ISO 13131:2021
Health informatics — Telehealth services — Quality planning guidelines
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.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
3.1 Quality characteristics
3.2 Actors
3.3 Care
3.4 Quality and risk
3.5 Services
3.6 Devices
4 Application of these guidelines
5 Quality management of telehealth services
5.1 Quality management
5.1.1 Telehealth service quality planning
5.1.2 Guidelines for quality and risk management
5.2 Management of quality characteristics
5.2.1 General
5.2.2 Guidelines for quality characteristics
5.3 Description of service scope and context
5.3.1 General
5.3.2 Guidelines for description of services
5.4 Description of healthcare processes
5.4.1 General
5.4.2 Guidelines
5.5 Evaluation and monitoring
5.5.1 General
5.5.2 Guidelines for evaluation and monitoring
6 Risk management
6.1 Telehealth service risk, quality and safety assessment
6.2 Risk assessment - Identification
6.2.1 General
6.2.2 Guidelines for risk assessment
6.3 Risk assessment - analysis
6.3.1 General
6.3.2 Guidelines for risk analysis
6.4 Risk assessment - evaluation
6.4.1 General
6.4.2 Guidelines for risk evaluation
6.5 Risk treatment
6.5.1 General
6.5.2 Guidelines for risk treatment
7 Financial management
7.1 Quality characteristics
7.1.1 General
7.1.2 Guidelines for sustainability
7.1.3 Guidelines for healthcare funds
7.1.4 Guidelines for service payment
8 Service planning
8.1 Quality characteristics
8.1.1 General
8.1.2 Guidelines for service design
8.1.3 Guidelines for service availability
8.1.4 Guidelines for duration of care
8.1.5 Guidelines for service level agreements
9 Human resources planning
9.1 Quality characteristics
9.1.1 General
9.1.2 Guidelines for human resources skills and training
9.1.3 Guidelines for consultation with human resources
10 Care planning
10.1 Quality characteristics
10.1.1 General
10.1.2 Guidelines for healthcare processes
10.1.3 Guidelines for care plans
10.1.4 Guidelines for healthcare continuity
10.1.5 Guidelines for emergency procedures
10.1.6 Guidelines for when clinical guidelines and protocols are unavailable
10.1.7 Guidelines for adverse event management
10.1.8 Guidelines for professional health record management
11 Responsibilities
11.1 Quality characteristics
11.1.1 General
11.1.2 Guidelines for healthcare mandates
11.1.3 Guidelines for informed consent
11.1.4 Guidelines for care recipient preferences
11.1.5 Guidelines for care recipients’ expenses
11.1.6 Guidelines for providing appropriate healthcare services
11.1.7 Guidelines for ensuring competence of care recipients
11.1.8 Guidelines for design of telehealth services
11.1.9 Guidelines for execution of care plans
12 Facilities management
12.1 Quality characteristics
12.1.1 General
12.1.2 Guidelines for healthcare organization facilities
12.1.3 Guidelines for care recipient facilities
13 Technology management
13.1 Quality characteristics
13.1.1 General
13.1.2 Guidelines for safety and quality
13.1.3 Guidelines for service support
13.1.4 Guidelines for service delivery
13.1.5 Guidelines for infrastructure management
13.1.6 Guidelines for deployment management
13.1.7 Guidelines for operations management
13.1.8 Guidelines for technical support
13.1.9 Guidelines for device management
14 Information management
14.1 Quality characteristics
14.1.1 General
14.1.2 Guidelines for privacy
14.1.3 Guidelines to protect care recipient identity
14.1.4 Guidelines for confidentiality of health records
14.1.5 Guidelines for consultations, ordering and prescribing
14.1.6 Guidelines for coordination and scheduling
14.1.7 Guidelines for data quality
Annex A (informative) Procedures for the implementation of telehealth services by a large organization
Annex B (informative) Using quality planning guidelines in real-world telehealth services
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
3.1 Quality characteristics
3.2 Actors
3.3 Care
3.4 Quality and risk
3.5 Services
3.6 Devices
4 Application of these guidelines
5 Quality management of telehealth services
5.1 Quality management
5.1.1 Telehealth service quality planning
5.1.2 Guidelines for quality and risk management
5.2 Management of quality characteristics
5.2.1 General
5.2.2 Guidelines for quality characteristics
5.3 Description of service scope and context
5.3.1 General
5.3.2 Guidelines for description of services
5.4 Description of healthcare processes
5.4.1 General
5.4.2 Guidelines
5.5 Evaluation and monitoring
5.5.1 General
5.5.2 Guidelines for evaluation and monitoring
6 Risk management
6.1 Telehealth service risk, quality and safety assessment
6.2 Risk assessment - Identification
6.2.1 General
6.2.2 Guidelines for risk assessment
6.3 Risk assessment - analysis
6.3.1 General
6.3.2 Guidelines for risk analysis
6.4 Risk assessment - evaluation
6.4.1 General
6.4.2 Guidelines for risk evaluation
6.5 Risk treatment
6.5.1 General
6.5.2 Guidelines for risk treatment
7 Financial management
7.1 Quality characteristics
7.1.1 General
7.1.2 Guidelines for sustainability
7.1.3 Guidelines for healthcare funds
7.1.4 Guidelines for service payment
8 Service planning
8.1 Quality characteristics
8.1.1 General
8.1.2 Guidelines for service design
8.1.3 Guidelines for service availability
8.1.4 Guidelines for duration of care
8.1.5 Guidelines for service level agreements
9 Human resources planning
9.1 Quality characteristics
9.1.1 General
9.1.2 Guidelines for human resources skills and training
9.1.3 Guidelines for consultation with human resources
10 Care planning
10.1 Quality characteristics
10.1.1 General
10.1.2 Guidelines for healthcare processes
10.1.3 Guidelines for care plans
10.1.4 Guidelines for healthcare continuity
10.1.5 Guidelines for emergency procedures
10.1.6 Guidelines for when clinical guidelines and protocols are unavailable
10.1.7 Guidelines for adverse event management
10.1.8 Guidelines for professional health record management
11 Responsibilities
11.1 Quality characteristics
11.1.1 General
11.1.2 Guidelines for healthcare mandates
11.1.3 Guidelines for informed consent
11.1.4 Guidelines for care recipient preferences
11.1.5 Guidelines for care recipients’ expenses
11.1.6 Guidelines for providing appropriate healthcare services
11.1.7 Guidelines for ensuring competence of care recipients
11.1.8 Guidelines for design of telehealth services
11.1.9 Guidelines for execution of care plans
12 Facilities management
12.1 Quality characteristics
12.1.1 General
12.1.2 Guidelines for healthcare organization facilities
12.1.3 Guidelines for care recipient facilities
13 Technology management
13.1 Quality characteristics
13.1.1 General
13.1.2 Guidelines for safety and quality
13.1.3 Guidelines for service support
13.1.4 Guidelines for service delivery
13.1.5 Guidelines for infrastructure management
13.1.6 Guidelines for deployment management
13.1.7 Guidelines for operations management
13.1.8 Guidelines for technical support
13.1.9 Guidelines for device management
14 Information management
14.1 Quality characteristics
14.1.1 General
14.1.2 Guidelines for privacy
14.1.3 Guidelines to protect care recipient identity
14.1.4 Guidelines for confidentiality of health records
14.1.5 Guidelines for consultations, ordering and prescribing
14.1.6 Guidelines for coordination and scheduling
14.1.7 Guidelines for data quality
Annex A (informative) Procedures for the implementation of telehealth services by a large organization
Annex B (informative) Using quality planning guidelines in real-world telehealth services
Bibliography