Artificial intelligence in clinical development and regulatory affairs – Preparing for the future

Artificial Intelligence (AI) is set to transform healthcare product development with enormous potential to benefit patients, but also to other stakeholders including regulators and industry. This progress will present new challenges to the systems in place which regulate these products. Stakeholders must now work together to ensure the current regulatory systems evolve in time to embrace the future benefits of AI. This article reviews several areas where AI is being applied in healthcare product development which test current regulatory frameworks, or are topics that will need further consultation between industry and regulators to determine the optimal way to regulate these products in the future. © 2018, TOPRA. All rights reserved.