We have revised the Levels with a new L0 added to cover none data collecting very simple Wellbeing Apps. Each other Level shows logical graduation in complexity or focus risk with L4 Apps very often falling into a regulated sphere either as a clinical service or medical device.
Our Review Domains now only impact those Apps to which they are relevant – L0 and L1 Apps are not reviewed for Clinical Assurance for example because of their focus on Wellbeing. Apps that don’t collect Data (except for L0 where none can collect Data), are now awarded the same baseline score in this section as collecting equivalent data App that has the minimum compliance standards in this area. Data collecting Apps can get a better score in this section if they deliver additional value-adding elements through their collection and management of data. They can also of course score less if they are not compliant with the core regulations and standards.
We have added several new Functions and Features to describe what an App does.
Each review question now has a more clear and consistent tariff applied to it which classifies it as either Low, Medium, High or Exceptionally High Risk or Value. Some questions apply a multiplier to this tariff where the risk associated with the App is greater (for example where the App collects identifiable and sensitive data).
Certain Apps that are at the highest level of complexity, sophistication or risk are now required to satisfy key minimum compliance tests displayed via a ‘general search’ or the site. The minimum compliance relates to Clinical Assurance and in particular the requirement to establish that the App is backed by a suitably qualified professional or organization and that has evidence to back up any claimed health benefits. The Apps that this minimum compliance standard relates to are all L4 Apps that offer ‘Personalized Advice and Treatment Support’ features.
The data bars illustrating an Apps performance in each area now show the score out of the ‘weighted’ score or each review area which aligns clearly to the overall score.