レガシーデバイスのサイバーセキュリティガイダンス

【IMDRF】レガシーデバイスのサイバーセキュリティに係るドラフトガイダンス

IMDRFは、2022年5月4日にレガシーデバイスのサイバーセキュリティに係るドラフトガイダンス「Principles and Practices for the Cybersecurity of Legacy Medical Devices」を発出した。

本ガイダンスは、2020年発出のサイバーセキュリティガイダンスではレガシーデバイスへの対応が不十分という意見を受けて策定されたものだ。

本ガイダンスには開発からサポートの終了に至るまで、レガシーデバイスのTPLCのさまざまな段階がリストアップされている。
そして、その全ての段階において製造業者とヘルスケアプロバイダーがお互いの責任を確実に理解するためにコミュニケーションをとる方法について概説している。

本ドラフトガイダンスは2022年7月3日まで利害関係者からのフィードバックを受け付けている。
その後、早くて来春にファイナルドラフトガイダンスが発出される予定となっている。

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