EL(I)SE Requirements for implementation of SurPass

Important in the implementation process of the digital SurPass is to be aware of the Ethical, Legal, (Information Technologies & Interoperability), Social, Economic (EL(I)SE) factors influencing the implementation of new digital solutions and the acceptance and sustainability for all stakeholders and the European regulatory environment.

WP1 gathered information from the PanCareSurPass clinics representing three distinct health system scenarios: (1) national electronic health information systems (EHISs) in Austria and Lithuania, (2) regional or local EHISs in Italy and Spain, and (3) cancer registries or hospital-based EHISs in Belgium and Germany. via an online survey and Open Space workshops, with results published in peer-reviewed journals, which will be linked to in the Toolkit on the PanCare website.

Via the online survey, 54 barriers and 50 facilitators related to the care process, as well as ethical, legal, social and economical aspects, were identified. Among the main barriers were a lack of time and (financial) resources, gaps in knowledge concerning ethical and legal issues and a potential increase in health-related anxiety in CCSs upon receiving a SurPass. Main facilitators included institutions’ access to electronic medical records, as well as previous experience with SurPass or similar tools.

Via the Open Space meetings, key barriers to SurPass implementation were identified in the areas of care, ethical considerations, and information & IT. To address these barriers and facilitate the implementation of SurPass, 27 recommendations were formulated by the consortium. Key recommendations include using the internationally developed protocols and guidelines to implement LTFU care, making clear decisions about which parties have access to SurPass data in accordance with CCSs, and facilitating (semi)automated data transfer and filing using Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR).

In terms of IT specifically, the main barriers and facilitators in all three health system scenarios related to semiautomated data input and interoperability included unaligned EHIS infrastructure and the use of interoperability frameworks and international coding systems. The main barriers and facilitators related to data protection or privacy and cybersecurity included pseudonymization of personal health data and data retention.

These findings fed into the country-specific Implementation Strategies developed in WP2, along with results from an extensive literature review and stakeholder interview series in the PanCareSurPass clinic countries. Diversity in national and regional legislation creates enormous complexities in implementation efforts and requires quite different strategies on a national basis to find solutions fitting the respective EL(I)SE environment, such that a general Implementation Strategy cannot be included in the Toolkit. Clinics implementing the SurPass in future will be able to request further information on implementation strategies from the project that may align with their contexts from PanCare, via the Toolkit.

Experiences and Best Practices from the clinics

Below is a short description of how the participating clinics experienced the four ELSE dimensions during the implementation of the SurPass, which will be included in the Toolkit on the PanCare website. ELSE requirements, as well as the appropriate measures to address them in the implementation process, can vary greatly per country and local infrastructure.

Ethical requirements for the implementation of the SurPass are considerations like alignment with ethical principles (fairness, transparency, accountability, and human dignity) and avoiding bias, discrimination, and harm to users.

During the implementation of the digital SurPass, participating clinics described two main ethical challenges:

(I) Privacy compliance: The SurPass deals with sensitive medical data and it is important that the CCSs give informed consent before their data is included in the SurPass. Furthermore, implementation of GDPR requirements may differ per country and different measures had to be taken into account for the respective national requirements. To address this challenge during the implementation, data protection experts and ethical committees were consulted by the clinics to ensure privacy compliance.

(II) Sharing sensitive information about late effects: Some clinics noted that some survivors and caregivers were unaware of the risk of certain late effects (e.g. potential fertility issues) until they received the SurPass. As a result, receiving the SurPass became a distressing experience for them. This was mitigated by the clinics by practicing consent-based communication about late effects and including psychologists, where necessary.

Legal requirements during the implementation of the SurPass are compliance with GDPR (General Data Protection Regulation) for data privacy, sector-specific rules (e.g., medical devices regulation for health apps) and intellectual property rights, liability issues, and cybersecurity regulations.

The biggest legal challenge faced by the participating clinics was the compliance with national and international data protection laws which was already described within the ethical requirements above. This was mitigated by involving legal advisors and data protection experts. In some countries, patient data had to be (pseudo)anonymized before it was shared with the SurPass platform.

Societal requirements for the implementation of the SurPass include how society and stakeholder groups are affected by it. This includes accessibility, inclusion, societal value and expectations as well as the effect on employment, education, public trust, and digital literacy.

During the implementation of the SurPass, the participating clinics identified a two key social challenges:

(I) The barrier of addressing all survivors and their caregivers equally regardless of their background (e.g. digital literacy, language or education) was identified. Acknowledgement of the diverse background of survivors is important to ensure all survivors have equal access to the SurPass and connected healthcare.

(II) As already described under Ethical requirements above, some clinics reported that receiving sensitive information about potential late effects was a distressing experience for some survivors. The impact of this was mitigated by including psychologists in the process of disseminating the SurPass.

Lastly, the economic requirements address whether the implementation of the SurPass is financially viable and scalable, whether there is return on investment or cost-benefit for organizations and users and whether it aligns with national and European economic strategies.

The participating clinics stated that the biggest economic challenge of implementing the SurPass were the high costs of developing, certifying and maintaining/updating the SurPass. Within the scope of PanCareSurPass project, the provided funds could cover the majority of the expenses needed for a pilot implementation. For future implementation, it is important to consider that maintaining the digital SurPass will need ongoing funding.

Disclaimer

PanCare strives to provide accurate and complete information that is up-to-date as of the date of publication.

No warranty or representation, expressed or implied, is made concerning the accuracy, reliability, completeness, relevance, or timeliness of this information.

The PanCare materials are free to use for anyone aiming to inform about late effects and long-term survivorship care. However, no financial advantage may be achieved. All communication should reference PanCare and link to the PanCare website.

PanCareSurPass has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 899999. The material presented and views expressed here are the responsibilities of the author(s) only. The EU Commission takes no responsibility for any use made of the information set out.