How HL7 FHIR Enables Prospective Clinical Research

03/22/2025

Professor Harnett

In the world of healthcare and medical research, data is crucial for discovering new treatments and improving patient care. However, collecting and sharing this data efficiently has always been a challenge. HL7 FHIR (Fast Healthcare Interoperability Resources -pronounced "fire") is changing the game by making it easier for researchers and healthcare providers to access and exchange patient information in real time. This is especially important for prospective clinical research, where researchers study participants over time to understand the effects of treatments, interventions, or diseases.

HL7 FHIR is less compelling for retrospective research since historical data can be easily collected by database queries. An example is analyzing historical “real world evidence”. But capturing medical artifacts as patients present - in real time – is a very different use case.

Imagine you are a researcher and are measuring the effectiveness of a new therapeutic and want to collect data automatically such as lab values, weight, nausea, or any other clinical elements. The traditional method is for a database expert or informatician to query each subject’s electronic health record (EHR) and identify changes, then extract the data and push updates to a data mart or electronic data capture tool. This is expensive, non-real time, and a manual process. 

FHIR enables secure, standardized, and automated data exchange between healthcare systems and research platforms. Using FHIR APIs, a research team can extract specific lab values (e.g., glucose level, hemoglobin A1C, or creatinine) from a patient's EHR and transfer them directly into an EDC system used for clinical trials or observational studies – automatically and standards-based.

What is HL7 FHIR?

HL7 FHIR is a modern standard for sharing healthcare data across different systems. Developed by Health Level Seven International (HL7), FHIR provides a flexible and fast way to exchange discrete data electronic health records (EHRs), ensuring that hospitals, clinics, and research organizations can communicate seamlessly.

FHIR is built on web-based technologies called RESTful APIs (the same technology that powers websites and apps), making it easier to integrate into existing systems. It structures healthcare data into "resources", such as patients, medications, lab results, and clinical observations, allowing researchers to retrieve only the information they need while ensuring privacy and security.

Think of FHIR as a set of Legos—each piece represents different medical information (like identifiers, allergies, or test results). Because they fit together the same way everywhere, hospitals and researchers can easily exchange and use health data without ambiguity.

How HL7 FHIR Supports Prospective Clinical Research:

Prospective clinical research requires ongoing and real-time data collection from patients over months or even years. Traditional research methods rely on manual data entry, outdated formats, and fragmented health records, making the process slow and error-prone. FHIR improves this by offering:

1. Real-Time Data Access and Integration:

With FHIR, researchers can automatically collect up-to-date patient data from a healthcare provider. This is also possible across multiple healthcare systems using multiple sources called Bulk FHIR but that is another blog. This eliminates the need for manual data entry and reduces delays in research studies. For example, if a researcher is studying the long-term effects of a new diabetes medication, FHIR allows them to access real-time glucose levels, lab tests, and medication adherence data from patients' EHR.

2. Standardized and Structured Data:

FHIR ensures that health data is uniformly structured, regardless of where it comes from. This standardization makes it easier to compare data from different sources and reduces errors caused by mismatched formats. In prospective research, this consistency is crucial for ensuring accurate analysis and valid study results.

3. Remote Monitoring and Wearable Device Integration:

Many prospective studies now incorporate wearables and remote monitoring devices, such as smartwatches that track heart rate or glucose monitors for diabetes patients. FHIR allows researchers to integrate this real-time data directly into their study databases, providing a more comprehensive picture of a patient's health without requiring frequent hospital visits.

4. Faster Patient Recruitment and Consent Management:

FHIR streamlines patient identification and recruitment by allowing researchers to search for eligible participants based on predefined criteria (such as age, diagnosis, or treatment history) within EHR systems. Additionally, FHIR supports digital consent management, ensuring that patients' permissions are properly recorded and respected throughout the study.

5. Secure and Compliant Data Sharing:

Privacy and security are top concerns in clinical research. FHIR incorporates built-in security measures, such as authentication and access controls, ensuring that patient data is shared only with authorized personnel. This is especially important for complying with regulations like HIPAA in the U.S. and GDPR in Europe.

Example: FHIR in Action for a Cancer Research Study -

Imagine a research team is conducting a 5-year study on a new cancer treatment.

With FHIR:

• They can pull patient health records automatically.

• They can track lab results, treatment responses, and side effects in real time.

• Wearable devices can provide continuous health monitoring data.

• Patients can use a secure app to update their symptoms or medication side effects, which integrates directly with the study database.

  
  

Instead of waiting months for data collection, researchers get instant access to high-quality information, accelerating discoveries and improving patient outcomes.

Conclusion

HL7 FHIR is revolutionizing prospective clinical research by enabling faster, more efficient, and more accurate data collection. With real-time access, standardized formats, remote monitoring, and enhanced security, researchers can focus on discovering new treatments instead of struggling with data management. As more healthcare systems adopt FHIR, the future of clinical research will become smarter, faster, more patient-centered, and at lower cost.