Browsing by Subject "Lääkinnälliset laitteet"

The usage of different types of wearable mHealth solutions for consumers has exploded especially since the start of the COVID-19 pandemic. A big question regarding these devices is the quality and accuracy of the data produced by them. When the consumer can use these devices to measure their heartbeat, blood sugar levels, sleep quality, blood oxygen levels etc. the quality and accuracy of this data is getting more important by the day. Not only for the consumer but also for the development of Artificial Intelligence the quality of data is of utmost importance. The importance of the data produced by these devices which the consumers wear voluntarily for long periods of time for the development of Artificial Intelligence in the medical sector cannot be overstated. Many of these mHealth devices also use Artificial Intelligence in one way or another already. In this Thesis the research question is how EU regulation affects the obligations of the producers of mHealth devices in regards the data quality of these devices. The starting point for the research is the define Artificial Intelligence in general and data quality by the EU standards. The method for this research is a legal dogmatic approach to present and future EU regulation surrounding this topic with the viewpoint of ensuring high quality data for Artificial Intelligence development. In the scope of this research there are the Medical Device Regulations for current regulation and the regulations based on the EU Data Strategy, Data Governance Act, the proposal for the Data Act and finally the proposal for the Artificial Intelligence Act. I note that there are many other important aspects to this topic that do not fit into the scope of this Thesis, namely access to data, movement of data, data protection, unfair commercial activities and “soft law” -type of regulation especially standards. The result of the research is that the situation is unclear in the light of the regulations inside the scope of this Thesis. For medical devices, the many obligations for medical devices do ensure that the devices need work as intended and as such ensure the data quality too. Many of the mHealth solutions, however, do not fit into the scope of either of the Medical Device Regulations, because their intended purpose is not ‘medical’. As these devices produce more and more intricate health data, the question left to be answered is when does the intended purpose become medical. EU has tried to tackle this problem mainly by soft law -instruments with the latest being the ISO/TS 82304-2 standard in regards the quality of health and wellness apps released in 2021. For the upcoming regulations the duo of Data related Acts do not bring any light to the problem. They mainly focus on access to data and movement of data with the data quality parts focusing on interoperability of data. The proposal for Artificial Intelligence Act has obligations mainly for the AI systems classified as ‘high-risk’. The interesting part for this paper is how medical devices and security systems for them would be classified as high-risk. This however leads the research back to the Medical Device Regulations and the issue with devices whose intended purpose is not medical.