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Bio-Regulatory Compliance

Meaning

Bio-Regulatory Compliance refers to the mandatory adherence to established governmental and professional standards concerning the clinical use, handling, and development of biological agents, personalized therapies, and all associated patient data. This encompasses strict observance of regulatory frameworks like the Health Insurance Portability and Accountability Act (HIPAA) in the United States. Maintaining this compliance is a critical operational requirement for ensuring patient safety, ethical practice, and clinical integrity within the health and wellness space.