Wednesday, January 22, 2014

Advice to the New National Coordinator

Karen DeSalvo started as the new National Coordinator for Healthcare Information Technology on January 13, 2014.   After my brief discussion with her last week, I can already tell she's a good listener, aware of the issues, and is passionate about using healthcare IT as a tool to improve population health.  

What advice would I give her, given the current state of healthcare IT stakeholders?

1.  Rethink the Certification Program -  With a new National Coordinator, we have an opportunity to redesign certification. As I've written about previously some of the 2014 Certification test procedures have negatively impacted the healthcare IT industry by being overly prescriptive and by requiring functionality/workflows that are unlikely to be used in the real world.   One of the most negative aspects of 2014 certification is the concept of "certification only".   No actual clinical use or attestation is required but software must be engineered to incorporate standards/processes which are not yet mature.   An example is the "transmit" portion of the view/download/transmit patient/family engagement requirements.   There is not yet an ecosystem for patients to "transmit" using CCDA and Direct, yet vendors are required to implement complex functionality that few can use.   I completely support the idea of "transmit", but it should have waited until the ecosystem was mature enough to make it an attestation requirement.  Another example is the use of QRDA I and QRDA III for quality reporting.   CMS cannot yet receive such files but EHRs must send them in order to be certified.   The result of this certification burden is a delay in 2014 certified product availability.   Certification should focus on rigorous interoperability testing, using mature standards, in practical use cases, supported by the evidence and experience.

2.  Evaluate the collective timelines of Meaningful Use, ICD10-CM, ACA and the HIPAA Omnibus Rule - Thousands of pages of regulations are hitting the industry at the same time and it's clear that like, haste will make waste.   My suggestion - extend Meaningful Use Stage 2 Year One attestation by 6-12 months (not just delay Stage 3 a year as has already been done) to enable clinicians to install certified software, redesign workflows, be properly trained, and educate their patients about the new functionality available.   I realize this may be a regulatory leap, but I've seen new rule making done as corrective action in the past.  Although I believe ICD10-CM requires more testing (the CMS planned March testing is not enough) and most applications will not contain the clinical documentation improvement features needed for clinicians to adequately justify the new codes, most hospitals have put so much time and resources into ICD-10-CM projects that they cannot afford to extend the project beyond October 1.  For ACA, re-evaluate quality measure submission requirements per point #4 below.   For the HIPAA Omnibus Rule, rethink the accounting of disclosures scope and timing.

3.  Declare victory for Meaningful Use -  Stage 1 of Meaningful Use was a phenomenal success.   Adoption rates of good EHRs by hospitals and eligible professionals has tripled.   Public health reporting and interoperability are accelerating.   Awareness of security issues has markedly improved.   Stage 1 was seen as a tide floating all boats.   Stage 2 was greeted with less excitement.   It exceeded the capacity of many organizations from a technology, policy, and workflow perspective.  It has been described as a burden that has slowed innovation, consumed industry resources, and co-opted local agendas for quality improvement projects.   However, it has many benefits and those gains can be captured with enough time.   By the end of Meaningful Use Stage 2, hospitals and eligible professionals will have reached a breaking point in their capacity to absorb regulatory burdens, so we have to progress beyond 2017 very thoughtfully.   If our policy goals are outcomes based, then we should offer a Stage 3 regulation which enables organizations to qualify for incentives if outcomes are achieved using IT as an enabler.   We should not prescribe specific functionality for the EHR other than interoperability and security.  As noted in point #1, focusing on certification and attestation for interoperability is reasonable as long as there are no "certification only" functions mandated.     We should eliminate penalties for non-compliance with Stage 3 and return EHR innovation to customers and vendors.   Meaningful Use will have succeeded if we capture the gains of Stage 1 and 2, then focus on Stage 3 incentives that drive us to better outcomes, rather than penalizing providers for not checking more attestation boxes.

4.  Fund pilots and research -  We are on the cusp of a sea change in interoperability, population management, and clinical decision support.   CCD led to CCDA which leads to FHIR for content summary exchange.    The Direct protocol will evolve to a RESTful interface using OAuth/OpenID for trust fabric creation.   However, we're not going to make the move to FHIR and REST unless pilots (followed by agile development of implementation guides) are funded to enable incremental progress.   FHIR is too new and REST has too many industry skeptics.   The pilots will create a tipping point which mitigates risk and enables progress.   Also, two of the great challenges in informatics - automated quality measures (QueryHealth and HQMF) and nationally curated decision support (Health eDecisions) would benefit from pilots.   In point #1 I noted that we need mature standards but at present our quality measurement and decision support standards are immature.   If we pilot them and revise them, we'll mitigate risk and can consider the use of quality and decision support standards which are optimized for purpose in future interoperability certification.

5.  Continue the ONC convening function for standards, privacy/security, and hearings to capture lessons learned about adoption/implementation -  ONC provides a very important and unique convening function in which issues can be discussed by multiple stakeholders.   There will be an ongoing need for standards selection and revision, bridging the work of standards development organizations and clinical stakeholders.   Privacy and security policy is informed and improved through national debate of the issues.   Evaluating the successes and shortcomings of the EHR related regulations is important to future refinement.   I suggest that ONC/CMS limit their regulatory focus on Meaningful Use requirements related to mature interoperability standards and privacy/security (as noted above), and focus much more on bridging gaps in five key areas:  a)  ONC versus CMS (certification versus attestation); b)  HHS versus CMS (disparate quality measure and other reporting requirements within the HHS domain); c) the government versus market (vendors and providers); d) vendors versus providers; and e)  providers versus patients.  In practical terms, this would focus less on a core belief that 'all EHRs should do X, Y and Z' to a focus on 'given what we are learning about an ever-evolving market (e.g., new payment models, new delivery models such as Patient Centered Medical Home, new technologies, new patient engagement models, etc), what EHR interoperability needs, quality measures, and privacy/security safeguards are needed.'

It's a fragile time at ONC when the excitement of the ARRA/HITECH funded grant programs has passed, many people have departed, and Congress is wary of IT projects in general.

Karen is the right person for the job at this time in history, just as her predecessors were the right people for their eras.   She can regain the trust of Congress, make midcourse corrections to the Meaningful Use program, and balance the burden/benefit on stakeholders.   If she can rebuild a city's health system after Katrina, she can polish those elements of the ONC strategy that experience in the marketplace has deemed to be necessary.


MightyCaseyMedia said...

You say "At present there is no place for a patient to "transmit", yet vendors are required to implement complex functionality that no one will use."

I say "Wrong."

What about medical devices like an ICD, or a Dexcom? How about wearable tech that monitors BP or heart rate or O2 sats? The patient should be able to monitor, AND TRANSMIT, data generated by those, to their clinical care team(s).

And wearables like FitBits and Fuels could be hugely useful to MDs. All sorts of data that doesn't have to be collected anecdotally, it could be collected in real time. TRANSMITTED by patients to their clinical teams.

BB+ (if it ever gets widely deployed, which I offer burnt sacrifices daily in service of that wide deployment) will put PATIENTS at the controls of data access for clinicians.

Yes, indeedy, patients will be transmitting. We're already trying to. The system can't handle us ... yet.

John Halamka said...

On Friday, the Standards Committee kicks off its hearings on device interfacing. I completely agree that healthcare devices in the home should be able to transmit using specific content, vocabulary, and transport standards. Continua has been working on implementation guides for a few years and at present Meaningful Use does not contain any certification criteria for device communications. We're analyzing the readiness of standards for device interoperability in Meaningful Use Stage 3

Unknown said...

"We should eliminate penalties for non-compliance with Stage 3 and return EHR innovation to customers and vendors."

I completely agree with this statement from Dr. Halamka. We need to focus as customers/vendors on solving interoperability issues and not trying to avoid penalties going forward!

peggyzuckerman said...

As a patient with some newly discovered and complex issues, involving a range of providers, it is essential that I can transmit to any and all, and to see that the transmission, not only from me, but from provider to provider is equally accessible to all whom I grant access, including to my family. The greatest problem in health care is the lack of efficient communication which impedes basic care, not to mention complex care, and especially care which reflects the goals of the patient.

Matthew Holt said...

As you might imagine John, this post is causing some consternation among the ePatients over at SPM, and for good reason. You say "There is not yet an ecosystem for patients to ‘transmit’ using CCDA and Direct, yet vendors are required to implement complex functionality that few will use: (changed & softened from your original version which was "At present there is no place for a patient to "transmit".

Sean Nolan and his gang at Healthvault would be very surprised to find out that there was "no place to transmit", as would Bettina Experton at Humetrix and everyone else who has built a data utility layer to receive Blue Button data. But to be fair, we can agree that that "ecosystem" is not yet large or popular

But it wont need much encouragement if we get to generallizable "download"--of which BlueButton is the lynchpin.

My concern with your criticism of "View, Download, Transmit" is that it looks like an excuse for vendors to not bother with (and lobby against) the "download" part.

I'm a user of Epic's portal on Sutter. There is as yet no way for me to download that information. I can view but not download. If I can download, then I can probably figure out a way to transmit (or a vendor in the emerging ecosystem will do it for for me). As you are such an influential leader both with the ONC and the general HIT community, I fear that this paragraph will be used as an excuse to wriggle out of the MU2 demand for patients to participate in their care. And so I think you need to really clarify what you think vendors must be held accountable for. Which IMHO should be full download of all data...

(Note, I had a brief email back and forth with John about a comment I submitted on his blog that resulted in him softening his statement and me changing this comment)

John Halamka said...

Agreed! The market and ecosystem are ready for View and Download in 2014. It's Transmit that should have waited for more market experience before making it a certification requirement.

Unknown said...

Excellent post. Let's hope that these suggestions are taken to heart at ONC.

Alex I said...


The whole process of getting certified has been an arduous effort. My company is modularly certified for 2014 Edition. We were adding measures in Waves to be as close to a complete EHR as we could be.

Now CCHIT, the vendor of choice for me, is telling me that the pace of ONC 2014 Edition certification has been slowed by the demands of more rigorous testing. Moreover, business conditions resulting from the unpredictability in federal health IT program requirements and timing have been challenging for all.

Bottom line is that CCHIT is not making money being a ATL/ATC. That is my commentary not theirs. Also that I've been dropped mid-stream in my efforts and they suggested that I should go to ICSA Labs. I'm familiar with them and a few of their personnel but I'm not happy with a transition that I did not expect.

Maybe Karen DeSalvo will listen to you and be more pragmatic in pushing out ONC changes. I've been chasing MU since its inception and I think the bar needs to be dropped a bit to get more momentum going.

Clint McClellan said...

It is great to see standards begin to play a larger role in the global dialog for connected health. It is also important to be aware that Continua’s Design Guidelines, which include the 11073 (IEEE) standards you referenced, were recently ratified by the United Nations' information and communications technologies standardization body, the International Telecommunications Union (ITU), as the single global connected health standard. To reiterate: the ITU has made Continua the global connected health standard—and there is no other standard on the way. Further, Last August the FDA formally recognized 25 standards for medical device interoperability, including 12 standards from the 11073 family of devices. These standards represent core elements of Continua’s guidelines, and their formal inclusion on FDA’s consensus list acknowledges that key standards underlying Continua’s Design Guidelines are part FDA’s common framework to support assessment of medical device safety in the United States.

Outside the US, two of the most innovative health ministries in the world, Denmark and Singapore, have mandated the use of Continua certified products for national connected health programs. Keep in mind that Continua is an industry organization. Its Design Guidelines derive from existing standards and interfaces developed in response to market need. For example, Bluetooth, Bluetooth Low Energy, Zigbee and USB are used in the medical devices Guidelines, while existing IHE and HL7 standards are used for transport and record systems.

Real innovation takes time, but the investment is worth it. Allowing attestations of interoperability only serves to confuse and delay, and results in higher cost down the road. Continua opted for innovation right from the beginning. We’re certain that ITU, Denmark, Singapore and others would agree: it was the right choice.

We welcome the opportunity to discuss this with you further and share with you the great progress Continua has made over the past year.