ISO 13131:2021 Health informatics — Telehealth services — Quality planning guidelines

标准简介

Health informatics — Telehealth services — Quality planning guidelines由国际标准化组织(International Organization for Standardization，简称ISO)于2021-05-28发布，适用于国际范围。

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标准部分原文

INTERNATIONAL STANDARD ISO 13131:2021

Health informatics — Telehealth services — Quality planning guidelines

1 Scope

This document provides processes that can be used to analyze the risks to the quality and safety of healthcare and continuity of care when telehealth services are used to support healthcare activities. Using risk management processes, quality objectives and procedures are derived which provide guidelines for the operations of telehealth services. These include but are not limited to the following domains:

— management of telehealth quality processes by the healthcare organization;

— strategic and operational process management relating to regulations, knowledge management (best practice) and guidelines;

— healthcare processes relating to people such as healthcare activities, planning, and responsibilities;

— management of financial resources to support telehealth services;

— management of information management and security used in telehealth services;

— processes related to the planning and provision of human resources, infrastructure, facilities and technology resources for use by telehealth services.

This document provides a set of example guidelines containing quality objectives and procedures for each domain. Organizations can apply the quality and risk management processes described in Clauses 5 and 6 to develop quality objectives and procedures appropriate to the telehealth services they provide.

This document does not provide guidance for the manufacture, assembly, configuration, interoperability or management of devices, products or technical systems.

Annex A provides procedures for the implementation of telehealth services by a large organization. Annex B provides use cases for the application of quality planning guidelines in different types of real-

world telehealth services.

2 Normative references

There are no normative references in this document.

3 Terms a nd definiti ons

For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https://www.iso.org/obp

— IEC Electropedia: available at http://www.electropedia.org/

ISO 13131:2021

3.1 Quality characteristics

3.1.1

accessibility

usability of a product, service, environment or facility by people within the widest range of capabilities

EXAMPLE Accessibility of healthcare for care recipients.

[SOURCE: ISO 9241-20:2008, 3.1, modified — Notes to entry removed and example added.]

3.1.2

accountability

state of being answerable for decisions and activities to the organization's governing bodies, legal authorities and, more broadly, its stakeholders

[SOURCE: ISO 26000:2010, 2.1]

EXAMPLE Accountability for healthcare activities delivered by a healthcare organization.

3.1.3

appropriateness

extent to which healthcare activities enable care recipients to achieve specified objectives

3.1.4

competence

ability to apply knowledge and skills to achieve intended results

[SOURCE: ISO/IEC 17021-1:2015, 3.7]

EXAMPLE Competence to participate in healthcare activities of care recipients or healthcare professionals.

3.1.5

c on f ident i a l it y

property that information is not made available or disclosed to unauthorized individuals, entities, or processes

[SOURCE: ISO/IEC 27000:2018, 3.10]

EXAMPLE Confidentiality of information to maintain the privacy of the care recipient in society or social life.

3.1.6

continuity of care

component of patient care quality consisting of the degree to which the care needed by a patient is coordinated among practitioners and across organizations and time

[SOURCE: ISO/TR 18307:2001, 3.42]

EXAMPLE Continuity of healthcare especially when several healthcare professionals or organizations share the delivery of services to a single care recipient.

3.1.7

dependability

ability to perform when and as required

EXAMPLE Dependability of healthcare for care recipients.

[SOURCE: ISO 9000:2015, 3.6.14]

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