Device Alerting (DEVAL) (Jira PSS-2005)

Medical devices often generate alert / alarm conditions as a result of risk analysis (including probability and severity of harm to the patient and their surroundings). These alert conditions are both:

The subject of numerous international standards, such as IEC 60601-1-8 and IEEE 11073 device informatics family, as well as profiles such as IHE Devices "Alert Communication Management" (which leverages both IEEE 11073 semantics and HL7 V2 messaging);

The subject of public / government regulatory agency oversight that has jurisdiction where the device is placed into use

These unique characteristics of an established multi-SDO pedigree for device alerting coupled with the potential for severe risk (including patient death) and regulatory agency oversight, necessitates consistent and coherent support in HL7 FHIR, including the specification of a carefully crafted resource and associated implementation guide, that can fully meet the requirements of the medical device community.