Can a growing health care informatics interoperability standard support the transformation of translational research to drive the clinical research as a care option movement? That’s the plan as leading health care technology vendor InterSystems inked a deal to join HL7s Vulcan FHIR Accelerator Program. Many experts increasingly believe that only by combining the data derived from the clinic, that is the information associated with electronic health records, and the growing acceptance of health interoperability standards associated, with what’s known as FHIR can translational research advance, ushering in the next generation of progress in healthcare. What is the Vulcan FHIR Accelerator Program? Why did InterSystems join in? What does it mean ultimately for clinical research?
Research Falls Behind the Clinic!
That’s right—and surprising perhaps to many that think about these sorts of challenges. In fact, it might be assumed by conventional wisdom that in healthcare the clinical research operation is somehow more technologically advanced than the clinic but frankly it’s just the opposite. Due to a confluence of factors and forces, research generally lags and in select segments, such as clinical trials operations, it’s as if it took a pandemic to wake up whole organizations to the potential of the basics, such as telehealth options.
While digitization of healthcare has resulted in the rapid expansion of electronic health record standards (EHRs) on the research side, actual technology advancements in drug discovery, the approval process with the U.S. Food and Drug Administration (FDA), and comparable regulators lags far behind healthcare. This leads to a very expensive problem that is ultimately felt not only by life science company shareholders but ultimately the patient.
A $2.6 Billion Problem
Exemplified by a 2016 Tufts Center for Study of Drug Development study, the development of prescription drugs now costs on average about $2.6 billion. A long sought after goal of drug developers was to leverage and harness EHR data from the clinical setting, but this remains elusive for most researchers leading to what is known as rampant and costly delays in the discovery of new treatments for disease.
Overcoming the Challenge: Vulcan FHIR Accelerator Program
Enter the Vulcan FHIR Accelerator Program introduced to start mitigating the challenges associated with delays in drug research. But how could this be done? The key next steps involve modernizing the sharing and representation of clinical data and translational discovery for clinical researchers via FHIR standards.
The Bridge to Modernity for Research?
The HL7 organization has set up the Vulcan FHIR Accelerator Program to work with communities and implementers with an interest in using FHIR to address common use cases, such as bringing the clinic data into research. This new initiative offers guidance and advisory services to navigate, tap into, and harness the ongoing work going with working groups, product families and project teams. The program purports to offer basic team collaboration infrastructure tools and a range of other optional support services.
What are the existing projects?
The Argonaut Project represents a private sector initiative to advance industry adoption of the modern, open interoperability standards in a quest to develop a first-generation FHIR-based API and Core Data Services specification to enable expanded information sharing for EHRs and other health tech based on internet standards and architectural patterns and styles.
Another effort known as the CARIN Alliance is led by risk-bearing providers, payers, pharmaceutical companies, and others working collaboratively to overcome barriers in advancing consumer-directed exchange across America. CodeX or Common Oncology Data Elements eXtensions represents a community seeking to accelerate interoperable data modeling and associated applications leading to improvements in cancer patient care and research.
Still, other initiatives (including the Da Vinci Project) center on driving patient-centered outcomes by bringing together payers and providers to create efficient care delivery solutions and effective care management models. Gravity Project is all about the social determinants of health and the effort required for achieving supporting data standards—a consensus-building community to expand what are agreed upon SDOH core data supporting even more powerful interoperability and meaningful use utilizing HL7 FHIR standards.
Enter Vulcan: Clinical Research as a Care Option
The Vulcan project vision was solidified in September 2019 by a multi-faceted group representing government agencies, academic medical centers, tech industry, standards organizations, patient groups and industry consortia. This momentum is driving the coming together of stakeholders across translational and clinical research interests to bridge existing gaps between clinical care and research, while strategically connecting industry collaboratives, maximizing collective resources, and delivering integrated tools and resource.
While the goal of leveraging clinic or healthcare informatics for clinical trials is not new, the actual acquisition and use of EHR data for prospective clinical research has remained largely separated from routine care. This impacts research not only from the pragmatic perspective of supporting delays but also inhibits the adoption of the research as a care option needed in select areas, such as oncology.
What are Vulcan stakeholders doing to help bring data from the clinic to research settings?
While the interoperability standard for health care informatics known as HL7 FHIR has gained considerable acceptance on a global scale to enable health data interoperability, it’s done so because the group backing the standard, HL7, a non-profit organization, knows it must focus on practical implementation and adoption.
The organization has emerged as a sort of global convenor for standards development to advance the effective use of FHIR in meeting the needs of stakeholders in the global healthcare ecosystem. Driving this, of course, is a growing array of use cases to apply FHIR to address critical yet discreet business needs.
This program operates within the HL7 organization and is designed to assist communities and collaborative groups across the global health care spectrum in the creation and adoption of high quality FHIR Implementation Guides and other standard artifacts to move toward the realization of global health data interoperability. A number of HL7 FHIR Accelerator projects while operating within the HL7 organization, represent a separate set of initiatives and include a number of benefits, including the ability to engage and input on the work that will be undertaken by the Accelerator.
They are first and foremost working to bridge existing gaps between care and research in a bid to improve patient lives, lower costs, and improve efficiency. Second, they support ongoing connection of industry collaborations, so for instance projects unfold today that involve the coordination between HL7 and pharma industry groups and regulators, from the FDA and NCATS (NIH) to the Danish Medicines Agency and TransCelerate Biopharma to name a few examples. Third, other efforts include the push to maximize collective resources of the shared community of players mentioned above and finally—as well as pragmatically—the effort to deliver integrated tools and actual solutions.
The InterSystems Case
Now InterSystems, a privately held technology vendor involved with software, systems integration, and database management—with a heavy focus on health information exchanges—joins the Vulcan FHIR Accelerator program to empower clinical researchers with greater interoperability.
With the goal of ultimately facilitating a “learning health system” accomplished by combining research data with clinical care data, InterSystems and Vulcan seek to improve patient outcomes and drive efficiency in clinical and translational research.
TrialSite suggests that this recent entry has the potential to be far more than just another marketing press release. InterSystems powers major health information exchanges (HIEs) and as such can leverage extensive data, domain expertise and client scenarios (e.g. real life business use cases) involving payers, patients, academic medical centers, and other health care organizations to build tools for transitioning real world data from EHRs to clinical researchers working on the latest advanced treatments across therapeutic areas. A key focal point: pilot new solutions for streamlining data exchange from the point of collection in the clinic to the clinical research setting.
Scenarios to Support Clinical Research as a Care Option
What is needed are methods, at scale, to not only aggregate but also clean and normalize health care data arising out of clinical care to power efficient medical research, reports InterSystems vice president of Healthcare Solutions for InterSystems. So what does this really mean? Well, imagine states where InterSystems powers the state health information exchange; where accumulating aggregate real-time data from the EHR, care management and population health systems become available, via an agreed-upon set of standards feeding research with what is essentially a ‘unified research record’ supporting the discovery of breakthrough treatments in healthcare to bringing heretofore not feasible inputs for site feasibility to patient recruitment and accrual efforts.
About Health Level Seven International (HL7)
Health Level Seven® International (HL7) is an ANSI-accredited, not-for-profit, standards-developing organization with the mission of empowering global health interoperability. With affiliates in over 30 countries, HL7’s global membership envisions a world in which everyone can securely access and use the right data when and where they need it. Widely implemented by vendor and healthcare systems, and required by governing bodies around the world, HL7 standards deliver solutions for health information technology, including HL7® Fast Healthcare Interoperability Resources (FHIR®), Version 2 (V2) and Clinical Document Architecture (CDA®).
Call to Action: Check out more information on the Vulcan FHIR ACCELERATOR Program here.