The regulatory framework has not kept pace with the speed of evolution of technological advancements viz Artificial Intelligence (AI) that some of the Apps incorporate. Another concern is in the categorization of features that shall need compliance, under which regulation, and to what extent. With Apps incorporating new and advanced attributes, and a lack of clarity on regulatory requirements, it is often confusing for builders to specify the design and development standards. App builders need to be continuously watchful of the dynamic regulatory framework and integrate new technologies in design and development with careful thought of its implications. Another challenge for developers is the absence of common standards and regulatory requirements globally.
This whitepaper shall attempt to identify different regulatory and compliance-related requirements to be wary of while developing Healthcare applications.
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