20/30378696 DC - BS ISO 13131. Health informatics. Telehealth services. Quality planning guidelines

20/30378696 DC

BS ISO 13131. Health informatics. Telehealth services. Quality planning guidelines

Status : Current, Draft for public comment   Published : July 2020



The purpose of this document to provide 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.

This document provides advice and recommendations on how to develop quality objectives and guidelines for telehealth services by using a risk managementprocess. The development of quality objectives and guidelines for telehealth services should include but may not be limited to the following domains:

  1. management of telehealth quality processes by the healthcare organization;

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

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

  4. management of financial resources to support telehealth services;

  5. management of information management and security used in telehealth services; and

  6. 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 quality of objectives and procedures for each domain. Organisations should 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. Readers should refer to other international or industry standards, some of which are listed in the bibliography.

Annex A provides an example use case for implementing the guidance contained in this document within a large organisation. Annex B provides several example use cases for implementing the guidance contained in this document in different types of health service.

Standard Number20/30378696 DC
TitleBS ISO 13131. Health informatics. Telehealth services. Quality planning guidelines
StatusCurrent, Draft for public comment
Publication Date17 July 2020
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)ISO/IEC 17021:2015, ISO/IEEE 11073, ISO 9241:2011, IEC 31010:2019, ISO 14971:2007, ISO 31000:2018, ISO 13940:2015, ISO/IEC Guide 51:2014, ISO 9001:2015, IEC 62304:2006, IEC 80001-1:2010, ISO 9241-11:2018, ISO/IEC 27000:2018, ISO 9000:2015, ISO/IEC 27001:2013, IEC 81346-1:2009, ISO/IEC 27002:2013, ISO/TR 18307:2001, ISO 9004:2018, ISO 26000:2010, IEC 82304-1:2016, ISO 13485:2016, ISO/IEC 25010:2011, ISO 9241-20:2008
International RelationshipsISO/DIS 13131
Draft Expiry Date09 September 2020
DescriptorsHealth services, Data processing, Data transfer, Data representation, Information exchange, Data transmission methods, Data storage, Records (documents), Data syntax, Data recording, Personal health, Data layout, Data handling, Information handling, Data transmission
Title in FrenchInformatique de santé ? Services de télésanté ? Lignes directrices pour la planification de la qualité
File Size1.057 MB
NotesWarning: this draft is not current beyond its expiry date for comments.

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