The working group established this year by the European Commission is rapidly developing the guidelines for assessing the validity and reliability of mobile health applications. Following last face to face meeting of the working group and an open stakeholder consultation held in Brussels on May 3rd and 4th and follow-up teleconferences, the group has come up with the second draft of the guidelines.
The mHealth guidelines will address all those apps that are not classified as medical devices (for which the EU Directive on Medical Devices applies) and will also include apps such as medical appointment booking apps or other apps that imply an exchange of sensitive personal information. The adoption of the guidelines is voluntary, however taking into account the urgent need of strengthened regulatory framework in mHealth, we are confident that many target groups will benefit from the guidelines, from citizens to healthcare professionals, from app developers to healthcare systems.
The second draft of the guidelines will be presented and discussed in an open stakeholder meeting at the eHealth week in Amsterdam on the 10th of June. If you are attending the eHealth week and would like to provide your feedback on the guidelines, please contact This email address is being protected from spambots. You need JavaScript enabled to view it.