Analytical validity must be determined by the manufacturers and a core set of indicators should be developed coherent with the MMA classification Technical soundness is highly significant for mobile technologies for multifold reasons: (i) limited constraints in terms of manufacturing and distribution, together with the high scalability of MMAs, make full‐scale adoption of apps possible and easier than it has ever been for previous technologies; (ii) most of the app solutions are developed to be managed by patients directly and require additional control mechanisms compared to traditional ones; and (iii) apps operate in complex environments, in which frequent changes and modifications can be implemented, often based on the output generated through the device.
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Recommendations for developing a lifecycle, multidimensional assessment framework for mobile medical apps.
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