Is My Data Safe and Are the Devices Efficient?
Published online by Cambridge University Press: aN Invalid Date NaN
Use case 1 in Chapter 4 explores the regulation of MDTs in the context of mental health and well-being under the General Data Protection Regulation (GDPR), the Medical Devices Regulation (MDR), the Artificial Intelligence Act (AIA), and the European Health Data Space (EHDS) Regulation. The analysis reveals that data protection issues in this sector are not primarily due to deficiencies in the law, but rather stem from significant compliance weaknesses, particularly in applications extending beyond the traditional medical sector. Consumer mental health and well-being devices could greatly benefit from co-regulatory measures, such as a sector-specific data protection certification. Additionally, legislators need to tackle the issue of manufacturers circumventing MDR certification due to ambiguities in the classification model. The EU’s regulatory approach to non-medical Brain–Computer Interfaces (BCIs) within medical devices legislation is highlighted as a potential blueprint and should be advocated in ongoing global policy discussions concerning neurotechnologies.
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