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IEC/DTS 81001-2-2

Health software and health IT systems safety, effectiveness and security — Part 2-2: Guidance for the implementation, disclosure and communication of security needs, risks and controls

General information

50.20     Jun 13, 2025

IEC

ISO/TC 215

Technical Specification

35.240.80     35.030  

Scope

This document presents an informative set of common, high-level security-related capabilities and additional considerations to be used across the entire life cycle of HEALTH SOFTWARE (including MEDICAL DEVICE software) and for the information exchange between the MEDICAL DEVICE MANUFACTURERS (MDMs), health software manufacturers, HEALTH DELIVERY ORGANIZATIONS (HDOs) and/or other stakeholders.

Life cycle

PREVIOUSLY

PUBLISHED
IEC/TR 80001-2-2:2012

PUBLISHED
IEC/TR 80001-2-8:2016

NOW

IN_DEVELOPMENT
IEC/DTS 81001-2-2
50.20 Proof sent to secretariat or FDIS ballot initiated: 8 weeks
Jun 13, 2025

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