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 health care 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.
Addressing cybersecurity vulnerabilities is a tricky business,
as many stakeholders, including industry, government, and health
care providers, among others, must work together. In many instances
this involves complex retrofitting of existing systems and careful
communication of complex situations. The need to tackle these
challenges simultaneously around the world, while also being
consistent with the concerns and
