Keeping Pace with Real-World Evidence: Evolving Software Regulations and the Growing Application of AI

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This paper says digital health is evolving beyond wellness into condition management across industries. Stakeholders increasingly rely on real‑world evidence (RWE) to support software-as-a-medical-device approvals and reimbursement. The FDA’s RWE framework applies evidence across the product lifecycle and sets rigorous data and scientific standards. The authors argue that integrating data from connected devices and AI can generate RWE for SaMD and accelerate adoption.

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Keeping Pace with Real-World Evidence: Evolving Software Regulations and the Growing Application of AI

Keeping Pace with Real-World Evidence: Evolving Software Regulations and the Growing Application of AI

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