Technology is rapidly transforming the healthcare sector as we know it. While it is generally accepted that eHealth and mHealth can improve citizens’ possibility to monitor and evaluate their health, there is less knowledge about the wide range of uses of robotics in healthcare – from service robots in hospitals who deliver bed-linen and retrieve medication, to highly sophisticated robotic tools to provide a super-steady hand for micro surgery, to cuddly robots to stimulate social interaction and communication with people with dementia.
Through its research budgets the EU has invested hugely in the scientific development of robotics in healthcare. The EU is now starting to reap significant benefits for researchers, industry and patients. However, recently the European Parliament has started to question if the existing legal framework is adequate to address the legal issues related to robotics in the healthcare sector, including data protection, product liability and intellectual property. Alongside these strictly legal issues, the ethical dimension of robots in healthcare and their potential impact on the doctor-patient relationship are also beginning to raise questions.
In spring 2015, the European Parliament Committee on Legal Affairs (JURI) set up a Working Group on Robotics and Artificial Intelligence to pave the way for the drafting of civil law rules in connection with robotics and artificial intelligence generally. After more than a year of meetings, the Committee is now in the process of developing a non-legislative Report on Civil Law Rules on Robotics. Given the importance of the issue to the healthcare sector, the European Parliament Committee on Environment, Public Health and Food Safety (ENVI) examined a first draft of the Report and discussed this topic yesterday (12th September 2016).
Members of the ENVI committee acknowledged that there is a growing market for robotics and artificial intelligence in healthcare, and noted that they have the potential to bring major benefits to patients, leading to increased quality of life, and also to reduce healthcare costs. However, they stated that when dealing with robotics, optimism should be combined with prudence, stressing that safety is a precondition to the introduction of robotics in the healthcare sector and that EU data protection rules should be adjusted to consider the growing interconnectivity of care and medical robots dealing with highly sensitive personal information and health data. The ENVI committee also called on the European Commission to consider adapting the current trial procedures designed for testing medicines in order to test new medical robotic devices.
The input of the ENVI committee will be approved on 12 October and will then feed into the final JURI committee Report. With the approval of the final Report, the European Parliament is likely to give a strong push to the European Commission to come up with new rules in connection with robotics and artificial intelligence: developments in this area will have to be followed closely in the upcoming months.
Watch this space for further discussion as the issue progresses.
Petra Wilson is Senior Advisor at FTI Consulting and leads the healthcare team in Brussels. Nicola Scocchi is Consultant in the healthcare team.