Adopting AI in Health Care Will Be Slow and Difficult

Artificial intelligence, including machine learning, presents exciting opportunities to transform the health and life sciences spaces. It offers tantalizing prospects for swifter, more accurate clinical decision making and amplified R&D capabilities. However, open issues around regulation and clinical relevance remain, causing both technology developers and potential investors to grapple with how to overcome today's barriers to adoption, compliance, and implementation. Over the past few years, the U.S. Food and Drug Administration (FDA) has been taking incremental steps to update its regulatory framework to keep up with the rapidly advancing digital health market. In 2017, the FDA released its Digital Health Innovation Action Plan to offer clarity about the agency's role in advancing safe and effective digital health technologies, and addressing key provisions of the 21st Century Cures Act.