The success of telehealth could be undermined if serious privacy and security risks are not addressed. For example, sensors that are located in a patient's home or that interface with the patient's body to detect safety issues or medical emergencies may inadvertently transmit sensitive information about household activities. Similarly, routine data transmissions from an app or medical device, such as an insulin pump, may be shared with third-party advertisers. Without adequate security and privacy protections for underlying telehealth data and systems, providers and patients will lack trust in the use of telehealth solutions. Although some federal and state guidelines for telehealth security and privacy have been established, many gaps remain. No federal agency currently has authority to enact privacy and security requirements to cover the telehealth ecosystem. This article examines privacy risks and security threats to telehealth applications and summarizes the extent to which technical controls and federal law adequately address these risks. We argue for a comprehensive federal regulatory framework for telehealth, developed and enforced by a single federal entity, the Federal Trade Commission, to bolster trust and fully realize the benefits of telehealth.T elehealth involves the use of telecommunication technologies to prevent and treat illness and promote the health of individuals and populations. Although telehealth has particular benefits for rural and underserved populations, it is increasingly recognized for its potential to control costs while providing real-time tools to promote wellness, prevent disease, and enable the home management of chronic conditions.Telehealth frequently involves bidirectional, digital collection and communication of sensitive health information among health care providers and patients. For a medical device to qualify as a telehealth device, there must be communication of health information from the device over a network. For example, a glucose monitor becomes a telehealth device when it sends readings to a provider or a provider's information system over an information network. Similarly, some generic communications technologies-such as videoconferencing-are frequently used to communicate health care information and thus become telehealth tools in those settings. Telehealth devices include mobile software applications (apps) in addition to hardware. This article focuses on network-enabled telehealth devices where a device collects information from the patient (for example, measuring a function of the body or scanning the environment for safety risks) and then transmits data to a health care provider.To realize telehealth's full potential, however, patients and providers must trust telehealth systems to keep personal information private and secure. We identify privacy and security risks of telehealth systems, summarize the extent to