We recently reached out to some of the DIOPTRA partners who are leading various activities to gain their perspectives on the project’s mission from their areas of expertise. This resulted in a series of video interviews (available on our website and official YouTube channel), where they share insights into their challenges and ongoing work.

In this sixth instalment, we touch upon the project’s legal aspects with partner Arthur’s Legal – from the challenge of keeping a balance between research purposes and privacy concerns when collecting data, to DIOPTRA’s place within the current European regulatory landscape.

Here below is a transcript of the interview:

The project’s legal perspective

Arthur’s Legal is located in Amsterdam, in the Netherlands, and we’re very active in terms of participation in EU projects, assuming the role of the legal partner: meaning looking into the legal and ethical considerations pertaining to the design and use of new technologies such as, for instance, Artificial Intelligence.

Legal role and responsibilities

Within DIOPTRA, we are involved in several Work Packages. Work Package 1, where we look into the the risk management aspects of the project. We’re also involved in Work Package 6, where we provide actively support to clinical partners when it comes to the drafting of the prospective clinical protocol, by addressing the legal and ethical aspects that are relevant for the submission of the protocol in the respective committees. And also we are involved in Work Package 7 by providing support relating to the exploitation aspects of DIOPTRA outcomes.

Keeping the balance with multidisciplinarity

The main challenge that pertains to the scope of DIOPTRA – and this is the case also with other projects in the area of health – is how to balance conflicting interests. As for instance, collecting a great amount of data, which is necessary for the performance of research while keeping the balance with personal data protection, for instance. Adopting, of course, a common approach can be a challenge, in consortia that involve diverse disciplines as for instance, in this case, medicine, engineering and law.

DIOPTRA and the current regulation landscape

DIOPTRA project is being funded at a quite transitional stage of the European regulatory landscape. A few months ago, EU institutions
adopted the Artificial Intelligence Act, that forms a pioneering piece of legislation worldwide that aims to to regulate the use of Artificial Intelligence. At the same time, the European Commission has released their proposed European Health Data Space Regulation*, that aims to facilitate the sharing of data in the healthcare domain. So one of the aspirations that’s quite relevant for DIOPTRA is to consider, to an extent, these ongoing developments while of course taking into account already applicable legal requirements. And something else that I find quite relevant for the case of DIOPTRA, being a quite wide consortium, quite a diverse consortium, is also to raise awareness within the existing consortium when it comes to, in this case, the legal and ethical implications when it comes to the use of a technology
that involves Artificial Intelligence for the particular purposes of of healthcare.

Interested in learning more about other aspects of the DIOPTRA project? Check the interviews on the DIOPTRA AppIdentifying protein biomarkers for Colorectal Cancer detection,  A Clinical perspective from the fieldThe Retrospective and Prospective Studies and Developing Clinical Protocols.

* Since this video interview, the Health Data Space Regulation proposal has officially been adopted as law to enhance cross-border access to EU health data. Read more here.

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