Picture Maria, a 70-year-old retired teacher living with Alzheimer's. Her journey, marked by gradual memory loss and confusion, represents a challenge faced by millions worldwide.
Now imagine a world where the next major breakthrough in treating Alzheimer's or heart disease is within reach, but stringent data privacy laws stand as a formidable barrier. Researchers find themselves at crossroads, caught between the potential to save millions of lives and the legal complexities of using sensitive health data.
This is not a distant reality but a pressing challenge faced by the scientific community today. Enter the Protection of Data in Medical Research (PaDME) project. By blending legal expertise with cutting-edge scientific research, PaDME aims to unlock the potential of health data while upholding the highest standards of privacy compliance.
Databanks serve as repositories for health and biometric data relating to diverse organ systems of patients with a spectrum of diseases. For instance, mental health disorders may be detected through abnormal brain structures and functions, which can be studied through Magnetic Resonance Imaging (MRI). These databanks offer a clear opportunity for targeted research, to enhance the diagnosis, prognosis, and treatment modalities for individuals. The potential impact extends beyond individual patient care, contributing to the broader betterment of society.
Despite clear advantages in the public interest for scientific research to be carried out which necessitates the establishment of such databanks, there are risks related to processing sensitive personal data such as health data. Therefore, it is crucial to ensure that appropriate measures are applied to be compliant with privacy laws. This presents a challenge as there is considerable uncertainty regarding the application of data protection laws to scientific research. Addressing this problem will also enable research to be carried out unhindered, while ensuring and upholding research participant rights and confidentiality.
The PaDME project will provide an innovative toolkit proffering a solution towards legal certainty. Established thanks to the MCST Research Excellence Programme grant and led by co-investigators Dr Mireille M Caruana from the Faculty of Laws and Dr Claude J Bajada from the Faculty of Medicine and Surgery, the project proposes original solutions through collaborative, interdisciplinary research between the legal and scientific fields.
PaDME will consider previous experience and best practices adopted in similar scenarios in other European countries through a comparative study of Member State specifications of the relevant provisions of the EU General Data Protection Regulation (GDPR). Furthermore, the project will shed light on aspects of the GDPR in the context of databanks storing MRI data for scientific research purposes where there remain significant conceptual uncertainties. Ultimately, the project aims to operationalise the relevant European data protection law provisions related to the processing of health and biometric data for scientific purposes in Malta, in particular by proposing model legislation to regulate the concerned processing by local research institutions.
This is not just about data; it is about people like Maria, whose hopes for a better life hinge on our ability to responsibly harness this information.
Further information about the project is available from the PaDME Website and feedback to any of the members of the research team is always welcome.