5. THE FIX
compliance with
21 CFR Part 11 (21 CFR 11 requires that closed computer systems must have a
collection of technological and procedural controls to protect data within the
system)
FISMA (The Federal Information Security Management Act (FISMA) is United States
legislation that defines a comprehensive framework to protect government
information, operations and assets againHIPAA (The Health Insurance Portability
and Accountability Act of 1996 (HIPAA) is a federal law that required the creation
of national standards to protect sensitive patient health information from being
disclosed without the patient's consent or knowledge)
st natural or man-made threats.)
GDPR (The General Data Protection Regulation is a regulation in EU law on data
protection and privacy in the European Union and the European Economic Area. It
also addresses the transfer of personal data outside the EU and EEA areas)