The FDA are Taking Cybersecurity in Medical Devices Seriously and So Should You

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Software Design for Medical Devices

12 min read ยท Apr 15, 2026

The FDA are Taking Cybersecurity in Medical Devices Seriously and So Should You

The risks to health must be kept in mind in the security of medical devices, equally important threat is the protection of patient medical data. Medical devices are undergoing a technical transformation in terms of software, interconnectivity and interoperability. This increase of function comes with an increase in risk from cybersecurity threats which puts not only the patients with medical devices potentially at risk, but has wider implications for connected digital infrastructure too. The safety, security and privacy of patients must be protected and the providers of software for medical devices must work with regulators and the wider industry to ensure this.

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