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Digital Health Regulatory Gap

Meaning

The Digital Health Regulatory Gap refers to the temporal and jurisdictional disparity between the rapid innovation and deployment of consumer-facing digital health and wellness technologies and the slow-moving, often geographically siloed, governmental and clinical regulatory frameworks. This gap creates an environment where apps and wearables collecting sensitive hormonal and physiological data may operate outside the stringent privacy and efficacy standards applied to traditional medical devices and clinical practice. It represents a significant challenge for ensuring patient safety and data security.