Part of the project’s overall goal is to create a set of dermoscopic images that can be used in the development and training of image classification algorithms.
Once a model has been trained, a data set of previously unseen images can be inputted into the system, and it will be able to classify the images according to a pre-defined ruleset.
This module within iToBoS is developed through a series of training, testing, and refining processes that include the digestion of open data sets, such as those released by the International Skin Imaging Collaboration (ISIC), which “is an academia and industry partnership designed to facilitate the application of digital skin imaging to help reduce melanoma mortality…ISIC is creating resources for the dermatology and computer science communities, including a large and expanding open source public access archive of skin images”.[1]
European Health Data Spaces
The European Commission, through its European Strategy for Data[2], “aims at creating a single market for data that will ensure Europe’s global competitiveness and data sovereignty. Common European data spaces will seek to ensure that more data becomes available for use in the economy and society, while keeping the companies and individuals who generate the data in control.”
The overarching strategy includes the development, curation, and regulatory oversight of a European Health Data Space (EHDS)[3], which:
- supports individuals to take control of their own health data
- supports the use of health data for better healthcare delivery, better research, innovation and policy making
- enables the EU to make full use of the potential offered by a safe and secure exchange, use and reuse of health data[4]
To support this strategy, the European Commission have recently published a Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Health Data Space[5] which outlines the overarching legal framework for this European initiative. The proposal states:
“The EHDS will also promote better exchange and access to different types of electronic health data, including electronic health records, genomics data, patient registries etc. Not only will this support healthcare delivery (services and personnel involved in providing health care or primary use of electronic health data), it will also support health research, innovation, policy-making, regulatory purposes and personalised medicine purposes (secondary use of electronic health data). It will also establish mechanisms for data altruism in the health sector.”[6]
Stakeholder Input
The Expert Group for Integrated Care and Digital Health Europe (EGID) recently published their guiding principles for a European Health Data Space[7], providing input into the debate about what an effective framework for the guidance and maintenance of the EHDS looks like.
They propose that a health data ecosystem requires a series of systemic supports to foster benefit for the wide range of stakeholders in the domain. Critical elements to the ongoing success of health data spaces are viewed as:
- Policy flexibility
- Support innovation focused on improved patient outcomes
- Trust: working in the best interest of patients
- Better and interoperable data
- Digital health education
- Understanding the role of all players in the process (stakeholder inclusion)
The regulatory proposal from the European Commission also received a formal opinion from the European Data Protection Board (EDPB) and European Data Protection Supervisor (EDPS).[8] Their publication outlined some key concerns with the existing text of the Regulation.
A core component of the EDPB opinion lies within the proposals’ interaction with existing regulatory frameworks, such as GDPR and the ePrivacy Directive, as well as emerging legislative frameworks such as the Data Act[9], Data Governance Act[10], and the Artificial Intelligence (AI) Act.[11]
The EDPB also request greater consideration and clarity from the appropriate European legislative bodies on how newly bestowed rights provisioned for by the EDHS regulation interact with existing rights, provisioned for already by GDPR.
iToBoS and the future of open data
While iToBoS does not explicitly try and create a dermoscopic image data space, it does attempt to tackle some complex issues that underpin the concept of open data, especially with regards to data governance, data interoperability, and data altruism.
iToBoS partners, pursuant to compliance with GDPR, are establishing a series of legally binding agreements led by the project coordinator University of Girona (UdG). These agreements set out the purpose and scope of data processed in the project and state the expectations, rules, and organisational and technical measures implemented by project partners to safeguard individuals’ data protection rights.
The iToBoS project seeks to create model agreements, from which other European projects and data sharing initiatives in the wider medical research field can build upon as they engage with the nuanced discussions surrounding data controllership, data rights, data sharing, and the further processing of previously collected data. These conversations will continue in the project led by the coordinator, and supported by Szamitastechnikai es Automatizalasi Kutatointezet (SZTAKI), within work conducted in T4.4 - Data management.
With regards to data interoperability, iToBoS is ensuring it has cross project alignment of its data sharing practice, through the implementation of the Digital Imaging and Communications in Medicine (DICOM) standard for medical images. The project, through task T4.3 - Image data anonymization, is aligning its collected digital images with the industry accepted DICOM standard, which will aid secondary processing for further research and commercial use, across the fields of oncology and dermoscopy. This effort is being led by UdG with support from the clinical sites Fundació Clínic per a la Recerca Biomèdica (FCRB), Universita Degli Studi Di Trieste (UNITS), and the University of Queensland (UQ).
Finally, the project is attempting to understand and integrate a wide range of stakeholder perspectives on data altruism and the use of novel technology in the field of both dermoscopy and oncology, through work package WP11 - Patient engagement and education.
Project partners will engage in a series of open, transparent forums with patients, clinicians, health service providers, policy experts, and medical application developers to understand views and opinions on the ongoing initiative to foster open data practices. This work is being led by partner Melanoma Patients Network Europe (MPNE), supported by all other partners in the project.
Understanding and integrating a diverse set of opinions is crucial to developing a more trustworthy medical data landscape and will foster a sense of openness and transparency amongst a varied set of participants.
This effort should go some way to creating a sustainable and healthy data sharing ideology within medical practice, and support the development of a more fruitful data sharing ecosystem for patients, clinicians, researchers, and health service providers
References
[1] ISIC Archive, available at: https://www.isic-archive.com/#!/topWithHeader/tightContentTop/about/aboutIsicOverview
[2] https://digital-strategy.ec.europa.eu/en/policies/strategy-data
[3] https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space_en
[4] https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space_en
[5] Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Health Data Space, COM/2022/197 final, available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52022PC0197
[6] Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Health Data Space, COM/2022/197 final, p.2, available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52022PC0197
[7] https://ehma.org/wp-content/uploads/2021/12/The-European-Health-Data-Space-a-step-towards-digital-health-and-integrated-care-systems-EGIDE-FINAL-6-Dec.pdf
[8] https://edpb.europa.eu/our-work-tools/our-documents/edpbedps-joint-opinion/edpb-edps-joint-opinion-032022-proposal_en
[9] https://digital-strategy.ec.europa.eu/en/library/data-act-proposal-regulation-harmonised-rules-fair-access-and-use-data
[10] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52020PC0767
[11] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52021PC0206