This workshop is organised in the framework of a study on the safety of non-embedded software focusing on the health sector, commissioned by the European Commission.

Today, over 250.000 health and wellbeing apps are available. Every one in three users of a smart phone has downloaded at least one such app. The new Medical Device Regulation is more stringent on quality assessment of stand-alone software than its predecessor. Still, a grey zone of many software applications for health and wellbeing exists, which poses serious problems to app developers and regulatory agencies.

The European Commission has commissioned a study to inventory the state of affairs with respect to the safety of non-embedded software related to health and wellbeing. The workshop will focus on the safety of health and well-being applications and the role of non-embedded software, including application software. It looks into newly emerging risks of non-embedded software and tries to identify regulatory responses.

As part of the project, various risks and incidents have been collected, mapped, and analysed. During the workshop the organisers will:

  • Present their findings so far on safety incidents and regulatory initiatives in various Member States across Europe
  • Delve into potential upcoming issues and risks surrounding non-embedded software and applications now and in the future
  • Discuss the role of -  and possible need for - harmonization of the regulatory landscape across the EU.

For more information, please contact Ms Maria Kirova.

The workshop is part of the validation activities undertaken as part of a study commissioned by the European Commission DG CONNECT on the ‘Safety of non-embedded software; Service, data access, and legal issues of advanced robots, autonomous, connected and AI-based vehicles and systems’.

TNO and VVA Consulting
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