Within the context of the ISO/IEEE 11073 family of standards for point-of-care (POC) and personal health devices (PHD) medical device communication (MDC), this standard provides the nomenclature that supports both the domain information model and service model components of the standards family, as well as the semantic content exchanged with medical devices. The nomenclature is specialized for patient vital signs information representation and medical device informatics, with major areas including concepts for electrocardiograph (ECG), haemodynamics, respiration, blood gas, urine, fluid-related metrics, and neurology, as well as specialized units of measurement, general device events, alarms, and body sites. The standard defines…
This document provides recommended test methods for assuring the radio frequency (RF) immunity of electronic devices and systems that might experience susceptibility from general use transceivers or the RF ambient.
Within the context of the ISO/IEEE 11073 family of standards for point-of-care (PoC) medical device communication, an architecture for service-oriented distributed PoC medical devices and medical IT systems is defined. This standard defines a binding of the Participant, Discovery, and Communication Model defined in IEEE Std 11073-10207™ to the profile for transport over Web Services defined in IEEE Std 11073-20702™. Moreover, a binding to Network Time Protocol (NTP) and Differentiated Services (DiffServ) is defined for time synchronization and transport Quality of Service requirements.
Within the context of the ISO/IEEE 11073 family of standards for point-of-care medical device communication, an abstract, object-oriented domain information model that specifies the structure of exchanged information, as well as the vents and services that are supported by each type of object, is provided in this standard. All data structure elements are specified using abstract syntax (ASN.1) and may be applied to many different implementation technologies, transfer syntaxes, and application service models. Core subjects include medical, alert, system, patient, control, archival, communication, and extended services. Model extensibility is supported, and a conformance model and statement template is provided.
The impact of artificial intelligence or autonomous and intelligent systems (A/IS) on humans is measured by this standard. The positive outcome of A/IS on human well-being is the overall intent of this standard. Scientifically valid well-being indices currently in use and based on a stakeholder engagement process ground this standard. Product development guidance, identification of areas for improvement, risk management, performance assessment, and the identification of intended and unintended users, uses and impacts on human well-being of A/IS are the intents of this standard.
For Personal Health Devices (PHDs) and Point-of-Care Devices (PoCDs), an iterative, systematic, scalable, and auditable approach to identification of cybersecurity vulnerabilities and estimation of risk is defined by this standard. The standard presents one approach to iterative vulnerability assessment that uses the Spoofing, Tampering, Repudiation, Information Disclosure, Denial of Service, and Elevation of Privilege (STRIDE) classification scheme and the embedded Common Vulnerability Scoring System (eCVSS). The assessment includes system context, system decomposition, pre-mitigation scoring, mitigation, and post-mitigation scoring and iterates until the remaining vulnerabilities are reduced to an acceptable level of risk.
For Personal Health Devices (PHDs) and Point-of-Care Devices (PoCDs), a security baseline of application layer cybersecurity mitigation techniques is defined by this standard for certain use cases or for times when certain criteria are met. The mitigation techniques are based on an extended confidentiality, integrity, and availability (CIA) triad and are described generally to allow manufacturers to determine the most appropriate algorithms and implementations. A scalable information security toolbox appropriate for PHD/PoCD interfaces is specified that fulfills the intersection of requirements and recommendations from the National Institute of Standards and Technology (NIST) and the European Network and Information Security Agency…
Clarifying and furthering the subject selection of the sample size in the clinical study; looking into the results of the validation study with respect to the patient's body position and activity level for their applicability to ambulatory patients; and addressing the issues of motion artifact is covered in the amendment.
