HIPAA: Health Insurance Portability and Accountability Act - Primary federal law governing healthcare data privacy and security in the US, including requirements for protected health information (PHI)
Common Rule: Federal policy for the protection of human subjects in research (45 CFR part 46), establishing basic provisions for IRB oversight, informed consent, and compliance monitoring
FDA Regulations: FDA requirements (21 CFR parts 50, 54, 56, and 312) governing clinical trials, including informed consent, IRB review, and investigator obligations
HITECH Act: Health Information Technology for Economic and Clinical Health Act - Extends HIPAA requirements and strengthens enforcement of privacy and security rules
State Privacy Laws: Various state-specific medical privacy and data protection laws that may impose additional requirements beyond federal regulations
State Breach Laws: State-specific requirements for notification and handling of data breaches involving personal health information
GDPR Compliance: European Union's General Data Protection Regulation considerations if the clinical trial involves EU data subjects or cross-border data transfers
ICH GCP: International Council for Harmonisation - Good Clinical Practice guidelines establishing ethical and scientific quality standards for clinical trials
CDISC Standards: Clinical Data Interchange Standards Consortium standards for data format and structure in clinical research
HL7 Standards: Health Level Seven standards for transfer of clinical and administrative data between healthcare systems
Informed Consent Requirements: Specific requirements for obtaining and documenting participant consent, including data use and sharing provisions
Data Security Requirements: Technical and organizational measures required to ensure data protection, including encryption, access controls, and audit trails
