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Risk-Proportionality in Apps

Meaning

Risk-Proportionality in Apps is the essential design and regulatory principle that mandates the rigor of a digital health application’s development, validation, and clinical oversight must be directly commensurate with the potential harm an error in the application could cause to the user. An app providing simple lifestyle tracking requires minimal oversight, whereas an application that algorithmically suggests changes to hormone medication doses demands the highest level of clinical validation and regulatory scrutiny. This principle ensures responsible technological development. It balances innovation with patient safety.