MedCity News May 10, 2023
Regulators have become increasingly concerned about the potential for medical devices to become a vector for spreading malware attacks across hospital networks, resulting in untold patient harm and billions of dollars globally.
The recent FDA guidance on security marks good and bad news for the industry. In short, the FDA can now refuse submissions from medical device manufacturers if they can’t demonstrate that they have comprehensive cybersecurity processes and detailed information on the composition of their software in place. This is good news for the public and healthcare industry in general.
While the FDA has published a number of plans to address medical device problems post-market, its plans and processes for addressing cybersecurity issues have been woefully inadequate. Regulators have...
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