In February 2016, the European Commission appointed a working group to draft mHealth assessment guidelines. These mHealth assessment guidelines are intended to establish a soft law reference framework for mHealth apps, providing a framework of safety, quality, and reliability, and effectiveness criteria, to improve the use, development, recommendation and evaluation of mHealth apps on the European market.
Authors – Marc Martens & Maria-Paz Martens
The large number of lifestyle and wellbeing apps available on the European market with no clear evidence in relation to their quality and reliability has raised concerns about the ability of consumers to assess their usefulness. In addition, taking into account that the quality of data is essential to link apps to electronic health records and for effective uptake in clinical practice, some further assurances as to the quality of the app were needed.
The working group includes representatives of patients, health professionals and providers, payers, industry, academia and public authorities, representing hereby all interested parties in the consultation process.
The mHealth assessment guidelines are foreseen to be drafted in four iterations, with each followed by further stakeholder engagement. The second iteration, the version which forms the subject of this article (hereafter ‘second draft’) and which was published at the end of May 2016, refined the content of the first draft, which was presented at an open stakeholder meeting at the beginning of May (hereafter ‘first draft’).
The last iteration of the guidelines is set to be produced at the end of December 2016. The feedback is to be included in the final report, which is expected on 25 January 2017.
Source: Bird & Bird