Daniel Fürstenau; Martin Gersch; Stefanie Schreiter · 2023 · Business & Information Systems Engineering
Paper
1 Including those whose primary purpose is directed towards patients and that entail both patients and therapists. 2 European countries are currently working out own regulatory frameworks, the European Medicines Agency has not yet designed a regulatory pathway for evaluation and reimbursement of DTx. 3 Denmark and other Nordic countries are taking a coordinated approach by stepwise integrating other main aspects of health care digitalization like electronic health records and platforms implementing mobile apps along the process (Nordic Innovation 2018).
Analysis
This paper discusses the current landscape and regulatory considerations for Digital Therapeutics (DTx), highlighting the need for evidence-based software interventions in healthcare.
Discovery
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