What role should digital therapies (DTx) play in our treatment landscape? What regulatory and access processes should be in place to ensure that these treatments are safe, effective, and of high value? What evidence is needed to support claims of safety, efficacy, and value?
These questions and more are addressed as part of the AMCP Partnership Forum on DTx. The proceedings of this meeting identified a number of areas in which DTx supervision and guidance could be improved including:
… standardization of product definitions and classification across the DTx industry; Emphasize the value of regulatory approval in setting DTx proof standards; Create evidence frameworks to guide coverage and reimbursement decisions for DTx; consider unique aspects of the DTx product such as data security, privacy, and product updates; Increase awareness and professional expertise in DTx among all healthcare stakeholders; and promoting DTx adoption and fair access.
The Abraham et al (2022) The post also has a nice table, discussing some of the key considerations regulators and payers will face when deciding whether to cover a digital cure.
More discussion available at full article.