Blog by Health-ISAC VP of Medical Device Security, Phil Englert
The ISO 81001-5-1:2021 standard Health software, and health IT systems safety, effectiveness, and security provides guidelines for the cybersecurity of health software and health IT systems, including medical devices. Part 5-1 focuses on security activities in the product life cycle. This standard is critical for ensuring that medical devices are secure by design, protect patient data and maintain the integrity of health care operations.
The Secure Product Development Framework (SPDF) provides manufacturers with a set of processes that, when effectively implemented, can help manufacturers demonstrate a reasonable assurance of safety and effectiveness during the regulatory submission process. Manufacturers should integrate security into each phase of the development process, from design to deployment.
