Health in Digital World: A Regulatory Overview in United States

Adaptation towards digitalization in pharmaceuticals leads to the utilization and development of Artificial Intelligence (AI). Significantly it is reducing human workload with the help of an algorithm. Already AI is acting as a key in clinical trial, health care, quality management, manufacturing, product development, and management. Top pharmaceutical companies have adopted AI in different applications within the pharma sector. Different AI models like Machine learning, Artificial Neural Network, Deep Learning, robotics, and Natural Language Processing are being used in pharmaceuticals and healthcare systems. The Worldwide AI market is growing remarkably with a compound annual growth rate of 49.6% and is expected to reach $18,119 million by 2025. So, for better regulation, concerning safety, privacy regulatory strategy is heading towards a better framework. Different regulatory authorities like China, Europe, and United States (US) have adopted AI for economic and policy aspects. Emerging countries are using these tools for administrative work. US has begun implementing frameworks for AI adaptation, research, and development. The AI policy strategy started in 2016 with a series of workshops conducted under the Obama administration. Federal Food and Drug Administration (FDA) has also published draft guidance for regulatory oversight of AI and Machine Learning. In 2021 FDA published a draft regulation for software as a medical device. This review article provides a snapshot of AI implementation in pharmaceuticals and health care with the regulatory approach in the US.