Hey everyone,
I’ve been working on learning Swift and SwiftUI in my free time for the last 6 months or so and have finally reached the point where I feel confident enough to build an app that’ll end up in the App Store.
Symptomatic is an iPhone app that helps people track health triggers like food, weather, moon phases, stress, medications and symptoms like anxiety, congestion and headaches (among other things). It has a custom correlation engine that uses statistical analysis to find patterns in the data that you provide as well as using (at least trying to use) Apple Intelligence (on iPhone 15 Pro and higher) to give some extra insights. There’s also a matching watchOS app for quickly starting and stopping symptom recordings.
I’d like to invite y’all to a public beta test of the app if you’re interested.
The onboarding screens are not done yet, but almost everything works. Certainly entering Food, Conditions, Weather and Symptoms as well as the analysis function. Insight is still a little wonky while I figure out the right AI prompt to avoid Apple’s restrictions (they don’t want people thinking that the AI told them to stop eating).
Privacy: Your data stays in your iCloud account and is never transmitted anywhere else. If you provide Location access, you get a few extra things.
If you’re interested, please send me a private message and I’ll get you hooked up through TestFlight.
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Be aware that it could be a medical app if it delivers data for Doctor’s decisions or if it works out any kind of diagnosis. In this case you need in europe a notified body and in US you need to do a market approval with the FDA. In both cases really complex. Read the rules before making the app available in public so you have really absolute control that it is not a medical app. only as a helping advise.
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While I am forgetting often things I forgot here also to present the right Guidance for FDA it is
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software
Similar rules are existing for canada, the asian pacific market, china, europe, south of america). This shows how complex this is. Is an app giving health informations for diagnosis to medical professional it is definitely a medical app. And then the nightmare begins: classification, documentation and so on. As I am developing medical software and medical device software for many of theese markets I have experiences with the authorities. Good luck and take care.
Thanks Torsten, this is very helpful.
It is a regulatory… Let me say it so: there are dragons in the mist. And they produce eggs which are producing another dragons in the mist. The rules are difficult to understand and the traps fast to step in. Especially in the American market hence they defined - like Europe done after - that Software CAN be a medical DEVICE. So it is in a risk class. As long as it is in Class one in europe: no problem. So delivering data the customer was writing down to collect symptoms and to collect medication situation can be in europe class I and it wuld be easy to bring out rhis. In America it can be Class II and it could need a 510k market approval declaration.
That starts to sound simple. it isn’t. For the market approval you HAVE to implement the IEC/ISO/ANSI 13845. While we are speaking about Software it falls under the 62304. Cause it has several risks it falls under the IEC/ISO/ANSI 14971. Not fulfilling that rules: lost. Problem: it has to be fulfilled at the beginning. To bring up this paperwork at the end of the development: impossible. At least nearly impossible. That’s why I am warning in this cases cause it is something you can decide to do, no question. But for this you would need much money to implement. So I was sending you this informations and you can ask me if you need for for American or Canadian market or even the european one.
Have a nice time and fun