Enabling Secondary Use of Health Data for the Development of Medical Devices Based on Machine Learning

Medical devicesMedical devices based on machine learning (ML)Machine learning (ML) promise to have a significant impact and make advances in healthcare. This chapter analyzes to what extent data protectionData protection law, de lege lata and de lege ferenda, enables the development of ML-based medical devices. A key aspect of this is the processing of health dataHealth data, which does not originate with the developers but with the healthcare providers. ML-based medical devicesMedical devices are trained with a large amount of health data. According to the current legal situation under the General Data Protection Regulation (GDPR)General Data Protection Regulation (GDPR), secondary use of health dataHealth data is possible in principle (Article 6 (4) GDPR). However, the consentConsent of the data subjects faces certain difficulties, and as the following analysis shows, the development of an ML-based medical device does not necessarily constitute scientific researchScientific research within the meaning of the GDPR. Therefore, this chapter argues that a separate legal basis is needed. This must be accompanied by technical-organizational measures that safeguard the rights of the data subject to a large extent and should only be allowed if the general public benefits from the research on and/or deployment of the ML-based medical deviceMedical devices. In addition, there is a need for infrastructural measures such as the establishment or expansion of intermediary bodies, given the lack of incentives, personnel capacity, and expertise among healthcare providers to share health data with a broad range of interested parties. Furthermore, to ensure a reliable output from ML-based medical devices, standards for data preparation must be established. Finally, this chapter discusses the proposal of the European Health DataHealth data Space (EHDS)European Health Data Space (EHDS) and briefly examines whether this is a step in the right direction.