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A Clinical Informaticist Shares Why FHIR Won’t Extinguish HL7, At Least Not in the Near-Term

June 30, 2016
by Heather Landi
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Russell Leftwich, M.D., a clinical informaticist and an HL7 International board member, discusses the promise of FHIR in healthcare and the near-term “hybrid" world that healthcare organizations will be operating in.
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Within the healthcare industry, there is much discussion about the promise of Health Level Seven’s (HL7) Fast Healthcare Interoperability Resource (FHIR) standard and the role it will play in health IT’s future to improve interoperability and data exchange. Transitioning to FHIR, and enabling the use of web technology to manipulate data within the framework of FHIR, will transform healthcare organizations, essentially making it easier for providers to share health data, according to Russell Leftwich, M.D., adjunct assistant professor of biomedical informatics at Vanderbilt University and senior clinical advisor for interoperability at Cambridge, Mass.-based InterSystems, And, adoption of the FHIR standard will help bring healthcare forward, essentially catching up healthcare IT to the technology and domains used by Facebook, Google and Amazon.

However, Leftwich, who is an HL7 International board member, also says that for the foreseeable future, healthcare providers will need to translate between different standards—HL7 v2, HL7 v3 and Consolidated-Clinical Document Architecture (C-CDA) and FHIR—as there will be a need to transform back to earlier standards so that legacy systems can consume data.

Leftwich chairs the HIMSS Office of the National Coordinator for Health IT (ONC) Interoperability Standards Advisory Task Force and has previously served on the HIMSS Interoperability and Standards Committee. In addition, he is co-chair of the IHE USA Implementation Committee. He recently founded and is co-chair of the HL7 Learning Health Systems Workgroup and a past co-chair of the HL7 Patient Care Workgroup. Most recently he served as chief medical informatics officer for the State of Tennessee Office of eHealth Initiatives. Leftwich recently spoke with Healthcare Informatics Assistant Editor Heather Landi about the promise of FHIR in healthcare and the near-term “hybrid” environment that healthcare organizations will be operating in as the FHIR standard continues to be built out.

There is a lot of discussion about the promise of the FHIR standard to transform healthcare organizations. What role do you see FHIR playing in healthcare IT?

There’s no doubt, it will transform organizations. It allows the same type of information exchange that we’re used to in other domains and accessing information on multiple different servers, and that might be information for a particular individual that exists in different electronic health records (EHRs). FHIR will make it much easier to access all that information. However, the other reality is that, for the foreseeable future, we will live in a hybrid world of standards. There’s the existing standards, HL7 v2 and C-CDA, and they are not going away, not in the next 10 or 20 years. They will still be in use, and the HL7 version 2 standard is the most widely used standard, and it’s being used in countless systems out there and people aren’t going to simply replace those systems. They are going to continue to use those systems because that standard does what it does very well, as far as exchanging lab orders and lab results, between the EHR and the lab system. FHIR, as it’s built out over the next two or three years, will be a standard that can be used to translate between standards and allow those systems that are legacy systems using an older standard to still exchange information within the ecosystem of health information data. But there will still be a huge portion of the information ecosystem that use older standards, so having FHIR as one means of translating between different standards will be the reality of the future.


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Russell Leftwich, M.D.

InterSystem has created a health information exchange (HIE) platform that’s enabled it to translate between HL7 v2 and C-CDA documents and FHIR, in both directions, so that people can use that as way of aggregating data about an individual and as a patient. If they turn that data into FHIR-based data, then it’s much easier to search and manipulate the data. I think that is one way FHIR will transform things at the point of care because once that data is in FHIR format, people will then use mobile devices to access that data, for things like decision support. FHIR is very adaptable to mobile devices such as smartphones and tablets, but also to mobile devices that are monitoring as well as medical devices, and the Internet of Things will be enabled by FHIR being the mechanism of interoperability. I think it will all feed into this hybrid ecosystem of different standards co-existing and FHIR will be the glue that ties all that together.

What is the latest progress on the FHIR standard?

We’re already starting to see FHIR-based apps and FHIR development going on. There was a panel at a meeting that I attended yesterday where people from four different organizations talked about how they are using FHIR in their organizations. In July, HL7 will have a two day event where different individuals and organizations will demonstrate what they’ve already done with FHIR within their organization. Right now, people have these apps that are enabled to use FHIR to access the data in that organization’s EHRs system but because these apps have been developed with earlier versions of FHIR, they won’t be easily carried across different organizations. Over the next year or two, as FHIR becomes stable enough and more developed, then apps will be developed. Organizations will have an app that you can get from an FHIR app store and actually be able to use that wherever your organization is.

Where does FHIR go from here?

That’s the future that’s coming very soon, the apps that people are using now are more proof of concept within the organizations. They’re using the apps and they are tremendously useful because they allow practitioners to do things and access the data in a way they couldn’t previously. And there’s work to be done with FHIR, as different parts of FHIR are not yet built out, particularly those parts that deal with very complex clinical data elements. The part of FHIR that deals with the more basic things like what’s the information around a patient or information around a particular condition, the way we specify a condition or a lab test, those things are fairly far along in FHIR. But more complicated concepts that relate to specialties and genetics and things like that are yet to be fully built out in FHIR. What needs to happen is that the entire FHIR community and the clinicians in particular need to get together, one data element at a time, and agree on a model, or how to represent that piece of data. You have to have that to really have interoperability across organizations. You have to agree that this is how we’re going to define this particular clinical data element or a particular diagnosis, but it’s not as complicated as some of these more sophisticated data elements.

So, FHIR will not eliminate the HL7 version 2 standard for now. What should health IT leaders be doing to ensure their information systems are prepared for this hybrid ecosystem of different standards?

Organizations certainly need to be planning their information architecture, if you will, for that future, which is probably not that far off, perhaps the next two to three years. I think they need to be strategic about the architecture they build out and the capabilities that are in the information architecture to adopt new standards like FHIR, but also to allow access to data that exists in these legacy systems that use older standards. And that’s because organizations can’t just go out and replace all these systems that are in use now. The average hospital in the US has something approaching 100 different IT systems within their hospital, and many of those systems are legacy systems that use older standards. But those standards work very well for what they are doing. They need to enable to make the best use of that data from these legacy systems in the future, so organizations need to have a strategy to bring these different types of data together.

One of the advantages of FHIR is that, in the past, to create an interface between two of those legacy systems using the existing standards like HL7 v2 and HL7 c-CDA, it took weeks to develop those interfaces. Those same interfaces leveraging FHIR can be developed in a matter of days, sometimes even hours, and having a strategy to adopt FHIR in a way that makes that data aggregation between old systems and new systems is going to be very important to organizations.

So it will be important for healthcare providers to be able to translate between these different standards to be successful, leveraging interoperability to achieve care coordination and value-based care, is that right?

Absolutely, with care coordination being the idea of having a virtual team that’s defined around an individual patient, and of those individuals some will be professionals and some family and community members. And that’s difficult to do right now because there’s no way to put data where it can be accessed by all of that virtual team. But with the FHIR standard, because of its adaptability with mobile devices and because all of the data could be put in a FHIR format, that will enable everybody on the virtual team to then access the data for that patient using a mobile device and using FHIR. And that’s the kind of thing that is already starting to happen within organizations. I would foresee in the next couple of years where it’ll start to happen more and more across organizations where there’s an HIE where they can access data with mobile devices and FHIR. And another angle to this that I think is very exciting is that each member of the virtual team will be able to have their own app, because app development with FHIR is relatively simple. And, in that sort of information ecosystem of the future, an app that’s developed for one place should be usable across the world.

So that’s a big part of the promise of FHIR, to create the universal platform that we have with Android and iOS in order to get an app from an app store that anybody can use on their device, anywhere, so that really is the promise of FHIR. And the idea that different individuals can have an app that suits their purposes instead of having to have a constant interface developed for a single EHR, which is prodigiously expensive. As an alternative, they can have an app that they got relatively inexpensively from an app store that will work wherever they are. I think a lot of people don’t understand that what’s been done with FHIR to this point is more proof of concept than it is proven out. What we’ll see in the next year or two with FHIR will be the realization of that promise of FHIR being a standard that can tie things together and give us access to all of the data about individuals as opposed to the data that’s in a single system.


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DirectTrust Touts 2018 Growth in Data Exchange Volume, Participants

January 23, 2019
by Rajiv Leventhal, Managing Editor
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DirectTrust, a nonprofit organization that supports health information exchange via the Direct message protocols, has announced continued steady growth in the number of healthcare organizations using its interoperability services during 2018.

The organization also noted an upsurge in the number of Direct message transactions, patient use, and addresses. According to year-end 2018 metrics:

  • There were nearly 274 million Direct message transactions between DirectTrust addresses in 2018, a 63-percent increase over the 2017 total of 168 million transactions. There were more than 110 million Direct messages transmitted during the fourth quarter of 2018 alone.
  • The number of patients/consumers involved using Direct increased approximately 35 percent to nearly 248,000.
  • The number of healthcare organizations served by DirectTrust accredited health information service providers (HISPs) increased 30 percent to nearly 139,000, compared with approximately 107,000 at year-end 2017.
  • The number of trusted DirectTrust addresses able to share PHI across the DirectTrust network increased 16 percent to more than 1.8 million since the end of 2017.
  • Eleven healthcare organizations joined DirectTrust during 2018, bringing the organization’s total membership to 115.

Last July, DirectTrust named former Cerner executive Scott Stuewe its new CEO to replace founding CEO Dr. David Kibbe. In a recent interview with Healthcare Informatics, Stuewe spoke about working more closely with EHR vendors and expanded opportunities for his organization’s trust framework.

He told Healthcare Informatics at the time that his organization could make more headway by engaging with the EHR (electronic health record) vendors who so far have not been very engaged with DirectTrust. “There are some gaps in features among the EHRs that frankly are the same gaps we saw in query-based exchange in CommonWell. There are usability problems; the way a given feature surfaces in one EHR is so different than another that you can’t even do the same work flow across the two systems,” Stuewe said.

Stuewe also noted that DirectTrust’s technical trust framework is about “stretching the highest security mechanism across identity-proofed endpoints,” which, he said, “is kind of a unique model.”

A recent data brief from the Office of the National Coordinator for Health IT (ONC) revealed that about four in 10 surveyed hospitals participated in more than one nationwide health information exchange network, such as Surescripts, the e-Health Exchange, DirectTrust, CommonWell, or Carequality. Surescripts was the most commonly network used; 61 percent of hospitals participated. The next highest participation rates were in DirectTrust and the e-Health Exchange; about a quarter of hospitals participated in each.


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Hospitals Outline Agenda to Accelerate Interoperability

January 22, 2019
by Heather Landi. Associate Editor
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Hospitals and health systems are making progress in sharing health information, with 93 percent making records available to patients online, but collaboration across many private and public sector entities, including technology vendors and policymakers, is necessary to achieve comprehensive interoperability, according to a new report from national hospital associations.

The report reviews the current state of interoperability, which show promises but is still a patchwork system, as well as outlines current challenges and provides an agenda for steps to take to improve interoperability among health IT systems. The report was compiled by seven national hospital associations—America’s Essential Hospitals, American Hospital Association (AHA), Association of American Medical Colleges, Catholic Health Association of the United States, Children’s Hospital Association, Federation of American Hospitals and the National Association for Behavioral Healthcare.

“We see interoperability in action all around us. Mobile phones can call each other regardless of make, model, or operating system. The hospital field has made good headway, but it’s time to complete the job. We are united in calling for a truly interoperable system that allows all providers and patients to benefit from shared health records and data, leading to fully informed care decisions,” AHA President and CEO Rick Pollack said in a statement.

“For the best care today, it’s the data stupid. Quality care depends on having the right information at the right time, so our patient’s records need to be available in the hospital or wherever our patients receive care. Hospitals are joining together to support improving interoperability because it is the key to assuring the best for our patients,” Federation of American Hospitals President and CEO Chip Kahn said in a prepared statement.

The report highlights that hospitals and health systems are making progress in sharing health information, with 93 percent making records available to patients online, up from 27 percent in 2012. What’s more, 88 percent of hospitals are sharing records with ambulatory care providers outside their system, up from 37 percent in 2012. And, 87 percent of hospitals enable patients to download information from their health record, up from 16 percent in 2012.

“We are inching closer to, but still short of, the ideal of seamless interoperability. In health care, this refers to the capacity to send and receive a patient’s health information from multiple sources between different systems and locations with its integrity intact,” the report authors wrote. “The information communicated must be useful to the receiving care provider, patients and families, and result in the care decisions that are best for them. Today, interoperability is a partially-achieved aim, working well in some but not all settings.”

The report authors note that the key to leveraging health data’s full potential for improving patient care is the establishment of a framework for compatible technical and linguistic (semantic) standards adopted by all parties that “lead us to a generic, vendor-neutral data exchange platform.” “We currently lack universally agreed upon ways of sharing and using information — “rules-of-the-road” that make possible the uncorrupted transfer of patient data between differing (and often proprietary) health record systems,” the report authors wrote.

Looking at progress made to date, hospitals and health systems have invest hundreds of billions over the past decade in electronic health records (EHRs) and other IT systems that record, store and transfer patient data securely among medical professionals. In 2017 alone, hospitals and health systems invested $62 billion in these IT systems.

According to the Office of the National Coordinator for Health Information Technology (ONC), the vast majority of hospitals use multiple mechanisms to share health information, and more than half must use four or more. Furthermore, most hospitals devote significant resources to manually matching patient records, since we do not have a national patient identifier, the report states.

And, according to 2010 AHA survey data, only 16 percent of hospitals had a basic EHR system in place. By 2017, 97 percent of surveyed hospitals had adopted a certified EHR system.

What’s more, hospitals and health systems have made efforts to link via health information exchanges (HIEs), however, the report notes while HIEs do deliver on some of the promises of interoperability, the exchangeable data is often limited to a regional or statewide scale. “In addition, some HIEs cannot reliably carry out full data exchange within a health system among different source technologies, or data



exchange across health systems including ambulatory or post-acute settings,” the report authors wrote. Also, HIEs may not enable individual patients to access their data.

The report authors also outline the ongoing barriers to comprehensive interoperability. According to an AHA analysis on barriers to health data exchange and interoperability, 63 percent of respondents cited the lack of capable technology as the biggest barrier. That survey also identified difficulties matching or identifying the correct patient between systems also as additional costs to send or receive data with care settings and organizations outside their system as significant interoperability barriers as well.

“Barriers to interoperability must be addressed in order to support the level of electronic sharing of health information needed to provide the best care, engage people in their health, succeed in new models of care, and improve public health. Doing so requires collaboration across many private and public sector entities, including hospitals and health systems, technology companies, payers, consumers, and federal and state governments,” the report authors wrote.

The report also outlines “pathways” to advance interoperability with a particular focus around privacy, security, standards and infrastructure as well as industry stakeholders committing to share best practices and lessons learned.

Among the report’s recommendations, new standards are needed to overcome the significant gaps making communication difficult between systems. “For example, APIs (application programming interfaces), including those based on the FHIR (Fast Healthcare Interoperability Resources) standard, allow for more nimble approaches to accessing needed data. Health care will benefit most from use of standard, secure, non-proprietary APIs that minimize the added costs associated with proprietary solutions and gatekeeping. API access should support both patient access to information from providers and other stakeholders, and the use of trusted third-party tools to support clinical care,” the report authors wrote.

“While we have made much progress, at present, we have the incomplete outline of a national data-sharing system in place, one that lacks the agreed upon rules of the road, conformance, technical standards and standardized implementations to ensure that all HIE platforms can communicate correctly with each other,” the report authors concluded.

The report authors note that true interoperability that advances improved health care and outcomes is within reach with effective federal policies and key stakeholders doing their part. The report calls on health systems to use their procurement power to drive vendors toward compatibility in systems design and lend a voice to the development process.

EHR and IT vendors, in turn, should commit to more field testing and consistent use of standards, the report authors wrote, and avoid pricing models that create a “toll” for information sharing. Vendors also should offer alternatives to expensive, labor-intensive workarounds that drain providers’ time and energy.


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HL7 Model Identifies Clinical Genomics Workflows, Use Cases

January 16, 2019
by David Raths, Contributing Editor
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Domain Analysis Model covers pre-implantation genetic diagnosis, whole-exome sequencing, RNA sequencing and proteomics

HL7’s Clinical Genomics Work Group has published an HL7 Domain Analysis Model (DAM) to identify common workflows and use cases to facilitate scalable and interoperable data standards for the breadth of clinical genomics scenarios.

The Domain Analysis Model (DAM), which has underdone a rigorous ISO/ANSI-compatible balloting process, covers a myriad of use cases, including emerging ones such as pre-implantation genetic diagnosis, whole-exome sequencing, RNA sequencing and proteomics.

The effort “builds on the DAM Clinical Sequencing work that is already being used to design precision medicine workflows at hospitals across the country,” said Gil Alterovitz, Ph.D., an HL7 Clinical Genomics Work Group co-chair, in a prepared statement. He also serves as a Harvard professor with the Computational Health Informatics Program/Boston Children’s Hospital.

The Clinical Sequencing DAM fueled the design of FHIR Genomics, the subset of HL7’s FHIR standard designed to communicate clinical genomic information. “By extending to broader domains, it can serve as a standard going forward to aid in the design of workflows, exchange formats as well as other areas,” Alterovitz added,

The document presents narrative context and workflow diagrams to guide readers through the stages of each use case and details steps involving the various stakeholders such as patients, health care providers, laboratories and geneticists. This contextual knowledge aids in the development and implementation of software designed to interpret and communicate the relevant results in a clinical computer system, especially a patient's electronic health record.

The HL7 Clinical Genomics Work Group developed several new applications and refinements in the Domain Analysis Model beyond its original scope of clinical sequencing. One notable addition is the analysis of the common workflows for pre-implantation genetic diagnosis (PGD). For those undergoing in-vitro fertilization, advanced pre-implantation genetic screening has become increasingly popular as it avoids the implantation of embryos carrying chromosomal aneuploidies, a common cause of birth defects. Implementers can follow the workflow diagram and see the context for each transfer of information, including the types of tests performed such as blastocyst biopsy and embryo vitrification.

As the clinical utility of proteomics (detecting, quantifying and characterizing proteins) and RNA-sequencing increases, the DAM also outlines clinical and laboratory workflows to capitalize on these emerging technologies.

HL7 notes that future challenges arise from uncertainty about the specific storage location of genomic data, such as a Genomics Archive and Computer/Communication System (GACS), as well as the structure of a patient’s genomic and other omics data for access on demand, both by clinicians and laboratories. Best practices in handling such considerations are being formulated within HL7 and include international input from across the spectrum of stakeholders. In parallel, the HL7 Clinical Genomics Work Group has been preparing an implementation guide for clinical genomics around many of these use cases, to be leveraged alongside the newly published HL7 FHIR Release 4 standard.


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