Digital health and other life sciences/tech developers, particularly those producing innovative new solutions, offer dynamic opportunities for investors, in part due to the continued evolution of the US Food and Drug Administration’s (FDA’s) approach to regulatory oversight. Read on for key takeaways that hospital and health system (HHS) innovation executives should consider when investing in companies that are developing FDA-regulated products

• Despite leadership changes at the FDA, the agency’s mission will stay the same: to ensure that the medical devices, drugs and biologic products that get to market are safe and effective. However, that mission is increasingly informed by a heightened focus on regulatory flexibility, particularly in the development of FDA-regulated software and mobile applications. For example, the FDA historically required FDA-regulated software developers to obtain prior clearance or approval for significant updates to previously approved or cleared products. This requirement delayed patient and healthcare personnel access to modified versions of these products, even though the changes could often be made fairly quickly. FDA is now considering several programs that have the potential to meaningfully improve patient and healthcare personnel access to innovative new products, including pre-certification and an evolving approach to oversight of artificial intelligence and machine learning-enabled products.