The last decade has not only seen an explosion in the amount of data captured, shared and stored, but has also witnessed a change in the way data is processed. However, when it comes to self-care and healthcare, the permitted use of data for research, improving tools or assessing personal needs is rather limited.

While welcoming and strongly supporting initiatives already launched by regulators (e.g., General Data Protection Regulation – GDPR, European Data Strategy, European Health Data Space, etc.), the self-care industry is calling for more concrete authorized applications and data infrastructures for self-care developed and managed in the EU to unlock the potential of data.

In particular, data obtained from the real-world use of medicines and health products can be useful to regulators. In a pioneering article, AESGP experts shed light on the importance of existing and potential applications of real-world data (RWD) and real-world evidence (RWE) for non-prescription medicines and how they can help in regulatory decision-making throughout the lifecycle of self-care medicines.

In addition, AESGP’s position on the European Health Data Space initiative highlights the need to accompany improved data sharing with the necessary (digital) literacy programs.