Health Level Seven International has been fighting the good fight for interoperability since it was founded in 1987. The group has worked for nearly thirty years to create, define and spearhead initiatives to enable the widespread adoption of interoperable standards. HL7's focus on interoperability goes beyond healthcare, and the standards the group works to develop are applicable to federal agencies such as the Food and Drug Administration and the Department of Veterans Affairs, among others around the world.
As CEO of HL7, Charles Jaffe, MD, oversees all aspects of the organization's mission. He works with groups that need to adopt widely interoperable standards to satisfy regulations, collaborates with stakeholders to evolve interoperability strategies and works to resolve problems that arise from conflicting technologies.
Dr. Jaffe took time to speak with Becker's Hospital Review about what HL7 has learned from organizations like Amazon and Facebook, how vendors fit into the picture and why we still don't have seamless interoperability.
Q: How do you explain HL7 and its goals when you're doing outreach for the organization?
Dr. Charles Jaffe: HL7 is thousands of volunteers all over the world — we're in more than 40 countries whereby statute or de facto. We are the standards by which healthcare information is exchanged on a multitude of platforms for different sorts of reasons. That includes patient care — in the U.S. for example, our work with CMS helps provide data on billing and quality measures. In most countries there are enormous initiatives around public health where we provide the standards for a host of public health problems, from consolidating quality data to immunization records and other registries. We also support national requirements in different countries that are unique to those countries. In the U.S., that refers to meaningful use, and other countries have taken some of the meaningful use requirements from the U.S. and leveraged the exact same standards we've developed here to not only simplify their national agenda, but ensure interoperability of healthcare providers across national borders.
The important work we do also includes trying to define where our standards will evolve, from regulation — which we support in the U.S. and other countries — to simply the critical issue of day-to-day patient data exchange. We also have a large initiative around both clinical and basic science research, including precision medicine and genomics research in the U.S.
Q: HL7 is often associated with increasing interoperability but is a very multi-faceted organization. How important is interoperability in the big picture?
CJ: I think interoperability is the key. There are many different definitions of interoperability, though — semantic interoperability, which the technophiles like to throw around, or business interoperability, workflow, utilization, and so forth. The fact is we need to have data exchange among entities, so we're not limiting the kinds of data that simply support one patient being cared for by one clinician. In today's world we have a multitude of stakeholders in the continuum of healthcare delivery and wellness. In the inpatient paradigm it's fairly simple, but the continuity of care and the types of individuals who interact with patients, loved ones and consumers to support people is growing, and they need that data to make decisions. Even more importantly, as we move toward a new vision of patient care and wellness, the data needs to be in a form that validates the efficacy and cost of intervention, whether it's medications. or procedures or studies.
Q: Does the technology exist today to make healthcare completely interoperable?
CJ: No, it doesn't exist now. And some of the obstacles relate to the way a multitude of standards evolve, the requirements for customization or localization and the technical barriers associated with it. I believe like many that policy supervenes technology. We've heard a lot in the last year about interoperability blocking. That's a serious misconception. End users of the data like healthcare systems are not keen on sharing the data, clinicians and provider systems misinterpret HIPAA requirements, there is often very little business case to develop solutions for interoperability or even health information exchange. The benefactor is often the patient and there's no way to sustain a business model with the patient at the center of the system. There are a number of competing platforms and philosophies that aim to achieve this, but to date none of them have become as important as the payment system needs. Until the policy changes, that's not going to happen very quickly. In San Diego where I live, we have health systems that have no business case for exchanging data, but more then that, we have big healthcare systems where data from the emergency room can't be shared with acute care unit in the hospital. That's not an interoperability problem, that's a problem of the way systems evolve and the business needs of our respective stakeholders. There's not the will to overcome the challenges, nor apparently the capabilities to do so.
Q: One of the challenges surrounding interoperability is figuring out how to incentivize stakeholders to participate, how do you view this issue?
CJ: The ultimate question is interoperable for whom? If you have a business case to share data between the lab, the electronic order entry, the billing entity, patient care providers and tax systems, it is one level of requirement. But to share it outside of your entity requires either a unified system or one-off mapping of resource to resource. For example, simply designating gender, male-female, mf, 0-1, can be a hurdle if two systems can't agree. Then you need an interface to map the two.
Then it gets far more complex when you have patient identification at the heart of this. For example, in Southern California for Kaiser there are 10,000 people named Maria Gonzalez. Kaiser does its very best to issue them unique patient identifiers but it's still a challenge. I've been told by the folks in Utah they have very similar naming problems. Until we embrace the notion of a unique patient identifier, we're going to have interoperability problems sharing patient data between systems. Our matching algorithm, while very good, doesn't achieve 100 percent accuracy. All you have to do is look at your own credit report. There are likely at least dozens of people with your name. Not only does their information make it into your credit report, but matching algorithms pull in data from people you might share just a first name or last name with. How did the matching algorithms based on Social Security number get so inaccurate? I don't know the answer to that, but until we have a unified system for the U.S. population, we'll still have interoperability problems.
Q: Do you see a separation between the proprietary side and the end goal?
CJ: The HL7 Fast Healthcare Interoperability Resources platform, which is now under development and implemented in small pilot programs around the world has the potential for reducing the interoperability barrier. There are many entities such as the USFDA that support open application programming interfaces. And with appropriate authorization you can enable reading of data and writing back to the database. HL7's FHIR utilizes the same authentication process and technology as well as the same security profile as Internet commerce.
HL7 hasn't created its own authentication and security protocol, we've used the best practices of the Internet and it works for Amazon and Facebook and other entities. The [EHR] vendors have participated in the co-development of these HL7-supported APIs through a private sector program called The Argnoaut Project. That program has not only helped accelerate the development of FHIR but also provided an environment where EHR vendors, small companies with two guys in a garage, public entities like the Veterans Administration or the CDC are able to exchange data with increasingly successful interoperability programs. The business requirements of FHIR continue to evolve but the commitment of the private sector to the development of FHIR has been quite remarkable. In fact at, the Geisinger Clinic in Danville, Pa., for example, they have developed a rheumatology application which is remarkably capable of sharing data for rheumatologic disorders for patients, nurses, pharmacists and other caregivers and interoperable out of the box without an interface with Epic, Cerner and athenahealth EHRs. Every day hundreds of solutions are being developed that work with the FHIR platform and as we continue to enhance FHIR, we increase the capability for intersystem exchange of health information, not simply within a healthcare system but between and among systems and reuse that data for other purposes. So one clinician could longitudinally follow his patients 'diabetic care or the healthcare system could evaluate a clinician's vertical care of numerous diabetic patients per hospital, physician or any entity you wish. Not only that, but the most recent implementations of FHIR allow users to write back information the system, not only read it. We're moving closer to interoperability with FHIR and part of our important work is collaborating with the many entities developing FHIR solutions as well as the many standards bodies contributing to the process. This collaboration is critical if FHIR and the API platform models are going to be successful.
Q: Do you see fewer barriers to implementing standards like this outside of the U.S.?
CJ: Each country has its own unique issues. In some countries, for example, the data is owned by the hospital, not by the patient. In some countries notions of safe harbor confound data exchange. In other countries, there are unique and complex systems for paying for patient care. In England, for example, you have the National Health Service but also private insurance. I spoke at a FHIR for the U.K. in November and they were very interested in the technology as a means to solve those policy problems. FHIR doesn't require some of the business models other software solutions do, so when you identify a need, getting to interoperability is far easier with FHIR.
Q: What is HL7's relationship like with the larger EHR vendors in the U.S.?
CJ: As a matter of fact, we've always had excellent relations with the EHR vendors, but FHIR has driven a level of cooperation and collaboration that frankly we've never seen. When I announced The Argnoaut Project in December 2014, most of the press was focused on the fact Epic and Cerner were at the table together, not that there was this unique project about accelerating interoperability. Today we have ongoing Argonaut projects around fast development and fast identification of problems. All of these require weekly conference calls among the big vendors in the U.S. and they collaborate at a level not before seen in terms of developing FHIR-based solutions in terms of security, authentication and data identification. These partnerships are remarkably open and collaborative; I can't speak more highly about the new level of cooperation that The Argonaut Project has fostered.
Q: What would you like readers to know about HL7?
CJ: I think it's important to note HL7 is a very large organization with broad interests. As we develop FHIR, we continue to evolve to version two, which is responsible for more data exchange around the world than everything else combined. We have a family of products and services that are written into regulation and a contract through ONC to enhance clinical documentation architecture and improve interoperability products in other areas.
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