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The FDA recently released guidance documents on the use of clinical decision support (CDS) and medical software that may be of concern to forward-thinking healthcare innovators who rely on these technologies to deliver exceptional care and improve outcomes. What will be the impact of this guidance on machine learning and predictive analytics efforts? How will the guidance affect timelines, costs, and effectiveness of ongoing machine learning implementation? As healthcare delivery increasingly relies on digital innovation and support, more questions emerge about the governance of the accompanying tools and technology. This article provides a summary of the FDA guidance on CDS, how CDS is defined, whether or not CDS is exempt from regulation, and how the FDA intends to enforce compliance. It also summarizes the FDA guidance on medical software, what software is exempt from regulation, and helps to answer some of the questions surrounding the digital health space.