Open Ecosystem Through Secure Plug and Play Interoperability: An Overview

Abstract

Background: Interoperability is a critical enabler for integrated Personalized Diabetes Management (iPDM), automated insulin delivery (AID), and the digital transformation of healthcare in general. However, manufacturers still create closed ecosystems (ie, solutions designed to work end-to-end minimizing collaboration with other organizations) with proprietary interfaces because of various interoperability challenges. Therefore, the aim of this article is to provide an overview of how to achieve organizational interoperability in an open ecosystem (ie, solutions designed to integrate different organizations via interoperability standards) for diabetes management.

Methods: The proposed interoperability design approach called Secure Plug and Play Interoperability (SPPI) supports building and using interoperable system elements in an open ecosystem. Secure Plug and Play Interoperability enables interoperability over the entire system life cycle with its reference architecture, secure interoperability standards, and organizational capabilities. These standards were developed with participation from healthcare providers, regulatory authorities, payers, academia, and manufacturers. Publicly available information provides examples of implementation support and practical usage.

Results: Organizational interoperability in an open ecosystem can be achieved through organizational capabilities and a selection of secure interoperability standards. ISO/IEEE 11073, Bluetooth profiles, and HL7 FHIR with test specifications, test tools, software development kits, and quality assurance programs represent a coordinated selection suitable for building an open ecosystem. Practical usage is demonstrated with real-world solutions that build on these standards.

Conclusions: Secure Plug and Play Interoperability facilitates the end-to-end integration of devices, digital products, and services from partners in an open ecosystem. Moreover, even a single manufacturer, who provides all system elements of a solution, can use and benefit from SPPI.

Keywords: automated insulin delivery; cybersecurity; integrated personalized diabetes management; privacy; reference architecture; standards.

Figure 1.

Elements of integrated Personalized Diabetes Management (iPDM).

Figure 2.

System elements of a multi-manufacturer AID system.

Figure 3.

Healthcare end-to-end reference architecture.

Figure 4.

Design verification and validation strategy for independent, modular system element and system integration testing.

Figure 5.

Interoperability challenges and how SPPI helps to overcome them.