Our Review aims to provide useful indications of whether an App appears to be safe and of value across a range of areas such as Data and Security and Clinical Assurance. It involves an evaluation of over 130+ elements of an App and validates crucial information such as compliance with relevant Data and Privacy regulations, compliance with key Medical Device regulations (currently being implanted to reflect new regulations) and it also assesses an App against a range of other areas of standards and best practice. It is not, however, the same as a full user test of an App and it does not validate all the claims made by App Developers many of which would require detailed clinical and other testing and in many cases, extensive user testing and trials.
Outside of a small number of national accreditation schemes, there is no other extensive review process that covers as many elements of an Apps delivery as ours. One such process is delivered in the English NHS via NHS England/Digital who have an assessment process which covers many of the elements we do, but also undertakes a more detailed analysis of other elements that goes beyond our current process (albeit we do also operate – but currently don’t publish- a secondary review stage that is aligned to these additional stages). We do however capture and note all the Apps that have achieved an ‘approval’ through this process and the few other equivalent national processes in operation.
Whilst these national schemes aspire to increase the number of Apps they look at, at present, they have only reviewed a tiny fraction of the Apps available and a small percentage of the numbers of Apps we have assessed. This means that the level of coverage and choice that these approaches offer is currently quite limited.
For some Apps, there is a further level of scrutiny applied if they are classified as Medical Devices, albeit it still depends a lot on what level of classification they reach as to how much additional scrutiny they are subjected to. Class i medical devices, for example, are largely based on a self-certification approach.
Even Apps that have undertaken and published clinical trials or equivalent studies and have been subjected to relevant peer review, whilst clearly showing a great commitment to establishing their clinical credentials and efficacy, may not properly comply with other crucial aspects of an Apps overall delivery such as data security or user configuration etc which we also evaluate. Against this backdrop and in this context, we believe our process is as robust as it is possible to be without undertaking a much more detailed and costly evaluation that would limit the range and scope of Apps we can consider. We also believe – and constantly monitor and test our process around this – that the combination of the measures we consider does give a very accurate view of an App which usually aligns to the view that other more detailed assessments deliver and as such is a reliable overall indicator of an App’s quality.