The rise of big data and digital health in medicine have been concurrent over the last two decades. Often confused, while virtually all digital health solutions, such as sensors wearable devices, and diagnostic algorithms, involve big data, not all big data in health care originates from digital health tools. Genomic sequencing data being one example of this. In this chapter, the role and importance of big data in medicines and medical device discovery and development are detailed with the specific focus of providing a detailed understanding of the product discovery, product development, clinical trials, regulatory authorization, and marketing processes. Concepts such as “dirty data,” regulatory decision-making, remote and virtualized clinical trials, and other key elements of digital health are discussed.