5 ms·

It's an excellent point and why we're very careful with the claims we make. The claim I think you are referring to is "86% of users report feeling better after

It's an excellent point and why we're very careful with the claims we make. The claim I think you are referring to is "86% of users report feeling better after their first session with Iona Mind" , which is based upon feedback the users give within the app, but does not relate to any specific measurements relating to any conditions within the DSM-5 which is the standard manual which defines mental health disorders within the United States. We are indeed not a medical device, and we do make it clear to users during sign up that Iona Mind is a self help tool. If we were making that claim that we treat specific diseases such as Major Depressive Disorder (MDD) or Generalised Anxiety Disorder (GAD) then you are correct in assuming that would require FDA approval as a medical device, although for the duration of the covid-19 pandemic the FDA published the following guidance on low-risk self help and general wellness apps: https://www.fda.gov/media/136939/download https://www.fda.gov/media/136939/download which states: "... Given these public health benefits, for the duration of the COVID-19 public health emergency, FDA does not intend to object to the distribution and use of computerized behavioral therapy devices and other digital health therapeutic devices for psychiatric disorders, which are described in Section III.A, without compliance with the following regulatory requirements, as applicable, where such devices do not create an undue risk in light of the public health emergency:..."

debarshri 5y ago
You answer makes me believe you really know what you are talking about and you have de-risk lot of stuff from investor point of view. But with that answer, as a customer now I have trust issues with the app as I am not sure if what you are claim is actually true and feels like you have hacked around a regulation that is meant to keep unfair and false app and service in check. It gives me snake-oily vibes.
- exdsq 5y ago
  It's a CBT app - if it helps people feel better that's good enough for most. Perhaps a message at the beginning saying "Remember this isn't a replacement for licenced therapy so if you're feeling particularly bad contact your GP or <suicide hotline>" could be useful. But for those who haven't got access to anything, something is better than nothing, and there is evidence even journals tracking your feelings help (which this appears to be, albeit in a more advanced form).
  - phowson83 5y ago
    Indeed, the general availability of something like an app means we can reach people who otherwise wouldn't have been reached and may not have learned about this kind of self-help skill, and there is a good evidence base that journalling and tracking feelings can really help people. Great feedback on the message at the beginning, actually the next version will have an upgraded "crisis line" / SOS section in the app for people who need it. While we are clear that Iona is not a crisis service at the beginning screens, it also makes sense to have appropriate signposting throughout the app in case people ignore or don't read the warnings.
- wutbrodo 5y ago
  A much more articulate and informed take than I'm capable of was recently written by a practicing psychiatrist, about the medicalization of CBT apps and how absurd it is. https://astralcodexten.substack.com/p/welcome-to-the-terrible-world-of https://astralcodexten.substack.com/p/welcome-to-the-terribl... > feels like you have hacked around a regulation that is meant to keep unfair and false app and service in check. Blind faith in every excess of the FDA's obstructionism and other bureaucratic pathologies was always insane to me, but it really, really shouldn't have survived for anyone paying even casual attention to the global pandemic we're in the midst of. Agencies like the FDA are taking on the herculean task of standardizing the messy landscape of scientific knowledge into bite-size, oversimplified answers that the dumbest layman can make use of. This is hard enough to begin with, and gets even worse when you remember that they're as subject as any institution to politics, inertia, bad organizational culture, etc etc etc. I get that most people have a powerful, almost-foundational urge to avoid critical thinking, but it's a fantasy to think that you can outsource 100% of your cognitive function to bureaucracies that can provide maximally-simplified, crystal-clear access to The Truth. When it comes to your health or that of those you care about, it's downright negligent to do so. To be clear: I think the FDA does a massive amount of necessary, fundamental work that the medical system depends on, and I'm not suggesting people go hog-wild trying every random substance without regards to efficacy and safety guidelines. But the approach you take in your comment is a dramatic and farcical example of bureaucracy-as-religion. Consider what we're talking about: you're concerned about non-medically-approved use of a chatbot that (reductively) helps you think about things more positively. Is there a principled reason that you're (presumably) okay with people watching yoga videos at home without a prescription? Or picking up a book on meditation? Or reading Couch-to-5K and starting jogging? Is there any difference between these activities and a CBT chatbot, beyond the fact that the latter has been medicalized by our regulatory bureaucracy?
  - ramraj07 5y ago
    I can see you have (probably justifiable) beef with FDA regulations, and the politics they play. But the posters worry is real. CBT is offered as a therapy to many mental disorders. It can indeed be done by yourself, so in theory it makes sense that you don’t need to regulate it, but it sits right at the border of that demarcation if you ask me. Questions about whether it should be regulated is valid, and the answer offered is also somewhat valid though perhaps not opportune.
- phowson83 5y ago
  That's good feedback and there is a lot of snake-oil in the industry in general, which is why we base our app around evidence-backed practices such as CBT ( as mentioned in the post, there's much evidence that CBT-based apps are beneficial e.g. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5727354/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5727354/ ). I think you're getting at an open question for regulators, which is the ongoing regulation of "wellness" apps, a category which this app currently falls into. The EU actually published a green paper about the Digital health space several years ago, in which they touch on the "wellness apps" space, with an possible eye to potential stricter regulation in future, although they are yet to enact anything in this space. https://digital-strategy.ec.europa.eu/en/library/green-paper-mobile-health-mhealth https://digital-strategy.ec.europa.eu/en/library/green-paper... The ultimate long term aim for the company is to actually work towards regulation as a medical device as this also unlocks more ways in which the app can be distributed (e.g. through healthcare systems).
- chalst 5y ago
  I haven't fact-checked the article yet, but the fact that this is an area with low-hanging fruit and the apparent expertise of the team leads me to think we should have some confidence here. Cf. from the OP: > Our clinical director, Professor Paul Farrand, was the architect of using Low-Intensity Cognitive Behavioural therapy at scale in the UK’s National Health Service (NHS), and the author of one of the first international textbooks on the subject.

debarshri 5y ago

You answer makes me believe you really know what you are talking about and you have de-risk lot of stuff from investor point of view. But with that answer, as a customer now I have trust issues with the app as I am not sure if what you are claim is actually true and feels like you have hacked around a regulation that is meant to keep unfair and false app and service in check. It gives me snake-oily vibes.

exdsq 5y ago
It's a CBT app - if it helps people feel better that's good enough for most. Perhaps a message at the beginning saying "Remember this isn't a replacement for licenced therapy so if you're feeling particularly bad contact your GP or <suicide hotline>" could be useful. But for those who haven't got access to anything, something is better than nothing, and there is evidence even journals tracking your feelings help (which this appears to be, albeit in a more advanced form).
- phowson83 5y ago
  Indeed, the general availability of something like an app means we can reach people who otherwise wouldn't have been reached and may not have learned about this kind of self-help skill, and there is a good evidence base that journalling and tracking feelings can really help people. Great feedback on the message at the beginning, actually the next version will have an upgraded "crisis line" / SOS section in the app for people who need it. While we are clear that Iona is not a crisis service at the beginning screens, it also makes sense to have appropriate signposting throughout the app in case people ignore or don't read the warnings.
wutbrodo 5y ago
A much more articulate and informed take than I'm capable of was recently written by a practicing psychiatrist, about the medicalization of CBT apps and how absurd it is. https://astralcodexten.substack.com/p/welcome-to-the-terrible-world-of https://astralcodexten.substack.com/p/welcome-to-the-terribl... > feels like you have hacked around a regulation that is meant to keep unfair and false app and service in check. Blind faith in every excess of the FDA's obstructionism and other bureaucratic pathologies was always insane to me, but it really, really shouldn't have survived for anyone paying even casual attention to the global pandemic we're in the midst of. Agencies like the FDA are taking on the herculean task of standardizing the messy landscape of scientific knowledge into bite-size, oversimplified answers that the dumbest layman can make use of. This is hard enough to begin with, and gets even worse when you remember that they're as subject as any institution to politics, inertia, bad organizational culture, etc etc etc. I get that most people have a powerful, almost-foundational urge to avoid critical thinking, but it's a fantasy to think that you can outsource 100% of your cognitive function to bureaucracies that can provide maximally-simplified, crystal-clear access to The Truth. When it comes to your health or that of those you care about, it's downright negligent to do so. To be clear: I think the FDA does a massive amount of necessary, fundamental work that the medical system depends on, and I'm not suggesting people go hog-wild trying every random substance without regards to efficacy and safety guidelines. But the approach you take in your comment is a dramatic and farcical example of bureaucracy-as-religion. Consider what we're talking about: you're concerned about non-medically-approved use of a chatbot that (reductively) helps you think about things more positively. Is there a principled reason that you're (presumably) okay with people watching yoga videos at home without a prescription? Or picking up a book on meditation? Or reading Couch-to-5K and starting jogging? Is there any difference between these activities and a CBT chatbot, beyond the fact that the latter has been medicalized by our regulatory bureaucracy?
- ramraj07 5y ago
  I can see you have (probably justifiable) beef with FDA regulations, and the politics they play. But the posters worry is real. CBT is offered as a therapy to many mental disorders. It can indeed be done by yourself, so in theory it makes sense that you don’t need to regulate it, but it sits right at the border of that demarcation if you ask me. Questions about whether it should be regulated is valid, and the answer offered is also somewhat valid though perhaps not opportune.
phowson83 5y ago
That's good feedback and there is a lot of snake-oil in the industry in general, which is why we base our app around evidence-backed practices such as CBT ( as mentioned in the post, there's much evidence that CBT-based apps are beneficial e.g. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5727354/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5727354/ ). I think you're getting at an open question for regulators, which is the ongoing regulation of "wellness" apps, a category which this app currently falls into. The EU actually published a green paper about the Digital health space several years ago, in which they touch on the "wellness apps" space, with an possible eye to potential stricter regulation in future, although they are yet to enact anything in this space. https://digital-strategy.ec.europa.eu/en/library/green-paper-mobile-health-mhealth https://digital-strategy.ec.europa.eu/en/library/green-paper... The ultimate long term aim for the company is to actually work towards regulation as a medical device as this also unlocks more ways in which the app can be distributed (e.g. through healthcare systems).
chalst 5y ago
I haven't fact-checked the article yet, but the fact that this is an area with low-hanging fruit and the apparent expertise of the team leads me to think we should have some confidence here. Cf. from the OP: > Our clinical director, Professor Paul Farrand, was the architect of using Low-Intensity Cognitive Behavioural therapy at scale in the UK’s National Health Service (NHS), and the author of one of the first international textbooks on the subject.