REGULATORY LANDSCAPE FOR AI IN HEALTHCARE - A COMPREHENSIVE REVIEW
Hemanth Adari*
ABSTRACT
The regulatory landscape for Artificial Intelligence (AI) in healthcare is rapidly evolving, presenting a complex tapestry of challenges and opportunities. This comprehensive review examines the current regulatory frameworks governing the use of AI in healthcare, shedding light on key considerations and emerging trends. The analysis encompasses the regulatory approaches of prominent bodies such as the FDA in the United States and the European Medicines Agency (EMA), while also exploring regulatory landscapes in other critical regions. The review delves into challenges related to standardization, technological advancements, and ethical concerns, providing insights into the opportunities for regulators to adapt and innovate. By offering a thorough exploration of the regulatory dynamics, this review aims to contribute to the understanding and advancement of responsible AI deployment in the healthcare domain.
Keywords: Artificial Intelligence, Healthcare, Regulation, FDA, EMA, Standardization, Technological Advancements, Ethical Concerns, Innovation, Regulatory Frameworks.
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