How HL7 FHIR Standards Are Changing Clinical Trials

By: Sari Holtz and Ronen Weinstein

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HL7 FHIR (Fast Healthcare Interoperability Resources) is a data standard developed by Health Level Seven International (HL7), a non-profit organization founded to “empower global health data interoperability”. HL7® FHIR® standard facilitates smooth communication between different healthcare systems by using technologies such as RESTful APIs, JSON, and XML, which are widely used in other industries. Unlike older standards such HL7 v2 or v3, FHIR was formulated to be simpler, faster to implement, and more easily adaptable to a wide range of healthcare scenarios.

The FHIR system acknowledges healthcare data points as individual building blocks that represent the industry’s components and players, such as patients, healthcare practitioners, medications, and observations. These building blocks are often shared, combined, and updated to support different needs related to clinical care, research, and administrative processes.

Why is HL7 FHIR important?

Interoperability, the ability to connect and integrate different systems, is a constant challenge in the world of healthcare, and is especially difficult in the clinical trials industry, where diverse data platforms and data sources should work together to create a unified dataset. Proprietary coding systems, data silos, and complex workflows make it difficult for sponsors to access and integrate patient data in a singular database that can be used for clinical research.

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FHIR addresses these complexities by providing a standard framework to achieve several important goals.

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1. Enhance data exchange: FHIR unifies data coding conventions between Electronic Health Records (EHRs), lab systems, wearable devices, and other platforms making it easier to process large datasets.
2. Support real-world evidence (RWE): FHIR facilitates the integration of real-world data (RWD) from EHRs into clinical trials and other research initiatives, improving the value and relevance of each data point.
3. Accelerate innovation: By offering a developer-friendly platform, FHIR supports innovation in healthcare apps, tools, and systems that can work together to improve outcomes and operations.
4. Stream clinical data: FHIR makes it easier to pass information directly from data platforms such as EHRs and wearable devices to clinical trial databases and data repositories without compromising on the formatting or quality of the data.

Challenges with Implementing HL7 FHIR

Despite the obvious advantages of having a global coding system within the healthcare industry, implementing HL7 FHIR standards globally has been a challenge for several reasons. For starters, institutional inertia, which is so common in the healthcare industry, makes it difficult to get systemic changes approved and implemented. In the same vein, loyalty to legacy systems that aren’t formatted to support the latest data standards and the time and costs required to modernize to FHIR standards, often discourage healthcare IT teams or executives from approving this change.

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Unified data formatting would, by its very nature, make it easier to share healthcare data between systems, a convenience which also raises privacy and security concerns that have slowed FHIR adoption.  Among the concerns related to data sharing include risks related to data breaches and the ability to remain compliant with regulations like HIPAA and GDPR.

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Addressing these challenges will require collaboration among healthcare providers, technology vendors, and regulators to ensure that FHIR standards are implemented consistently and securely across the ecosystem.

The Future of HL7 FHIR

Supporters of FHIR believe that the potential of FHIR goes beyond its current applications, and that additional opportunities will likely be discovered as FHIR becomes more prevalent. Some applications include:

Global interoperability standards

FHIR proponents believe that this system will ultimately set the global standard for healthcare interoperability. Initiatives like the U.S. Office of the National Coordinator’s (ONC) interoperability mandates and Europe’s Digital Health initiatives are driving adoption across borders and could pave the way for wider spread adoption in the coming years.

Advanced analytics and artificial intelligence (AI)

FHIR offers a unique opportunity to expand upon the use of advanced analytics and AI in healthcare by providing standardized, high-quality data sets. This will help accelerate predictive modeling, personalized medicine, and clinical decision support.

Integration with wearable and IoT devices

The proliferation of wearable health devices and Internet of Things (IoT) in healthcare will demand real-time data exchange. FHIR’s flexible and lightweight architecture is well-suited for these use cases.

Enhanced support for research

With its ability to integrate RWD easily into clinical trial workflows, FHIR will continue to support decentralized and hybrid trials and the easier analysis of large data sets. This could redefine how trials are designed, conducted, and analyzed.

Conclusion

HL7 FHIR has the unique potential to transform the way healthcare and clinical research systems exchange information. By enabling standardized formats for data sharing, HL7 FHIR addresses long-standing interoperability challenges in the healthcare sector at large, and for clinical trials professionals specifically. Nevertheless, there remain additional hurdles that are preventing widespread implementation, including overburdened technical teams and data quality concerns.

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