PORTUGAL Trends and Developments Contributed by: Margarida Roda Santos, Paulo Sampaio Neves and Mariana Pereira Dias, Eversheds Sutherland
the General Data Protection Regulation (GDPR) is essential, particularly with regard to the rules on data minimisation, obtaining unequivocal consent from the data subject for the processing of data as required, automated profiling – which, because sensitive data is involved, requires that appropriate measures be applied to safeguard the rights and freedoms and legitimate inter- ests of the data subject – and the international transfer of data. Accordingly, it is necessary to ensure that those who develop AI solutions, as well as the health institutions themselves, imple- ment systems to guarantee compliance with the legislation, not least because in Portugal the national supervisory authority, the National Data Protection Commission ( Comissão Nacional de Protecção de Dados CNPD), is increasingly vigi- lant; fines of up to EUR20 million or 4% of world- wide annual turnover, whichever is higher, can be imposed for violating the GDPR. Alongside the aforementioned AI Act, the Council of the European Union adopted the Regulation on the European Health Data Space (the “EHDS Regulation” ), which aims to improve people’s access to and control over their personal elec- tronic health data, facilitating the international exchange of health data between health service providers located in various member states. The EHDS Regulation distinguishes two health data infrastructures: primary use of data (clinical con- text) and secondary use of data (for research, decision-making, etc). With the application of the EHDS Regulation, it is expected that people will have easier access to their electronic health data, regardless of where they are located (ie, in their country of origin or in any other member state). Therefore, each country in the European Union will have to designate at least one e-health authority, which
will be responsible for implementing these new provisions. The interoperability of data is also fundamental to the quality of AI, since the higher the quality of the data used to train AI systems, the more like- ly it is that the algorithms will provide accurate and reliable results. A structured, organised and accurate database will give AI systems greater capacity for analysis, reducing the risk of biased decisions and gross errors in healthcare. In Portugal, Order No 3030/2025 of 7 March designated the SPMS as the entity responsi- ble for co-ordinating the preparatory work for the implementation of the EHDS Regulation. As such, the SPMS will co-ordinate an interdiscipli- nary working group to monitor and follow up the implementation and development of electronic health record systems, in line with European guidelines. Electronic health record systems are essential if the EHDS Regulation is to be implemented effectively in Portugal, bearing in mind that citi- zens’ health information not only includes that which is collected and used within the scope of the National Health Service (NHS), but also that collected in other sectors. As such elec- tronic health records must be operationalised for health operators in all sectors that keep elec- tronic clinical records. Although the EHDS Regulation is ambitious and has the positive aim of promoting a true single market for electronic health record systems, it does present some obstacles that the compa- nies to which it applies must be aware of. As well as intellectual property, sensitive commercial information is at stake, so it is of great impor- tance for the organisations concerned to adapt accordingly.
250 CHAMBERS.COM
Powered by FlippingBook