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Are apps interventional or non-interventional?

Are apps interventional or non-interventional? Harvard University mobile health app screenshot

Is a health app a therapeutic intervention?

The development of health-related apps (particularly when linked to devices for monitoring health) has transformed collection of real world data for new treatments. Health-related apps are now playing a key role in generating patient reported outcome data and can capture data with minimal disturbance to the patient or their treatment regimen. This approach allows developers of new treatments to have direct-to-patient contact and really understand the impact for patients. Apps can also augment conventional treatments to become part of the therapeutic intervention. However, the value of this approach needs to be evaluated in rigorous clinical trials. To meet regulatory requirements, it is important to prospectively decide if such studies are clinical trials of medicinal products or non-interventional clinical trials. There is a timely review of this topic by Fournie et al at It is important not to over-regulate the clinical evaluation of health-related apps. To date, they are the least intrusive method of capturing outcome data as reported directly by patients. 

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