gaps.

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Will your EHR meet meaningful use? Majority of providers say “Yes”

by CCHIT Staff on January 6, 2010

A new report from KLAS indicates that 85% of providers believe their electronic health record (EHR) will help them qualify for federal “meaningful use” standards.

For the report, KLAS interviewed more than 1,400 health care providers about their experiences with EHR products from 26 vendors. The survey asked the providers whether they thought their EHRs would meet the preliminary meaningful use recommendations issued by the Health IT Policy Committee in July (Monegain, Healthcare IT News, 1/6).

The survey found that health care providers using athenahealth, Epic and NextGen EHR products had the highest confidence that their systems would meet the meaningful use requirements.

For more on the report, read iHealthbeat.

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EHR Certification under ARRA: Early Trends

by Mark Leavitt, MD, PhD on December 7, 2009

On October 7, CCHIT launched its new 2011 certification programs. We announced results from the first few inspections last week and have more underway, but with everyone eager for predictions about “life under ARRA” we thought it might be helpful to share some details that point to early trends.

Since opening up the two 2011 programs a month ago, we’ve received a total of 25 applications already. About two-thirds are for the CCHIT Comprehensive program – which aims for maximal assurance to EHR buyers — and one-third for the Preliminary ARRA program which maximizes flexibility instead.

Within the Comprehensive program, the optional add-on programs are proving popular, with a total of 12 applications seeking to demonstrate these extra qualifications. Although most Comprehensive applications are for Ambulatory EHR, as expected, we have Inpatient, Emergency Department, and ePrescribing vendors in the mix as well.

Under the Preliminary ARRA program, two-thirds of the products are for Eligible Providers and one-third are targeted to Hospitals. We’re also seeing a nice spread between vendors focusing on just a few meaningful use objectives, those aiming for all of them, and some more in between.

It’s too early for statistical analysis, but some things are becoming apparent. First, it looks like our decision to move ahead rather than waiting for final rules next summer was valid. And we believe these numbers will accelerate once the upcoming ONC and CMS postings help to reduce the general uncertainty. Second, it looks like a sizable and diverse group of certified products will be available in the pipeline, and that’s good news for the whole ARRA initiative.

But let’s not minimize the challenges ahead. We’ve also been gathering data on how well providers and hospitals understand the ARRA incentives, the role of certification, and the fact that having certified EHR technology is only the first step on a complex road to meaningful use. The scores here are not good. At a focus group we held for non-EHR-using physicians, awareness of the meaningful use concept was essentially zero. In recent conversations with hospital representatives, we find their understanding is much better, but fear and doubt scores run high.

We’re going to do our best to make certification efficient to obtain, and easy to understand, but explaining and motivating meaningful use to hundreds and thousands of doctors, nurses, and managers will take a coordinated effort from everyone in health IT. To do our part, we plan to increase the number of Town Calls and educational programs we offer, and we look forward to partnering with others in the public and private sector to maximize effective outreach and communications. We would be pleased to hear your ideas about how to take on this challenge as well.

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Having an EHR alone is not sufficient says National Coordinator for Health Information Technology

by Alisa Ray on December 1, 2009

David Blumenthal, MD, MPP, the National Coordinator for Health Information Technology, has some thoughts on the future of healthcare in the United States. But at the core of his argument is a very simple premise: “having an EHR alone is not sufficient.”

To the extent that they accurately capture past experience with EHRs, these studies illustrate something that the Congress and the President understand and have allowed for:  namely, that having an EHR alone is not sufficient.  Doctors and hospitals have to use this technology effectively, have to employ its extraordinary power to improve clinical decisions, in order to achieve its potential benefits.  The federal government’s new programs of incentives and penalties are totally focused on encouraging the meaningful use of EHRs.  The resources set aside by the Congress to encourage the adoption of EHRs will go only to physicians, hospitals, and other providers who meet carefully designed new requirements for the use of EHRs that will translate into health improvements and cost reductions for the American people.  And the plan passed by Congress includes new resources and support that will help make it possible for providers and hospitals to meet these requirements.

For more, read Blumenthal’s post on “The Evidence for HIT.”

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CCHIT announces new comprehensive certification and preliminary ARRA products

by Alisa Ray on December 1, 2009

Today, the Certification Commission announced the first group of products certified under its two new programs—CCHIT Certified® 2011 Comprehensive and Preliminary ARRA 2011.

The CCHIT Certified 2011 Comprehensive program differs from the Preliminary ARRA certification program by providing a more rigorous inspection of integrated EHR functionality, interoperability, and security in addition to full compliance with Federal standards.  As part of the Comprehensive inspection process, key aspects of successful use are verified at live sites, and usability is rated.  The CCHIT Certified Comprehensive program is intended to serve health care providers looking for maximal assurance that a product will meet their complex needs, as well as support their achievement of meaningful use to qualify for the ARRA financial incentives.

The product certified in the CCHIT Certified 2011 Comprehensive program is ABELMed EHR-EMR/PM, Version 11, by ABEL Medical Software Inc.

The Preliminary ARRA 2011 program is a modular, limited certification and inspects technology only against the Federal standards. It offers maximal flexibility for health IT companies, developers and providers in meeting ARRA 2011-2012 certification requirements. The products certified in the Preliminary ARRA 2011 program are:

For more information on the products and the new programs, read the press release from the Certification Commission.

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Healthcare Informatics: One-on-One With CCHIT Chair Mark Leavitt, part 2

by CCHIT Staff on November 2, 2009

Anthony Guerra of Healthcare Informatics continues his interview with CCHIT Chair Mark Leavitt, MD, PhD. In part 2, they discuss the policy committee’s recommendations, CCHIT’s response to those recommendations, and the effects of ARRA on certification.

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

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Healthcare Informatics: One-on-One With CCHIT Chair Mark Leavitt

by CCHIT Staff on October 15, 2009

Anthony Guerra of Healthcare Informatics has posted his interview with CCHIT Chair Mark Leavitt, MD, PhD.

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.

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Results from Our September 3 Town Call on New 2011 Certification Programs

by Mark Leavitt, MD, PhD on September 8, 2009

On September 3, we held a Town Call to gather feedback from vendors and developers about our launch plans for new 2011 certification programs. What we heard was very encouraging and we’d like to share those results. To put the results in context if you didn’t attend the Town Call, you may want to review the presentation slides or even a full recording of the meeting.

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.

Poll: Which best describes your role?

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:

Poll: Tell us your plans regarding certification

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.

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A Clearer Path Forward for Health IT Certification

by Mark Leavitt, MD, PhD on August 17, 2009

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.

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Fred Trotter on open source and the new CCHIT certifications

by CCHIT Staff on June 25, 2009

We recently unveiled new options for CCHIT certification in a series of Town Calls. One of those calls was specifically designed to address the guidance we had received from the open source and FOSS (free and open source software) community.

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.

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