< + > FDA FHIR Pilot Automates Adverse Events Reporting and Validation with Cedars-Sinai and the VA Through eHealth Exchange

The following is a guest article by Jay Nakashima, President at eHealth Exchange

An FDA project aims to make it as easy as possible for clinicians to report adverse drug events and share important clinical data with public health agencies to investigate the event.

When new drugs and biologics are vetted for release, clinical trials provide a strong understanding of overall safety and efficacy. When the drug or biologic is rolled out to wider populations, the FDA has the continued responsibility to track safety and adverse events to better understand the drug’s effects on broad populations over time. Doing this effectively requires access to accurate, timely information from healthcare settings across the country.

Traditionally, when a medical provider witnesses an adverse event, the clinician is responsible for reporting the occurrence through the FDA.gov website. Because the process is voluntary and takes place outside of the clinician’s everyday workflow, adverse events often go unreported. Most current studies estimate that only between 10% to 20% of all adverse drug or biologic events are reported to the FDA, hindering the agency’s ability to fully understand the safety for Americans.

To increase the likelihood of events being reported and to make it faster and easier to receive needed supporting medical data, the FDA Center for Biologics Evaluation and Research (CBER) Biologics Effectiveness and Safety (BEST) initiative explored ways to streamline the process. The goal was to enable clinicians to report adverse events directly from their electronic health records (EHRs) in a highly automated manner.

To make this happen, the FDA partnered with eHealth Exchange, a non-profit health information network, and multiple health systems. The organizations created a Fast Healthcare Interoperability Resources (FHIR)-based implementation leveraging the existing eHealth Exchange infrastructure as the central network to send and receive FHIR messages about adverse events.

The BEST pilot was created with three primary goals: 

• Demonstrate the feasibility of semi-automated case reporting and validation
• Examine data obtained from FHIR-based platforms to see if it provides enough evidence to validate events
• Increase awareness of adverse event reporting within existing clinical workflows

The first use for the live implementation occurred at Cedars-Sinai in California in September 2022 to track adverse events due to COVID-19 vaccines. Cedars-Sinai implemented an algorithm to identify events potentially related to COVID-19 vaccines and notify the FDA. The FDA received the notifications and was able to quickly respond with bi-directional electronic queries for medical records to validate and better understand the encounters. The process of communicating and retrieving records happened electronically, replacing a process that was previously based on manual data entry and faxing back and forth. The new process proved faster and easier for everyone involved.

The goal was to prove that reporting and validation could be much more automated, and we achieved that. Set up for new organizations still requires some manual processes that the FDA is working through, but once processes are in place, adverse event reporting has the potential to become much easier.

The decision to leverage HL7’s FHIR Release 4 is important for the long-term viability of this project as it expands to include reporting for other drugs and use cases. FHIR allows organizations to tightly control the specific information that should be shared for a variety of purposes.

For public health reporting, federal agencies typically need only a subset of a medical record – for example, lab results, medication lists, and clinician observations – and the shared information is usually stripped of information that would tie it to a specific individual. FHIR allows organizations to break up records into smaller bits of information, known as “resources,” and decide exactly which resources should be shared under which circumstances.

eHealth Exchange’s hub-and-spoke FHIR architecture leverages InterSystems solutions to power its massively scalable eHealth Exchange Hub to eliminate the need for participating healthcare organizations – including federal agencies such as the FDA – to implement and maintain expensive interfaces directly with hundreds or thousands of other healthcare organizations. This means the Cedars-Sinai pilot can quickly be scaled for production implementation by any of the more than 300 eHealth Exchange network participants.

Since the successful pilot and go-live in California, the Veterans Health Administration (50 states) and 11 large integrated delivery networks (IDNs) have leveraged the single eHealth Exchange connection using one trust agreement to enable exchange with the FDA for adverse drug event tracking and validation. This FDA rollout is the first-of-its-kind, large-scale Networked FHIR implementation in the country. This ground-breaking project focused on public health validated FHIR R4 can be deployed at scale nationwide.