Active Standard

IEEE/ISO 11073-40101-2022

IEEE/ISO International Standard-Health informatics – Device interoperability –Part 40101: Foundational – Cybersecurity – Processes for vulnerability assessment

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.

Sponsor Committee
EMB/11073 - IEEE 11073 Standards Committee
Status
Active Standard
Adoption of
11073-40101-2020
History
Published:
2022-03-18

Working Group Details

Society
IEEE Engineering in Medicine and Biology Society
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Sponsor Committee
EMB/11073 - IEEE 11073 Standards Committee
Working Group
PHD - Personal_Health_Device
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IEEE Program Manager
Tom Thompson
Contact
Working Group Chair
Daidi Zhong

P11073-10206

IEEE Draft Standard - Health informatics -- Device interoperability -- Part 10206: Personal health device communication -- Abstract information content model

Within the context of the ISO/IEEE 11073 family of standards for device communication, a simplified framework for making an abstract model of personal health data available. The specification addresses the structure and content of information. It does not address communication of the information between devices.

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P11073-10406

Health Informatics--Personal Health Device Communication Part 10406: Device Specialization--Basic Electrocardiograph (ECG) (1- to 3-lead ECG)

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between personal basic electrocardiograph (ECG) devices and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology and IEEE Std 11073-20601 information models. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth basic ECG (1- to 3-lead ECG) devices. Monitoring ECG devices are distinguished from diagnostic ECG equipment with respect to including support for wearable ECG devices, limiting the number of leads supported by the equipment to three, and not requiring the capability of annotating or analyzing the detected electrical activity to determine known cardiac phenomena. This standard is consistent with the base framework and allows multifunction implementations by following multiple device specializations (e.g., ECG and respiration rate).

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P11073-10417

Health Informatics -- Personal Health Device Communication Part 10417: Device Specialization -- Glucose Meter

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of communication between personal telehealth glucose meter devices and compute engines (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards, including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth glucose meters.

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P11073-10419

IEEE Draft Standard for Health Informatics - Personal Health Device Communication - Part 10419: Device Specialization - Insulin Pump

Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of communication between personal telehealth insulin pump devices and compute engines (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability, is established in this standard. Appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards are leveraged. The use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability are specified. A common core of communication functionality for personal telehealth insulin pump devices is defined.

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P11073-10421

Health informatics--Personal health device communication Part 10421: Device specialization--Peak expiratory flow monitor (peak flow)

The scope of this standard is to establish a normative definition of communication between personal telehealth peak flow monitoring devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles and application profile standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of functionality of a peak-flow monitoring device. The use case is restricted to personal respiratory monitoring and therefore does not include hospital-based spirometry. Continuous and high-acuity monitoring (e.g., for emergency response) are outside the scope of the use case. In the context of personal health devices, a peak flow meter is a device is used to measure the respiratory function of those managing respiratory conditions such as asthma and chronic obstructive pulmonary disease. The ability to identify declining respiratory status prior to the need for acute intervention improves the quality of life for the individual while reducing the overall costs of care. Respiratory status data are collected by a personal respiratory monitoring device and forwarded to a central data repository for review and action by a health care provider. The data are episodic in nature and are forwarded at designated intervals or when the person is symptomatic.

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P11073-10425

Standard for Health Informatics -- Personal Health Device Communication - Part 10425: Device Specialization -- Continuous Glucose Monitor (CGM)

This standard establishes a normative definition of communication between personal health continuous glucose monitor (CGM) devices (agents) and managers [e.g., cell phones, personal computers (PCs), personal health appliances, set top boxes] in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality of CGM devices. In this context, CGM refers to the measurement of the level of glucose in the body on a regular (typically 5 minute) basis through a sensor continuously attached to the person.

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P11073-10426

Health Informatics - Personal Health Device Communication - Device Specialization - Home Healthcare Environment Ventilator

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between personal respiratory equipment and managers (e.g. cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environment restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for telehealth in Home Healthcare Environment Ventilator. In this context, the Home Healthcare Environment Ventilator is defined as equipment that provides assistance for patient respiration in the home environment.

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P11073-10427

Health Informatics - Device Interoperability - Part 10427: Personal Health Device Communication - Device Specialization - Power Status Monitor of Personal Health Devices

This standard specifies a normative definition of communication between devices containing a power source (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set-top boxes) in a manner that enables plug-and-play interoperability. Using existing terminology, information profiles, application profile standards, and transport standards as defined in other ISO/IEEE 11073 standards, this standard defines a common core of communication functionality of personal health devices (PHDs) containing a battery, including: 1) Current device power status ( e.g., for instance on mains or on battery); 2) Battery charge status and prediction (for instance percent of full charge, expected remaining lifetime of battery); and 3) Estimated battery run- time remaining (for instance, minutes) ; 4) Support for battery lifetime simulation.

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P11073-10427-2016/Cor 1

Standard - Health informatics--Personal health device communication - Part 10427: Device specialization--Power Status Monitor of Personal Health Devices - Corrigendum 1

This standard establishes a normative definition of communication between devices containing a power source (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set-top boxes) in a manner that enables plug-and-play interoperability. Using existing terminology, information profiles, application profile standards, and transport standards as defined in other ISO/IEEE 11073 standards, this standard defines a common core of communication functionality of personal health devices (PHDs) containing a battery, including: 1) current device power status (e.g., on mains or on battery); 2) power charge status (e.g., percent of full charge); and 3) estimated time remaining (e.g., minutes).

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P11073-10429

IEEE Draft for Health Informatics -- Device Interoperability -- Part 10429: Personal Health Device Communication -- Device Specialization - Spirometry

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between personal telehealth spirometry devices and managers (e.g. cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth spirometry.

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P11073-10441

Health Informatics--Personal health device communication Part 10441: Device specialization--Cardiovascular fitness and activity monitor

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between personal cardiovascular fitness and activity monitoring devices and managers (e.g. cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models and application profile standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth cardiovascular fitness and activity monitor devices. In this context, cardiovascular fitness and activity monitor devices are being used broadly to cover cardiovascular fitness and activity monitor devices that measure physical actions and the body's various physiological responses to that activity.

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P11073-10442

IEEE Draft Health Informatics - Personal Health Device Communication Part 10442: Device Specialization - Strength Fitness Equipment

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between personal strength fitness devices and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology and information models. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth strength fitness devices. In this context, strength fitness devices are being used broadly to cover strength fitness devices that measure musculo-skeletal strength-conditioning activities.

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P11073-10471

IEEE Draft Health Informatics - Personal health device communication - Device Specialization - Independent living activity hub

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of communication between personal telehealth independent living activity hub devices and compute engines (e.g. cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth independent living activity hubs.

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P11073-10472

Health informatics--Personal health device communication--Part 10472: Device specialization--Medication monitor

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between medication monitoring devices and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models and application profile. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting ambiguity in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for medication monitors. In this context, medication monitors are defined as devices that have the ability to determine and communicate (to a manager) measures of a user's adherence to a medication regime.

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P11073-20601

Health Informatics - Device Interoperability - Part 20601: Personal Health Device Communication - Application Profile - Optimized Exchange Protocol

Within the context of the ISO/IEEE 11073 personal health device standard family, this standard defines an optimized exchange protocol and modeling techniques to be used by implementers of personal health devices to create interoperability between device types and vendors. This standard establishes a common framework for an abstract model of personal health data available in a transport-independent transfer syntax required to establish logical connections between systems and to provide presentation capabilities and services needed to perform communication tasks. The protocol is optimized to personal health usage requirements and leverages commonly used methods and tools wherever possible.

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11073-00103-2012

Health informatics - Personal health device communication Part 00103: Overview

Within the context of the ISO/IEEE 11073 family of standards for device communication, the landscape of transport-independent applications and information profiles for personal telehealth devices is described in this guide. Defined in these profiles are data exchange, data representation, and terminology for communication between personal telehealth devices and compute engines (e.g., health appliances, set top boxes, cell phones, and personal computers). A definition of personal telehealth devices as devices used for life activity, wellness monitoring, and/or health monitoring in domestic home, communal home, and/or mobile applications is provided in this guide. Use cases relevant to these scenarios and environments are also presented.

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11073-10404-2020

IEEE Standard - Health informatics--Personal health device communication Part 10404: Device specialization--Pulse oximeter

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of communication between personal telehealth pulse oximetry devices and compute engines (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth pulse oximeters.

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11073-10406-2011

Health informatics--Personal health device communication Part 10406: Device specialization--Basic electrocardiograph (ECG) (1- to 3-lead ECG)

Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of the communication between personal basic electrocardiograph (ECG) devices and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability is established in this standard. Appropriate portions of existing standards including ISO/IEEE 11073 terminology and IEEE 11073-20601 information models are leveraged. The use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability is specified. A common core of communication functionality for personal telehealth basic ECG (1- to 3-lead ECG) devices is defined. Monitoring ECG devices are distinguished from diagnostic ECG equipment with respect to including support for wearable ECG devices, limiting the number of leads supported by the equipment to three, and not requiring the capability of annotating or analyzing the detected electrical activity to determine known cardiac phenomena. This standard is consistent with the base framework and allows multifunction implementations by following multiple device specializations (e.g., ECG and respiration rate).

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11073-10407-2020

IEEE Health informatics--Personal health device communication Part 10407: Device specialization--Blood pressure monitor

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of communication between personal telehealth blood pressure monitor devices and compute engines (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth blood pressure monitors.

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11073-10408-2019

IEEE Health informatics--Personal health device communication Part 10408: Device specialization--Thermometer

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of communication between personal telehealth thermometer devices and compute engines (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth thermometer devices.

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11073-10415-2019

IEEE Standard - Health informatics--Personal health device communication Part 10415: Device specialization--Weighing scale

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of communication between personal telehealth weighing scale devices and compute engines (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards, including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth weighing scales.

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11073-10417-2015

IEEE Health informatics -- Personal health device communication Part 10417: Device Specialization -- Glucose Meter

Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of communication between personal telehealth glucose meter devices and compute engines (e.g., cell phones, personal computers, personal health appliances, and set top boxes) is established by this standard in a manner that enables plug-and play interoperability. Appropriate portions of existing standards are leveraged, including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. The use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability are specified. A common core of communication functionality for personal telehealth glucose meters is defined in this standard.

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11073-10418-2011

IEEE Standard - Health informatics--Personal health device communication Part 10418: Device specialization--International Normalized Ratio (INR) monitor

A normative definition of communication between personal telehealth International Normalized Ratio (INR) devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes) is established in this standard in a manner that enables plug-and-play interoperability. Work done in other ISO/IEEE 11073 standards is leveraged, including existing terminology, information profiles, application profile standards, and transport standards. The use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability is specified. A common core of functionality of INR devices is defined in this standard. In the context of personal health devices, the measurement of the prothrombin time (PT) that is used to assess the level of anticoagulant therapy and its presentation as the International Normalized Ratio compared to the prothrombin time of normal blood plasma is referred to in INR monitoring. Applications of the INR monitor include the management of the therapeutic level of anticoagulant used in the treatment of a variety of conditions. The data modeling and its transport shim layer according to ISO/IEEE 11073-20601:2010 are provided by this standard, and the measurement method is not specified.

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11073-10418-2011/Cor 1-2015

IEEE Health informatics--Personal health device communication Part 10418: Device specialization--International Normalized Ratio (INR) monitor - Corrigendum 1

A normative definition of communication between personal telehealth International Normalized Ratio (INR) devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes) is established in this standard in a manner that enables plug-and-play interoperability. Work done in other ISO/IEEE 11073 standards is leveraged, including existing terminology, information profiles, application profile standards, and transport standards. The use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability is specified. A common core of functionality of INR devices is defined in this standard. In the context of personal health devices, the measurement of the prothrombin time (PT) that is used to assess the level of anticoagulant therapy and its presentation as the International Normalized Ratio compared to the prothrombin time of normal blood plasma is referred to in INR monitoring. Applications of the INR monitor include the management of the therapeutic level of anticoagulant used in the treatment of a variety of conditions. The data modeling and its transport shim layer according to IEEE Std 11073-20601(TM)-2014 are provided by this standard, and the measurement method is not specified. This standard corrects errors that have been identified in the IEEE Std 11073-10418-2011 to make it easier to implement the standard in an interoperable fashion.

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11073-10419

IEEE Draft International Standard - Health informatics- Personal health device communication- Part 10419: Device Specialization- Insulin Pump

Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of communication between personal telehealth insulin pump devices and compute engines (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability, is established in this standard. Appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards are leveraged. The use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability are specified. A common core of communication functionality for personal telehealth insulin pump devices is defined

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11073-10419-2016

ISO/IEEE International Standard - Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump

Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of communication between personal telehealth insulin pump devices and compute engines (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability, is established in this standard. Appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards are leveraged. The use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability are specified. A common core of communication functionality for personal telehealth insulin pump devices is defined.

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11073-10419-2017

IEEE Health informatics--Personal health device communication - Part 10419: Device Specialization--Insulin Pump

Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of communication between personal telehealth insulin pump devices and compute engines (e.g., cell phones, personal computers, personal health appliances, set top boxes), in a manner that enables plug-and-play interoperability, is established in this standard. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. The standard defines a common core of communication functionality for personal telehealth insulin pump devices.

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11073-10420-2020

IEEE Standards for Health informatics--Device interoperability - Part 10420: Personal health device communication--Device specialization--Body composition analyzer

Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of the communication between personal body composition analyzer agents and managers (e.g., cell phones, personal computers, personal health appliances, set-top boxes) is established by this standard in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments to restrict optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth body composition analyzers.In this context, the phrase u201cbody composition analyzeru201d is used broadly to cover analyzing devices that measure body impedances and compute the various body components including body fat from the impedance.

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11073-10422-2016

Health informatics--Personal health device communication Part 10422: Device Specialization--Urine Analyzer

Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of communication between personal telehealth urine analyzer devices and compute engines (e.g., cell phones, personal computers, personal health appliances, and set-top boxes) is established by this standard in a manner that enables plug-and-play interoperability. Appropriate portions of existing standards are leveraged, including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. The use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability is specified. A common core of communication functionality for personal telehealth urine analyzers is defined in this standard.

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11073-10424-2014

IEEE Standard - Health informatics--Personal health device communication - Part 10424: Device Specialization--Sleep Apnoea Breathing Therapy Equipment (SABTE)

Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of the communication between sleep apnoea breathing therapy equipment (SABTE) devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes), in a manner that enables plug-and-play interoperability, is established in this standard. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for SABTE. In this context, SABTE is defined as a device that is intended to alleviate the symptoms of a patient who suffers from sleep apnoea by delivering a therapeutic breathing pressure to the patient. SABTE is primarily used in the home health-care environment by a lay operator without direct professional supervision.

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11073-10424-2016

ISO/IEEE International Standard - Health informatics--Personal health device communication - Part 10424: Device Specialization--Sleep Apnoea Breathing Therapy Equipment (SABTE)

Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of the communication between sleep apnoea breathing therapy equipment (SABTE) devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes), in a manner that enables plug-and-play interoperability, is established in this standard. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for SABTE. In this context, SABTE is defined as a device that is intended to alleviate the symptoms of a patient who suffers from sleep apnoea by delivering a therapeutic breathing pressure to the patient. SABTE is primarily used in the home health-care environment by a lay operator without direct professional supervision.

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11073-10424-2014/Cor 1-2017

IEEE Standard - Health informatics–Personal health device communication - Part 10424: Device Specialization--Sleep Apnoea Breathing Therapy Equipment (SABTE) - Corrigendum 1

Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of the communication between sleep apnoea breathing therapy equipment (SABTE) devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set-top boxes), in a manner that enables plug-and-play interoperability, is established in IEEE Std 11073-10424-2014. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. IEEE Std 11073-10424-2014 defines a common core of communication functionality for SABTE. In this context, SABTE is defined as a device that is intended to alleviate the symptoms of a patient who suffers from sleep apnoea by delivering a therapeutic breathing pressure to the patient. SABTE is primarily used in the home health-care environment by a lay operator without direct professional supervision. This corrigendum corrects errors that have been identified in IEEE Std 11073-10424-2014 to make it easier to implement the standard in an interoperable fashion.

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11073-10425-2017

IEEE Health informatics--Personal health device communication - Part 10425: Device Specialization--Continuous Glucose Monitor (CGM)

Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of the communication between continuous glucose monitor (CGM) devices and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes), in a manner that enables plug-and-play interoperability, is established in this standard. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology and information models. It specifies the use of specific term codes, formats, and behaviors in telehealth environments, restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality of CGM devices. In this context, CGM refers to the measurement of the level of glucose in the body on a regular (typically 5 minute) basis through a sensor continuously attached to the person.

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11073-10427-2016

IEEE Standard - Health informatics--Personal health device communication - Part 10427: Device specialization--Power Status Monitor of Personal Health Devices

Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of power status communication between personal health devices (PHDs) and managers (e.g., cell phones, personal computers, personal health appliances, and set-top boxes) is established by this standard in a manner that enables plug-and-play interoperability. Appropriate portions of existing standards are leveraged, including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. The use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability are specified. A common core of communication functionality for monitoring the power status of PHDs is defined in this standard.

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11073-10441-2013

Health Informatic--Personal health device communication Part 10441: Device specialization--Cardiovascular fitness and activity monitor

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of communication between personal telehealth cardiovascular fitness and activity monitor devices and compute engines (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth cardiovascular fitness and activity monitor devices.

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11073-20601-2019

IEEE Health informatics--Personal health device communication - Part 20601: Application profile--Optimized Exchange Protocol

Within the context of the ISO/IEEE 11073 family of standards for device communication, a common framework for making an abstract model of personal health data available in transport-independent transfer syntax required to establish logical connections between systems and to provide presentation capabilities and services needed to perform communication tasks is described in this standard. The protocol is optimized to personal health usage requirements and leverages commonly used methods and tools wherever possible.

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11073-40101-2020

IEEE Standard - Health informatics--Device interoperability Part 40101: Foundational–Cybersecurity–Processes for vulnerability assessment

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.

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11073-40102-2020

IEEE Standard - Health informatics--Device interoperability Part 40102: Foundational–Cybersecurity–Capabilities for mitigation

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 (ENISA). A mapping of this standard to the NIST cybersecurity framework; IEC TR 80001-2-2; and the Spoofing, Tampering, Repudiation, Information Disclosure, Denial of Service, and Elevation of Privilege (STRIDE) classification scheme is defined.

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11073-40102-2022

IEEE/ISO International Standard - Health informatics--Device interoperability Part 40102: Foundational–Cybersecurity–Capabilities for mitigation

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 (ENISA). A mapping of this standard to the NIST cybersecurity framework; IEC TR 80001-2-2; and the Spoofing, Tampering, Repudiation, Information Disclosure, Denial of Service, and Elevation of Privilege (STRIDE) classification scheme is defined.

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11073-10404-2008

IEEE Standard - Health Informatics - Personal Health Device Communication - Part 10404: Device Specialization - Pulse Oximeter

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of communication between personal telehealth pulse oximetry devices and compute engines (e.g. cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth pulse oximeters.

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11073-10407-2008

IEEE Health Informatics - Personal Health Device Communication - Device Specialization - Blood Pressure Monitor

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of communication between personal telehealth blood pressure monitor devices and compute engines (e.g. cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth blood pressure monitors.

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11073-10408-2008

IEEE Health informatics--Personal health device communication Part 10408: Device specialization -- Thermometer

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of communication between personal telehealth thermometer devices and compute engines (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth thermometer devices.

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11073-10415-2008

IEEE Health Informatics - Personal Health Device Communication - Device Specialization - Weighing Scale

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of communication between personal telehealth weighing scale devices and compute engines (e.g. cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth weighing scales.

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11073-10417-2009

Health informatics--Personal health device communication Part 10417: Device specialization- Glucose meter

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of communication between personal telehealth glucose meter devices and compute engines (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth glucose meters.

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11073-10417-2011

IEEE Health informatics--Personal health device communication Part 10417: Device specialization--Glucose meter

Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of communication between personal telehealth glucose meter devices and compute engines (e.g., cell phones, personal computers, personal health appliances, and set top boxes) is established by this standard in a manner that enables plug-and play interoperability. Appropriate portions of existing standards are leveraged, including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. The use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability are specified. A common core of communication functionality for personal telehealth glucose meters is defined in this standard.

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11073-10419-2015

IEEE Health informatics- Personal health device communication- Part 10419: Device Specialization- Insulin Pump

Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of communication between personal telehealth insulin pump devices and compute engines (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability, is established in this standard. Appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards are leveraged. The use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability are specified. A common core of communication functionality for personal telehealth insulin pump devices is defined.

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11073-10420-2010

IEEE Health informatics -- Personal health device communication Part 10420: Device specialization -- Body composition analyzer

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between personal body composition analyzing devices and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology and IEEE 11073-2060(TM) information models. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth body composition analyzer devices. In this context, body composition analyzer devices are being used broadly to cover body composition analyzer devices that measure body impedances, and compute the various body components including body fat from the impedance.

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11073-10425-2014

Health informatics--Personal health device communication - Part 10425: Device Specialization--Continuous Glucose Monitor (CGM)

Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of the communication between continuous glucose monitor (CGM) devices and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes), in a manner that enables plug-and-play interoperability, is established in this standard. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology and information models. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality of CGM devices. In this context, CGM refers to the measurement of the level of glucose in the body on a regular (typically 5 minute) basis through a sensor continuously attached to the person.

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11073-10441-2008

IEEE/ISO International Standard - Health Informatics - Personal Health Device Communication - Part 10441: Device Specialization - Cardiovascular Fitness and Activity Monitor

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of communication between personal telehealth cardiovascular fitness and activity monitor devices and compute engines (e.g. cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth cardiovascular fitness and activity monitor devices.

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11073-20601-2008

IEEE Health informatics u2013 Personal health device communication u2013 Part 20601: Application profile u2013 Optimized exchange protocol

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard defines a common framework for making an abstract model of personal health data available in transport independent transfer syntax required to establish logical connections between systems, provide presentation capabilities and services needed to perform communication tasks. The protocol is optimized to personal health usage requirements and leverages commonly-used methods and tools wherever possible

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11073-20601-2014

IEEE Health informatics--Personal health device communication - Part 20601: Application profile- Optimized Exchange Protocol

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard defines a common framework for making an abstract model of personal health data available in transport-independent transfer syntax required to establish logical connections between systems and to provide presentation capabilities and services needed to perform communication tasks. The protocol is optimized to personal health usage requirements and leverages commonly used methods and tools wherever possible.

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11073-20601-2014/Cor 1-2015

IEEE Health informatics--Personal health device communication Part 20601: Application profile--Optimized Exchange Protocol - Corrigendum 1

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard defines a common framework for making an abstract model of personal health data available in transport-independent transfer syntax required to establish logical connections between systems and to provide presentation capabilities and services needed to perform communication tasks. The protocol is optimized to personal health usage requirements and leverages commonly used methods and tools wherever possible. This corrigendum removes the ambiguities and corrects the wrong nomenclature codes and qualifier status that have been identified in IEEE Std 11073-20601-2014 to improve implementation of the standard in an interoperable fashion.

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11073-20601a-2010

IEEE Health informatics--Personal health device communication Part 20601: Application profile--Optimized Exchange Protocol Amendment 1

Issues found within IEEE Std 11073-20601-2008 while implementing the standard and/or testing and certifying products are addressed in this amendment.

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No Inactive-Withdrawn Standards

11073-10421-2010

IEEE Standard - Health informatics--Personal health device communication Part 10421: Device specialization--Peak expiratory flow monitor (peak flow)

Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of communication is established in this standard between personal telehealth peak expiratory flow monitor devices and compute engines (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. Appropriate portions of existing standards are leveraged, including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. The use of specific term codes, formats, and behaviors is specified in telehealth environments restricting optionality in base frameworks in favor of interoperability. A common core of communication functionality is defined for personal telehealth peak expiratory flow monitor devices.

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11073-10442-2008

Health informatics - Personal health device communication Part 10442: Device specialization - Strength fitness equipment

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between personal strength fitness devices and managers (e.g. cell phones, personal computes, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology and information models. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth strength fitness devices. In this context, strength fitness devices are being used broadly to cover strength fitness devices that measure musculo-skeletal strength conditioning activities.

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11073-10471-2008

IEEE Health informatics--Personal health device communication Part 10471: Device specialization--Independent living activity hub

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of communication between personal telehealth independent living activity hub devices and compute engines (e.g. cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth independent living activity hubs.

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11073-10472-2010

IEEE Standard for Health informatics--Personal health device communication--Part 10472: Device specialization--Medication monitor

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of communication between personal telehealth medication monitor devices and compute engines (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth medication monitor devices.

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