We’re excited to share an important milestone at PurpleLab: we’ve officially submitted our first-ever response to a federal Request for Comment (RFC), and it’s now live on regulations.gov.
Ann Phillips, our Senior Director of Regulatory and Standards, pulled together an impressive response to the FDA’s RFC focused on the use of HL7 FHIR (Fast Healthcare Interoperability Resources) to support real-world data (RWD) in clinical research. It’s a topic that sits right in our wheelhouse – so naturally, we had something to say.
Why We Responded
This is a meaningful step forward for us as a company, on many levels. Here’s why we decided to respond:
- As a leader in healthcare analytics, we feel it’s our duty to step up as a national voice in health innovation. Engaging with federal agencies like the FDA makes it clear we’re serious about leading conversations on healthcare data, interoperability and real-world evidence (RWE).
- We’re already building solutions that help life sciences, pharma, payers and providers navigate complex data landscapes. Supporting a standards-based, automated infrastructure using FHIR is completely aligned with our mission.
- FHIR is already used across care coordination and public health reporting. Expanding it to clinical research could cut out the time-consuming and error-prone mapping work that slows everything down.
What We Said
Our comment expressed enthusiastic support for the FDA’s efforts to embrace HL7 FHIR for clinical data submissions derived from RWD sources. We emphasized the power of combining clinical and claims data to produce robust, high-quality real-world evidence.
We also shared some of the real-world challenges that the pharmaceutical industry faces today – particularly the lack of standardization across systems, and the operational burden of preparing data for submission.
One of the more important recommendations we made was to encourage the FDA to consider adding “Research” as an official data exchange purpose within TEFCA™, the federal data-sharing framework.
We also advocated for the use of Expert Certification for de-identification of data, rather than relying on the HIPAA Safe Harbor method, which we’ve found often renders data unusable for research while offering weaker privacy protection.
We highlighted existing pilot projects and case studies that show what’s already possible using FHIR – like the CRISP and American College of Cardiology’s work to automate clinical registry data collection, and the CDISC PhUSE prototype that show how FHIR can streamline electronic case report forms.
These efforts are already laying the groundwork for broader adoption, and we’re proud to be part of that momentum.
You can read the full submission here on regulations.gov. We hope you’ll take a look and share in this exciting step forward with us.