FAQ

Yes, the Bigpicture platform will be fully compliant with the European General Data Protection Regulation (GDPR), ensuring adequate usage of data while fully respecting patients’ privacy and data confidentiality.

The project is funded by the EU Innovative Medicines Initiative (IMI) who works to improve health by speeding up the development of, and patient access to, innovative medicines, particularly in areas where there is an unmet medical or social need. IMI is a partnership between the European Union (represented by the European Commission) and the European pharmaceutical industry (represented by EFPIA, the European Federation of Pharmaceutical Industries and Associations), facilitating collaboration between the key players involved in health research, including universities, research centres, the pharmaceutical and other industries, small and medium-sized enterprises (SMEs), patient organizations, and medicines regulators.

The pharmacuitical industry will identify and supply 2 million of high quality annotated non-clinical slides from different safety and research studies. They will also contribute to building the infrastructure, creating relevant AI methods, interacting with regulators to ensure acceptability of AI-boosted drug development. 

The EFPIA partners will bring the background of general knowledge they accumulated in other IMI projects like eTRANSAFE, eTOX, especially in the area of harmonization of nomenclature and shareability of data.

The safety of your medical record is guarded by European regulation, notably the General Data Protection Regulation (GDPR) and national laws. Bigpicture will operate in full compliance with GDPR and national laws. In short, this means that any data related to personal health may only be used under strict conditions like irreversible anonymity or legal grounds for pseudonymized use. The most common legal ground is that you have given informed consent to share your data for research purposes. You can never be personally identified by the data or images in the repository. For more information on GDPR see https://gdpr.eu/. 

Access to the collection will be limited to consortium partners and authorized third parties. Access is regulated by specific arrangements upon access of individual data series. Compliance with the General Data Protection Regulation and specific arrangements will be checked when providing access. This process will be managed by a so-called ‘honest broker’: a system of procedures, software tools and responsible partners that set-up and monitor the trustworthiness of the platform.  

"You go faster on your own, but you get farther together”. The broad commitment to this project is an absolute necessity for putting together a unique collection of knowledge in all the related aspects, for procurement of data series and for creating European coverage and adoption of the repository. Especially considering that Bigpicture should exist long after the project ends, we will start building a strong and broad community to support it, early on. 

As any other research project involving the use of clinical data, Bigpicture is governed by high ethical standards ensured by the presence of several control mechanisms. First, sharing the patient data with Bigpicture has to be authorised by a local ethic board in the hospital where the patient is treated. Then when data are brought into the repository a mechanism ensures that all the authorisation are checked and that only the allowed data is shared. Finally, the entire project is monitored by an ethics review board.

The initial collection will contain 3 million images, which is expected to require 5 petabytes (i.e. 5000 terabytes) of storage space. Of course, we hope that the collection will grow in the future and even become much larger than that. 

The Bigpicture project is purely a research project. All images and data that are collected and stored are only included AFTER the pathologists have done their work. In no way will this project interfere with the quality and speed of regular diagnostics in any hospital. Also, as the platform only collects digital slides, the original tissue specimen will remain available for additional analyses if commanded by the clinical situation.