This publication provides evidence-based expectations for how DTx products should be validated by payors globally, building on principles from pharmaceutical and general medical device standards, while acknowledging digital therapeutics' unique mechanisms of action, iterative development lifecycles, and clinical outcomes. To enable movement toward a fit-for-purpose DTx evidentiary standard, DTA will continue to engage with the broader healthcare ecosystem to develop harmonized and DTx-specific clinical evidence frameworks.
About DTA
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The Digital Therapeutics Alliance (DTA) is a global non-profit trade association of industry leaders and stakeholders with the mission of broadening the understanding, adoption, and integration of digital therapeutics into healthcare. DTA works to enable expanded access to high quality, evidence-based digital therapeutics for patients, clinicians, and payors in order to improve clinical and health economic outcomes.
About Curebase
At Curebase, our mission is to bring quality medical innovations to patients faster and improve human well-being through more efficient clinical studies. We are proving that clinical research can be radically accelerated if we empower physicians everywhere to enroll patients in the communities where they live. By applying cutting-edge clinical software and remote study management techniques to the problem, we are reinventing clinical trials and research from the ground up.
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