FDA’s discouraging role in medical device security

According to a Wall Street Journal report (unfortunately firewalled), hospitals are pointing a very long finger at medical device manufacturers for not updating software and leaving devices open to breaches. Yet the manufacturers readily cite FDA’s most recent guidance as prohibiting software updates and security patches without resubmitting their devices for approval–something a spokesperson for the FDA denies as long as the update is for cybersecurity only. If the draft guidance issued in June is actually finalized, it will go the distance in helping manufacturers and hospitals. Hospitals Say Device Manufacturers Resist Boosting Cybersecurity (iHealthBeat)

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