The European Commission has published a ‘Study on Safety of non-embedded software; Service, data access, and legal issues of advanced robots, autonomous, connected, and AI-based vehicles and systems’ (SMART 2016/0071). The Study comprises of two parts: 1.) on Safety of health, lifestyle and wellbeing apps 2.) on CAD/CCAM and Industrial Robots.
No safety incidents have been found
The report focusing on safety of health, lifestyle and wellbeing apps, encompasses desk research, interviews and a workshop. The overall conclusion on the basis of this fact finding mission is that at present no safety incidents concerning non-embedded software, in particular in this study of health, lifestyle and wellbeing apps, that do not fall under the Medical devices legislation, can be found in public sources. This however does not mean that safety incidents with health, lifestyle and wellbeing apps do not exist. A number of reasons for underreporting have been identified, such as users who experience a safety incident, but do not relate this incident to the use of the app or users who experience a safety incident, but do not know where and how to report this safety incident, and others.
The study checked for relevant legislation applicable to safety incidents of health, lifestyle and wellbeing apps. The main conclusion here is that at present it is unclear whether and what European legislation covers the safety of health, lifestyle and wellbeing apps.
Based on an investigation in eight European Member States - Austria, France, Germany, Italy, the Netherlands, Spain, Sweden and the United Kingdom - it can be concluded 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.
In fact, effectiveness is hard to evaluate, given the lack of formal and enforceable guidelines in practice. For many countries, medical professional organisations and medical quality assurance organisations (BSI, GGD, etc.) have the lead in these initiatives. Next to this, the European Committee for Standardization (CEN) has formally agreed to start a working group that will address the safety of health, lifestyle and wellbeing apps.
Awareness is high
The overall conclusion is that, notwithstanding the lack of reported incidents at this point in time, many countries 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. Especially medical professional organisations and public organisations active in assuring quality of health care, develop activities to help controlling the safety of health, lifestyle and wellbeing apps. The initiative, started by CEN will also be of help in preventing potential safety incidents of health, lifestyle and wellbeing apps, while assuring the quality of these apps given the purposes they serve.
Report on CAD/CCAM and Industrial Robots
As part of the ‘Study on Safety of non-embedded software’, the legal and business landscape and the challenges and opportunities related to new advanced technologies associated with digitisation and AI have also been analysed. The study identified specific issues which affect the impact of CAD-CCAM and provided empirically founded recommendations for policy measures to facilitate the future business uptake of the technology.