ISO 13131:2021 Health informatics — Telehealth services
ISO 13131:2021 details the processes and requirements that can be used to analyse the risks to the quality and safety of healthcare and continuity of care when telehealth services are used to support healthcare activities.
What are Telehealth services?
Healthcare activities rely on communication between healthcare actors. When the point of care is geographically separated from healthcare resources and healthcare actors are geographically separated, technology enabled services can support healthcare activities. There are diverse forms of healthcare activity, including care by a health professional, self-care activity, treatment, investigation, management, assessment, and evaluation, provision of resources, documentation and education. (For an explanation of these terms, refer to ISO 13940). Health services rely on many technical devices and services including, but not limited to facsimile machines, telephones, cameras, mobile phones, mobile devices, health state monitors, diagnostic scanners and communications services including email, telephony, video conferencing, image transmission and electronic messaging to convey health information and data between healthcare actors.
These services can be described as telehealth services because information and communication technology services are being used to support healthcare activities. Telehealth services can include but are not limited to telemedicine, telecare, mhealth (healthcare supported by mobile devices), remote use of medical applications, tele-monitoring, tele-diagnostics and virtual care.
Examples of health services include but are not limited to tele-pathology, tele-dermatology, tele-cardiology, tele-rehabilitation, tele-oncology, and tele-orthopaedics.
Healthcare activities that directly or indirectly support care recipients include but are not limited to teleconsultation, telephone advice, health alarm systems and health status monitoring at home.
Telehealth services can support immediate healthcare activities using synchronous communications services such as a telephone or video conversation, or delayed health care activities using asynchronous communications services such as messaging services.
Within the healthcare industry, these services are described as digital health or ehealth (electronic health) products provided to support healthcare activity.
Electronic health information systems are an example of products that support the capture, storage and transmission of healthcare information and data, which may or may not be used for telehealth services. It is expected that telehealth services will improve the quality of health and healthcare. For example, healthcare professionals can have health information about the care recipient available in the right place at the right time, and they will have easier access to support from medical specialists.
The care recipient can be monitored in his or her home, and receive advice without the need to travel to consult a health advisor or healthcare professional as well as having easier access to healthcare information and education to support self-care.
Application of ISO 13131
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,
- processes related to the planning and provision of human resources, infrastructure, facilities and technology resources for use by telehealth services.
ISO 13131:2021 provides guidelines for quality objectives and procedures for each domain. Organizations can apply the quality and risk management processes as part of management planning to develop quality objectives and procedures appropriate to the telehealth services they provide.
QMS Solutions services
We provide full systems support at all stages of development. Services include:
- Completion of an initial assessment and gap analysis
- The preparation of all required systems documentation Note: systems requirements may be addressed via digital / automated
systems. - Training and mentoring throughout systems development
- Completion of internal audit as a pre-requisite to certification
- Support with the completion of the annual management review as a pre-requisite to certification
ISO 13131:2021 provides guidelines for quality objectives and procedures for each domain. Organizations can apply the quality and risk management processes as part of management planning to develop quality objectives and procedures appropriate to the telehealth services they provide.
Steps to Certification
QMS Solutions will complete the application for certification and liaise with the certification body to ensure a successful outcome.
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