Bias Mitigation – Geunim

Navigating US Health Technology Regulation & Compliance

Meta Description: The regulatory landscape for health technology—including AI, SaMD, and connected devices—is rapidly evolving. Learn about FDA oversight (510(k), PMA), key compliance areas (HIPAA, cybersecurity), and the shift toward risk-based frameworks. Understanding the Complex Web of Health Technology Regulation The health technology sector is revolutionizing care delivery, driven by innovations like Artificial Intelligence (AI), […]

510(k), 510(k) Clearance, and the Stark Law, bias, Bias Mitigation, cybersecurity, Data Integrity, developers, Drug, efficacy, ethical, FDA Regulation, health plans, HIPAA Compliance, HITECH, HITECH Act, injunctions, marketed, medical advice, medical expert, PMA), product recall, SaMD, Stark Law, transparency, treatment