ISO/TS 11633-1:2019
(Main)Health informatics — Information security management for remote maintenance of medical devices and medical information systems — Part 1: Requirements and risk analysis
Health informatics — Information security management for remote maintenance of medical devices and medical information systems — Part 1: Requirements and risk analysis
This document focuses on remote maintenance services (RMS) for information systems in healthcare facilities (HCFs) as provided by vendors of medical devices and health information systems. This document specifies the risk assessment necessary to protect remote maintenance activities, taking into consideration the special characteristics of the healthcare field such as patient safety, regulations and privacy protections. This document provides practical examples of risk analysis to protect both the HCF and RMS provider information assets in a safe and efficient (i.e. economical) manner. These assets are primarily the information system itself and personal health data held in the information system.
Informatique de santé — Management de la sécurité de l'information pour la maintenance à distance des dispositifs médicaux et des systèmes d'information médicale — Partie 1: Exigences et analyse du risque
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Standards Content (Sample)
TECHNICAL ISO/TS
SPECIFICATION 11633-1
First edition
2019-08
Health informatics — Information
security management for remote
maintenance of medical devices and
medical information systems —
Part 1:
Requirements and risk analysis
Informatique de santé — Management de la sécurité de l'information
pour la maintenance à distance des dispositifs médicaux et des
systèmes d'information médicale —
Partie 1: Exigences et analyse du risque
Reference number
ISO/TS 11633-1:2019(E)
©
ISO 2019
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ISO/TS 11633-1:2019(E)
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ii © ISO 2019 – All rights reserved
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ISO/TS 11633-1:2019(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 An outline of RMS security of medical devices and medical information systems .2
4.1 Contents of RMS security of medical devices and medical information systems . 2
4.1.1 General. 2
4.1.2 RMS using a public switched telephone network. 3
4.1.3 RMS using the Internet . 4
4.2 Security requirement of RMS of medical devices and medical information systems . 4
4.2.1 General. 4
4.2.2 Security measures in RMS operation . 4
4.2.3 Contracts between HCF and RSC including 3rd parties . 4
4.2.4 Protection of personal information . 4
4.3 Roles of RSC and HCF. 5
5 Risk analysis . 5
Annex A (informative) Use case of RMSs. 6
Annex B (informative) Example of risk analysis result of remote maintenance services .11
Annex C (informative) Example of risk analysis criteria .15
Bibliography .
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