ISO 13131:2021

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 Clauses5 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.

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