Reference Architecture-Based Analysis of Rule Coverage: Use Cases in Plasma Glucose Measurement and Cell Processing

Standards increasingly function as guidelines to help regulated entities interpret and comply with complex regulatory requirements, creating a need for a systematic methodology to organize the relationships between regulations and standards. However, medical services lack a framework to evaluate their intersecting coverage. To address this gap, we developed the Reference Architecture for Medical Services (RAMS), inspired by the Smart Grid Architecture Model, which represents medical services on two orthogonal axes — processes and resources (including stakeholders and assets) — and maps applicable regulations and standards to each matrix cell. We applied RAMS to two out-of-hospital services — traditional plasma glucose measurement and emerging cell processing—to visualize regulatory and standard coverage across both dimensions. The coverage mapping clarified that each process–resource combination is governed by regulations, standards, or both. Classification of these interactions into complementarity patterns then enabled identification of gaps, complementarities, and missing regulations or standards, thereby allowing prioritization of services with overlapping, fragmented, or disjointed coverage for targeted development and refinement. Moreover, as a generalizable model, RAMS enables systematic verification of the comprehensiveness of regulations and standards across diverse medical service contexts. Our findings demonstrate that RAMS offers a robust framework for guiding the creation and revision of regulatory and standardization efforts, advancing policy-making in medical services.