EUROPEAN JOURNAL OF HEALTH LAW最新文献

Considering the difficult procedure of obtaining consent, consent-free health data reuse is believed to be one major contributor towards the creation of thriving health innovation ecosystem. While classic researchers are supported by the GDPR to reuse health data without consent, the innovator's situation remains unclear, and this uncertainty continues to exist upon the introduction of the EHDS. To shed light on grey areas, positions of GDPR and EHDS on the ability of innovators for consent-free health data reuse were assessed. The study concludes that, while academicians are able to reuse health data without consent, a private company's ability has been impeded by individual member states' deviations from Article 9(2) GDPR. Furthermore, in contracts to EHDS (2022) which appeared in favour of innovators through the elimination of consent mechanism, EHDS (2024) with the inclusion of opt-out mechanism, and exclusion of private sector bodies from the Article 35(f), has negatively affected private companies.

The current legal test for capacity under the common law is a functional test. It determines whether a person can make a particular decision at a particular time; it focuses on retained abilities rather than on presumed deficits - in order to promote patient autonomy in decision-making. International evidence suggests however that the test is not well understood and consequently not being correctly applied in practice by a range of medical professionals. Donnelly has argued that gaining a better understanding of how capacity assessments are actually employed is essential to improving the quality of assessments. To date, there is little data on how doctors in particular make their assessments in practice. Using a socio-legal methodology, this quantitative study aims to assess understanding of capacity among a group of general practitioners/family medicine doctors in Ireland, and to determine how they assess capacity in clinical practice. Our study found that notwithstanding a lack of confidence in their ability to assess decision-making capacity, that respondents in fact demonstrated a high level of understanding and of ability to correctly apply the functional test in practice.

The European healthcare sector is transforming toward patient-centred and value-based healthcare delivery. The European Health Data Space (EHDS) Regulation aims to unlock the potential of health data by establishing a single market for its primary and secondary use. This paper examines the legal challenges associated with the secondary use of health data within the EHDS and offers recommendations for improvement. Key issues include the compatibility between the EHDS and the General Data Protection Regulation (GDPR), barriers to cross-border data sharing, and intellectual property concerns. Resolving these challenges is essential for realising the full potential of health data and advancing healthcare research and innovation within the EU.

The creation of the European Health Data Space is a milestone. It establishes something new and makes it possible to have faster and more efficient health treatment, but also to untap the potential of unused data for policy-making and development of new technologies. However, for the EHDS to be functional, it is imperative that a balance it struck between the aim of having useful data to achieve important public objectives on one side and the goal of enabling patients to have control over their health data. The original Draft Report of the European Parliament came closest to achieving these objectives and should have represented the blueprint for the final compromise. Having a harmonised opt-out for secondary use is crucial for striking the right balance between the mentioned objectives. The end result is far from perfect regarding primary use, but represents a good balance in the area of secondary use concerning the opt-out.

Uterus transplantation (UT) is a surgical procedure that seeks to correct absolute uterine infertility. As such, it is coupled with assisted reproductive technologies (ART). Currently performed as an investigational procedure in France, this technique could be subject to a legal framework in the future. Given its specificities, the French legislator will need to state their position on several matters. Regarding the donor, they will need to determine whether the benefits for the infertile woman justify exposure of a living person to the risks of the removal procedure. If necessary, they will have full freedom to set the criteria for selecting the living donor based on age, the existence or not of past pregnancies or the nature of the donor-recipient relationship. On the other side, the conditions for becoming a recipient should be consistent with the existing rules for ART. Other considerations could include age and past pregnancies again. Lastly, the legislator will also need to address the possible desire for UT without the endpoint of pregnancy.