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The rise in in-home medical device use offers patients more medical flexibility than ever before. But more connections mean more attack vectors, posing a massive threat to patients and the manufacturers and providers the public entrusts with their lives.
vulnerabilities per medical device
of end-of-life medical devices lack security patches or upgrades
In 2023, the FDA announced regulatory changes to address the historical lack of security standards for new and in-market products, requiring manufacturers to submit Software Bills of Materials (SBOMs), along with plans for monitoring, identifying and addressing cybersecurity issues in their devices.
The FDA’s announcement marked a major shift in the healthcare ecosystem. It’s a step in the right direction—but for manufacturers struggling with budgetary constraints and device sprawl, ensuring new and existing medical devices live up to the new standards is a heavy lift.
Navigate the Evolving Regulations in Medical Device Security
So what separates vulnerable and secure medical devices? A trustworthy device:
Technological and regulatory changes will continue to reshape how medical devices operate, communicate and deliver vital patient data. For organizations that recognize the importance of patient safety, regulatory compliance and scalability, developing an effective device security strategy is a must.