About CEN
The European Committee for Standardization is one of three European Standardization Organizations (together with CENELEC and ETSI) that have been officially recognized by the European Union and by the European Free Trade Association (EFTA) as being responsible for developing and defining voluntary standards at European level.
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Project
| Reference | EN ISO 13131:2022 |
|---|---|
| Title | Health informatics - Telehealth services - Quality planning guidelines (ISO 13131:2021) |
| Work Item Number | 00251387 |
| Abstract/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. |
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Published
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| Reference Document |
ISO 13131:2021 (EQV)
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| date of Availability (DAV) | 2022-11-16 |
| ICS | 35.240.80 - IT applications in health care technology |
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| Special National Condition(s) |
Legal
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| Mandate(s) | |
| Citation in OJEU |
Implementation Dates
| date of Ratification (DOR) (1) | 2022-11-14 |
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| date of Availability (DAV) (2) | 2022-11-16 |
| date of Announcement (DOA) (3) | 2023-02-28 |
| date of Publication (DOP) (4) | 2023-05-31 |
| date of Withdrawal (DOW) (5) | 2023-05-31 |
Relations
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(1) Date of ratification (dor) date when the Technical Board notes the approval of an EN (and HD for CENELEC), from which time the standard may be said to be approved
(2) Date of availability (dav) date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat
(3) Date of announcement (doa) latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level
(4) Date of publication (dop) latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement
(5) Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn
(6) This list of normative references is purely indicative. The only official list of normative reference is the list of the published standard.
In the case of undated standard, a link to the last dated version is provided.
In the case of series, a link to each standard identified in the series is provided.
We also invite you to check (via the website) whether corrigenda and/or amendments shall be read in conjunction with the main standard.