Harmonizing cybersecurity for medical devices: International collaboration moves forward

Hogan Lovells
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On 1 October 2019 the International Medical Device Regulators Forum (IMDRF) Medical Device Cybersecurity Working Group released a draft document titled "Principles and Practices for Medical Device Cybersecurity" (IMDRF draft). The document reflects the increasing concern evinced by cybersecurity events that have touched medical devices, hospitals, and healthcare networks. Recognizing the need for global convergence to address these threats, the IMDRF draft proposes a broad risk-based framework, with recommendations for harmonized standards and approaches.

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