Yet another ONC Interoperability "Roadmap"

Letter from the National Coordinator

In June 2014, the Office of the National Coordinator for Health Information Technology (ONC) laid out a vision for a future health IT ecosystem where electronic health information is appropriately and readily available to empower consumers, support clinical decision-making, inform population and public health and value based payment, and advance science. In Connecting Health and Care for the Nation: A 10-Year Vision to Achieve an Interoperable Health IT Infrastructure (ONC’s 10-Year Interoperability ConceptPaper), ONC committed to leading and collaborating with the health IT and health sector to define a shared Roadmap for achieving interoperable health IT that supports a broad scale learning health system by 2024. This Roadmap reflects the result of that collaborative work with federal, state and private partners. It lays out a plan for what needs to happen, by when, and by whom, to see that electronic health information is available when and where it matters most for those we are here to serve: the American people.

In the decade since ONC began its service to the nation, the United States has experienced remarkable progress in the digitization of the health experience. There has also been significant advancement of payment reform that is driving the need for better visibility of the care experience and demand for straightforward quality measurement. Consumers are increasingly expecting their electronic health data to be available when and where it matters to them, just as their data is in other sectors. And new technology is allowing for a more accessible, affordable and innovative approach. However, barriers remain to the seamless sharing and use of electronic health information.

This draft Roadmap proposes critical actions that the public and private sector need to take to advance the country towards an interoperable health IT ecosystem over the next 10 years. Achieving such an interoperable system is an essential element towards HHS Secretary Sylvia Burwell’s vision of better care through smarter spending, leading to healthier people. Achieving that better care system and better health for all will, through health IT interoperability, require work in 3 critical pathways: 1) Requiring standards; 2) Motivating the use of those standards through appropriate incentives; and 3) Creating a trusted environment for the collecting, sharing and using of electronic health information. It will require us to agree to a set of rules of engagement that will bring trust to the system for consumers and others, it will allow us to see that the privacy expectations of consumers are respected, that states are aligned in policy, that we are aligning payment and other levers to advance and sustain a durable interoperable ecosystem, to make data more portable and liquid with tools like APIs, and to have a set of standards that allow more seamless, yet appropriate, sharing of electronic health information for “small” (individual patient), “big” (population level and beyond) and “long” data (wrapping around the individual and telling their health story over time).

We are thankful to our federal, state and private sector partners who have worked with us over these past few months to shape this path forward and help us to identify the most impactful actions to achieve a learning health system. To date, there have been contributions from over forty individuals and organizations, twenty-five federal partners, 90 individuals from 38 states and ONC’s Federal Advisory Committees (FACAs) whose membership includes 167 representatives from over 140 private and public organizations.

The Roadmap identifies critical actions that should be taken by a wide range of stakeholders to help advance nationwide interoperability. I invite you to review the Roadmap, provide your input and choose a critical action that you are willing to commit to, or even take the lead on. It is only through everyone’s combined efforts that we will achieve a learning health system that brings real value to electronic health information as a means to better care, wiser spending, and healthier people.

This Roadmap is intended to be a living document owned and guided in its evolution by all health IT stakeholders. Because the Office of the National Coordinator for Health IT (ONC) is charged with supporting the adoption of health IT and promoting nationwide health information exchange to improve health and care, it has played a major role in coordinating with a broad array of stakeholders to develop this initial draft. ONC will continue to support stakeholders by coordinating input and publishing future versions of the Roadmap. ONC is accepting public comment on this draft version of the Roadmap until 5 p.m. ET on April 3, 2015 on www.healthit.gov/interoperability. After carefully reviewing and integrating the public’s feedback, ONC will release an updated Roadmap later in 2015.

ONC is also releasing an open draft of the 2015 Interoperability Standards Advisory that is an initial version of a “best available standards and implementation specifications” list for interoperability of clinical health information that enables priority learning health system functions. Development of this list is identified as a critical action in the Roadmap that ONC has committed to. Please review this list and provide comments on www.healthit.gov/interoperability. While you take time out to comment on these documents, please do not slow your work to advance interoperability.

Thank you for your participation in this collaborative process. And thank you in advance for your thoughtful comments and willingness to take the lead on critical actions. It is a testament to the remarkable spirit of this nation’s health IT community and our shared interest in putting the person at the center.

Karen B. DeSalvo, MD, MPH, MSc
National Coordinator for Health Information Technology

A lot to consider in this 166 page document. Below, I see the cliches are in order right off the bat.

A distressing degree of Irony-Free Zone in Figure 1, given the numerous cross-contradictions.

Page 11:

"In a country as large and heterogeneous as the U.S., it is not realistic to suggest that all health information needs will be met with a single electronic health information sharing approach."

This assertion troubles me. I have posted my concerns at some recurrent length in 2014: e.g., here, here, here, here, here, here, and here. And, also apropos of the fray, let us not forget the current darling HL7® FHIR®.

A nation "as large and heterogeneous as the U.S." seems to be managing just fine on standard 3-prong 120VAC wall outlets (into which, of course, we plug the computers housing the thousands of "certified" EHR software apps that can't talk to each other). "BP=120/80" denotes normal blood pressure in every hamlet in the country, and a lab result of "HBa1c less than 5.7" likewise indicates "non-diabetic serum glucose" everywhere. An ICD-9 code for a specific dx or px is precisely the same in Anderson, Alabama as it is in San Francisco, New York, or Marquette, Michigan.

More from Page 11.

Critical Actions for Near Term Wins

The four most important actions for public and private sector stakeholders to take to enable nationwide interoperability of electronic health information through health IT in the near term are: (1) establish a coordinated governance framework and process for nationwide health IT interoperability; (2) improve technical standards and implementation guidance for sharing and using a common clinical data set; (3) enhance incentives for sharing electronic health information according to common technical standards, starting with a common clinical data set; and (4) clarify privacy and security requirements that enable interoperability. 

Number one -- "governance framework and process" -- well, I really tire of the increasingly meaningless word "governance," which often just serves as an enabler invoking years of no-progress busywork meetings. It's a beloved term in the public and non-profit sectors, to be sure, but, entails a significant "multi-stakeholder" "herding cats" risk.

[2] and [3] "common clinical data set." Well, yeah, that's precisely what I -- and Dr. Jerome Carter -- have been harping on for quite some time. Clinical data are already rather extensively standardized. What is still lacking is a clinical health IT metadata standard (goes to my "std. data dictionary" rant).

[4] I take that as a given. HIPAA is, after all, established law with extensive finalized attendant operational regulations (e.g., 45 CFR 164.3, .4. and .5). And, yes, inexorably complicated by the fact that states' laws and regs deemed "stricter" than HIPAA trump HIPAA. None of which is exactly news.

Page 27 and 28:

Shared governance of policy and standards that enable interoperability
A. Shared governance of policy and standards that enable interoperability: Nationwide interoperability across the diverse health IT ecosystem will require stakeholders to make collective decisions between competing policies, strategies, standards in a manner that does not limit competition. Maintaining interoperability once established will also require ongoing coordination and collaborative decision-making about change.

Background and Current State

The need for governance arises anytime a group of people or organizations come together to accomplish an end. In general, “governance is the process by which authority is conferred on rulers, by which they make the rules and by which those rules are enforced and modified.” Governance generally includes setting priorities, making decisions, establishing authority(ies) and ensuring accountability.

Governmental Governance to Enable Interoperability

ONC has made several attempts regarding governance to enable the secure nationwide exchange of electronic health information. In 2005, ONC formed the American Health Information Community (AHIC) as a federal advisory committee to discuss how to accelerate the development and adoption of health information technology and the Nationwide Health Information Network (NwHIN)...

It is now 2015. Lordy. Do I really need to elaborate here? This is a recipe for the ever-so-collegial continuation of stasis, all elaborated reported on episodically in lengthy, aesthetically pleasing pdf documents verbosely re-plowing the same ground. And, the putative upshot will be that (re Figure 1) we will "simplify" and "focus on value" to "empower individuals" through "scalable universal access," all while "maintaining modularity," recognizing that "one size does not fit all," in deference to "considering the current environment" and "building on existing infrastructure" so as to "leverage the market." I feel a song comin' on...

What could possibly go wrong?

Respected medical economist J.D. Klienke (also ten years ago):

If the state of U.S. medical technology is one of our great national treasures, then the state of U.S. HIT is one of our great national disgraces. We spend $1.6 trillion a year on health care—far more than we do on personal financial services—and yet we have a twenty-first-century financial information infrastructure and a nineteenth-century health information infrastructure. Given what is at stake, health care should be the most IT-enabled of all our industries, not one of the least. Nonetheless, the “technologies” used to collect, manage, and distribute most of our medical information remain the pen, paper, telephone, fax, and Post-It note.

Meanwhile, thousands of small organizations chew around the edges of the problem, spending hundreds of millions of dollars per year on proprietary clinical IT products that barely work and do not talk to each other. Health care organizations do not relish the problem, most vilify it, many are spending vast sums on proprietary products that do not coalesce into a systemwide solution, and the investment community has poured nearly a half-trillion dollars into failed HIT ventures that once claimed to be that solution. Nonetheless, no single health care organization or HIT venture has attained anything close to the critical mass necessary to effect such a fix.

This is the textbook definition of a market failure. All but the most zealous free-market ideologues recognize that some markets simply do not work. Indeed, reasoned free-market champions often deconstruct specific market failures to elucidate normal market functioning...

Health Care’s Blue Screen Of Death: Reboot Or Reform?

The compulsion today is to find the elusive “business case” for health care IT. Legions of IT vendors and consulting companies have struggled to cobble together “the ROI” (consultantspeak for “return on investment”) to prove that an individual health care organization would benefit by investing in better IT and that the failure to date has been merely a cultural problem on the demand side (“the doctors won’t use computers”) or a sales problem on the supply side (“it’s all vaporware”). These objections are hardly sufficient to stop a force as revolutionary as IT. The practical reality is that the typical ROI is modest at best, ephemeral for most, and attainable only well past its investment horizon—a dressed-up way of saying that it exceeds the political capital of its current CEO and CIO. If there were a strong business case for a health care organization to break from the pack and build out a twenty-first-century IT system, we would have no need for this paper—or, for that matter, this entire issue of Health Affairs. If the health care IT market worked, it would have worked by now...

The business case for no HIT. The first step in understanding the real intractability of the problem is ignoring the rhetoric. There is a veritable cottage industry involving the articulation of moral outrage over the health care quality “crisis,” much of it public relations spadework for someone’s political or commercial ambition and most of it culminating in a the naïve insistence that the system is on the verge of collapse and cannot go on like this. Actually, it can and will go on like this forever, absent any major intervention by the nation’s largest health care purchaser—the U.S. government...

Cited in my June 2011 post "Use Case."

Moving along. Pages 81-82:

Moving Forward and Critical Actions

Over time (and for a learning health system to rapidly innovate), it will be necessary for the industry to converge and agree on the use of the same content and vocabulary standards to satisfy each specific interoperability purpose. The use of multiple data formats over the long term is not sustainable and retains systemic costs and burdens that could otherwise be removed from the health care system for health IT developers, providers and individuals. Content standards should continue to accommodate the exchange of structured and unstructured data, but developers and end-users should design and subsequently implement systems with a very intentional movement and bias toward increased exchange of more structured, standardized and discrete information.

At a minimum, we must as a nation agree to a standardized common clinical data set that is consistently and reliably shared during transitions of care (and with individuals and their caregivers) to achieve our near-term goal of establishing a foundation of interoperability that can be expanded over time. The industry seeks significant progress in the standards that support structured information so that the information can be computable and usable by other systems and ultimately users of those receiving systems. However, stakeholders have also made it clear that there remains value in the documentation and exchange of some uunstructured data, such as a physician note that is typically documented as free text in a system...

While it is unlikely that a single data format (at least structured as a document) will support all of the needs of a learning health system, every effort should be made to minimize not only the number of data formats, but also to have agreement on the use cases that each data format supports (see Appendix H for Priority Interoperability Use Cases). This will be even more challenging when social services, genomic, personally generated information, environmental sciences and other forms of information have to be integrated to support a learning health system. Initiatives such as the National Information Exchange Model (NIEM) may be helpful when needing to exchange across sectors (see Appendix E for more on NIEM).

Over the long-term, document-centric ways of exchanging electronic health information will likely be overtaken by more specific, tailored, data-centric ways of exchanging information – meaning that individual data elements are exchanged (e.g., medications or allergies) rather than an entire document with multiple information sections about a patient. This will allow electronic health information to be defined (and reused) in a more granular fashion and create more flexibility in how information is used. To do this, over the next six to ten years, the industry will need to develop standards for granular data elements that can be used in documents and move toward ways of exchanging information that do not require information to be in document form. HL7’s Fast Healthcare Interoperability Resources (FHIR) [emphasis mine] effort is one effort that is emerging and exploring ways to accommodate new methods of exchanging information. Importantly, it will be increasingly necessary for the industry as a whole to invest time in thoughtfully planning the migration and transition from one standard to another as well as from one version of a standard to a newer version...

Well, again, as I wrote above:

Clinical data are already rather extensively standardized. What is still lacking is a clinical health IT metadata standard (goes to my "std. data dictionary" rant).

And, I'm not gonna re-post what I've already written about FHIR. See my prior "Interoperability solution? HL7® FHIR® -- We ® Family."

Again,

Over the long-term, document-centric ways of exchanging electronic health information will likely be overtaken by more specific, tailored, data-centric ways of exchanging information – meaning that individual data elements are exchanged (e.g., medications or allergies) rather than an entire document with multiple information sections about a patient.

Yes, that is a significant concern. Anyone who has ever tried to manage his or her email accounts and folders across time should be able to fathom precisely why with nil mental effort. How will "document-centric" data be linked up seamlessly to a given recipient's EHR RDBMS, in ways that are at once iteratively and recursively accurate and not workflow disruptive? It bears repeating that no clinical datum -- structured or unstructured -- has any effective dx/px/tx value in isolation. Clinical data derive their diagnostic and therapeutic utility from relational context (often spanning multiple encounters). It also bears repeating that "interoperability" is fundamentally a (non-trivial) misnomer. We're really talking about "data exchange." Recipient clinicians have to use their own EHRs, irrespective of the sources of the patient data.

WHAT ABOUT "USABILITY"?

Page 10 (among other locations):

Specifically, the Roadmap focuses on actions that will enable a majority of individuals and providers across the care continuum to send, receive, find and use a common set of electronic clinical information at the nationwide level by the end of 2017. Although this near-term target focuses on individuals and care providers, interoperability of this core set of electronic health information will also be useful to community-based services, social services, public health and the research community. This includes standardized data elements, such as demographics, that will enable better matching and linking of electronic health information across all systems and platforms.

These standardized data elements support better stratification of electronic health information when aggregated to identify and address important issues such as health disparities and also support research and evidence-based personalized medicine. The intersection of clinical and administrative electronic health information is a critical consideration, but is out of scope for the Roadmap at this particular time. Use cases, standards, technologies and tools that leverage both administrative and clinical electronic health information will be an important topic to address in future iterations. There are also many aspects of health IT beyond interoperability that are important and will be critical to a learning health system, including technology adoption, data quality, usability and workflow. However, these topics are out of scope for this Roadmap at this particular time and deserve separate, dedicated attention...

Well, a trifecta there: workflow, data quality, and usability. But, "out of scope?" What? Separate 10 year plan/roadmaps for each of those?

Federal history is not comforting. Recall my October 2012 post "In the Federal Register Oct 31st: yet another healthcare workflow study proposal," wherein I reported on AHRQ's RFP for a two year study in which to investigate and report on the upshot of one of their prior two year "studies" on workflow.

So, Not To Worry. We're gonna have a first broad pass at "interoperability" by the end of 2017. Whether the data are crap, the usability of the myriad incumbent "certified" systems remains suboptimal, and (relatedly) usability remains a front-burner issue is someone else's problem.

It gets worse. Stay tuned for "mHealth/BYOD."

Given the increasing volume of mobile technology usage among consumers and across the care delivery system, approaches to enable "send, receive, find and use" in the near-term must support the flow of electronic health information across both institutional and mobile-based technologies. This means traditional approaches to health IT interoperability will need to become more agile and leverage the experience of modular consumer applications, such as those created by Facebook, Amazon and Apple. These secure, but simple architectures have enabled an ecosystem of applications that allow users to engage with electronic health information across a variety of different platforms and devices and open opportunities for entrepreneurial third parties to thrive... [pg 10]

Again, need I elaborate? Seriously? The naivete here is rather breathtaking. First of all consumer-facing/social media apps do not have to manage the thousands of variables seen in the typical EHR (hundreds of which have to be accessed, assessed, and updated in the typical routine ambulatory encounter). Second, -- and relatedly -- we risk deluging EHRs with tsunamis of mostly useless, workflow-obstructing, time-consuming"web-centric" (i.e., XML-laden) "data" appendages.

On this count, as reported at iHealthBeat:

Joseph Smith -- CMO and chief science officer of West Health in California -- said the roadmap lacks a plan for device-to-device interoperability. He said, "I think it's essential to make sure as we push on interoperability we need to make sure we leave no information source behind." He added that data sharing among medical devices "needs to be wrapped [into the plan] if this is to be an interoperability framework that handles all the issues" (Modern Healthcare, 1/30). 

The APIs are gonna be called upon to work miracles.

UPDATE

Brookings: Full interoperability won't be achieved in current environment
Changes needed in reimbursement, incentives, and HIE structure
February 3, 2015 | By Marla Durben Hirsch

Health information exchanges (HIEs) won't work well and interoperability will not be sustained unless the business models and incentives are changed, according to a new paper from the Brookings Institution.

The paper, written by Niam Yaraghi, a fellow in governance studies at the Center for Technology Innovation, posits that the interoperability problem is more economic and political than technical. In the current fee-for-service reimbursement format, as data sharing lowers costs, it serves as a disincentive for certain providers, such as physicians, labs and radiology centers.

Moreover, Stage 3 of the Meaningful Use program will likely set the interoperability bar too low, and will have the inadvertent consequence of helping not the providers but the dominant vendors, who will need only provide a minimum amount of interoperability, Yaraghi writes... 

I guess some people might shrug and argue that APIs such as FHIR will render HIEs -- at least as standalone 3rd party intermediaries --  obsolete anyway. But, yeah the problems are as much economic and political as they are technical.
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ERRATA

Came across an intriguing blog this morning.

to wit, 

The Therapeutic Paradox: What's Right for the Population May Not Be Right for the Patient

An article in this week's New York Times called Will This Treatment Help Me?  There's a Statistic for that highlights the disconnect between the risks (and risk reductions) that epidemiologists, researchers, guideline writers, the pharmaceutical industry, and policy wonks think are significant and the risks (and risk reductions) patients intuitively think are significant enough to warrant treatment.

The authors, bloggers at The Incidental Economist, begin the article with a sobering look at the number needed to treat (NNT).  For the primary prevention of myocardial infarction (MI), if 2000 people with a 10% or higher risk of MI in the next 10 years take aspirin for 2 years, one MI will be prevented.  1999 people will have gotten no benefit from aspirin, and four will have an MI in spite of taking aspirin.  Aspirin, a very good drug on all accounts, is far from a panacea, and this from a man (me) who takes it in spite of falling far below the risk threshold at which it is recommended.

One problem with NNT is that for patients it is a gratuitous numerical transformation of a simple number that anybody could understand (the absolute risk reduction  - "your risk of stroke is reduced 3% by taking coumadin"), into a more abstract one (the NNT - "if we treat 33 people with coumadin, we prevent one stroke among them") that requires retransformation into examples that people can understand, as shown in pictograms in the NYT article.  A person trying to understand stroke prevention with coumadin could care less about the other 32 people his doctor is treating with coumadin, he is interested in himself.  And his risk is reduced 3%.  So why do we even use the NNT, why not just use ARR?...

Interesting stuff. Added to my Blogroll.

Also noteworthy, from ScienceBasedMedicine.org:

Screening for disease in people without symptoms: The reality
David Gorski, February 2, 2015

One of the most contentious questions that come up in science-based medicine that we discuss on this blog is the issue of screening asymptomatic individuals for disease. The most common conditions screened for that we, at least, have discussed on this blog are cancers (e.g., mammography for breast cancer, prostate-specific antigen screening for prostate cancer, ultrasound screening for thyroid cancer), but screening goes beyond just cancer. In cancer, screening is a particularly-contentious issue. For example, by simply questioning whether mammography saves as many lives lost to breast cancer as advocates claim, one can find oneself coming under fire from some very powerful advocates of screening who view any questioning of mammography as an attempt to deny “life-saving” screening to women...

ALSO TIMELY AND TOPICAL

CODA

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More to come...