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Straight Talk About FHIR

April 30, 2018
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“The surest path to robust interoperability is to enable market forces to drive us forward.”

Hype

  1. n. extravagant or intensive publicity or promotion.
  2. v. to promote or publicize (a product or idea) intensively, often exaggerating its importance or benefits.

FHIR and the Hype Cycle

Have you noticed the hype around Fast Healthcare Interoperability Resources (FHIR)? It was hard to miss at HIMSS2018, where enthusiasts proclaimed that FHIR will solve our interoperability woes. It will not, and it is essential we dispel the misconceptions and hype—for they pose significant risks to fixing our broken healthcare system.

Hype often accompanies the emergence of new technology. The Gartner Hype Cycle, a well-known guide to healthcare technology life-cycles, can be fascinating and useful in understanding these natural occurrences.

The hype cycle reminds us that while enthusiasm, optimism and high expectations are commendable, reality tends to have a way of humbling our best intended efforts. As a CMIO and healthcare consultant, I have watched this play out countless times. We are all subject to falling for hype and I confess that, at times, I have been either a perpetrator, a victim or both! Being aware of this cycle is a good way to guard against the ill effects of buying into the hype.

It’s important to be clear about two things. First, the folks actually working to develop FHIR are consistently the most realistic and cautious in making claims. They bear little, if any responsibility for the surrounding hype. Second, while FHIR has limitations just like any technology, there’s nothing wrong with it per se. Quite the opposite. I favor almost anything that moves healthcare away from using outdated legacy integration technologies and towards the API-based approach that enables interoperability in the rest of the (non-health care) digital economy.

FHIR is not the problem. The problem is the misconceptions and hype surrounding FHIR. It’s vital we address those misconceptions and mitigate the risks posed by the hype.

Four Hard Truths About FHIR

There is a common misbelief that FHIR is going to provide a rapid path to robust interoperability between third-party applications and electronic health records (EHRs). Many believe FHIR will result in a standardized plug-and-play approach for rich data exchange. Just plug your application into FHIR and you are off and running!

This is flat out wrong for at least four reasons:

  1. FHIR is not a standard, it is a “suggestion”. The biggest FHIR misconception is that it will be an industry standard. In theory, FHIR could be a standard. In practice, there are no enforcement mechanisms and EHR vendors (and others) have already implemented different versions of FHIR. It is clear that FHIR is NOT going to be a robust standard that is consistent across implementations.
  1. EHR vendors are not implementing all available FHIR APIs. This creates another critical source of inconsistency. Developers who rely on FHIR for EHR integration must keep track of which EHRs have implemented which APIs. A robust API provided by one EHR may be completely absent in another.
  1. EHR vendors are not consistently implementing the entire API. Even if two vendors implement the same FHIR API, they may not implement the entire specification for that particular API. One may have all data elements, while the next only includes a portion of the specification.
  1. FHIR extensions undermine standardization. In principle, allowing developers to extend upon the basic FHIR specification can have advantages. In practice, this further undermines any attempt to create a standard. History shows that permissive models—like “z-segment” customization of HL7—opens the door to the wild west and results in divergence rather than convergence.

These are not theoretical concerns. FHIR endpoints are being implemented differently by EHR vendors. This is clearly illustrated in Table 1 below (and in a more detailed analysis here).

This reality places huge limitations on FHIR and largely defeats the purpose of having a standard specification in the first place. We have seen this movie before and it does not end well! Both HL7 and CCD have had well defined specifications but did not control the implementation. Sorting out the many different flavors and maintaining fragile, one-off implementations is a nightmare and a huge waste of resources for application developers and integration teams. It is also an enormous barrier to innovation. Unfortunately, FHIR will not solve these problems and may make things worse by introducing even more variants.

Why the Hype Matters

Lack of robust interoperability is the most important issue in healthcare IT today. Widespread deployment of EHR silos that don’t interoperate with each other and inhibit the wider exchange of data has cast a harsh light on these problems. When health system leaders and digital health innovators consistently cite lack of interoperability as one of their biggest challenges, you know it’s a big deal. The recent announcement by CMS that they will be retooling the meaningful use program to place more emphasis on interoperability provides further confirmation.

The stakes are exceedingly high. Health systems are dealing with enormous economic pressure, increasing competition and market turbulence. They recognize they must innovate and leverage healthcare IT (HIT) to enable greater value and satisfaction for patients and providers. The same applies to digital health companies. In short, lack of robust interoperability is the biggest bottleneck in healthcare innovation and must be rapidly resolved.

Which brings us to the risk associated with FHIR hype. Too many are placing too much faith in one unproven approach. Putting all our interoperability “eggs” in the FHIR “basket” is a single-threaded approach that greatly compounds the risk of failure.

Instead, we should mitigate the risks by pursuing diverse solutions. Just like you shouldn’t bet your retirement on a single stock, we shouldn’t be betting on a single approach to solve a complex issue like interoperability. Healthcare needs a mix of legacy technology, FHIR APIs, EHR vendor APIs and commercial APIs. This diversity allows us to match the best solution to the problem at hand, lessens the risk of relying on any one solution and promotes competition.

This last point is vital. The surest path to robust interoperability is to enable market forces to drive us forward. This will rapidly produce a variety of options, as competitors race to provide the best performance at the lowest price.

Dr. Dave Levin has been a physician executive and entrepreneur for more than 30 years. He is a former Chief Medical Information Officer for the Cleveland Clinic and serves in a variety of leadership and advisory roles for healthcare IT companies, health systems and investors. You can follow him @DaveLevinMD or email DaveLevinMD@gmail.com.

 

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/news-item/interoperability/hl7-model-identifies-clinical-genomics-workflows-use-cases

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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ONC Releases Interoperability Standards Advisory Reference 2019

January 15, 2019
by Heather Landi, Associate Editor
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The Office of the National Coordinator for Health IT (ONC) has released the 2019 Interoperability Standards Advisory (ISA) Reference Edition, which serves as a “snapshot” view of the ISA.

The 2019 Interoperability Standards Advisory represents ONC’s current assessment of the heath IT standards landscape. According to ONC, this static version of the ISA won’t change throughout the year, while the web version is updated on a regular basis. The ISA contains numerous standards and implementation specifications to meet interoperability needs in healthcare and serves as an open and transparent resource for the industry.

The Interoperability Standards Advisory (ISA) process represents the model by which ONC coordinates the identification, assessment, and public awareness of interoperability standards and implementation specifications that can be used by the healthcare industry to address specific interoperability needs including, but not limited to, interoperability for clinical, public health, research and administrative purposes. ONC encourages all stakeholders to implement and use the standards and implementation specifications identified in the ISA as applicable to the specific interoperability needs they seek to address. Furthermore, ONC encourages further pilot testing and industry experience to be sought with respect to standards and implementation specifications identified as “emerging” in the ISA.

The newest ISA reference edition includes improvements made based on comments provided by industry stakeholder during the public comment period, which ended Oct. 1, according to a blog post written by Steven Posnack, executive director of ONC’s Office of Technology, Chris Muir, standards division director, Office of Technology, and Brett Andriesen, ONC project officer. ONC received 74 comments on the ISA this year, resulting in nearly 400 individual recommendations for revisions.

According to the blog post, the ISA contains “a variety of standards and implementation specifications curated by developers, standards gurus, and other stakeholders to meet interoperability needs (a term we use in the ISA to represent the purpose for use of standards or implementation specifications – similar to a use case) in healthcare.”

“The ISA itself is a dynamic document and is updated throughout the year, reflecting a number of substantive and structural updates based on ongoing dialogue, discussion, and feedback,” Posnack, Muir and Andriesen wrote.

The latest changes to the reference manual include RSS feed functionality to enable users to track ISA revisions in real-time; shifting structure from lettered sub-sections to a simple alphabetized list; and revising many of the interoperability need titles to better reflect their uses and align with overall ISA bets practices. According to the ONC blog post, the updates also include several new interoperability needs, including representing relationship between patient and another person; several electronic prescribing-related interoperability needs, such as prescribing weight-based dosing and request for refills; and operating rules for claims, enrollment and premium payments.

The latest changes also include more granular updates such as added standards, updated characteristics and additional information about interoperability needs.

The ONC officials wrote that the ISA should be considered as an open and transparent resource for industry and reflects the latest thinking around standards development with an eye toward nationwide interoperability.

The ISA traditionally has reflected recommendations from the Health IT Advisory Committee and its predecessors the HIT Policy Committee and HIT Standards Committee and includes an educational section that helps decode key interoperability terminology.

 

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ONC Report: Health IT Progress Stifled by Technical, Financial Barriers

January 15, 2019
by Heather Landi, Associate Editor
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While progress has been made in the adoption of health IT across the U.S. healthcare industry, significant interoperability hurdles remain, including technical, financial and trust barriers, according to a report from the Office of the National Coordinator for Health Information Technology (ONC).

Currently, the potential value of health information captured in certified health IT is often limited by a lack of accessibility across systems and across different end users, the ONC report stated.

The annual report from the U.S. Department of Health and Human Services (HHS) and ONC to Congress highlights nationwide health IT infrastructure progress and the use of health data to improve healthcare delivery throughout the U.S.

The report, “2018 Report to Congress: Annual Update on the Adoption of a Nationwide System for the Electronic Use and Exchange of Health Information,” also reflects progress on the implementaions of the Federal Health IT Strategic Plan 2015-202 and the Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap.

In the report, ONC notes that most hospitals and health care providers have a digital footprint. As of 2015, 96 percent of non-federal acute care hospitals and 78 percent of office-based physicians adopted certified health IT. The increase in health IT adoption means most Americans receiving health care services now have their health data recorded electronically.

However, hurdles to progress still remain. For example, ONC notes that many certified health IT products lack capabilities that allow for greater innovation in how health information can be securely accessed and easily shared with appropriate members of the care team. “Such innovation is more common in other industries. Also, lack of transparent expectations for data sharing and burdensome experiences for health care providers limit the return on investment for health care providers and the value patients are able to gain from using certified health IT,” the report authors wrote.

While health information is increasingly recorded in a digital format, rather than paper, this information is not always accessible across systems and by all end users—such as patients, health care providers and payers, the report authors note. Patients often lack access to their own health information, healthcare providers often lack access to patient data at the point of care, particularly when multiple healthcare providers maintain different pieces of data, own different systems or use health IT solutions purchased form different developers, and payers often lack access to clinical data on groups of covered individuals to assess the value of services provided by their customers.

Currently, patients electronically access their health information through patient portals that prevent them from easily pulling from multiple sources or health care providers. Patient access to their electronic health information also requires repeated use of logins and manual data updates, according to the report. For healthcare providers and payers, interoperable access and exchange of health records is focused on accessing one record at a time. “Without the capability to access multiple records across a population of patients, healthcare providers and payers will not benefit from the value of using modern computing solutions—such as machine learning and artificial intelligence—to inform care decisions and identify trends,” the report authors wrote.

Looking at the future state, the report authors contend that certified health IT includes important upgrades to support interoperability and improve user experience. Noting ONC’s most recent 2015 edition of certification criteria and standards, these upgraded capabilities will show as hospitals and healthcare provider practices upgrade their technology to the 2015 edition, the report authors state.

“As HHS implements the provisions in the Cures Act, we look forward to continued engagement between government and industry on health IT matters and on the role health IT can play to increase competition in healthcare markets,” the report authors wrote, noting that one particular focus will be open APIs (application programming interfaces). The use of open APIs will support patients’ ability to have more access to information electronically through, for example, smartphones and mobile applications, and will allow payers to receive necessary and appropriate information on a group of members without having to access one record at a time.

Healthcare industry stakeholders have indicated that many barriers to interoperable access to health information remain, including technical, financial, trust and business practice barriers. “In addition, burden arising from quality reporting, documentation, administrative, and billing requirements that prescribe how health IT systems are designed also hamper the innovative usability of health IT,” the report authors wrote.

The report also outlines actions that HHS is taking to address these issues. Federal agencies, states, and industry have taken steps to address technical, trust, and financial challenges to interoperable health information access, exchange, and use for patients, health care providers, and payers (including insurers). HHS aims to build on these successes through the ONC Health IT Certification Program, HHS rulemaking, health IT innovation projects, and health IT coordination, the report authors wrote.

In accordance with the Cures Act, HHS is actively leading and coordinating a number of key programs and projects, including “continued work to deter and penalize poor business practices that lead to information blocking,” for example.

The report also calls out HHS’ efforts to develop a Trusted Exchange Framework and a Common Agreement (TEFCA) to support enabling trusted health information exchange. “Additional actions to meet statutory requirements within the Cures Act including supporting patient access to personal health information, reducing clinician burden, and engaging health and health IT stakeholders to promote market-based solutions,” the report authors wrote.

Moving forward, collaboration and innovation are critical to the continued progress on the nationwide health IT infrastructure. To that end, the HHS report authors recommend that the agency, and the health IT community overall, focus on a number of key steps to accelerate progress. Namely, health IT stakeholders should focus on improving interoperability and upgrading technical capabilities of health IT, so patients can securely access, aggregate and move their health information using their smartphones, or other devices, and healthcare providers can easily send, receive and analyze patient data.

The health IT community also should focus on increasing transparency in data sharing practices and strengthen technical capabilities of health IT, so payers can access population-level clinical data to promote economic transparency and operational efficiency, which helps to lower the cost of care and administrative costs, the report authors note.

Health IT developers and industry stakeholders also needs to prioritize improving health IT and reducing documentation burden, time inefficiencies and hassle for healthcare providers so clinicians and physicians can focus on their patients rather than their computers.

 

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