FHIR and AI Collaboration: Proposing a New Standard Model for Pharmaceutical Data Exchange

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This article reports on the latest trends in data exchange within the pharmaceutical industry. A key focus is an API interface utilizing FHIR (Fast Healthcare Interoperability Resources). Companies such as Amgen are developing this new model for CMC fields, aiming to improve traditional challenges like fragmented data and inefficient processes. Technically, the system is based on the HL7 FHIR standard, utilizing standards like PQI's APIX. It incorporates advanced features such as OAuth 2.0 for security and Topic-Based Subscriptions. This allows it to move beyond simple data exchange, enabling real-time information gathering and analysis using AI and machine learning. This represents a crucial step toward realizing the Digital Regulatory Exchange Model. The technology provides a foundation that can link various healthcare IT systems, including LIMS (Laboratory Information Management Systems), MES (Manufacturing Execution Systems), and QMS (Quality Management Systems), supporting international quality standards like ICH M4Q(R2). Given the ongoing standardization and AI adoption in Japan's healthcare sector, this model holds extremely high relevance.