During the 9 September 2021 meeting of the European Parliament’s Special Committee on Beating Cancer (BECA) regarding the European Health Data Space (EHDS), both digital twins and in silico medicine were mentioned by the Commission.
Representatives from the Commission’s Directorate-General for Health and Food Safety (DG SANTE) and Directorate-General for Communications Networks, Content and Technology (DG CNECT) presented the potential of the EHDS for cancer, focusing on both primary impacts on patients and secondary impacts on research and development.
The representatives specifically pointed out the current difficulties in sharing data, limited interoperability, fragmented infrastructures, and the limited control to – and access of – patients to their own data. They also described the difficulties related to reimbursement, labeling and certifications, and data privacy.
In response to these difficulties, the Commission is currently piloting the EHDS and conducting impact assessments, with the goal of having EU-wide infrastructure in 2025.
The representatives provided examples of initiatives that would be enabled by the EHDS, such as the European Cancer Imaging Initiative, which uses anonymised cancer patient data to develop digital technologies to diagnose and treat cancer. They also introduced a collection of Horizon 2020 projects related to cancer and data platforms(one of which is in silico) and included a slide describing the future potential of digital twin technology with three research project examples.
Finally, the representatives introduced the preliminary 2021-2022 work programme for Health in Digital Europe (still to be adopted). The proposed funding opportunities include the following, as well as additional topics not yet provided.
Thirteen BECA members and draft report rapporteur Veronique Trillet - Lenoir (Renew, FR)commented on the presentation. These are the main topics included in the BECA Response:
The balance of privacy and patient interests with research, development, and industry interests
The need to support and evaluate implementation to prevent a fragmented response as was seen with the General Data Protection Regulation (GDPR)
How to ensure equal access for all EU citizens and ensure trustworthiness
Commission Response
A second impact assessment is currently underway reviewing access and data interoperability, as well as funding and reimbursement mechanisms.
The Commission would currently prefer to approve the EHDS as a regulation, not a directive, to increase interoperability.
Key tools to improve trust and data security are being researched, including increased digital identification tools and ensuring that data is stationary and secure while algorithms “travel.”
Analysis
The creation of the European Health Data Space appears widely supported by all stakeholders, but its implementation remains uncertain – the fragmented and fractured nature of the EU’s digital domain will make it difficult for the project to reach its full potential and to make sure that all countries and their patients and researchers have adequate access.
The issues of trust and interoperability of different systems remain the main points of tension when it comes to the implementation of the EHDS, but experiences in the domain of data and the joint adoption of common frameworks in the field could lead us to believe that it will be extremely difficult for all EU countries to arrive at the same end-point simultaneously.
The regular and casual inclusion of digital twin technologies, in silico medicine, and other computer modelling health interventions in the discussions seems to be promising for further inclusion and regulation of in silico. Particularly, it reflects that the Commission realizes the value of recognizing and supporting technological innovations beyond just AI applications. This in turn provides additional grounds to call for Good Simulation Practice (GSP) standards as well as the establishment of a governance framework to support the training, testing, validation, and exploitation of all in silico technologies under the EHDS. The Avicenna Secretariat will make sure to highlight these objectives within communication to the Commission in the following months preceding the launch of the EHDS’ legislative proposal.
Additionally, the introduction of funding opportunities within the Digital Health Europe programme piques interest for an upcoming adopted release of funding options, some of which may be of interest to Avicenna.
Next Steps
The BECA Committee announced that, in the following meetings, they will focus on the draft report "Strengthening Europe in the fight against cancer – towards a comprehensive and coordinated strategy.” This meeting served to discuss related files.
Draft amendments to the file were due on 14 September 2021 and will be considered on 14 October 2021. A vote on the file is scheduled for 6 December 2021, and on 23 December 2021 the BECA mandate ends.
On 27 September 2021, the National Parliaments, BECA, and the European Commission will have a joint meeting to discuss the draft report.
A legislative proposal for the EHDS will be submitted at the start of 2022.
