Advise on a symptom tracker app; does this need PAAB review?
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We have developed a symptom tracking app for a rare disease on behalf of a pharmaceutical client. The app is not overtly branded but does state that it is "Developed and funded by..." the pharmaceutical company, and the company is referenced in the Terms and Conditions and Privacy statement. The app is for patients to track their symptoms and help them to explain any changes since their last HCP appointment. All data is stored on the patients device and not shared with any online repository, though the option to be able to share information with their HCP via email will feature in a coming update. This app has already been released for download across 19 countries in the EU and the UK. Does this app need to be PAAB reviewed? And if so, what label or badge would need to be shown on the Canadian versions of the app?
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We have developed a symptom tracking app for a rare disease on behalf of a pharmaceutical client. The app is not overtly branded but does state that it is "Developed and funded by..." the pharmaceutical company, and the company is referenced in the Terms and Conditions and Privacy statement. The app is for patients to track their symptoms and help them to explain any changes since their last HCP appointment. All data is stored on the patients device and not shared with any online repository, though the option to be able to share information with their HCP via email will feature in a coming update. This app has already been released for download across 19 countries in the EU and the UK. Does this app need to be PAAB reviewed? And if so, what label or badge would need to be shown on the Canadian versions of the app?
Happy Friday @iainb
A symptom tracker that relates to a disease and not medication AE’s or medication outcomes, which contains no branding elements, could be considered exempt if there was no mention of treatment. If the tool speaks to treatment (even in an unbranded context) it would be subject to review. PAAB can provide an opinion if the piece is exempt. If you’ll want to proceed to approval if the piece is not considered exempt, please indicate this in the submission letter.
