Precision medicine has the potential to impact patients, health-care delivery systems, and research participants in ways that were unimaginable 15 years ago, when the human genome was first sequenced. While precision medicine technologies have advanced research, they have just recently begun to be implemented into clinical treatments. Despite remarkable technological advances, increasing resource allocation, and ongoing expenditures in PM, this industry continues to face significant roadblocks. The extent of regulation required in the development of clinical products for PM to ensure patient safety and foster innovation remains a challenge at the policy level.