PORTUGAL Trends and Developments Contributed by: Margarida Roda Santos, Paulo Sampaio Neves and Mariana Pereira Dias, Eversheds Sutherland
Upcoming Challenges for Life Sciences in an Ever-Changing World The world is constantly changing, and the law is no exception. In a society where innovation and technology are the watchwords, there is an increasing need for the law to keep up with developments, particularly in the area of health. The challenges are manifold: technological advances occurring at breakneck speed, regu- latory changes and the increase in cyberthreats are just some of the issues in the healthcare and pharmaceutical sectors. It is crucial to address these fundamental issues in order to strike a balance between patient access to innovative health technologies and safe and ethical promo- It is impossible to talk about challenges and not mention artificial intelligence (AI). We are wit- nessing a revolution in various industry sectors owing to AI, with life sciences being one of the most exciting in this respect. AI could play a role in drug discoveries, improve- ments in disease diagnosis, clinical research, support for patient care during treatment and even increased productivity when carrying out administrative tasks. However, although AI is here to stay, concerns remain. The increased use of AI raises both ethical and legal ques- tions, which explains why the European Union has attempted to regulate this new technology, albeit with some difficulties. tion of sustainable of health systems. The future of medicine and artificial intelligence Currently, AI is notoriously flawed. We know that it is biased, can have hallucinations, makes clas- sification or prediction errors, provides allegedly reliable results based on non-existent sources and is characterised by a lack of transparency
regarding its design, development, evaluation and use. Questions also arise about how to determine responsibility when AI makes mis- takes. Is the system itself to blame, or is it the person who developed the software, the health professional accompanying the patient or even the healthcare institution? The European Union has endeavoured to address these issues, notably through the AI Act (Regulation (EU) 2024/1689), which applies risk-based regulatory frameworks to AI applica- tions – ie, it provides for a uniform legal regime for developing AI and placing it on the market, and for putting AI systems into service and use in Europe, using a classification based on the risks posed to citizens’ health, safety and/or fun- damental rights. The law classifies AI systems used in critical infrastructure that could jeopardise the lives and health of citizens as high risk; therefore, such systems are subject to a set of strict require- ments that must be met before they can be used. In this context, Serviços Partilhados do Minis- tério da Saúde , EPE (SPMS) published a white paper entitled Inteligência Artificial na Saúde em Portugal: Regulamentação, Impactos e Perspe- tivas de Futuro (Artificial Intelligence in Health in Portugal: Regulations, Impacts and Future Pros- pects) in February 2025, providing a glimpse of the state of the art in Portugal in the use of AI technologies, as well as some recommendations and good practices identified as important for the application of AI solutions in the healthcare area. Furthermore, as a rule, the use of AI in the health sector involves the processing of a special cat- egory of data: “sensitive” health data. Therefore, now more than ever, compliance with the rules of
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