HealthData@PT


FAQs

The digital transformation of healthcare in the European Union is greatly aided by the European Health data space (EHDS).  The EHDS puts citizens first by granting them complete control over their data, free of charge, so they can benefit from better healthcare delivery throughout the European Union. Additionally, the EHDS aims at providing a consistent and regulated framework for leveraging health data to accelerate health innovations and improve research studies, to ultimately lead to better live-saving medicines, healthcare policies and healthcare outcomes to all EU citizens. The EHDS has a regulation proposal, currently being debated and negotiated. For more information on EHDS regulation proposal, please consult the provided Link.

Personal information is handled and protected in compliance with current EU regulations. Regarding the primary use of data, in some countries, sharing of data may be allowed by law or need your signature on a consent form. Regarding the use of health data for research purposes (secondary use), several rules and principles apply for this data to be provided. For example, data needs to be anonymized in most cases. The anonymized data will be only provided for secondary use after a careful evaluation of the purpose motivating the request to use the data (for example, does the purpose has the intention to benefit healthcare services?). If the evaluation yields a positive outcome, the data will be shared in a manner that ensures the privacy of citizens and secure data processing.

The term “secondary use of health data” describes the use of collected health data for research, medical innovation and decision-making, towards improving citizens healthcare and providing a stronger health system. 

Some examples of secondary use of health data include:

  • Researchers using health data to identify risk factors for diseases before they manifest.
  • Researchers using health data to understand factors responsible for making a treatment more effective in specific individuals, towards tailoring medical care accordingly to each individual for better therapeutic outcomes.
  • Health professionals using health data to track the spread of diseases or to identify populations at risk for particular health issues.

Secondary use of health data can be a helpful tool for enhancing population health and well-being. Nevertheless, the EU is committed in providing a regulated and safe environment for this data to be used, defending citizen’s privacy, and ensuring that the information is being used properly. The guidelines, processes and frameworks to accomplish this are being discussed, under the scope of the EHDS regulation proposal, available at the Link.

Personal information is handled and protected in compliance with current EU regulations. Regarding the primary use of data, in some countries, sharing of data may be allowed by law or need your signature on a consent form. Regarding the use of health data for research purposes (secondary use), several rules and principles apply for this data to be provided. For example, data needs to be anonymized in most cases. The anonymized data will be only provided for secondary use after a careful evaluation of the purpose motivating the request to use the data (for example, does the purpose has the intention to benefit healthcare services?). If the evaluation yields a positive outcome, the data will be shared in a manner that ensures the privacy of citizens and secure data processing.

This project aims to set the groundwork necessary to warrant the access and secure use of health data for secondary use.  The objective of HealthData@PT is to make data accessible through a national dataset catalogue for secondary use of health data. Access will occur through a management system capable to receive, process and reply to health data access requests in a short timeframe. Such system will be deployed in a way to ensure citizen’s privacy along with heath data with a high-quality for re-use purposes.  

Furthermore, this project aims to provide the groundwork necessary to make health data usable in a cross-border setting for secondary use. This is an essential initial phase for preparing Portugal for its participation in HealthData@EU (or EHDS2 – European Health Data Space 2), an European infrastructure for the secondary use of health data,  which will be similar to  MyHealth@ EU, but aiming at secondary use of health data.

Researchers, innovators, policy makers and regulators that have presented a data assessment request, that was evaluated accordingly to a set of guidelines, and had a positive appreciation.


The HealthData@PT action is co-funded by the European Union, EU4Health Program 2021-2027 under Grant Agreement Nr 101128332. The views and opinions expressed are those of the author(s) and do not necessarily reflect the position of the European Union or HaDEA. Neither the European Union nor the grant-awarding authority can be held responsible for these opinions.

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