For the purposes of the Framework, DHTs are systems that use computing platforms, connectivity, software, and/or sensors for health care and related uses. They include technologies intended for use as a medical product, in a medical product, or as an adjunct to other medical products (devices, drugs, and biologics). DHTs may also be used to develop or study medical products. There is a large spectrum of DHTs available for potential use to support drug development and review, some of which meet the definition of a device under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and others that do not.
DHTs may take the form of hardware and/or software. DHTs often consist of sensor hardware that allows for continuous or intermittent recording of physiological and/or behavioral data (e.g., blood pressure, physical activity, glucose levels).
DHTs can also be software applications that are run on general-purpose computing platforms (e.g., mobile phone, tablet, or smart watch). These DHTs may be used to administer electronic clinical outcome assessments, including electronic patientreported outcome and electronic performance outcome instruments. Some DHTs consist of hardware and software (e.g., a continuous glucose monitoring device that includes a sensor and a mobile application), both of which are necessary to achieve the DHT’s intended function or functions.
Framework for the Use of Digital Health Technologies in Drug and Biological Product Development