April 21, 2019

April 19, 2019

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EU Commission Creates New mHealth Data Quality Working Group

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.

© 2019 Covington & Burling LLP


About this Author

Philippe Bradley-Schmieg, Covington Burling, Data privacy and cybersecurity attorney

Philippe Bradley-Schmieg's practice covers a range of regulatory and commercial matters affecting the IT, internet media, e-health and telecoms sectors across the world.

Mr. Bradley-Schmieg advises on legislation, enforcement, advocacy and contracts relating to privacy, data protection, consumer protection, intermediary liability, copyright and databases, Big Data, medical confidentiality, cybersecurity, law enforcement data requests, and smart medical devices and apps.