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FDA mandates cybersecurity measures for medical devices.

1 min read
Source: CNN
FDA mandates cybersecurity measures for medical devices.
Photo: CNN
TL;DR Summary

The FDA has issued new guidelines requiring all new medical device applicants to submit a plan on how to monitor, identify, and address cybersecurity issues, as well as provide a process that ensures the device is protected. The move comes after concerns that internet-connected medical devices could be hit by hacks and ransomware attacks, with a 2022 FBI report finding that 53% of digital medical devices in hospitals had known critical vulnerabilities. The FDA must also update its medical device cybersecurity guidance at least every two years as part of the new law.

Topics:business#cybersecurity#fda#hacking#healthcare-technology#medical-devices#patient-safety
Share this article
  1. FDA requires medical devices be secured against cyberattacks  CNN
  2. New law sets FDA cybersecurity rules for medical devices  FierceBiotech
  3. Medical device makers must now prove cybersecurity to FDA  STAT
  4. Ready or Not, Here Comes Medical Device Cybersecurity Legislation  Medical Device and Diagnostics Industry

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