Livestreaming of the morning of the second day of the first WHO EPI-WIN and WMA open expert meeting on the revision of the Declaration of Taipei. WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Participants – WMA – The World Medical Association 05/12/2025. https://www.wma.net/policies-post/wma-declaration-of-helsinki/
The morning of the second day started with discussion of problem AI occurrences - “bromide self-medication” - AI suicide cases, and Optum’s algorithm. Optum’s algorithm used previous health expenditure as the metric by which to judge patients’ health needs, whereas it had been known that black patients’ health expenditure was lower because of socioeconomic factors, and not because of lower morbidity.
The working group considered “The AI Act - a European regulation on artificial intelligence (AI) is the first comprehensive regulation on AI by a major regulator anywhere [ https://artificialintelligenceact.eu/the-act/ ]. The EU AI Act’s first stage was enacted in August 2024. The Act contains 113 articles, and 180 recitals. Article 5 prohibits subliminal techniques beyond a person’s consciousness, purposefully manipulative or deceptive techniques, systems that exploit the vulnerabilities of a natural person or a specific group of persons, and detrimental or unfavourable treatment of certain natural persons or groups of persons. Article 99 legislates for fines applicable to infringements of this Regulation by operators of up to 35,000,000 Euros, or up to 7 % of its total worldwide annual turnover for the preceding financial year, whichever is higher.
Article 13 ensures that the operation of AI is sufficiently transparent to enable deployers to interpret a system’s output and use it appropriately.
Article 14 ensures that High-risk AI systems are designed so that they can be effectively overseen by natural persons during the period in which they are in use.
EHRs are created by doctors and other healthcare professionals during health service provision. On Tuesday the Taiwan Legislative Yuan passed a law that regulates the use of National Health Insurance (NHI) data. The law grants individuals the right to opt out of having their records used for nonmedical purposes, imposing fines for unauthorized access.
There is clear authorization to give data to the state for public benefit of care, criminal investigation, material rights, and drug research. 80% of patients, and 72% of the public were willing to participate in research. The Taiwan constitutional court ruled that citizens had the right to withdraw consent for their personal health data in the National Health Insurance Research Data (NIHRD) base to be accessed beyond the requirements of service provision. However, the court ruled that citizens cannot opt out in certain legally defined conditions (a similar arrangement to the NHS COPI notices).
The US Senate voted 99-1 to remove a 10-year federal moratorium on state regulation of artificial intelligence. Large tech companies in the USA suggest that development races are not usually won by going slower, but most agreed to a code of practice of transparency, copyright compliance, safety, and security.
The working group considered how health AI could reflect the ethical and moral norms of the doctor-patient relationship, and heard the suggestion that AI will not replace doctors, but will replace doctors who do not use AI. The working group referred to the ethical principles of non-maleficence, mutual benefit, willingness, and public interest and felt that doctors should strive to change legislation in conflict with medical ethics. Doctors should protect patients’ dignity, autonomy, privacy, and autonomy should be balanced against the benefits of the discoveries of new knowledge.
AI provided care is overtaking certain fields of human provided care and care for certain populations. Interactions have moved from doctor-patient interactions to biomedicine, from biomedicine to biomedical manipulation of human data, and from biomedical manipulation of human data to treating data representations of patients (avatars?).
Patients act autonomously to share their data on social media, and medical ethics does not affect personal health data that citizens share with social media.
Strong data governance, transparency, help to maintain trust. Patients, families, industries, researchers, civic organizations, and broader society, need to collaborate to envision the future, support worldwide legal standards, and fair data principles for processing findable, accessible, explicable, interoperable, accountable, and reusable data.
Designs of future models of dynamic consent will proactively seek to find out how much research participants can, and wish, to know and understand, according to their level of literacy. Projections of future healthcare research on donated data or biomaterials would give research participants greater understanding of how their data is used. Dynamic consent that updated research plans on donated data and biomaterials would require a personalised, digital interface enabling two-way communication between participants and researchers. Messaging systems, on a phone, using web 3.0, would need to send messages to research participants with a means of reply, however this would be cumbersome, difficult, and expensive to implement.
HIFA profile: Richard Fitton is a retired family doctor - GP. Professional interests: Health literacy, patient partnership of trust and implementation of healthcare with professionals, family and public involvement in the prevention of modern lifestyle diseases, patients using access to professional records to overcome confidentiality barriers to care, patients as part of the policing of the use of their patient data Email address: richardpeterfitton7 AT gmail.com