On 15 September, Sara Roda, the HALL affiliated researcher and EU Senior Policy Adviser at CPME – Standing Committee of European Doctors, gave a presentation at the 4th Open Expert Meeting on the revision of the Declaration of Taipei (DoT), co-organised by the World Medical Association, the Norwegian Medical Association and the Israeli Medical Association.
Sara compared the DoT and the European Health Data Space (EHDS) Regulation, discussing consent, common good and trust in public authorities for secondary use purposes. She brought the perspective of considering “personal autonomy” as the overarching element, arguing that the real question was not whether informed consent existed, but rather personal autonomy was genuinely protected through other safeguards. Sara argued for a granular opt-out to ensure individuals can object to specific uses (e.g. public, private, ethical objections, commercial research, etc.), instead of an all or nothing choice.
As the sharpest difference between the two frameworks, Sara mentioned that the DoT requires personalised information to each individual, while the EHDS relies on public transparency that people must actively seek out (Note: the principle of transparency is less demanding, not personalised to the individual - for more information on transparency read this blog from Wenkai Li and on the impossible tasks of the Health Data Access Body by Paul Quinn.
As open questions, she highlighted how individuals will know that their opt-out functioned, if the principle of transparency is not personalised to the individual; and whether the entity informing the opt-out would be free of a conflict of interest. Finally, she noted that the DoT is much more detailed than the EHDS and that it should continue to be (e.g. cases of unconscious patient, assent, or regaining capacity to consent, and on teens). For Sara, informed consent should continue to be the gold standard in medical ethics.
The co-panellist was Sofia Peltola (Finish Innovation Fund - SITRA) and moderation from Leah Wapner (Secretary General at Israeli Medical Association). The exchange brought hard questions from the audience, e.g. will Member States allow for individuals to opt-out in secondary use from countries that do not offer the same level of ethical requirements such as an ethics committee; or the use of the e-evidence Regulation to access data from electronic health records, looking at the safeguards which needed to be put in place, such as use of secure networks which flag professional secrecy, or a stronger role for national medical associations in virtual settings (can it be equivalent as with the physical setting?).
