Interoperable Metadata Standards for Regulatory Document Management: Towards Global Harmonisation Using FAIR Principles and HL7 FHIR

Abstract

Global management of regulatory documents improved through interoperable metadata standards like the FAIR principles and HL7 FHIR. This study examines the possibilities of improving global management of regulatory documents through interoperable metadata standards as the FAIR principles and HL7 FHIR. Lack of regulatory harmonisation remains an issue, as there are still a number of fragmented metadata systems and incompatible data exchange protocols, causing inefficiency and delays in the process of compliance with regulations in the healthcare and pharmaceutical sectors. The study uses explanatory research design as relying on secondary qualitative and quantitative data to analyse FAIR and FHIR can positively affect data standardisation, accessibility, and interoperability. The results indicate that effective incorporation of these standards can lead to enhanced regulatory submissions, data-coordination of patients, and worldwide teamwork. The study recommends a hybrid metadata model that integrates FAIR and HL7 FHIR to facilitate ease of compliance, transparency, and ease of cross-border regulatory operations.