Regulatory Frameworks for Emerging Medical Technologies

Mukisa Ian Mugaiga

Department of Pharmacology Kampala International University Uganda

Email:mugaiga.mukisa@studwc.kiu.ac.ug

ABSTRACT

The rapid evolution of emerging medical technologies, particularly those driven by artificial intelligence (AI), the Internet of Things (IoT), and big data, presents unprecedented opportunities and challenges for global healthcare systems. From wearable devices to surgical robots and voice conversational interfaces, these innovations are reshaping diagnosis, treatment, and patient engagement. However, the adaptive nature of these technologies, especially machine learning systems that evolve post-deployment, poses unique risks that traditional regulatory frameworks are ill-equipped to manage. This paper explores the need for dynamic, responsive, and ethical regulatory frameworks that ensure the safety, efficacy, and accountability of such medical devices without stifling innovation. Drawing on global case studies, evolving risk management approaches, post-market surveillance strategies, and ethical considerations, it underscores the importance of international collaboration and adaptive policymaking. Ultimately, effective regulation must balance technological advancement with patient safety and public trust in a rapidly digitizing medical landscape.

Keywords: Emerging Medical Technologies, Artificial Intelligence, Medical Devices Regulation, Post-Market Surveillance, Risk Management, Ethics in Healthcare, IoT in Medicine.

CITE AS: Mukisa Ian Mugaiga (2025). Regulatory Frameworks for Emerging Medical Technologies. NEWPORT INTERNATIONAL   JOURNAL OF SCIENTIFIC AND   EXPERIMENTAL SCIENCES 6(3):197-202 https://doi.org/10.59298/NIJSES/2025/63.197202