Table A1.

Definitions of Terms Attached to the Canvas.

Term	Definition
Adverse event	An adverse event is an unexpected and undesirable occurrence or outcome that happens during or after a medical treatment, intervention, or the use of a DTX. Adverse events can range from mild side effects to severe complications and may include reactions to medications, medical procedures, medical device malfunctions, or incidents related to healthcare delivery. The identification, reporting, and analysis of adverse events are crucial in healthcare to monitor and improve the safety and effectiveness of treatments and interventions.
Clinical evidence	Clinical evidence refers to the information and data obtained from clinical research studies and trials that provide insights into the effectiveness, safety, and potential benefits or risks of medical treatments, interventions, therapies, or procedures. This evidence is gathered through systematic scientific research involving human participants under controlled conditions and is a fundamental component of evidence-based medicine.
Clinical model	Therapeutic approach underlying a non-digital health intervention.
Contraindication	A contraindication or counter-indication is a circumstance that prohibits the use of a diagnostic or therapeutic procedure in the case of a given indication or only permits it after strict consideration of the risks involved.
Digital Therapeutic (DTX)	DTX provide patients with evidence-based therapeutic interventions. They are delivered through high-quality software programs.
Gamification	Gamification is the practice of incorporating game-like elements, such as points, challenges, and rewards, into DTX to engage and motivate individuals, encouraging desired behaviors and achieving specific goals. It aims to make tasks or interactions with a DTX more enjoyable and interactive, often enhancing engagement and adherence.
Harm	Harm refers to any adverse effect or negative outcome experienced by individuals as a result of using DTX. This can include physical harm, such as health complications arising from the use of a medical app, as well as privacy breaches, emotional distress, or misinformation that may result from the interaction with DTX.
Impact	Impact in the context of DTX refers to the measurable and often intended outcomes or effects resulting from the implementation and use of DTX. These impacts can be categorized as follows: Expected Impact: These are the anticipated and planned positive outcomes that DTX aim to achieve. Expected impacts may include improved patient outcomes, enhanced access to healthcare services, increased efficiency in healthcare delivery, cost savings, and better management of health conditions. These effects are typically part of the intervention’s intended goals and objectives. Undesired impact: These are unanticipated consequences, whether positive or negative, that arise from the use of DTX. Undesired impacts can include unanticipated benefits or risks that were not initially foreseen during the development and implementation of the intervention. These effects may emerge as users engage with the technology, and they may require adjustments or further evaluation to address.
Problematic use	Problematic use of a DTX refers to when an individual excessively relies on or becomes overly preoccupied with a DTX or applies it for other purposes then foreseen, leading to negative impacts on their well-being or health outcomes. This can include spending too much time using the tool, prioritizing it over professional advice, experiencing negative emotions related to its use, and even neglecting other aspects of their life, potentially harming their health.
Privacy	Privacy refers to the protection of individuals’ personal health information and data collected, processed, or shared through DTX. It involves ensuring that sensitive health-related data are kept confidential and secure.
Risk	Risk refers to the potential for adverse outcomes or harm associated with the use or deployment of DTX. These risks can include issues related to data security and privacy, inaccurate health information, user dependence, and negative health consequences resulting from the intervention.