The FDA released their updated guidance on Cybersecurity in medical devices: Quality System Considerations and content for Premarket submissions at the end of June in 2025. In this guidance the FDA ...
Anyone who has wrestled with the HIPAA Security Rule’s risk‐analysis requirement knows that the government’s free Security Risk Assessment (“SRA”) Tool can be a practical starting point—particularly ...
Effective protection comes from combining both approaches: aligning IT and business processes and conducting regular system ...
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