HIPAA: Health Insurance Portability and Accountability Act - Federal regulation governing privacy and security of medical information and patient data protection requirements
21 CFR Part 50: FDA regulations concerning Protection of Human Subjects, defining requirements for informed consent and safeguards for clinical trial participants
21 CFR Part 56: FDA regulations governing Institutional Review Boards (IRBs), their composition, functions, operations, and responsibilities
21 CFR Part 312: FDA regulations concerning Investigational New Drug Applications, outlining requirements for clinical investigations of drugs and biologics
21 CFR Part 812: FDA regulations regarding Investigational Device Exemptions, governing clinical investigations of medical devices
Good Clinical Practice (GCP): International ethical and scientific quality standards for designing, conducting, recording, and reporting trials involving human subjects
CLIA: Clinical Laboratory Improvement Amendments - Federal standards for laboratory testing and quality assurance requirements
Common Rule: Federal Policy for the Protection of Human Subjects (45 CFR 46) establishing basic provisions for IRBs, informed consent, and Assurances of Compliance
State Privacy Laws: Various state-specific regulations governing patient privacy and data protection, which may exceed federal requirements
Stark Law: Federal law prohibiting physician self-referral for certain designated health services payable by Medicare
Anti-kickback Statute: Federal law prohibiting the exchange (or offer to exchange) of anything of value in an effort to induce referrals of federal healthcare program business
False Claims Act: Federal law imposing liability on persons and companies who defraud governmental programs, including clinical research billing compliance
ICH Guidelines: International Conference on Harmonisation guidelines providing unified standards for clinical trials across multiple regions
Professional Liability Requirements: Insurance and indemnification requirements for clinical research activities and medical professional liability
Intellectual Property Laws: Federal and state laws governing patents, copyrights, and trade secrets in the context of clinical research and development
