Ecosphere Principles for Medical Application Platforms

A Medical Application Platform (MAP) enables multi-vendor heterogeneous medical devices to be integrated via network infrastructure and provides an application hosting facility that supports a wide range of clinical applications for data fusion, decision support, multi-device safety interlocks, workflow automations, and closed-loop control of actuating medical devices. The assurance of MAP components and systems is distributed across a broad group of stakeholders including medical device manufacturers, platform infrastructure providers, application vendors, third-party certification organizations, and regulatory agencies. Realization of the MAP vision requires that all stakeholders involved in developing, testing, certifying, regulating, purchasing, and using medical devices and applications operate and cooperate within a well-defined ecosphere. This paper presents a high-level overview of the organization of such an ecosphere. We focus on identifying stakeholder roles, responsibilities, artifacts, and interactions, we also indicate the contributions of each of these to the development and safety/security assurance of MAP-based systems.