Here are five thoughts:
1. The FDA is tackling the cybersecurity issue from both the premarket and postmarket management sides.
2. In 2014, the FDA released guidance for companies filing premarket medical device submissions. Companies should provide possible cybersecurity vulnerabilities, as well as the likelihood of threats.
3. The FDA expects companies to offer protocols if cyberattacks thwart the devices.
4. Companies should include “Identify and Protect” measures as well as “Detect, Respond, Recover” measures in their submissions.
5. The FDA is also addressing the cybersecurity’s postmarket management, calling on the industry to follow certain protocols if cyberattacks occur. The following include the FDA’s major concepts:
- Compensate controls
- Cybersecurity routine updates
- Controlled risk
- Cybersecurity signal
- Clinical performance
- Exploit, threat, vulnerability
- Remediation
Click here to read more about the FDA guidelines.
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