Federal Mandates on Medical-Device Cybersecurity Get Serious
In October, the US Food and Drug Administration will start rejecting medical devices that lack a secure design or a post-market cybersecurity plan.
Stay updated with the latest healthcare cybersecurity trends, news, and tips to protect patient data and comply with medical industry security standards.
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Background for this topic.
Healthcare is the delivery of clinical care and related services through hospitals, clinics, laboratories, pharmacies, insurers, and connected medical devices. It depends on electronic health records (EHRs), patient identity systems, diagnostic and imaging platforms, medication and scheduling systems, and data exchanges between organizations. These environments hold sensitive health and payment information, while the availability and integrity of systems can affect treatment, diagnostics, and patient safety.
Security concerns include unauthorized access or disclosure of records, alteration of clinical data, and disruption of care through attacks on EHRs, connected devices, or third-party services. Defenses require risk-based access controls, strong authentication, network separation where appropriate, secure device and software maintenance, backups that support clinical continuity, and tested downtime and incident-response procedures. Vulnerability management must account for legacy systems and devices that cannot be patched quickly. Privacy and compliance obligations, such as HIPAA in the United States, shape how organizations collect, use, share, retain, and report health information.
In October, the US Food and Drug Administration will start rejecting medical devices that lack a secure design or a post-market cybersecurity plan.
The operators of the Rhysida ransomware-as-a-service have claimed credit for a crippling attack on Mississippi's Singing River health system.
Vital medical equipment was unaffected, but attackers stole and leaked lots of personal data.