Following a 2014 mHealth consultation and two open stakeholder meetings in 2015 (see here and here), the European Commission has announced the formation of a new working group aiming to draft guidelines on mHealth app data quality.

The new Working Group is composed of representatives from public authorities and a diverse 20-strong group of stakeholders, ranging from prominent European trade associations (including DIGITALEUROPE and Eucomed), patient associations, medical schools, research institutes, NGOs and corporate members.  They were selected from 75 applicants.

The Working Group, which holds its first meeting in March, will work throughout 2016 to produce common quality criteria and assessment methodologies for health and wellbeing apps.

The Commission’s consultation suggested that a trust deficit (caused for instance by limited information being available about the way in apps record and analyze data) may be one the main issues holding back the market at present, at least in clinical settings.

It is hoped that those guidelines, if followed, would give physicians the confidence to start factoring app data into their clinical assessments, and linking it to patient electronic health records.

Photo of Phil Bradley-Schmieg Phil Bradley-Schmieg

Philippe Bradley-Schmieg’s practice covers a range of commercial, regulatory and intellectual property matters affecting the IT, e-health, internet media and telecoms sectors, often with a multi-jurisdictional scope.  He advises on intellectual property, compliance and policy matters such as online consumer rights, liability for…

Philippe Bradley-Schmieg’s practice covers a range of commercial, regulatory and intellectual property matters affecting the IT, e-health, internet media and telecoms sectors, often with a multi-jurisdictional scope.  He advises on intellectual property, compliance and policy matters such as online consumer rights, liability for third party content, patent, copyright and database right licensing, privacy and data protection, medical confidentiality, cybersecurity, data breach responses, and law enforcement data disclosure.  Mr. Bradley-Schmieg advises on UK, EU and international law, and has worked in London and Brussels.