As part of the ‘Study on Safety of non-embedded software’ TNO, VVA, and the team from Scuola Suepriore Sant’ Anna coordinated by Prof. Andrea Bertolini analysed the legal and business landscape and the challenges and opportunities related to new advanced technologies associated with digitisation and AI. 

The main objective of the study is a fact finding mission on safety incidents with health, lifestyle and wellbeing apps and the legal framework that covers these incidents. Based on desk research, confirmed via stakeholder consultation and a workshop, it is concluded that presently it is unclear whether and what European legislation covers the safety of health, lifestyle and wellbeing apps. Notwithstanding the lack of reported incidents at this point in time, many of the eight Member States studied as part of the project are fully aware of the need to offer some kind of transparency with regard to the safety of health, lifestyle and wellbeing apps to the public at large. The investigation showed that many countries undertake activities to help citizens in assessing the relevance, adequacy and effectiveness of health, lifestyle and wellbeing apps. No general framework to do so is yet in place, though many guidelines that are produced focus on a similar set of activities: medical content, security and privacy, usability, effectiveness. International and European standardisation efforts are under way as well, but these are still far from a conclusive phase.

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