/PRNewswire/ The "Software as a Medical Device (SaMD) Market - Forecasts from 2023 to 2028" report has been added to ResearchAndMarkets.com s offering. The.
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As regulatory processes and reimbursements are refined, there needs to be a continued focus on how to maximize the benefits for patients and ensure DTx can play a role in improving outcomes. The key to this is integration into the clinical workflow.
In 2022, FDA retreated from a flexible approach to its regulation of digital health in two key areas: (1) its PreCertification Program for software as a medical device (SaMD) and (2) its guidance.