Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 25 January 2016 | By Zachary Brennan
The European Commission is bringing together a working group to develop guidelines by the end of 2016 for assessing the validity and reliability of the data that mobile health (mHealth) applications collect and process in order to make these ubiquitous apps more useful for public health.
The working group comes as such lifestyle and well-being mHealth (everything from step trackers to heart rate analyzers to weight-loss helpers) has skyrocketed to more than 100,000 apps in recent years.
The development of such guidance comes as a public consultation from last year found no clear evidence on the quality and reliability of such apps, which raised concerns about their usefulness to consumers and their effectiveness in benefiting public health.
Now, the 20 members of the EU working group on mHealth, which will meet for the first time in March, will work to provide common quality criteria and assessment methodologies that could help users, developers, vendors of electronic health record systems, payers, physicians and others assess the validity and reliability of mHealth applications.
Members of the working group range from representatives of eight national administrations, industry, academia, non-governmental associations and other groups, including the EU device industry group Eucomed, the European Institute for Health Records, King’s College London and the UK’s Digital Health & Care Alliance.
According to a stakeholder meeting in July, the aim of the guidelines would be to assess only those mHealth apps that are intended to be linked to a patient’s electronic health record or those that would be used in clinical practice.
The commission noted: “This means that patients would be able to give access to their health professionals to consult the data collected by the apps. Also, health professionals need the reassurance about the reliability of the apps, in order to be able to recommend apps to their patients and take apps' data into consideration in a treatment/monitoring process.”
The development of the guidelines is one of the follow-up activities to the Commission's Green Paper on mHealth from April 2014. Safety and data transparency were identified by the respondents to one of the consultations as one of the main issues for mHealth uptake.
In contrast to this push in the EU, the US Food and Drug Administration (FDA) has made clear in recent years that it’s tailoring its regulation of mHealth apps to only the small subset that meet the regulatory definition of a medical device.
Similarly, UK regulators are taking their own approach to the regulation of mHealth apps, though apps that only provide information to consumers do not fall under MHRA’s purview.
The International Medical Devices Regulators Forum (IMDRF), the regulators-only successor group to the Global Harmonization Task Force (GHTF), in 2014 also formed a working group and put out a proposed guidance document on software as a medical device that in some instances would include mHealth apps.
New EU working group aims to draft guidelines to improve mHealth apps data quality
FDA on Mobile Medical Applications
Tags: mHealth, mobile health apps, mobile health app data, mHealth regulations