The Transforming Breast Cancer Together initiative (TBCT) believes that cancer care would benefit from the effective exploitation of the momentum of digitalisation and enhanced access to health data. Data, including Real-World Data/Evidence, is a powerful tool for detecting diseases, decision-making for clinical care, supporting innovation, and patient management and monitoring.
TBCT welcomes the European Commission’s proposal for a European Health Data Space (EHDS), which aims to:
- Empower individuals to increase and control digital access to their personal health data, support its free movement, and promote a single market for digital health services and products. In this way, breast cancer patients will have the possibility to access their health records anytime and anywhere across the EU
- Facilitate access to health data for research, innovation, policymaking and regulatory decision-making, ensuring the development of new and more personalised medicines for both early and metastatic patients
The interoperability of data will enable the creation of an EU-harmonised registry to collect breast cancer data, increasing the chances of successful diagnosis and treatment for breast cancer patients.
To improve diagnosis, the European Institutions should support Members States by:
- Leveraging the European Health Data Space (EHDS) to create an EU-harmonised registry for breast cancer data, including metastatic breast cancer data. Currently, most European cancer registries do not collect data on relapse, and therefore, we do not know how many Europeans are living with metastatic cancer
- Ensure access to interoperable electronic data, patients’ health records and clinical information for primary and secondary uses, and enable access and exchange of data for innovation purposes
- Leveraging the EHDS to improve screening, quality of diagnosis and care and facilitate personalised medicine
Access to care
Data and Real-World Data/Evidence are critical to assess quality, performance, safety, effectiveness of treatments, and to inform policy decisions. Through the promotion of data standards and interoperability, the EHDS should enable the creation of more robust databases and knowledge centres which will support innovation and improve intervention in breast cancer.
To improve access to care, the European institutions should support Member States by:
- Supporting outcome-based healthcare and the establishment of a strong EHDS, one that will improve prevention and early diagnosis of breast cancer and will facilitate the optimisation of treatment and care
- Supporting the establishment of a European interoperable format of electronic health records (EHRs), allowing patients to access their records and clinical information free of charge and be able to share with oncologists, radiologists, surgeons and healthcare providers
- Leveraging the EHDS to ensure data can be used to develop innovative cancer treatments and diagnostics, by facilitating access to a wide range of data sources and data types (including EHRs data, clinical data, Real World Data/Evidence). This will lead to better identification of the existing gaps in cancer treatment and supports the goals of Europe’s Beating Cancer Plan and the Mission on Cancer
Data literacy and patients’ empowerment
The EHDS aims to ensure that patients are empowered and understand their data rights, how to access their data and how their data is used and can contribute to the creation of Real-World Evidence. Additionally, the EHDS aims to equip healthcare professionals with adequate digital skills and tools to access data.
TBCT calls on policymakers at EU and national level to:
- Ensure that the EHDS supports the development of digital literacy of both patients and healthcare professionals. Digital solutions are only as effective as the extent to which they are understood and implemented, it is therefore pivotal that patients and healthcare professionals are equipped with the digital skills required to make full use of the EHDS
- Promote digital literacy in order to foster trust amongst both patients and healthcare professionals and enable them to benefit from digital health solutions and technologies. Increased digital literacy empowers patients and allows them to understand how and why their data is accessed, exchanged and used, which increases patients’ confidence in sharing it for both primary and secondary purposes
- Ensure that the EHDS supports the development of user-friendly interfaces for both patients and healthcare professionals. It is pivotal that patients and healthcare professionals are equipped with user-friendly digital tools to make full use of the EHDS
- Establish a feedback mechanism to gather input from breast cancer patients, their caregivers, and healthcare professionals
Quality of care
To improve the quality of care of people living with breast cancer, the European Institutions should ensure:
- Appropriate and timely implementation of the EBCP’s initiatives, including ‘Cancer patients securely accessing and sharing electronic health record through European Health Data Space’ and ‘Support secondary access to data’
- Quick and effective exchange of information between healthcare providers across the EU, enables improved and quicker diagnosis and treatment of breast cancer patients, as well as facilitating large clinical studies to improve the understanding of diseases, development of new care models and guidelines, amongst others. In order to ensure all Europeans benefit from the EHDS and that pan-European clinical studies can be conducted, the Commission should look to address the digital divide across different Member States
- Development of ‘self-management’ tools and extensions of existing tools, such as ‘Cancer Survivor Smart-Card’, not only limited to cancer survivors but also to patients who are undergoing their treatment, especially metastatic patients. These tools would help patients and survivors improve their quality of life and quality of care