Reply To: Creating a Research Kit app

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Great to to have dedicated forum area for ResearchKit-related topics. Some more aspects that often pop up regarding ResearchKit apps (in random order):

– IRB / ethics committees approval for ResearchKit apps
– Other legal issues reg. ResearchKit apps, e.g. insurance, HIPAA compliance
– Sample size calculation for “public” ResearchKit apps (i.e. those not limited to a closed group of subjects)
– Implementing tools (e.g. pain scales) that have only been validated as a paper & pencil version
– Recruiting subjects for a ResearchKit app
– Quality management for development of a ResearchKit app (e.g. IEC 62304)
– Lifecycle management of a ResearchKit app (e.g. updating without violating the study protocol)
– Deployment of ResearchKit apps (or even devices) to a closed group of subjects
– Aligning adaptive study designs with app updates (OK, that’s a niche topic)
– Use of (context-aware?) push notifications in compliance with study protocol
– blurry lines between a “research app” and a “mobile medical app” (as defined by FDA & EU directives) and implications
– Tools, clinicians, consultants, CROs, etc. that proved to be helpful working with for ResearchKit-based studies

I look forward to discussing any of these aspects!