What is the Origin of Informed Consent Digital Health?

This term adapts the long-standing ethical and legal doctrine of "Informed Consent" from traditional clinical practice to the complex environment of "Digital Health." Its emergence is necessitated by the proliferation of non-traditional data sources, such as wearables and mobile apps, which often operate outside established medical privacy laws. The concept addresses the unique data risks inherent in digitally collected, highly granular health metrics.

What is the Mechanism of Informed Consent Digital Health?

The mechanism involves providing the patient with clear, easily understandable documentation that details which specific data points—like heart rate variability or sleep stage data—will be collected, how they will be stored, and who will have access. Crucially, the consent process must explain the potential for data re-identification and the implications of sharing information with third-party vendors. This transparent mechanism empowers the patient to make a truly autonomous decision regarding their digital physiological footprint.

Informed Consent Digital Health ∞ Area

Informed Consent Digital Health

Meaning

Informed Consent Digital Health is the process by which a patient grants explicit, voluntary permission for the collection, processing, and utilization of their physiological data generated through digital devices and platforms, following a comprehensive disclosure of all associated risks and benefits. This consent must be specific, revokable, and clearly delineate the secondary uses of the data, extending beyond the immediate clinical context. It is the ethical foundation of modern personalized wellness.

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