Artificial Intelligence in Biotechnology: A Framework for Commercialization

Abstracts Developing and commercializing new biotechnology products that rely on artificial intelligence (AI) require compliance with multiple regulatory structures that govern (1) the use and disclosure of individually identifiable information, (2) the sales and marketing of AI as a medical device, and (3) coverage and reimbursement for items and services that incorporate AI. In this chapter we will review some principles to help provide a framework for the biotech entrepreneur to consider, as products from AI and their resulting regulatory guidance evolves.