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IEC 81001-5-1:2021 Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle

  • 1.  IEC 81001-5-1:2021 Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle

    Posted 22 days ago
    H All,

    ISO/IEC has recently published IEC 81001-5-1:2021 Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle

    This document defines the LIFE CYCLE requirements for the development and maintenance of HEALTH SOFTWARE needed to support conformance to IEC 62443-4-1 – taking the specific needs for HEALTH SOFTWARE into account. The set of PROCESSES, ACTIVITIES, and TASKS described in this document establishes a common framework for secure HEALTH SOFTWARE LIFE CYCLE PROCESSES.

    The purpose is to increase the CYBERSECURITY of HEALTH SOFTWARE by establishing certain ACTIVITIES and TASKS in the HEALTH SOFTWARE LIFE CYCLE PROCESSES and also by increasing the SECURITY of SOFTWARE LIFE CYCLE PROCESSES themselves.

    It is important to maintain an appropriate balance of the key properties of SAFETY, effectiveness, and SECURITY as discussed in ISO 81001-1.
    This document excludes the specification of ACCOMPANYING DOCUMENTATION contents.

    This Standard can be previewed here: https://www.iso.org/obp/ui/#iso:std:iec:81001:-5-1:dis:ed-1:v1:en

    This Standard can be purchased here: https://www.iso.org/standard/76097.html



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    Michael Roza CPA, CISA, CIA, MBA, Exec MBA
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