Purpose

The increasing number of medical devices and clinical information systems is driving the demand for vendor-independent interoperability to integrate medical device systems and software solutions into one comprehensive infrastructure in operating room and clinic . To meet these specific needs, communication schemes and protocols have been developed and standardized. For critical clinical environments - such as the intensive care unit - the most important innovations are included in the IEEE 11073 Service-Oriented Device Connectivity (SDC) and HL7 Fast Healthcare Interoperability Resources (FHIR) standards. The IEEE 11073 SDC is essentially concerned with cross-vendor device-to-device communication, aiming for the interoperability of medical devices. The domain information and service model IEEE 11073-10207 consists of two parts and includes both the device description and information about the current state of the device. HL7 FHIR is a new standard that supports the exchange of data from healthcare software systems, focusing on a simple implementation.

In clinical environments, communication takes not only place among medical devices and under hospital information systems, but also between these two worlds. Interoperability between these structures is necessary in order to fully develop their potential to improve healthcare and clinical workflows. Focusing on only one of the two domains to improve interoperability would not lead to a holistic solution. The standard HL7 FHIR should be extended by this information.

The goal is to create an implementation guide (IG) which covers the mapping of medical device data from IEEE 11073-10207 to HL7 FHIR, as it already exists for point-of-care devices (IEEE 11073-10201) and personal health devices (IEEE 11073-20601) of the same family of standards. The IG should allow a more flexible communication of medical devices with several different devices without a loss of information. Furthermore this Implementation Guide describes how to use FHIR resources to transfer measurement data and supporting data from acute care point-of-care medical devices (PoCD) devices to receiving systems for electronic health records, assisting with clinical decision-making, and archiving medical data to measure the quality of care and research purposes.