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HL7 Publishes Release 4 of FHIR Standard

January 3, 2019
by Heather Landi, Associate Editor
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Standards organization Health Level Seven (HL7) has published Release 4 of its Fast Healthcare Interoperability Resources (FHIR) Standard, marking the first release with normative content.

 “R4 is the culmination of 18 months of extensive work to finalize the base parts of the specification, and incorporate changes and enhancement requests received from implementation partners across the world,” Grahame Grieve, HL7 FHIR Product Director, wrote in a blog post.

FHIR is a standards framework that leverages the latest Web standards and applies a tight focus on implementation. FHIR includes a RESTful application programming interface (API), which is an approach based on modern Internet conventions and widely used in other industries. FHIR can be applied to mobile devices, Web-based applications, cloud communications, and EHR data-sharing using modular components. The FHIR Maturity Model helps implementers understand how the various parts of the standard are advancing through the standards development lifecycle.

FHIR Release 4 marks a significant milestone with the introduction of a normative base. “This new maturity will help support our very active and growing community,” Grieve wrote in the blog post.

“What we have now is a solid foundation which provides a framework for implementers to rely upon and that they know they can use it, and implementers should have more confidence in using the tool moving forward,” says Wayne Kubick, HL7’s chief technology officer. “Our expectation is that this will sort of diffuse some of the arguments and some of the fence-sitters who kept saying that FHIR is still in development, and while that’s true, it’s widely in use in thousands of applications and countries all around the world now. With FHIR R4, implementers should have confidence that it’s going to be around a long time and it’s going to be stable.”

Between release 3 and release 4, there have been nearly 3,000 change proposals applied to the specification, including more than 1,000 substantive changes, according to the organization.

The most significant change in FHIR Release 4 is that the base platform of the standard has passed a normative ballot, and will be submitted to ANSI as a normative standard. This means that future changes should be backward compatible, so that applications that implement the normative parts of R4 no longer risk being non-conformant to the standard, the organization said.

“The message to the community is that we are asserting they should not expect breaking changes in the future; if they adopt this version, they should expect whatever they build off this version to be supported for the foreseeable future. That should give implementers the confidence to invest more of their time and effort in using the FHIR standard,” says Wayne Kubick, HL7’s chief technology officer.

The following portions of the standard are now normative:

  • The RESTful API, the XML and JSON formats, and the basic datatypes
  • The Terminology layer (CodeSystem and ValueSet)
  • The Conformance Framework (StructureDefinition and CapabilityStatement)
  • The key resources Patient and Observation

Creating and publishing normative content is critical for allowing health IT developers to implement FHIR consistently and uniformly, according to HL7 officials.

Recent data from the Office of the National Coordinator for Health Information Technology (ONC) found that adoption and implementation of the HL7 FHIR standard in health IT is steadily progressing. Approximately 32 percent of certified health IT vendors said that they are using FHIR, specifically the “FHIR Release 2” API (application programming interface) standard. Nearly 51 percent of health IT developers appear to be using a version of FHIR combined with the OAuth 2.0 standard, according to ONC.

Kubick notes that with the publication of FHIR release 4, not all of FHIR is normative. “The features that have been defined as normative and submitted for approval as normative are essentially the infrastructure pieces—the pieces that determine how to use terminologies, how to build APIs, as well as resources around defining about how you recognize a patient and how you record observations about a patient. That’s a lot of the data you collect in healthcare, but by no means all of it,” he says.

The plan is to release FHIR, new releases on an 18- to 24-month release cycle. “We’ll expect to see another version of FHIR coming out around 2020. With the next release, we expect more of these medical content-type pieces, working on the resources defining drug products, for example,” Kubick says.

Moving forward, the HL7 FHIR working group will likely focus on fleshing out clinical content, Kubick says. “We will be building up more of the content resources that we currently have, as well as broadening capabilities for interacting with devices and images. We want to be able to get, with R5, a more complete view of as much of the types of health information necessary in place. We’ve got the Infrastructure solid and pretty much in place now with R4, and now we want to focus more on content, which is a much more complex issue, because we’re trying to move to a more structured, consistent way of representing health information, as recorded by doctors,” he says, adding, “The content is the tricky part, there is still a lot of variation in place. Reaching the level where the definition of the clinical content is much more consistent, we help us to get closer to interoperability, and that is really our next horizon.”

 

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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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