The European General Data Protection Regulation (GDPR) stands as a cornerstone of data privacy legislation in the European Union (EU), impacting a myriad of sectors including healthcare and patients with cancer. For organisations like the European Society for Medical Oncology (ESMO), GDPR implementation has profound implications, shaping the landscape of cancer research and patient care both in the EU and globally.
ESMO’s contribution to the recently launched public consultation by the European Commission (EC) that aims to feed its forthcoming report on the implementation of the GDPR, emphasises the necessity to incorporate the day-to-day experiences of medical oncologists, including the main challenges and favourable solutions. With global membership exceeding 35,000 professionals from 172 countries, ESMO underscores the imperative inclusion of these frontline insights to further inform fit-for-purpose policy formulation.
ESMO’s feedback outlines several key points that should be envisaged in the implementation report:
- Impact on daily work: The implementation of GDPR has introduced multiple communication and coordination challenges within healthcare sector, impacting the delivery of cancer care services. Notably, there has been a visible increase in administrative burden reported by medical oncologists as well as additional financial costs across a range of studies. It has also resulted in delays and restrictions in data collection, creating hurdles in identifying health issues, particularly among minority groups.
- Impact on cancer research: The GDPR has also presented hurdles in data sharing and conducting retrospective studies across multiple cancer centres. It has led to difficulties in fostering collaboration across European countries, resulting in diminished research effectiveness.
- Impact on cancer registries: The Regulation has caused significant delays in conducting studies due to regulatory constraints imposed on cancer registries.
- Impact on cross-border cancer research projects: Multiple projects have encountered regulatory burdens and financial constraints, impeding their participation in crucial multinational studies, particularly those involving non-EU countries.
Proposed solutions
- Simplify and harmonize GDPR rules and interpretation to facilitate research collaboration within and beyond EU borders while upholding ethical principles.
- Standardise procedures across countries for multiple cancer research projects, ensuring effective collaboration and implementation, including the use of anonymised aggregate genomic data.
- Integrate clinical practice and research activities, particularly in consent for data use, to ensure comprehensive and high-quality cancer care for patients.
Incorporating these frontline perspectives and proposed changes will offer invaluable insights into practical implications of GDPR implementation, fostering conducive environment for cancer research and patient care.
About the GDPR
The GDPR, which entered into force on 25 May 2016, and has been applicable since 25 May 2018, is EU legislation that governs the processing and movement of personal data across the EU, and it sets EU-wide rules on data privacy as well as on how data is to be handled in the EU. Although the GDPR is not health-specific legislation, it introduced important changes impacting the collection and use of data for all sectors, including cancer research.
To access ESMO’s feedback click here.