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Stage Two – Levels

There are a huge array of different types of health and care Apps available with an equally wide array of functionality and sophistication. At ORCHA we believe that just because an App offers more functionality it doesn’t mean it is automatically better than a functionally simple App. Apps that for example simply provide information and guidance, similar to health leaflets, can be very useful in certain circumstances and this isn’t impacted by their relative functional simplicity.

Apps in this area are also focused on a wide array of areas. Some are clearly health focused and within that are often targeting specific conditions or diseases, others however are more general and many are actually focused on wellbeing rather than health. A focus on wellbeing would include areas such as exercise and fitness and diet and these Apps are really important and offer really valuable support in the maintenance or improvement of overall wellbeing which is crucial for overall health.

Against this very varied backdrop, having a one size review process does not work and it is important that the review itself is responsive to the type (in terms of focus and functionality) of the App in question.

It is for this reason that we developed the ORCHA App classification system which categorises Apps in one of 4 Levels (1-4) based on their area of focus and their functional capabilities. The more health focussed and functionally rich an App is the higher its Level and the more areas of investigation are enabled in relation to it.

Very simple well-being focused Apps (typically L1) are not for example assessed based on their clinical assurance because they are not really delivering a clinical solution. Level 4 Apps on the other hand are at the top end in terms of focus and functionality and are often required to establish compliance with other regulatory environments such as medical device regulations or the equivalent in other jurisdictions.

The Orcha Levels are as follows:

Level 1 - Well-being/Utility         
These apps are focused on either general well-being with a health focus or are utility apps used in a health context.

Level 2 - General health
These Apps are focused on general health.

Level 3 - Condition management              
These Apps can be focused on general health or supporting specific health conditions.

Level 4 - Regulated         
These Apps can be focused on general health or specific conditions and contain advanced and complex features that are subject to formal regulation.

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