The Standard

The Spectrum of Interoperability

In a world of polychromatic nuance, it’s interesting to see how often some individuals try to see things in black and white.  This tendency also seems to apply to healthcare data interoperability, as if any given product, organization or service can be classified as either “interoperable” or not. To me it’s absolutely clear that interoperability is a spectrum, which can only be aspired to as a matter of degree. 

Any given player may be viewed as more or less interoperable, but not wholly interoperable, because we live in such a heterogeneous world, with science and medicine continuously evolving. But no matter how you might personally think of interoperability, we can probably all agree that we still have a long, long way to go before we get there.

This is why we need events like Partners in Interoperability.  To achieve real progress, we must engage major stakeholders to stop and listen for awhile, and roll up their sleeves to make small incremental steps to move along that spectrum from the cold blue reality of the recent past to a warm, FHIR-y future based on improved interoperability. 

Partners in Interoperability October Meeting

The second Partners in Interoperability meeting was held at the Johns Hopkins Mt. Washington Conference Center in Baltimore on Oct. 18-19, an arcadian space conducive to deep thought.  As before, the meeting included a set of opening talks each day followed by breakouts focusing on the particular challenges of using FHIR among three distinct business communities:  Clinicians, Payers and Biopharma. 

Day 1

The meeting opened with a welcome from Dr. Christopher Chute, a long-time thought leader in the world of health data standards.  Dr. Chute evoked the history of the Great Baltimore Fire of 1904, which even predates the last Chicago Cubs championship, and led to the establishment of national standards for fire hose fittings.  The metaphor of a great fire being a pivotal event that burned down the old to create a new and improved place did not go unnoticed by the 60+ attendees at the event.

Next was a fast-paced set of five short insights on what FHIR means to the three represented communities, the health IT industry, and, above all, to the future of interoperability which we all aspire toward. 

The morning concluded with three lively presentations on FHIR’s promise and reality:

• Micky Tripathi gave an update on the Argonaut Project, which is close to completing its implementation guides for using the FHIR API and is already thinking about what to tackle next
• Ricky Bloomfield, MD gave an exciting visual talk on how FHIR is enabling several mobile apps to enhance patient care and interaction at Duke University’s Health System
• Sean Khozin, MD, presented on how the FDA is reinventing itself to capitalize on real world evidence from EHRs as well as multiomics big data sources – portraying several opportunity areas where FHIR can help advance the FDA’s mission.

Day 2

The second morning included recaps  from each of the breakouts, followed by one more set of plenary presentations:

• Avinash Shanbhag of ONC discussed the importance of FHIR to realize the goals of the next phase of Meaningful Use
• Titus Schleyer, PhD, of the Regenstrief Institute painted the vision that health information should flow like water, and demoed a FHIR app that allows patients to collect all their medication data from disparate health IT systems into one unified list
• The legendary Dr. Clem McDonald discussed and demonstrated an intriguing JSON-based forms generation toolset used by the National Library of Medicine that can be used, for example, with the Surgeon General’s Family Health History form.

Vote for the 2017 Top 50 in Digital Health 

Each year 50 of the leading entrepreneurs, investors, technologists, reporters, and providers dedicated to bringing technological advancements to healthcare are recognized at the Top 50 in Digital Health dinner hosted by Rock Health, Fenwick & West, Goldman Sachs, and Square 1 Bank. 

 
Many have asked the question: When are we going to realize the promises of sequencing the human genome?

Some argue the benefits are here. Others say not much has changed for healthcare consumers and patients. Some have invested in pharmcogenomic programs in the clinic, while there remain pharmacists who say the evidence still isn’t there. Patients see advertisements for cancer services that utilize genetic testing for targeted therapy, while others still claim most cancer patients don’t see any benefit.

We are in a period of both confidence and uncertainty, enough evidence and not enough evidence; let’s move forward with expanded testing and let’s only adopt a few tests, promises and warnings, a cost benefit or just increased cost.

Investments in Genomics Advances

In spite of the controversy, billions of dollars in investments are developing more products and services directed at healthcare consumers. This already includes direct-to-consumer genetic and genomic testing.

The precision medicine initiative is emerging as a high profile effort in genomic research and encourages patient-directed data ownership and sharing. It will be a major driver in building awareness and demand for genetic-based clinical services.

Tools from vendors—that range from biomarker and drug discovery to the clinical knowledge of diagnosis, risk assessment, and clinical meaning—are working toward advancing genetic-based care and realizing greatly improved outcomes.

Amidst this debate, many are committed to moving ahead to find clarity and the right path forward. In increasing numbers, people with day jobs are participating in mostly volunteer organizations to define and complete demonstration projects that prove both clinical utility to healthcare providers and significant value to patients.

Progress in Genomics

Internationally-focused organizations—like the Global Alliance for Genomics and Health (GA4GH), the Global Genomic Medicine Collaborative (G2MC), and US-based activities like the Genetic Alliance, the National Academies DIGITizE action collaborative, NIH grants like IGNITE and eMerge, and HL7 clinical genomics and Fast Healthcare Interoperability Resources (FHIR®)—are all making substantial progress. And there are many more related and critical activities I haven’t listed. Not only do we need to coordinate these activities, but we also need to bring together the diverse stakeholders in academics, research, technology, and national and global policy to see the vision move forward as well as how we’ll get there together.

 
Why FHIR for LATAM?
Latin America (LATAM) arrived on the scene late in terms of the use of earlier HL7 standards. HL7 Version 2 was created in 1985 but we (LATAM) did not begin using it until after 2000). HL7's Clinical Document Architecture (CDA®) was published in 2000 but we  began using it after 2005. HL7's Fast Healthcare Interoperability Resources (FHIR®) is being created now and we are starting to use it in LATAM. Two implementation guides have been developed in Argentina and Colombia; Chile is working on one. We can discuss the ‘we’ (as in ‘Who in LATAM’?), but the trend cannot be discussed.  Some countries in our region have yet to use any standard—there is NO installed base— why get stuck with stuff that’s 10 or 20 years old?

However, work is still in progress. While CDA Release 2 is good for document repositories, when it comes to mobile, what you can/should exchange is more discrete and granular. The choices will come down to how to use FHIR for examples such as:

• Only display allergies
• Only display the lab results for a graph. 

 
A little history

Studying HL7 history, our standards went from a plain text, replication/messaging-based paradigm in the 1980s to the current, Internet 2.0, resource-based paradigm. We also created document-based standards such as the Clinical Document Architecture (CDA®) Release 2 and SOA based standards like Common Terminology Services (CTS).

These 30 years of history gave us a good insight on what we need as standards users and developers.

What do we need as standards users?

People who implement and use standards want open access to standards and implementation guides. They need understandable and short specifications, off-the-shelf tools, reference implementations, friendly representation of information (instances), easy access to vocabularies, automated validation of instances, affordable education, a formal extension mechanism. 

Finally, they need examples, examples, and more examples. They need lots of examples!

What do we need as standards developers?

Standards developers have different needs. They want easy profiling with graphical user interfaces (GUI) and the ability to reuse templates. They also want one-click, automated publishing, validation and QA profiles, validation of instances, global profile registry, and ease of vocabulary binding.

A litte about me

My name is Tim Hricik and I am a consultant with Accenture. I have been with the firm since late 2011 and have been a member of the HL7 community since 2013.

In May, I had the opportunity to attend my first HL7 working group meeting (WGM) in Montreal. As I attempted to navigate the WGM, I was introduced to a fellow Accenture colleague and longtime HL7 leader, Ken McCaslin. Ken is the head of HL7’s Technical Steering Committee and kindly helped shepherd me through the agenda and activities of the WGM. He provided introductions, shared his past experiences, and gave general words of wisdom to help me get the most out of my own experience.

Subsequently, Ken asked if I would write an article that might serve as a guide for future first-time attendees. Wishing that I had had a little more information about the WGM before my first visit, I jumped at the opportunity to share my observations with others. So, for all those attending a WGM for the first time in the near future, here is a little bit about my experience and what you might expect.

What did I anticipate for the working group meeting?

I really had no idea what to expect for my first visit to an HL7 WGM, but I knew that this would likely be different from other types of conferences I had previously attended. My initial intention was to simply attend the Fast Healthcare Interoperability Resources (FHIR®) sessions and connect-a-thon in hopes of learning as much as I could about the emerging standard.

I knew the HL7 organization was actually more than just one standard, but I will admit I let myself get a bit pessimistic about what I would encounter:

• Is this going to be the usual bunch of tech people laboring and debating over dry discussions of standards?
• Am I going to be stuck attending lengthy, drawn out lectures, struggling to maintain interest and attention?
• Will it be relevant to my interest areas and career development?

The Power of Community in HL7

I first became involved with HL7 a decade ago as I transitioned from medical practice to clinical informatics. I attended my first HL7 meeting, as many do, to take advantage of the tutorial sessions offered around foundational standards like HL7 Version 2 and the Clinical Document Architecture (CDA®).  The most valuable takeaway from that first meeting however was not the knowledge of the standards but the beginning of my relationship with the community of individuals who are HL7.

HL7 is a diverse community

It is a remarkable community of individuals that are as diverse as the countries they call home, the organizations that employ them, and their backgrounds of education and experience. The one thing that is common and shared across the community is the sense that we move the needle as a community; move the needle a little with each use case enabled with an HL7 standard and each project that ends with consensus on a new data standard.

HL7 FHIR: A Standard You Can Use Today! 

A Recap of the HL7 FHIR Applications Roundtable

“A standard is not used because we created it. It is a standard because people use it.”

This familiar quote from Charles Jaffe, MD, PhD, CEO of HL7, could have been the motto for the inaugural FHIR Applications Roundtable held this July at Harvard Medical School in Boston.

As so many of the smiling attendees attested, this was indeed a very different kind of meeting.
The premise was to show how widespread HL7 Fast Healthcare Interoperability Resources (FHIR®) usage already is, and the answer was – more than we could have ever imagined.

The FHIR is spreading

Although FHIR is currently designated as a Standard for Trial Use (STU), it has already captivated the development community who is drawn to its advanced, elegant technology platform. The roundtable, like most FHIR events, cements the impression that interoperability through FHIR is not a pipe dream, but a burgeoning reality.

What is the role of HL7 standards in the eHealth Digital Services Infrastructure (eHDSI)?

eHDSI calls for EU-wide specifications and national extensions or localizations. Interoperability assets and shared terminology resources supporting HL7 standards adoption are needed to streamline large scale eHealth deployment at a reasonable time and cost.

The eStandards project, led by the HL7 Foundation, aims to create a roadmap for collaborative eStandards development fit for the purpose of large scale eHealth deployment. CEN/TC251 and IHE Europe participate in the eStandards project along with key eHealth stakeholders in Europe.

In view of these developments, it is worth reflection on:

• How should HL7 standards be promoted at the national and European level?
• What kind of tools and resources can HL7 offer to support its European members?
• What synergies does HL7 need to engage in Europe?

HL7 as an International Organization

The whole idea of regional offices for HL7 goes back to Ed Hammond’s third HL7 chairmanship in 2008-2009, inspired by the vision to turn HL7 into a truly international organization. This began with changing the organization’s name from Health Level Seven, Inc to Health Level Seven International.

It was not the first time that HL7 Europe came up in discussions. In the 1990’s, the European HL7 affiliates abandoned the idea thinking there wasn’t enough common ground: HL7 was the place for global standards development and localization was national business: France, Italy, and Germany had as much in common as with Australia, Canada, and Japan.