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Structuring Pharmaceutical Knowledge: Conversion from PDF/Word to FHIR

ePI Digital Solutions epidigitalsolutions.com Human-in-the-loop conversion from PDF/Word to FHIR

ePI Digital Solutions developed a human-in-the-loop system to convert unstructured data from PDF and Word formats into structured FHIR XML.

September 10, 2025ePI Digital Solutions

Summary

ePI Digital Solutions addresses the challenge of critical pharmaceutical knowledge being trapped in non-structured formats like PDFs and offers a solution to convert this data into validated, structured FHIR R5 XML. This capability is crucial for adapting to the transition toward electronic Product Information (ePI) within the European Union.

Key Players

ePI Digital Solutions

Details

The article highlights the fundamental problem that vital pharmaceutical knowledge remains locked in unstructured documents such as PDFs and Word files. The company provides infrastructure services to convert product information documents—including SmPC, Package Leaflets, and Labelling—into validated FHIR R5 XML, a standard electronic healthcare format. This effort is directly tied to the regulatory shift toward ePI (electronic Product Information) within the European Union, aiming for the elimination of paper leaflets around 2031. Technically, the service guarantees output in structured, validated data formats like FHIR R5 XML. Furthermore, the company demonstrates its ability to expand this conversion infrastructure across multiple jurisdictions, including the EU and Jordan, anticipating global adoption of ePI standards by regulators. This suggests a scalable architecture designed for regulatory compliance worldwide. The solution offers two paths: 'Conversion as a Service,' where the provider handles the end-to-end process; or 'ePI Bridge,' allowing users to upload PDFs themselves and review the structured output, maintaining control over the text at every step. These options aim to solve the massive and continuous data accessibility challenge posed by pharmaceutical companies and regulatory bodies globally.

Technology Note

FHIR(Fast Healthcare Interoperability Resources)は医療データ交換の国際標準。このエントリの関連技術: FHIR

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