As discussed in our previous post, a European Commission mHealth Working Group has been set up to develop guidelines for assessing the validity and reliability of data that is collected and processed by health and wellbeing app. The first draft of the Guidelines was published on 25 April 2016. These aim to establish a common set of criteria relating to quality, safety, reliability and effectiveness to underpin the methodologies that can be used for assessing health apps. While the Guidelines, when adopted, will be voluntary, they are nonetheless important to guide good practice in developing mobile health apps, and to instil confidence among healthcare professionals so apps can be used as an integral part of the treatment pathway.
As discussed in our advisory the Guidelines divide the evaluation of an mHealth app into three phases: (i) Initial validation and assessment of the app platform; (ii) Risk assessment to determine the level of scrutiny required, and drive the degree to which the answers to the scrutiny assessment are considered relevant, and (iii) Scrutiny, which sets out a series of questions, taking account of the technology platform and the medical aspects of the app, which ought to be considered when assessing an app. The draft Guidelines focus on the safety and utility evaluation, and an assessment of the efficacy of such apps is being considered separately, along with details of the risk assessment (step (ii)). It is contemplated that all these aspects will be consolidated into a single guidance document. However, much of the operation of the Guidelines is unclear at this time, and the practical impact is dependent on a number of other factors.
The Guidelines are now being consulted on with a range of stakeholders; the deadline for providing input is 16 May 2016. Feedback from the consultation will lead to further development of the Guidelines, and at least three more drafts are anticipated. A final version of the Guidelines is expected by the end of 2016.