IEC/TS 81001-2-2 Ed. 1.0 en:2025

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

standard by International Electrotechnical Commission - Technical Standard , 09/01/2025

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IEC TS 81001-2-2:2025 This document presents an informative set of common, high-level security-related capabilities and additional considerations to be used across the life cycle of health software and health IT systems, for the information exchange between the health software manufacturers (including medical device manufacturers), healthcare delivery organizations (HDOs) and other
stakeholders. It is applicable to health software running on any platform and in any environment
such as cloud, on premise or hybrid.

While important security topics, the following are outside the scope of this document:
a) the security policies of the HDO,
b) the product and services security policies of the manufacturer,
c) determinations of risk tolerance by the HDO or manufacturer, and
d) clinical studies where there is a need to secure personal data.
As security risks can be caused by any product on health IT systems and health IT Infrastructure,
considerations in this document can be applied for other products that are not health software.

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Document History

  1. IEC/TS 81001-2-2 Ed. 1.0 en:2025

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

    • Most Recent

  2. IEC/TR 80001-2-8 Ed. 1.0 en:2016


    Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2

    • Historical Version

  3. IEC/TR 80001-2-4 Ed. 1.0 en:2012


    Application of risk management for IT-networks incorporating medical devices - Part 2-4: Application guidance - General implementation guidance for healthcare delivery organizations

    • Historical Version

  4. IEC/TR 80001-2-2 Ed. 1.0 en:2012


    Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls

    • Historical Version

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Product Details

Edition:

1.0

Published:

09/01/2025

ISBN(s):

9782832707395

Number of Pages:

108

File Size:

1 file , 1 Byte

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This product is restricted and cannot be purchased in the following countries Canada