21 CFR Part 11
FDA Electronic Records and Electronic Signatures
FDA requirement for electronic records and signatures in clinical trials, R&D, and pharmaceutical manufacturing environments.
Learn moreHITECH
Health Information Technology for Economic and Clinical Health Act
Mandates strict breach notifications, increases penalties for HIPAA non-compliance, and extends requirements to business associates.
"Strengthened Enforcement, Stronger Protections"
Other compliance standards in this category.
FDA Electronic Records and Electronic Signatures
FDA requirement for electronic records and signatures in clinical trials, R&D, and pharmaceutical manufacturing environments.
Learn moreHealth Insurance Portability and Accountability Act
The baseline for Protected Health Information (PHI) privacy and security in healthcare organizations.
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