HIPAA: Health Insurance Portability and Accountability Act - Includes Privacy Rule, Security Rule, and Breach Notification Rule for protecting patient health information
HITECH Act: Health Information Technology for Economic and Clinical Health Act - Expands HIPAA requirements and strengthens enforcement of privacy and security protections
Common Rule: Federal Policy for the Protection of Human Subjects (45 CFR Part 46) - Establishes basic provisions for IRBs, informed consent, and human subject protections
FDA Regulations: Includes 21 CFR Parts 50, 56, and 312 covering protection of human subjects, IRB requirements, and investigational new drug applications
Stark Law: Physician Self-Referral Law - Prohibits physicians from referring patients to entities with which they have financial relationships
Anti-Kickback Statute: Prohibits offering, paying, soliciting, or receiving anything of value to induce or reward referrals of federal healthcare program business
CLIA: Clinical Laboratory Improvement Amendments - Regulates laboratory testing and requires clinical laboratories to be certified
State Privacy Laws: State-specific privacy regulations that may impose stricter requirements than federal laws
State Medical Practice Acts: State-specific laws governing the practice of medicine and healthcare delivery
State Licensing Requirements: State-specific requirements for healthcare provider licensing and credentialing
Medicare/Medicaid Compliance: Federal healthcare program requirements affecting clinical services and billing practices
Joint Commission Standards: Accreditation standards for healthcare organizations affecting clinical care and facility operations
