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Heart rate variability biofeedback (HRV-BFB) is a promising tool for correcting autonomic dysfunction in PTSD, with subsequent changes in clinically significant outcome measures. This paper outlines a systematic approach for the development, distribution, and implementation of a prescription at-home HRV-BFB digital therapeutic. We provide recommendations for evidence-generation strategies and propose appropriate regulatory pathways within existing frameworks. Widespread access to HRV-BFB could potentially reduce the distress, disability, and healthcare burden associated with PTSD. Promoting HRV-BFB as a primary intervention could also serve to reduce the stigma associated with \u201cmental\u201d illness and increase health literacy regarding the neuroimmune impacts of psychosocial factors. These processes might in turn improve treatment-seeking, adherence, and supported self-management of these conditions.<\/jats:p>","DOI":"10.3389\/fdgth.2025.1503361","type":"journal-article","created":{"date-parts":[[2025,2,11]],"date-time":"2025-02-11T06:59:31Z","timestamp":1739257171000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":1,"title":["Designing and developing a prescription digital therapeutic for at-home heart rate variability biofeedback to support and enhance patient outcomes in post-traumatic stress disorder 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