The Standard

Clinical care data is a foundation for research. It is used to understand patient populations and as the core for clinical data capture. The introduction of HL7 Fast Healthcare Interoperability Resources (FHIR®) and its adoption rate creates a new opportunity to exchange data for clinical and translational research. Building off the work already accomplished to create interoperability standards for the exchange of healthcare data bridges clinical research into the greater healthcare ecosystem.

HL7 FHIR® accelerators have been a successful catalyst for standards development and adoption. Following the path of other accelerators, the research community collaborated to create Vulcan. In August 2020, Vulcan was launched by convening the following member organizations: TransCelerate Biopharma, Duke University, Johns Hopkins, Oregon Health and Sciences University, UT Health San Antonio, Society for Clinical Data Management, U.S. National Library of Medicine, National Center for Advancing Translational Sciences (NCATS), Danish Medicines Agency and U.S. Food and Drug Administration. Membership is rapidly growing with new organizations being onboarded each month.

Vulcan Use Cases

After consultation with the Steering and Operations Committee of Vulcan, project teams have been formed to move forward three use cases. These were selected from a larger effort to collect as many as eighteen uses cases which were prioritized based on impact and the ability to deliver to the community. The initial selected use cases include:

• Real world data (including secondary use of electronic health record data)
• Phenopackets
• Schedule of activities

Social Determinants of Health Data Matter for National COVID-19 Response Efforts

The Gravity Project is pleased to announce the publication of its consensus recommendations for food insecurity, housing instability and homelessness data elements. The Gravity Project is a national cross sector grassroots informed collective charged with building consensus data elements and data standards for the capture, exchange, and use of social determinants of health (SDOH) information. The Gravity food insecurity and housing data elements are the result of a year of development with input from its over 1,000 participants with intentional representation from key stakeholders such as patients, providers, community based organizations, payors, technology vendors, and federal and academic food insecurity and housing subject matter experts.

Social determinants of health—the circumstances in which we are born, grow, live, work and age—are estimated to account for 80-90% of health. There is growing interest from the healthcare sector to integrate social risk evaluation and intervention to advance the triple aim: improved health outcomes and quality of care while containing costs. In 2018, Gravity founders University of California San Francisco (UCSF) Social Interventions Research and Evaluation Network (SIREN) conducted an assessment of existing SDOH data and found much work was needed to advance the documentation and use of this data. Enter, the Gravity Project. The Office of the National Coordinator for Health Information Technology (ONC), a Gravity Project sponsor, noted the growing recognition across healthcare that by capturing and accessing SDOH data during the course of care, providers can more easily address non-clinical factors, such as food, housing and transportation insecurities, which can have a profound impact on a person’s overall health.

Doing Less, but Better

Imagine you’re struggling in a long race – maybe an ultra-marathon over a winding, hilly course. You’ve been running for many hours, and you’re tired, sore and hungry. You’re running up a hill, hoping the end will soon be in sight. But when you get to the top, you only see a turn, not a finish. And after that turn – oh, no! – another hill. We’ve had that feeling during the long pandemic, and, for some of us, we’ve had that feeling even longer with respect to tooling at HL7. We’ve covered a lot of ground, and climbed a lot of hills, and we can feel the end should be in sight very soon. But we’re still running.

Fortunately, we have a team of supporters handing out Gatorade, clapping and cheering us on, and we’ve got our fellow runners pulling us along. And so it is with the HL7 community. We ask a lot of you to help us move forward, with support and understanding; sometimes contributing your valuable time to help us with development or testing, or to struggle patiently with change and the unexpected discoveries of new technology rollouts. While we don’t see that finish line yet, we see plenty of blue skies and greener fields beyond. We won’t always make it on the podium, and sometimes we stumble along the way. But the important thing is to keep moving forward and getting better.

The View from Above

We may not always seem to be progressing very fast, but we’ve really come a long way in the last few years thanks to the important contributions of many of you as well as the ongoing generous support of the US Office of the National Coordinator for Health IT (ONC), which has funded many of our retooling efforts. To list a few prominent examples:

The Centers for Medicare & Medicaid Services (CMS) released the much-awaited Interoperability & Patient Access Rule in early March this year. This rule establishes policies that aim to break down barriers in the health system across the US for better patient engagement. Government bodies are taking significant efforts for governments-sponsored health plans to adopt interoperability to make healthcare system efficient. Multiple initiatives by the Department of Health and Human Services (HHS) and its CMS and Office of the National Coordinator for Health Information Technology (ONC) aim to improve care-coordination and member experience. CMS had proposed the Interoperability & Patient Access Rule to support regulations of the MyHealthEData initiative, with implementation timelines to drive programs such as BlueButton, BlueButton 2.0 and Data at the Point of Care.

In the times of pandemic, healthcare organizations have realized the importance of having access to data for better care coordination and efficient care delivery. With seamless data access, organizations can:

• Share health data of beneficiaries with different care teams
• Identify high-risk population and implement preventive actions to control risk
• Leverage tele-health with access to patient historical health data
• Take timely decisions on emergency treatments based on patient medication history

Doing Less, but Better

For many of us, this desperate pandemic year has led to plenty of introspection.  This has also been true for the HL7 Board, which has been contemplating the future of the HL7 organization after emerging from the current crisis. Among a set of core principles adopted by the Board are agility and focus. To be agile, we need to simplify and refine the organization and core processes as well as provide support with continued improvements to our tooling. This also requires getting our global community to better understand and use the processes more consistently and effectively, so we can better focus on our core work of developing and implementing interoperability standards.  This a perfect segue back toward my long-held core belief in essentialism.

Back to Basics

I first espoused the concept of essentialism to an enthusiastic Board and Technical Steering Committee back in 2016. While we’ve only made small incremental progress in the four years since, it has been guiding our process improvement and tooling initiatives. Essentialism was a driving force behind our adoption of Confluence and JIRA as well as efforts to simplify our product portfolio. Of course, we operate in a complex field, and there were many confounding forces acting at the same time. The HL7 community is more adept at introducing new processes, tools and content than at retiring or eliminating the old stuff. Thus, our commitment to essentialism faded over time, tempered by inertia and continuing demands, not the least of which has been the black swan events of 2020.

Perhaps it’s time to once again review the key elements of essentialism and discuss how it fits with our ongoing tooling strategy and plans.

Limitations in existing healthcare interoperability present a significant barrier to next-gen computing solutions such as Machine Learning (ML) and Artificial Intelligence (AI). New workflow standards aimed at addressing the integration of AI/ML actors to clinicians in delivering better patient care.

One of the main limitations of standards is streamlining access to data from electronic medical record (EMR) applications. There is a growing need for a holistic view of patient data, and the inclusion of the allied healthcare services such as radiology will play a crucial role in building a 360° patient view. This will help healthcare professionals take accurate and informed decision on patient care, and bridge the gap between fragmented and siloed information that is currently limiting hospitals and healthcare systems from gaining insights to drive better health outcomes.

To seek better exchange of health data among providers and patients, the Health and Human Services (HHS) published final rules that put patients first and bring one step closer to achieving Interoperability. The ONC’s (Office of the National Coordinator for Health Information Technology) rule aims to standardize API via HL7 Fast Healthcare Interoperability Resources (FHIR®) R4, a latest version of the FHIR standard, and making its use mandatory under this rule.

Report from Virtual FHIR DevDays 2020 on HL7 Da Vinci Project Use Cases

Developers are fine-tuning ways to use the HL7 Fast Healthcare Interoperability Resource (FHIR) standard to reduce communication challenges and decision impediments between providers and payers.

Working on use cases involving coverage and burden reduction, the HL7 Da Vinci Project is refining early versions of standards and developing implementation guides for value based care (VBC). Speaking to more than 150 attendees during the virtual HL7 FHIR DevDays event, Dr. Viet Nguyen, Da Vinci Project Technical Director, noted that the coverage and burden reduction use cases are intended to address workflows around provider-payer interactions. FHIR implementation guides are then created based on a set of use cases. 

Coverage Requirements Discovery

One use case, Coverage Requirements Discovery, gives providers real-time access to payer approval requirements, documentation and rules at point of service to reduce provider burden and support treatment planning. In its essence, this would answer a provider’s question about whether a procedure or treatment needs a prior authorization from a payer. The aim is to use CDS Hooks to supply an answer to a clinician posing the request within his or her workflow. Work is continuing on developing an implementation guide for this use case.

Report from Virtual FHIR DevDays 2020 on the Patient Innovator Track

Initiatives seeking to expand the use of HL7’s Fast Healthcare Interoperability Resources (FHIR®) standard were highlighted at the recent HL7 FHIR Dev Days 2020 virtual event.

The Patient Innovator track included four presentations highlighting its recent move to encourage the use of technology to support patient involvement in care. HL7’s Patient Empowerment Work Group has a mission of promoting and amplifying the viewpoint of patients and caregivers in HL7’s standards work. Its initial priorities include enabling patients to correct errors in records, contribute their data to records, plan care, and efficiently gather and store patient consents.

The four presentations were judged by a panel of HL7 experts for their use or projected vision for the use of FHIR to solve problems in patient empowerment in healthcare. In addition, attendees at the virtual Dev Days event could vote to award one of the participants a People’s Choice award.

Report from Virtual FHIR DevDays 2020

The Cleveland Clinic and Oscar Health announced a partnership in mid-2017 that was going to require a level of provider-payer integration that the organization hadn’t attempted before.

More challenging still was the fact that the timeline was short – some of the capabilities that would enable improved patient interactions had to be in place by January 2018. The use of the HL7 Fast Healthcare Interoperability Resources (FHIR®) standard addressed many of the technical challenges in hitting those deadlines.

Integration between the entities still was difficult to achieve, noted Matthew Coolidge, who was then the IT product director at the Cleveland Clinic and is now CEO of Orbital Health. When he was in his Cleveland Clinic role, he was the organization’s subject matter expert on FHIR. Coolidge shared lessons learned in the initiative in a keynote presentation at the recent HL7 FHIR DevDays virtual meeting.

Report from Virtual FHIR DevDays 2020

A New York State initiative is aiming to change its approach for exchanging patients’ health information among the state’s health information exchanges, using HL7’s Fast Healthcare Interoperability Resources (FHIR®) standard as the conduit.

In addition, the new approach being implemented for the State Health Information Network for New York (SHIN-NY) has taken less time to develop and is expected to enable the exchange of more granular patient data than is possible with the current approach.

Speaking at the HL7 FHIR DevDays virtual meeting on June 15, Luke Doles, senior director of services management for the New York eHealth Collaborative (NYeC), said further implementation of the FHIR-based framework has been delayed because of the urgency to shift resources to support the state’s COVID-19 response. However, the initiative has thus far proven that the concept can be expanded to provide more information across SHIN-NY.