Workshop "Navigating legal and ethical challenges in health data-driven environments"

Emilia NiemiecTopic: Legal and ethical issues in the development of an AI-based real-time surgery support tool “CLASSICA”

SpeakerEmilia Niemiec, CeBIL, University of Copenhagen 

The CLASSICA is a 4-year EU-funded project that aims to clinically validate an AI-based surgery support system. The CLASSICA system analyses videos during surgery (in real time) to identify regions of cancer and provide guidance for the surgeons during biopsy and local resection of rectal tumours. The CLASSICA tool is meant to enable surgeons to “see better” the tumour before biopsy sampling and cutting.

The development and future commercialization process of the CLASSICA tool raise legal and ethical issues. These include questions about legal bases for the processing of health data, data anonymization, sharing and security. There are also issues related to future placing on the market of the system, which entails the compliance with the EU Medical Device Regulation requirements. Another set of challenges relates to potential biases; the CLASSICA tool can be analysed in the light of ethical guidelines as well as future requirements on bias that may be imposed by the proposed EU AI Act. Liability in the context of future uses of the CLASSICA is another important topic.

This talk will provide an overview of the CLASSICA project and our research on the related legal and ethical issues.

Taner KuruTopic: Investigative Genetic Genealogy: An Emerging Legal Concern in Europe?

Speaker: Taner Kuru, TILT, Tilburg University

DNA has been used as powerful evidence in criminal justice for decades. To benefit from this source of evidence, law enforcement authorities maintain national forensic DNA databases in which they store DNA profiles extracted from people who somehow found themselves in criminal investigations. Due to the invasive nature of DNA retention on the fundamental rights and freedoms of individuals concerned, national legislation in Europe provides specific laws to regulate DNA retention and national forensic DNA databases. In the last two decades, these laws have been scrutinized by the European Court of Human Rights and the Court of Justice of the European Union, which eventually formulated the legal restraints attached to these practices in Europe.

However, a recent ground-breaking advancement in criminal investigations, Investigative Genetic Genealogy, may pose significant challenges to this well-established set of legal requirements. Since the arrest of the Golden State Killer, it was reported that investigators in the United States and beyond have benefited from this novel technique to solve hundreds of (cold) cases. Unsurprisingly, this practice did not take long to be tested on the other side of the Atlantic. While the Swedish law enforcement authority became the first in Europe to experiment with investigative genetic genealogy in 2019, Dutch law enforcement has recently been green-lighted for a pilot project to test this new technique. Other European law enforcement authorities, including the Danish law enforcement authority, are expected to follow the same path soon.

In light of these developments, this talk will provide an overview of the investigative genetic genealogy in Europe and shed light on how the use of this novel technique may challenge the legal restraints on DNA retention formulated by the two European courts.


Please register no later than the 22 November 2023 at 09:00 CET using this registration form