Fig. 1

This general product-development lifecycle is meant to be broadly applicable to digital health products, including both software and devices. At each step of the product-development lifecycle, developers must make decisions or take actions that – implicitly and explicitly – have ethical or regulatory dimensions. If they are made or taken mindfully, these decisions and actions are opportunities for advancing desirable outcomes. If these decisions and actions are not approached mindfully, developers risk engaging in ethically problematic behavior or running afoul of regulators