From an idea to the marketplace: identifying and addressing ethical and regulatory considerations across the digital health product-development lifecycle

Abstract

Widespread adoption of digital health tools has the potential to improve health and health care for individuals and their communities, but realizing this potential requires anticipating and addressing numerous ethical and regulatory challenges. Here, we help digital health tool developers identify ethical and regulatory considerations – and opportunities to advance desirable outcomes – by organizing them within a general product-development lifecycle that spans generation of ideas to commercialization of a product.