At the Consumer Electronics Show in Las Vegas, the FDA announced the release of two new guidelines aimed at reducing the regulatory burden for digital health products, including wearable devices and artificial intelligence systems used in the clinic. The goal is to simplify the entry of such technologies into clinical practice while maintaining safety and efficacy requirements. The guidelines refer to a category of digital health technologies that includes software, mobile applications and wearable devices used to monitor or support healthcare. With this step, the FDA adjusts which types of digital products will be subject to more lenient regulatory requirements, for example in the area of pre-market submissions. At the same time, the agency is indicating that it will focus more on post-market oversight than strict upfront regulation for certain low-risk digital health tools. FDA Commissioner Marty Makary, MD, MPH, touted the changes as the agency's effort to "get out of the way" of innovation in wearables and artificial intelligence in healthcare. The article does not provide specific statistics or clinical trial results, but describes the FDA's regulatory actions.