FDA’s HL7 FHIR RWD Initiative: Transforming Medical Device Post-Market Surveillance

Navigating the Future of Post-Market Surveillance: The FDA Explores HL7 FHIR for Real-World Evidence

For regulatory and quality professionals in the medical device industry, particularly those deeply involved in post-market surveillance, staying ahead of the curve in data standards and submission requirements is paramount. A recent announcement from the U.S. Food and Drug Administration (FDA) signals a potentially significant shift in how real-world data (RWD) might be utilized and submitted for regulatory purposes in the future. The FDA has established a public docket to explore the use of the Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR) standard for the submission of study data collected from RWD sources. This initiative has profound implications for how medical device companies collect, analyze, and report post-market data, and warrants close attention from all stakeholders in the industry.

Understanding the FDA's Move Towards FHIR and RWD

The FDA's announcement reflects a growing recognition of the value of RWD in supporting claims of safety and effectiveness for regulated medical products, including medical devices. RWD is defined by the FDA as "data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources". These sources can include electronic health records (EHRs), medical claims data, data from product or disease registries, and data gathered from digital health technologies.

Acknowledging the challenges inherent in standardizing clinical study data derived from these diverse RWD sources for regulatory submissions, the FDA is proactively exploring solutions. This exploration aligns with the new Department of Health and Human Services (HHS), Assistant Secretary for Technology Policy/Office of the National Coordinator for Health (ASTP/ONC) policy on health information technology (health IT). The ASTP/ONC policy emphasizes greater alignment of health IT-related activities to support HHS’s health IT and interoperability goals.

A key element in this alignment is the HL7 FHIR standard, which was established in 2014 to facilitate the exchange of healthcare data. In 2020, the ONC published a final rule under the 21st Century Cures Act that established FHIR as a nationwide standard for access, exchange, and use of data for healthcare delivery organizations. This rule requires ONC-certified health IT to enable patients, clinicians, researchers, and other authorized parties to access data from certified EHRs and other certified health IT using application programming interface (API) technology.

Why FHIR Matters for Medical Device Post-Market Surveillance

The ubiquity of FHIR-based data elements generated, exchanged, and used in healthcare organizations presents a significant opportunity for streamlining the use of RWD in regulatory submissions. Given the overlap between healthcare data and the information required for clinical research derived from RWD sources, the FDA is seeking to understand the challenges and opportunities associated with using FHIR for this purpose.

For medical device companies engaged in post-market surveillance, this exploration of FHIR could lead to:

• Enhanced Data Interoperability: FHIR aims to standardize data formats and exchange mechanisms, potentially simplifying the integration of data from various RWD sources used in post-market studies and adverse event reporting.
• More Efficient Data Collection: If RWD sources like EHRs increasingly adopt FHIR and support standardized data elements like the United States Core Data for Interoperability (USCDI), it could become more efficient to collect relevant data for post-market analysis.
• Streamlined Regulatory Submissions: In the future, the FDA might accept or even prefer data submitted in FHIR format, potentially simplifying the submission process and reducing the burden of data transformation and standardization for manufacturers.
• Improved Data Quality and Consistency: Standardized data elements and exchange formats could contribute to more consistent and higher-quality data for post-market safety and performance evaluations.

FDA Initiatives Already Utilizing HL7 FHIR

The FDA is not new to exploring the potential of FHIR. The agency has already initiated several projects that leverage this standard, demonstrating its commitment to information systems modernization:

• Structured Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (PQ/CMC): This initiative aims to standardize electronic common technical document module 3 data elements, terminologies, and data structures by adopting the FHIR standard to enhance the automation of exchange and analyses of PQ/CMC data.
• Structured Product Labeling (SPL) on FHIR: The FDA is exploring potential approaches for transitioning SPL submissions from HL7 version 3 to HL7 FHIR.
• CBER Biologics Effectiveness and Safety (BEST) Innovative Methods (IM) Platform: This FHIR-based platform aims to improve CBER’s post-market surveillance capability through the validation, detection, and reporting of adverse events from EHRs. This platform has even piloted studies to evaluate the quality and timeliness of FHIR for public health use cases and to explore using semi-automated detection of adverse events.
• Application of HL7 FHIR to collect data directly from EHRs in a clinical trial: FHIR APIs are being used to read discrete data from EHRs for research, and FHIR is being used as the exchange standard between health IT and clinical research systems.
• Common Data Model Harmonization: This project aims to build a data infrastructure for patient-centered outcomes research using RWD, including harmonization with HL7 FHIR US Core.
• Risk Evaluation and Mitigation Strategies (REMS) Integration and Interoperability Initiative: This initiative explores using FHIR APIs with pharmacy data standards to integrate REMS into prescriber and pharmacy workflows, aiming to improve REMS implementation and the quality of REMS data.

These examples underscore the FDA's active engagement with FHIR across different aspects of regulatory science and submission, suggesting a potential future where FHIR plays a more central role in the submission of post-market data for medical devices as well.

Key Questions and Challenges for the Medical Device Industry

The FDA's notice specifically requests public comment on several questions. For regulatory and quality professionals in the medical device industry focused on post-market surveillance, these questions present an opportunity to shape the future of RWD submissions:

1. Current Challenges: What challenges do you see for the pharmaceutical industry regarding the current state of submitting clinical study data collected from RWD sources to FDA? While this question is framed towards the pharmaceutical industry, medical device companies also face challenges in utilizing and submitting RWD for post-market purposes. These could include:
   • Data Heterogeneity: RWD comes from diverse sources with varying data formats, terminologies, and levels of completeness.
   • Data Quality Concerns: Ensuring the reliability and accuracy of RWD collected outside of traditional clinical trials can be challenging.
   • Lack of Standardization: The absence of uniform standards for RWD collection and reporting can hinder analysis and regulatory review.
   • Privacy and Security Issues: Handling sensitive patient data from RWD sources requires robust privacy and security measures.
   • Integration with Existing Systems: Integrating RWD workflows with existing post-market surveillance systems and regulatory submission processes can be complex.
2. Opportunities and Challenges with FHIR: What opportunities and/or challenges do you see for the pharmaceutical industry on reaching a future state of clinical study data submissions collected from RWD sources using HL7 FHIR (e.g., business processes, technical considerations)? Again, these considerations are highly relevant for the medical device industry:
   • Opportunities:
     • Improved Interoperability: FHIR could facilitate seamless data exchange between healthcare providers, registries, and medical device manufacturers.
     • Enhanced Efficiency: Standardized FHIR-based submissions could streamline regulatory processes and reduce the administrative burden.
     • Richer Data Insights: Easier access to and integration of diverse RWD sources could lead to more comprehensive post-market safety and performance insights.
     • Alignment with Healthcare Ecosystem: Adopting FHIR aligns with broader trends in the healthcare IT landscape, potentially simplifying data acquisition from healthcare organizations.
   • Challenges:
     • Implementation Costs: Transitioning to FHIR-based data collection and submission systems could involve significant upfront investment in technology and training.
     • Data Mapping and Harmonization: Mapping existing RWD to FHIR standards and ensuring semantic interoperability across different FHIR implementations can be complex.
     • Data Completeness and Granularity: Ensuring that FHIR-based RWD captures the necessary level of detail and completeness for post-market surveillance of specific medical devices might require careful consideration.
     • Evolving FHIR Standards: Keeping pace with updates and changes to the FHIR standard will be crucial.
     • Security and Privacy Compliance: Ensuring compliance with data privacy regulations (e.g., HIPAA) when exchanging RWD using FHIR is essential.
3. Suggestions for FDA: What are your suggestions on how, from a data standards perspective, FDA might reach a future state of clinical study data submissions collected from RWD sources that aligns with ASTP/ONC health IT goals for HL7 FHIR-based exchange? Medical device professionals can offer valuable input here, such as:
   • Developing specific FHIR implementation guides tailored to the unique data requirements of medical device post-market surveillance.
   • Providing clear guidance on how to map common medical device data elements to relevant FHIR resources and USCDI data elements.
   • Establishing pilot programs to evaluate the feasibility and effectiveness of FHIR-based RWD submissions for medical devices.
   • Collaborating with industry stakeholders and standards development organizations to ensure that FHIR standards adequately address the needs of medical device post-market surveillance.
   • Developing tools and resources to support the medical device industry in adopting FHIR for RWD.
4. USCDI Adequacy: Does USCDI version 3 provide enough information for collecting RWD for research purposes? Is there information that USCDI version 3 does not sufficiently address? The USCDI is a standardized set of health data classes and constituent data elements for nationwide, interoperable health information exchange. Medical device companies should assess whether the current USCDI version adequately captures the data elements necessary for comprehensive post-market surveillance of their products. Gaps might exist in areas specific to device usage, performance, or adverse events directly related to device malfunction.
5. TEFCA and Research: Under the Trusted Exchange Framework and Common Agreement (TEFCA), a variety of “Exchange Purposes” are authorized. If “Research” was added as an “Exchange Purpose,” what role could TEFCA play with using RWD for clinical research? How could TEFCA support more efficient collection and exchange of RWD for clinical research purposes? What challenges might exist with this approach? TEFCA is a nationwide framework for health information sharing. If "Research" were included as an exchange purpose, it could potentially facilitate broader access to and exchange of RWD for post-market studies and safety surveillance. However, challenges related to data privacy, security, data use agreements, and the specific needs of medical device research would need to be addressed.

Engaging with the FDA: Your Opportunity to Shape the Future

The FDA's request for comments signifies a critical juncture in the evolution of RWD utilization for regulatory purposes. For regulatory and quality professionals in the medical device industry, this is an opportune moment to contribute their expertise and perspectives. By carefully considering the challenges and opportunities presented by FHIR and providing thoughtful feedback to the FDA, you can help shape a future where post-market surveillance data is more interoperable, efficient to collect, and ultimately contributes to improved patient safety and device performance.

Interested parties, including regulated industry, health IT vendors, academic medical centers, and electronic data capture vendors, as well as other interested parties, are encouraged to submit comments. Comments must be submitted electronically through the Federal eRulemaking Portal at https://www.regulations.gov, referencing Docket No. FDA-2025-N-0287, or via written/paper submission to the Dockets Management Staff.

Take the time to review the FDA's notice and the referenced materials and consider the implications for your organization's post-market surveillance activities. Your input is vital in ensuring that the FDA's exploration of HL7 FHIR for RWD effectively addresses the needs and challenges of the medical device industry, paving the way for a more streamlined and robust future for post-market data utilization.

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