Regulatory Compliance
Ensuring AI systems adhere to applicable laws, regulations, and industry standards (e.g., GDPR, FDA, financial oversight) throughout their operation.
Definition
The ongoing process of mapping legal requirements to technical and operational controls—privacy-by-design for GDPR, explainability and clinical validation for FDA, audit trails for financial regulators—and then implementing, monitoring, and documenting those controls. Compliance activities include legal-impact assessments, automated policy enforcers, training programs, and periodic audits to demonstrate adherence to regulatory obligations.
Real-World Example
A medical-device company ensures FDA compliance for its diagnostic-AI by conducting clinical trials, documenting software validation activities, and maintaining a design history file. Post-market, they monitor adverse events and submit regular safety reports to regulators, aligning technical practices with legal mandates.
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