Software-as-a-medical device (SaMD) came into its own during the pandemic as digital health applications enabled patients to receive care from home through telemedicine, apps and remote patient monitoring. At the 2021 Medtech Conference, a panel of regulators, advocates and digital health executives discussed how the last 18 months may permanently change the regulation of these devices, the steps manufacturers can take to secure the footholds they gained, and how the U.S. CMS can enable digital health to achieve its promise.