Transforming Pharmaceutical Labeling: Digital ePI with FHIR Standards

TL;DR

Digital electronic Product Information (ePI) powered by FHIR R5 standards modernizes pharmaceutical labeling by making it transparent, accessible, standardized, and machine-readable.

Key Benefits

• Improved compliance with global standards (e.g., HL7/FHIR, LOINC, WCAG).
• Traceability & automation for product updates and lifecycle management.
• Structured data reuse across regulatory submissions, packaging, and patient communications.
• Future-ready foundation for digital transformation in regulatory processes.

1. Why Does Digital ePI Matter for Pharmaceutical Labeling?

Pharmaceutical labeling has traditionally relied on static documents, making it difficult to ensure consistency, transparency, and accessibility. Digital ePI solves these challenges by enabling structured, machine-readable formats that regulatory agencies increasingly recommend.

With digital ePI, pharmaceutical organizations can:

• Improve transparency of product information.
• Increase accessibility for healthcare providers, regulators, and patients.
• Support automation in validation, traceability, and updates.
• Reduce duplication and compliance risks.

The shift to digital ePI represents more than a format change—it is a strategic move toward regulatory readiness and digital maturity.

2. What Makes FHIR R5 the Right Standard for Structured Labeling?

While earlier FHIR versions (e.g., FHIR R4) could be used for structured labeling, FHIR R5 delivers enhancements that make it especially effective for regulatory and pharmaceutical use cases.

Key capabilities include:

• Comprehensive product representation with resources like MedicinalProductDefinition, ManufacturedItemDefinition, Ingredient, SubstanceDefinition, and RegulatedAuthorization.
• Standardized labeling sections using Composition.section with LOINC codes for clear and precise regulatory communication.
• FHIR Bundles (type: Document) that support:
  • Version control and lifecycle management.
  • Packaging and labeling updates.
  • Rendering content into structured HTML or PDF formats.

This structured approach transforms labeling into dynamic, governed, and reusable content, paving the way for automation and compliance-by-design.

3. How Does a FHIR ePI Bundle Work?

A FHIR ePI Bundle is the foundation for digital labeling. Its capabilities include:

• Retrieving bundles by type and ID for consistency.
• Accessing version histories and performing differential comparisons.
• Dynamically creating, updating, and validating bundles.

These functions ensure labeling is not only machine-readable but also traceable, up-to-date, and regulator-ready.

4. How Is FHIR Being Applied in the Real World?

In practice, FHIR enables pharma teams to treat ePI as a central hub of regulatory data.

• Governed and reusable content → improves accuracy across multiple submissions.
• Streamlined regulatory processes → reduces manual effort and error.
• Seamless integration into enterprise systems and downstream communication channels.

Ultimately, FHIR future-proofs labeling processes by embedding structure, validation, and scalability into the heart of regulatory data management.

5. What Strategic Benefits Does Digital ePI Deliver?

Adopting FHIR R5 is not just about labeling—it is about laying the groundwork for broader digital transformation in pharmaceutical regulatory management.

• Expanded asset coverage – applying structured standards to more regulatory content.
• Automation at scale – reducing reliance on manual workflows.
• Bi-directional integration – enabling real-time collaboration between regulators, manufacturers, and healthcare providers.

Together, these benefits create a regulatory ecosystem that is accurate, compliant, and ready for future demands.

6. What’s the Bottom Line for Pharma Organizations?

The move toward digital ePI powered by FHIR R5 is a pivotal step in advancing pharmaceutical labeling. By adopting structured, compliant, and reusable content formats, organizations can:

• Improve regulatory communication.
• Enhance labeling accuracy and accessibility.
• Build a digital-first foundation for regulatory transformation.

This shift is not only about compliance—it is about preparing the pharmaceutical industry for a more connected, automated, and patient-centered future.

7. How Is Appnovation Driving Digital ePI Adoption?

At Appnovation, we are currently working with leading global pharmaceutical and life sciences organizations to adopt digital ePI solutions powered by FHIR standards. By combining our expertise in healthcare technology, regulatory compliance, and digital transformation, we help companies streamline regulatory processes, improve labeling accuracy, and future-proof their operations.

Our teams collaborate across pharma, MedTech, and health associations to build structured, scalable, and compliant solutions that not only meet today’s needs but also lay the foundation for innovation tomorrow.