Dr. Bell, who I first met while doing research on the PHR market, was instrumental in having me present to then Sec. Leavitt on consumer-facing healthcare technology trends – still one of the highlights of my relatively short career as a healthcare industry analyst.  Since that presentation in 2008, my relationship with Dr. Bell has deepened and she has been one of several key mentors who have assisted me in understanding the healthcare IT market.

So, now that Dr. Bell has accepted this position to take over the reigns at CCHIT immediately, what might we expect:

Dr. Bell knows Washington DC and HHS quite well from her many years there.  She is effective in a highly politicized environment and will be able to effectively lead CCHIT through that political minefield.

She also knows the issues and is fairly competent on the technical side of the fence, though certainly not a coder.  Dr. Bell may be one of the better choices for CCHIT as she can advocate for this organization at a time when many still call into question its very existence.  Of course, that existence has been somewhat guaranteed by ARRA legislative language (was this put in by HIMSS/CCHIT lobbying efforts?) that states organizations will receive incentive reimbursement for “meaningful use of certified EHRs“.

Dr. Bell will put up a Chinese Wall between CCHIT and the HIT vendor organization, HIMSS.  She is fully aware of the perceived conflicts of interest between CCHIT and HIMSS and will seek to create some distance between these two organizations.

A strong advocate of consumer control of PHI, interoperability of EHRs, and the need for “open” HIE platforms/apps one can expect Dr. Bell to put extra emphasis on these issues at CCHIT within the context of certification requirements.  This actually works out just fine with HHS as that is just what they are looking to foster with ARRA funding.

But what is less clear about Dr. Bell’s future role at CCHIT is how she will lead this organization forward in bringing together those that truly know HIT (reaching beyond the vendor community), the challenges of adoption (e.g., workflow), the cumbersomeness of many apps (plenty of them already having been blessed in the past by CCHIT), the need to create a certification structure and pricing model that fosters innovation rather than stunts it (CCHIT certification is still too expensive for many young, innovative companies) and finally, insuring that CCHIT does not over-reach (as it was doing under Mark Leavitt’s leadership) and focus where it can make the most meaningful impact.

This is a very tall order for anyone and while I still question even the very existence of CCHIT (have yet to see any demonstrable proof that CCHIT certification has moved the EHR/EMR adoption needle in any statistically meaningful way), I do have faith in Dr. Bell.  If anyone can right this listing ship, it is her at the tiller.

Congratulations Dr. Bell and may you see smooth sailing in the not so distant future.

Appendix:

Anthony Guerra of HealthSystemCIO has a podcast interview with Dr. Bell now up on his website.

The first document, at 136 pgs, titled: Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology is targeted at EHR vendors and those who wish to develop their own EHR platform.  This document lays out what a “certified EHR” will be as the original legislation of ARRA’s HITECH Act specifically states that incentives payments will go to those providers and hospitals who “meaningfully use certified EHR technology.”  This document does not specify any single organization (e.g. CCHIT) that will be responsible for certifying EHRs, but does provide some provisions for grandfathering those EHRs/EMRs that have previously received certification from CCHIT.

The second document at 556 pgs titled: Medicare and Medicaid Programs; Electronic Health Record Incentive Program addresses the meaningful use criteria that providers and hospitals will be required to meet to receive reimbursement for EHR adoption and use.  Hint, if you wish to begin reviewing this document, start on pg 103, Table 2.  Table 2 provides a fairly clear picture of exactly what CMS will be seeking in the meaningful use of EHRs.  In a quick cursory review CMS is keeping the bar fairly high for how physicians will use an EHR within their practice or hospital with a focus on quality reporting, CPOE, e-Prescribing and the like.  They have also maintained the right of citizens to obtain a digital copy of their medical records.  An area where they pulled back significantly is on information exchange for care coordination.  Somewhat surprising in that this was one of the key requirements written into the original ARRA legislation.  But then again not so surprising as frankly, the infrastructure (health information exchanges, HIEs) is simply not there to support such exchange of information.  A long road ahead on that front.

In Closing…

As I am on vacation and today is a powder day here in the Rockies, I will come back to this at a later date after I have had some time to review and digest these two documents.  First thought though that comes to mind is that the only initial winners here will be the consultants as few doctors have the time or inclination to pour over the 556pgs of the incentive program.  Heck, in my own brief encounters with many doctors, most have only the most cursory knowledge of the HITECH Act and that knowledge is most often full of inaccuracies.  Hopefully, those regional extension centers that HHS will be funding will go live in the very near future as there is a tremendous amount of education that needs to occur to insure this program’s future success.

The Certification workgroup presented their refined recommendations today (these were first announced at the July 16th meeting), which were subsequently approved by the broader HIT Policy Committee.  Marc Probst of InterMountain Healthcare and co-chair of the workgroup led discussions which began with a high level list of five recommendations, (see slide below).  For simplicity, we will focus on these five recommendations in our discussions as they encapsulate the entire meeting and what was ultimately approved.

In Recommendation 1 the workgroup emphasized that certification criteria must be kept at a high level, (e.g., not specify how an alert would be presented, simply that one would be presented) criteria must directly link back to supporting the meaningful use criteria that were approved on July 16th. Th workgroup also emphasized that the creation of certification criteria must be the responsibility of HHS/ONC and not a third party such as CCHIT. (Note: CMS is now converting MU criteria into actual rules – and based on some comments today, it is not an easy task.  Creating certification criteria will be easier, but still a lot to add on to the plate of HHS who already has its hands full.)

But where the workgroup wants a lot of specificity is with interoperability suggesting that HHS/CMS develop certification criteria that is quite specific to insure interoperability between systems. With such tight time-frames and deadlines in place, this issue of interoperability could become one of the most challenging aspects of the whole HITECH Act, for underlying all three workgroups (Meaningful Use, Certification and HIEs) is interoperability.  But what is interoperability anyway?  Is it computable data? Is it transmittal and sharing of PDFs? Is it order sets, med lists, labs?

Looking back, the Meaningful Use matrix does provide some guidance as to what data is to be shared for care coordination, but that still does not eliminate the challenge of creating specific criteria for interoperability that can be readily certified and put into the market.  Also, it is important to note that certification for vendors may have to occur every two years (2011, 2013, 2015) in lock-step with the ever increasing requirements for meaningful use which itself calls for ever more complex data sets to be shared.

Recommendation 2 was pretty much a no brainer as ARRA legislation specifically calls for certain enhancements to security and privacy of medical records (audit trails, consent, etc.).   Here again the workgroup emphasized the need for HHS to get aggressive on establishing clear certification guidance on interoperability as it pertains to addressing security and privacy.

It was in Recommendation 3 that the workgroup suggested that HHS allow multiple certification organizations (not just CCHIT), to conduct certifications of EHR systems stating that this will help create a competitive market for such services and increase transparency into the certification process.  The workgroup also recommended that NIST establish and execute an accreditation process for certifying organizations.

While CCHIT has certainly been marginalized, they will still play an important role in the interim.  Right now there are no other certifying organizations, the market is being quite cautious in making any large EMR purchases awaiting to see what comes out of DC and this whole certification/accreditation development and meaningful use rule-making is going to take time.  What was proposed today is that CCHIT take the lead until at least October (it will more likely end up being well into Q1’10) for mapping meaningful use criteria, as defined in the matrix, to high level certification criteria and provide an interim certification for EHR systems.  Remember, this role of CCHIT is on an interim basis and NOT permanent, though others may want you to think differently (Note, Government Health IT is owned by HIMSS a strong advocate of CCHIT.)

The workgroup also wanted to acknowledge the investments that HIT vendors have already made to get CCHIT certified.  Thus, for those vendors with 2008 CCHIT certification, they need not go through a whole re-certification once guidelines are released, but simply be certified for any gaps that may exist between these two certification processes, with the latter focused on meaningful use.

For Recommendation 4 it appears that like CCHIT, the workgroup received a lot of feedback from Open Source advocates, those that developed their own solutions and smaller software companies that have developed EHR enabling modules.  Therefore, the workgroup followed CCHIT’s lead wih a similar strategy recommending that all systems be tested equally with same high level criteria, regardless of the source of the software. They also encouraged a “flexible certification process” that will account for non-traditional software sources (eg, the RYO camp) and that there be a process to certify distinct, meaningful use enabling modules (eg, eRx).  Chilmark thought CCHIT did a good job here and it is equally good to see the workgroup recommend the same.

Recommendation 5 ties back into what we discussed earlier with regards to the future role of CCHIT – there needs to be a transition phase to account for the time-lag between the need to begin certifying EHRs for market and the lengthy rule-making process for meaningful use.  The workgroup recommends adopting what certification criteria that exists today (obviously from CCHIT) that supports meaningful use and where there are no existing criteria, work to converge criteria to meaningful use rules through close internal collaborations within HHS.

This is where it is going to get a little tricky as both the meaningful use matirx is a bit vague and well certification criteria, that is even more vague.  How do we bring convergence for all this in a timely fashion so that physicians and hospitals can begin installing certified EHRs that provide them the capability to demonstrate meaningful use in order to get their 2011 reimbursement?   We’re not sure how to get there from here, but one thing is for sure, it will be a rocky road ahead.

How much is too much?

The recommendations for meaningful use paid a fair amount of attention to the issue of consumer/patient access to their medical records.  The big question, however, is just how much access is appropriate?  Does one let the consumer see absolutely everything within the record including all notes despite how esoteric they may be, challenging to understand and potential for mis-interpretation?  For some perspective:

A very thoughtful, extremely funny and intelligent physician who goes by the twitter handle of @doc-rob wrote about his own practice’s deliberations on the subject and the comments are just as insightful as his.

The Boston Globe had an article in today’s edition on Beth Israel’s decision to let their customers/patients have full access to the complete record.

And the Wall Street Journal’s own Health Care Blog also drew attention to the Boston Globe article with again, some great comments.

Outside of mental health, where there are some extremely valid reasons for not sharing clinician notes, the consumer should indeed have full access for as we have seen in countless other industry sectors, information liberation solves far more problems that it creates.

CCHIT looking to become contortionist?

This week, CCHIT’s Mark Leavitt hosted two townhall meetings to present changes that CCHIT is considering in its certification process.  Prompting these changes is CCHIT’s clear desire to be the go-to certification entity for all “certified EHRs” which is the only technology that will receive reimburse under the HITECH Act.  Going through the slidedeck our quick conclusion was that CCHIT is bending over backwards to try and address concerns in the market about their certification process.

What Chilmark likes about the proposed changes:

A three tiered process that acknowledges different technologies and architectures for EHRs (e.g. modular apps and roll-your-own) that fall outside of the common EMR vendor model upon which CCHIT was founded.

A pricing model that is fair and reasonable.

What Chilmark is not so crazy about:

Like anything, the devil is always in the details and what CCHIT presented is still pretty thin on details.  At first glance, we see a growing complexity in the certification process as often times, software does not abide by strict boundaries.  This is especially true from EMR-Comprehensive vs. EMR-Modular.

Not convinced that CCHIT has the resources available to keep up with technology developments and changes to insure innovative products reach the market quickly.  More complexity is typically a time sink of major proportions.

The HIPAA and EMR blog’s author, John did sit in on both CCHIT townhall meetings and has a good write-up/analysis that is worth the read.

Mark Leavitt also wrote a piece for California Health Care Foundation’s iHealthBeat providing his perspective on the monumental changes coming to healthcare and of course the great role his organization plans to serve in those changes.  My advice to Mark, don’t count your chickens before they hatch.

Get a Life

Last Friday, the Pew Charitable Trust released their latest study on consumer use of the Internet for health.  Chilmark has a lot of respect for their work which is always thoughtful, well-reasoned, applies good methodology and results always have a few surprises.  Unfortunately, have yet to read the full report, only the post that the lead reseacher, Suzannah Fox, wrote on the report.  Do know this though, if you are even remotely interested in understanding how the public is using the Internet to address their health issues and also want to understand underlying demographic differences, just go read the report.  I’ll be doing that myself on Sunday as I recover from the infamous Harpoon Brewery to Brewery ride tomorrow.

The workshop itself came about as a follow-on to the paper CHIP researchers Mandl and Kohane published in NEJM last March.  Maybe with all that ARRA money floating about in the HITECH Act, ONC should just go ahead and build such an “Open” platform that supports modular apps to meet specific needs wihin this highly fragmented market.

Seriously, this needs some consideration.

Congress did grant authority in the ARRA legislation for HHS to develop an open-source EHR if existing vendor solutions do not adequately meet market needs. So, rather than build a full-fledge EHR which is almost doomed to fail in the market (despite what VistA promoters may argue) a better strategy may indeed be the building of an Open, iPhone-like platform with open SDK, open APIs, etc., heck, even throw in an AppStore (with an app review feature) and let the development community have at it.  This could really get things moving and accelerate adoption of HIT, especially in small practices where 80% of care is delivered.

Are you listening Washington?

We’ll tell the world what meaningful use is on 6/16.

Referring to the next meeting of the ONC Policy Committee.If this indeed comes true, Chilmark will feel pretty good about this as it is something we predicted back on April 30th.

Many a vendor will also breath a sigh of relief as the delay in a meaningful use definition, which is required as part of the ARRA stimulus funding for EHRs, has stalled the market.  But that raises another question: Will the market continue to keep checkbooks in their drawers awaiting the definition of “certified EHRs?”

Hopefully, when it comes to certified EHRs, ONC will take a more measured and rational approach as advocated by the likes of the Markle Foundation, Adam Bosworth (former head of Google Health and one of the original developers of XML standard), Chilmark Research and many others rather than the approach that one legislator down in the Garden State of New Jersey has proposed in recent legislation that states, and I kid you not:

A prohibition on the sale or distribution in this State of HIT products that have not been certified by CCHIT…

Needless to say, it appears (thanks Mr. HIStalk) that this legislator has fans in Chicago (HIMSS), who, as we all know, is a big time supporter of all things CCHIT.

I won’t bother with the argument that hey doc, ever hear of caveat emptor?  Take the time to actually call a reference customer or two and go see the software in action before you buy it.  I mean do you really need someone to do that work for you by way of certification when you are paying for it?

Okay, so if it is not certification, it must be all about the money so let’s pour billions of dollars into the market to encourage clinicians to adopt “certified EHRs”.  Oh, and doctor, you are going to have to pay upfront for that software, install it and prove you can use it in a meaningful fashion before we give you one red penny.  To which a clinician may reply:

Well it’s nice to see some potential dollars come my way to buy such software, but is it really worth the trouble? I mean after all, it is well-known among the peers I talk to out on the golf course that one takes a huge productivity hit for months after installing this stuff.

To which policy makers and those that echo them reply, well if productivity is an issue, than it must be an issue of usability of the EHR software so let’s set-up a process to certify usability.

Now certifying usability is virtually impossible for a whole host of reasons and worse, traveling down such a path would detrimentally impact innovation, the last thing we need in this market so lacking in such within HIT.  And no, such a certification process will have absolutely no effect on adoption of EHRs.  Adoption will occur when there is sufficient reason (value) to adopt.

But for those EHR developers out there who are looking to increase the value proposition that they can offer clinicians, certainly making their software easier to use is a good place to start.  And to learn more about usability, you may want to take a look at the presentation below that the company User Centric recently presented to the Chicago HIMSS group.  Tip: Slide 33 will give you some idea why harried docs hate eCharts and maybe more broadly, EHRs for encounters (something which athenahealth confirmed when I visited their offices today – more on that next week).

Is Leavitt’s post a desperate act from an organization who seems to be coming under increasing scrutiny for its close relationship to the HIT vendor advocacy organization, HIMSS? At first blush, the vitriol of his response comes off that way which is unfortunate and really misses the point.

Yes, there may be some questionable conflicts of interest between CCHIT and HIMSS, a relationship that remains extremely close. As an example, earlier this week Chilmark received a copy of an email that was sent by a HIMSS subcommittee to Mark Leavitt with an attached draft White Paper on “Defining & Testing EHR Usability” an area that CCHIT has made noises about certifying in the future.  Looks to us as if HIMSS is directly advising and guiding CCHIT. Is that really appropriate?

We’ll leave that for others to answer.

What Chilmark’s chief concern has been all along, and one that Dr. Kibbe shares as well as those who participated in the recent Markle Framework workshop and are signatories to the published report: Getting Health IT Right is that the potential for sole reliance on CCHIT for “certifying EHRs” under the ARRA is an extremely risky proposition, though this is exactly what HIMSS and CCHIT have been promoting all along. Reporter Dana Blackenhorn of ZDNet also has chimed in on the issue from the perspective of one who has seen more than a few similar efforts over the years covering IT.

Sole reliance on one organization such as CCHIT to certify EHRs will result in stagnation of innovation as they simply will not be able to keep up. Let’s also not forget that CCHIT certification is a fairly cumbersome and expensive process that has had little actual impact on EMR/EHR adoption, so why bother?  Maybe we need to look at self-certification models that support meaningful use of EHRs, thereby minimizing the burden on innovators and maximizing the options for providers.

Getting back to the beginning,

Leavitt may have been attempting to “set the record straight” but ultimately, his post does little to address primary concerns among many: CCHIT’s continued close relationship to a vendor advocacy organization HIMSS, nor how CCHIT will not stand in the way of innovation but promote such, nor how CCHIT can accelerate adoption and meaningful use of EHRs among clinicians.  Skipping over these critical questions and concerns does little to articulate the role that CCHIT may play in the future regarding the meaningful use of certified EHRs.

The first pertains to HITECH Act language regarding extension of HIPAA compliance to Google and Microsoft where he states:

It extends the privacy and security regulations of the Health Insurance Portability and Accountability Act to health information vendors not previously covered by the law, including businesses such as Google and Microsoft, when they partner with health care providers to create personal health records for patients.

At this time, neither Google or Microsoft provide the PHR to a hospital who then provides it to their customers.  Rather, the current model that both Google and Microsoft are using is one that supports portability of the consumer’s health record allowing the consumer to invoke an export of their records from the hospital to one of these Personal Health Systems (PHS), of course provided the hospital establishes a link to a PHS.  Our interpretation is that in this scenario, HIPAA does not extend to Google or Microsoft, as the consumer drives the transaction of data flow.  Hopefully, others in HHS will convince Blumenthal of this as well as otherwise, such HIPAA extensions may thwart portability and subsequently consumer engagement and ultimately control of their records.

The second Blumenthal comment that caught us off-guard pertained to the term “certified EHR” where he states:

ONCHIT currently contracts with a private organization, the Certification Commission for Health Information Technology, to certify EHRs as having the basic capabilities the federal government believes they need. But many certified EHRs are neither user-friendly nor designed to meet HITECH’s ambitious goal of improving quality and efficiency in the health care system. Tightening the certification process is a critical early challenge for ONCHIT.

While we certainly agree with Blumenthal that defining the critical terms of “certified EHR” and “meaningful use” is paramount and must be done quickly, yet judiciously, his views on certified EHR, as defined above are downright frightening for two reasons.

First, he condones the work of CCHIT as certifying the minimum capabilities for EHR.   Minimum capabilities?  If anything, those minimum capabilities are already restrictive in defining use of specific standards and models that do not provide the flexibility for true innovation.

What is even worse though, is that Blumenthal appears to want to extend certification requirements to “user-friendly” and defining how “quality and efficiency” will be embedded within an EHR.

User-friendly? There is simply no way you can certify such – end of story.  Let the market define what is user-friendly by what a doctor or hospital chooses to purchase.

Quality? Maybe, just maybe you can ask for the simplest of quality metrics to be recorded within the EHR, but highly doubt that is something you want to certify.  Would it not be better to simply verify quality actions supported as part of meaningful use reimbursement?

Efficiency? That is certainly not something you can certify and falls in the realm of implementation (process mapping/workflow) and training.  You can’t certify that!

Suggesting that we tighten the certification process is heading in the wrong direction.  Instead, we need to actually relax the certification process to encourage innovation in the HIT market allowing developers to create solutions that will truly provide value to their users while concurrently meeting the broader objectives of delivering better care and better outcomes.  Creating light certification criteria and focusing more on what outcomes we wish to see occur as a result of broad HIT adoption is where Blumenthal and his staff need to focus their energies.  To do otherwise will lead to a stifling of innovation, stalled HIT adoption among physicians and ultimately a poor investment of the tax payers’ dollars, which we can ill-afford.

In our post on the subject, we were miffed that rather than countering Jablonski’s claims, HIMSS, through their lawyers, sought censorship. We did not comply.

What we countered with was what we thought a great idea:

HIMSS, we at Chilmark Research will gladly offer you the opportunity to guest post on Chilmark Research where, in full view of the public/readership you can provide a point-by-point response to Jablonski’s claims.

Seems sensible to us but for some odd reason, HIMSS has yet to respond to this offer.  Is there really something to hide here?  Does the cartoon above (simply substitute CCHIT for FDA) accurately portray what is really going on here?

Honestly, we tend to side with the belief that Jablonski is in some way a very disgruntled individual (former employee, contractor etc.) who has some ax to grind and was intimately familiar with some of the inner workings of both CCHIT and HIMSS.  But disgruntled or not, Jablonski does raise some broader issues that really need far closer review and scrutiny in light of the recently passed Stimulus Bill and the HITECH Act which will pour some $20B+ into the HIT market.

In today’s issue of Healthcare IT News, Neil Versel does a very good job of reporting on the controversy surrounding the Jablonski post and interviews others in the industry, including yours truly, on what many perceive as a strong potential for conflict of interests between an organization that is charged with certifying EMRs (CCHIT) and one responsible for promoting EMRs (HIMSS).

Many industry pundits, including John Glaser, CIO of Partners and senior member of NeHC (AHIC 2.0) believe that CCHIT will be the one responsible for making sure that all those EHRs that get adopted under HITECH Act, meet the “certified EHR” requirement.  But is CCHIT really in the best position to grant certification?  In one sense yes, as they have been doing just that for the last several years and claim over 160 products are now CCHIT certified.

But given their all to close relationship with the “HIT establishment” (HIMSS and the entrenched EMR vendors), are they really the best organization to oversee certification going forward?  Probably not in their current form.  Rather than contracting out to some third party, ala CCHIT, maybe a better solution would be to just let NIST do it themselves as they are truly neutral, have been given the authority (it’s in the legislation) and if they have sufficient staff, could certainly accomplish this task.

Ideally though, would not it be better to get the legislative body to go back and simply strike “certified” from the language of the HITECT Act?  To do so would leave us with providing incentives to physicians for “the meaningful use of EHR” by still promoting such behaviors as care coordination, quality, and eRx, without the burdensome requirement for “certified” EHR that will almost always be 3-5 years, at best, behind technology advances.

And by the way, just because it is “certified” does not, by any means, equate to interoperable.  One of the biggest fallacies in the market today.