With this consultation, the European Commission seeked to gather input in the development of the legal framework for a European Health Data Space (EHDS). The creation of the EHDS has become a priority for the Commission as the COVID-19 pandemic has highlighted the importance of having timely access to health data.
The establishment of the EHDS is expected to have a significant effect on the developments of innovations in health care. Among other things, the Commission wants to push for innovations increasing the cost-effectiveness for patients and healthcare systems, optimising treatment options, facilitating personalised medicine and improving the monitoring of healthcare products.
The Avicenna Alliance reflected within its contribution its perspective on the access and use of health data, the development and use of digital health services and products as well as the development and use of artificial intelligence in healthcare. We would like to thank Avicenna Members for their contributions, and more particularly, the Members who have provided us with their input: Voisin Life Sciences Consulting, Johnson & Johnson, Ansys, the Virtual Physiological Human institute (VPHi), MCR, University Hospital Heidelberg and Medtronic.
Following the ongoing consultation process, the Commission is expected to publish a new legislative proposal (Regulation) on the EHDS by the end of 2021.
Rare diseases & paediatric regulations
The aim of this consultation on the Regulations of medicines for children and rare diseases was to collect stakeholder views and experiences to examine what barriers currently exist to the treatments for children and individuals with rare diseases.
The Avicenna Alliance used this opportunity to put forward insights on major challenges when it comes to treatments for children and patients with rare diseases and especially their inputs on how to address these with the use of in silico medicine. We would like to thank Avicenna Members for their contributions, and specifically the Members who have provided us with their input: Voisin Life Sciences Consulting, University of Catania, the Virtual Physiological Human institute (VPHi), Johnson & Johnson and Servier.
This contribution via the online questionnaire will support the evaluation of the current Regulations and feed into the preparation work of the European Commission to put forward new legislative proposals in the first quarter of 2022.