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Did the government get it right on EHR certification?

Glenn Laffel, MD, PhD
Health Technology
January 22, 2010
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Last week, the Office of the National Coordinator for Health Information Technology (ONC) released criteria that will be used to certify EHRs as appropriate support tools for providers who want to qualify for Bonanza Days.

The criteria are subject to a 60-day comment period before being finalized.

I congratulate ONC on its elegant piece of rule making. Its so-called Interim Final Rule (IFR) provides a foundation that can support years of progress in health care IT. Someday, it will probably be recognized as the most important quality-enhancing, cost-reducing initiative ever launched by the Feds in health care.

Certainly its agenda is more transformational than the hodgepodge, incremental approach being used to “reform” our nation’s health care system.

ONC’s Interim Final Rule is deftly articulated with existing legislation, which is no small feat since health care is so heavily regulated. In its own jurisdiction, the IFR sets direction clearly and aggressively. It reconciles cultural, bureaucratic and legal issues to get Medicare and Medicaid more or less aligned and supportive of the rule making, and it works well with the CMS companion document, a Notice of Proposed Rulemaking that outlines Meaningful Use.

The IFR is also appropriately incremental in its approach: its 3-stage implementation scheme correctly anticipates a decade of work to enhance the interoperability, functionality, utility, and security of health information technology in this country.

For those who believe the implementation timeframes—even for Stage 1 criteria—are too aggressive, it is well to remember that these were set by the HITECH legislation, not by ONC. ONC had no choice but to make those timeframes work.

But the thing I most admire about ONC’s IFR is that it manages to create a marketplace that both gives the Big Iron EHR vendors a chance to survive and clears a path for innovators in the space.

To do this, ONC riffed on HITECH verbiage which featured the joined phrase, “EHR Technology,” rather than the single phrase, “EHR.” ONC interpreted Congress’ intent in this regard to mean that it expected providers to implement several technological components, or “EHR Modules,” rather than a complete, all-in-one solution when it came time to demonstrate Meaningful Use.

This interpretation has already proved prescient. Beth Israel Deaconess Hospital’s CIO, John Halamka, who doubles as the Vice Chair of ONC’s HIT Standards Committee, recently confided that his hospital’s system will require partnerships with approximately six 3rd party vendors in order to qualify for HHS certification, for example.

ONC defines the term “EHR Module” to mean any service, component, or combination thereof that can meet the requirements of at least one certification criterion. Examples include:

– software or interfaces that enable the electronic exchange of health information
– software that lets individuals access health information contained in EHRs
– clinical decision support rules engines
– software that enables quality reporting.

EHR Modules are a godsend for legacy vendors to the extent that their systems cannot accommodate certain certification criteria. In such instances, the legacy vendor can simply contract with a third party to offer the service, or better, acquire the vendor.

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But ONC also envisions EHR Modules as central to its strategy for accelerating the pace innovation in the EHR marketplace, a strategy that was first proposed by Mandl and Kohane and that is being actualized by David Kibbe and colleagues at the Clinical Groupware Collaborative.

The idea is that future-state EHRs will evolve into open platforms, like the iPhone or Facebook, a phenomenon that would allow enterprising companies to develop “apps” that plug into the platform. This accelerates innovation by letting niche vendors focus on the things they do best, and creating an open market in which the swappable apps compete on price and performance.

Essentially, ONC wants the HIT marketplace to look like the one for consumer electronics, in which those interested in installing a home theater can buy a flat-panel TV, a DVD player and a stereo system from 3 different vendors, or one, whatever they prefer. The pace of innovation in that space has been remarkable in the last decade.

It’s all pretty impressive to me. Yes, I remain worried that there isn’t going to be enough time for interested providers to acquire, learn and meaningfully use their EHRs in time for Bonanza Days. Yes, I would prefer to see ONC specify all 3 stages of the EHR certification now because that would help my company make better decisions for the long-term. But all that’s for another day.

Right now, my hat is off to ONC.

Glenn Laffel is Sr. VP, Clinical Affairs at Practice Fusion.

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Did the government get it right on EHR certification?
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