HIPAA: Health Insurance Portability and Accountability Act - Federal law that protects sensitive patient health information from being disclosed without patient consent
FDCA: Federal Food, Drug, and Cosmetic Act - Provides FDA authority over clinical trials and drug development processes
Public Health Service Act: Federal law governing public health and research activities, including requirements for protection of human subjects
CLIA: Clinical Laboratory Improvement Amendments - Federal standards for laboratory testing and quality assurance
Common Rule: 45 CFR Part 46 - Federal policy for protection of human subjects in research
FDA Regulations: 21 CFR Parts 50, 56, and 312 - Regulations governing informed consent, IRB oversight, and investigational new drugs
Patent Act: Federal law protecting novel inventions and discoveries that may arise during clinical research
Trade Secrets Act: Federal law protecting confidential business information and trade secrets
DTSA: Defend Trade Secrets Act - Federal law providing uniform protection for trade secrets across states
State Privacy Laws: State-specific regulations governing privacy and data protection, which may exceed federal requirements
State Medical Record Laws: State-specific requirements for maintaining and protecting medical records
ICH Guidelines: International Council for Harmonisation Guidelines providing standards for clinical research
GCP Standards: Good Clinical Practice standards ensuring ethical and scientific quality in clinical trials
IRB Requirements: Institutional Review Board protocols and requirements for protecting human subjects in research
Data Breach Laws: State and federal requirements for notification and response to data breaches involving confidential information
