Reimbursement Pathways for Digital Health and SaMD Solutions in the US As digital health technologies evolve, understanding the reimbursement landscape becomes increasingly important for stakeholders. This comprehensive guide discusses the reimbursement pathways for Software as a Medical Device (SaMD) and digital health solutions in the United States, helping regulatory, clinical, and quality leaders navigate this complex ecosystem. Understanding the Reimbursement Environment for Digital Health The reimbursement environment for digital health revolves around the approval and acceptance by payers, which supports market access for these innovative solutions. At a high level, key elements influencing reimbursement include the medical necessity of the…