A I RECOMMEND FORMULATING AN IMPLEMENTATION STRATEGY after an extensive review of existing and emerging regulations. The FDA’s Digital Health Innovation Plan released in January 2019 is part of the Pre-Cert. Pilot Program that is based on the De Novo pathway for novel technologies. This is applicable to low- to moderate-risk medical devices and is likely to be used for submissions, particularly for medical imaging products and smart devices. AI in Europe is likely to fall under the new Medical Device Regulation. We in biopharma should be followers, first determining where we can use these technologies most effectively. For instance, AI can be used to examine biological data to identify drug targets, or it can be used to analyze the output of smart devices to improve patient data quality in clinical trials.
DAVID PYOTT is the chairman of Bioniz Therapeutics, a biopharma startup in Irvine, CA. He is the former CEO of Allergan.