AI-driven medical devices in precision medicine and the right to health

This seminar will introduce Sarah de Heer’s doctoral project concerning the effects of AI-driven medical devices in precision medicine and their potential to (negatively) impact the right to health, specifically its four pillars, namely availability, accessibility, acceptability and quality. While these medical devices may improve the quality under the right to health, they may also have the opposite effect and deteriorate quality. Since the quality of AI-driven medical devices in precision medicine cannot be ensured, the other three elements of the right to health are also at risk. The availability, accessibility, and acceptability of these AI-driven medical devices in precision medicine can be questioned when the quality of these devices is not guaranteed.

Abstract

Scenario 1: Patient A is a 62-year-old woman whose blood had been tested by using an AI-driven medical device in precision medicine that predicts the likelihood of pancreatic cancer. Based on Patient A’s blood sample, demonstrating a high likelihood of pancreatic cancer, the multidisciplinary team suggested starting chemotherapy. Since multiple combinations of various medicinal drugs could have been included in the chemotherapy treatment plan, patient A’s blood was tested again with another AI-driven medical device in precision medicine to determine the drug sensitivity of the medicinal products that could have been used. Patient A was given the medicinal products that showed high sensitivity.

Scenario 2: Patient B is a 34-year-old male whose CT scan had been inconclusive regarding the presence of pancreatic cancer. Thus, an endoscopic ultrasound and a fine needle biopsy of the found mass in the pancreas were performed. The results demonstrated that the tissue is malignant. As with Patient A, the multidisciplinary team recommended initiating chemotherapy, which consisted of a panel of pharmaceutical drugs commonly used, thanks to their effectiveness for the general population. Unfortunately, the tumour did not respond to the chosen panel of medicinal products. Luckily, the new medical regimen appeared to be effective.

The use of AI in these scenarios has the potential to lead to quicker diagnoses and more suitable treatments. However, an inaccurate outcome of the AI-driven medical device in precision medicine may have significantly detrimental effects on the patient’s health.

Speaker bio

Sarah de Heer is a third-year doctoral candidate at the Faculty of Law at Lund University. Her research focuses on AI-driven medical devices in precision medicine and the right to health. More specifically, Sarah examines the extent to which the conformity assessment procedure under the EU regulatory framework can ensure the quality of these medical devices. This doctoral project is part of the AICARE project, which is funded by the Wallenberg AI, Autonomous Systems and Software Program – Humanity and Society programme (WASP-HS).