IT-Related Barriers and Facilitators to the Implementation of a New European eHealth Solution, the Digital Survivorship Passport (SurPass Version 2.0): Semistructured Digital Survey.

BACKGROUND: To overcome knowledge gaps and optimize long-term follow-up (LTFU) care for childhood cancer survivors, the concept of the Survivorship Passport (SurPass) has been invented. Within the European PanCareSurPass project, the semiautomated and interoperable SurPass (version 2.0) will be optimized, implemented, and evaluated at 6 LTFU care centers representing 6 European countries and 3 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. OBJECTIVE: We aimed to identify and describe barriers and facilitators for SurPass (version 2.0) implementation concerning semiautomation of data input, interoperability, data protection, privacy, and cybersecurity. METHODS: IT specialists from the 6 LTFU care centers participated in a semistructured digital survey focusing on IT-related barriers and facilitators to SurPass (version 2.0) implementation. We used the fit-viability model to assess the compatibility and feasibility of integrating SurPass into existing EHISs. RESULTS: In total, 13/20 (65%) invited IT specialists participated. The main barriers and facilitators in all 3 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. According to the fit-viability model, the first health system scenario provides the best fit for SurPass implementation, followed by the second and third scenarios. CONCLUSIONS: This study provides essential insights into the information and IT-related influencing factors that need to be considered when implementing the SurPass (version 2.0) in clinical practice. We recommend the adoption of Health Level Seven Fast Healthcare Interoperability Resources and data security measures such as encryption, pseudonymization, and multifactor authentication to protect personal health data where applicable. In sum, this study offers practical insights into integrating digital health solutions into existing EHISs.

The Role of HL7 FHIR in the European Project GATEKEEPER.

The European Project GATEKEEPER aims to develop a platform and marketplace to ensure a healthier independent life for the aging population. In this platform the role of HL7 FHIR is to provide a shared logical data model to collect data in heterogeneous living, which can be used by AI Service and the Gatekeeper HL7 FHIR Implementation Guide was created for this purpose. Independent pilots used this IG and illustrate the impact of the approach, benefit, value, and scalability.

Design and Adoption of a FHIR IG to Support a Telemonitoring Environment in Gatekeeper Project.

Telemedicine can provide benefits in patient affected by chronic diseases or elderly citizens as part of standard routine care supported by digital health. The GATEKEEPER (GK) Project was financed to create a vendor independent platform to be adopted in medical practice and to demonstrate its effect, benefit value, and scalability in 8 connected medical use cases with some independent pilots. This paper, after a description of the GK platform architecture, is focused on the creation of a FHIR (Fast Healthcare Interoperability Resource) IG (Implementation Guide) and its adoption in specific use cases. The final aim is to combine conventional data, collected in the hospital, with unconventional data, coming from wearable devices, to exploit artificial intelligence (AI) models designed to evaluate the effectiveness of a new parsimonious risk prediction model for Type 2 diabetes (T2D).

Experience from the Development of HL7 FHIR IG for Gatekeeper Project.

The GATEKEEPER (GK) Project was financed by the European Commission to develop a platform and marketplace to share and match ideas, technologies, user needs and processes to ensure a healthier independent life for the aging population connecting all the actors involved in the care circle. In this paper, the GK platform architecture is presented focusing on the role of HL7 FHIR to provide a shared logical data model to be explored in heterogeneous daily living environments. GK pilots are used to illustrate the impact of the approach, benefit value, and scalability, suggesting ways to further accelerate progress.

Barriers and facilitators to implementation of the interoperable Survivorship Passport (SurPass) v2.0 in 6 European countries: a PanCareSurPass online survey study.

PURPOSE: Long-term follow-up (LTFU) care for childhood cancer survivors (CCSs) is essential to improve and maintain their quality of life. The Survivorship Passport (SurPass) is a digital tool which can aid in the delivery of adequate LTFU care. During the European PanCareSurPass (PCSP) project, the SurPass v2.0 will be implemented and evaluated at six LTFU care clinics in Austria, Belgium, Germany, Italy, Lithuania and Spain. We aimed to identify barriers and facilitators to the implementation of the SurPass v2.0 with regard to the care process as well as ethical, legal, social and economical aspects. METHODS: An online, semi-structured survey was distributed to 75 stakeholders (LTFU care providers, LTFU care program managers and CCSs) affiliated with one of the six centres. Barriers and facilitators identified in four centres or more were defined as main contextual factors influencing implementation of SurPass v2.0. RESULTS: Fifty-four barriers and 50 facilitators 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. CONCLUSIONS: We provided an overview of contextual factors that may influence SurPass implementation. Solutions should be found to overcome barriers and ensure effective implementation of SurPass v2.0 into routine clinical care. IMPLICATIONS FOR CANCER SURVIVORS: These findings will be used to inform on an implementation strategy tailored for the six centres.

FAIRness for FHIR: Towards Making Health Datasets FAIR Using HL7 FHIR.

Medical data science aims to facilitate knowledge discovery assisting in data, algorithms, and results analysis. The FAIR principles aim to guide scientific data management and stewardship, and are relevant to all digital health ecosystem stakeholders. The FAIR4Health project aims to facilitate and encourage the health research community to reuse datasets derived from publicly funded research initiatives using the FAIR principles. The 'FAIRness for FHIR' project aims to provide guidance on how HL7 FHIR could be utilized as a common data model to support the health datasets FAIRification process. This first expected result is an HL7 FHIR Implementation Guide (IG) called FHIR4FAIR, covering how FHIR can be used to cover FAIRification in different scenarios. This IG aims to provide practical underpinnings for the FAIR4Health FAIRification workflow as a domain-specific extension of the GoFAIR process, while simplifying curation, advancing interoperability, and providing insights into a roadmap for health datasets FAIR certification.

Factors Influencing Implementation of the Survivorship Passport: The IT Perspective.

Compared to the general population, childhood cancer survivors represent a vulnerable population as they are at increased risk of developing health problems, known as late effects, resulting in excess morbidity and mortality. The Survivorship Passport aims to capture key health data about the survivors and their treatment, as well as personalized recommendations and a care plan with the aim to support long-term survivorship care. The PanCareSurPass (PCSP) project building on the experience gained in an earlier implementation in Giannina Gaslini Institute, Italy, will implement and rigorously assess an integrated, HL7 FHIR based, implementation of the Survivorship Passport. The six implementation countries, namely Austria, Belgium, Germany, Italy, Lithuania, and Spain, are supported by different national or regional digital health infrastructures and Electronic Medical Record (EMR) systems. Semi structured interviews were carried out to explore potential factors affecting implementation, identify use cases, and coded data that can be semi-automatically transferred from the EMR to SurPass. This paper reflects on findings of these interviews and confirms the need for a multidisciplinary and multi-professional approach towards a sustainable and integrated large-scale implementation of the Survivorship Passport across Europe.

An Agile Approach to Accelerate Development and Adoption of Electronic Product Information Standards.

The Medical Product Information found in most medication boxes offer a wealth of information, including terms of active ingredients, excipients, indications, dosage, route of administration, risks, and safety information. Digital health services that help patients, their care givers, and health professionals to manage medication, can be improved with tailored information based on user profile, the patient's Electronic Health Record (EHR) summary, and Medicinal Product Information. The electronic Product information (ePI) comprises the summary of product characteristics, package leaflet, and product label. The European Medicines Agency released in 2021 the first version of the EU proof-of-concept ePI standard based on HL7 FHIR. The Gravitate-Health project uses this common standard as a springboard to implement a federated open-source platform and services that helps advance access, understanding, and adherence by providing trusted medicinal information in an interoperable and scalable way. In this paper, we present the agile technical approach and co-creation process to design, test, and progressively mature interoperability working with the HL7 Vulcan Accelerator and FHIR connectathons.

FAIR4Health: Findable, Accessible, Interoperable and Reusable data to foster Health Research.

Due to the nature of health data, its sharing and reuse for research are limited by ethical, legal and technical barriers. The FAIR4Health project facilitated and promoted the application of FAIR principles in health research data, derived from the publicly funded health research initiatives to make them Findable, Accessible, Interoperable, and Reusable (FAIR). To confirm the feasibility of the FAIR4Health solution, we performed two pathfinder case studies to carry out federated machine learning algorithms on FAIRified datasets from five health research organizations. The case studies demonstrated the potential impact of the developed FAIR4Health solution on health outcomes and social care research. Finally, we promoted the FAIRified data to share and reuse in the European Union Health Research community, defining an effective EU-wide strategy for the use of FAIR principles in health research and preparing the ground for a roadmap for health research institutions. This scientific report presents a general overview of the FAIR4Health solution: from the FAIRification workflow design to translate raw data/metadata to FAIR data/metadata in the health research domain to the FAIR4Health demonstrators' performance.

The International Patient Summary Standard and the Extensibility Requirement.

The International Patient Summary Standard (EN 17269) normalizes the dataset within the European Guideline on cross-border exchange of a patient summary. This dataset has been widely appreciated and been taken as the basis for projects in both Europe and wider afield, e.g. U.S.A, Canada and more. The dataset is a relatively mature dataset and it is currently in its third iteration (i.e., 2013, 2016, 2020). Even so, to move from a policy-driven guideline to a formal standard was not straight forward. The paper describes how the 'minimal and non-exhaustive' dataset could be the basis for a reference standard; one that was intended to facilitate both an 'implementable' and 'sustainable' solution. In particular, the requirement of 'extensibility' for the standard dataset had to be addressed.

From Raw Data to FAIR Data: The FAIRification Workflow for Health Research.

BACKGROUND: FAIR (findability, accessibility, interoperability, and reusability) guiding principles seek the reuse of data and other digital research input, output, and objects (algorithms, tools, and workflows that led to that data) making them findable, accessible, interoperable, and reusable. GO FAIR - a bottom-up, stakeholder driven and self-governed initiative - defined a seven-step FAIRification process focusing on data, but also indicating the required work for metadata. This FAIRification process aims at addressing the translation of raw datasets into FAIR datasets in a general way, without considering specific requirements and challenges that may arise when dealing with some particular types of data. OBJECTIVES: This scientific contribution addresses the architecture design of an open technological solution built upon the FAIRification process proposed by "GO FAIR" which addresses the identified gaps that such process has when dealing with health datasets. METHODS: A common FAIRification workflow was developed by applying restrictions on existing steps and introducing new steps for specific requirements of health data. These requirements have been elicited after analyzing the FAIRification workflow from different perspectives: technical barriers, ethical implications, and legal framework. This analysis identified gaps when applying the FAIRification process proposed by GO FAIR to health research data management in terms of data curation, validation, deidentification, versioning, and indexing. RESULTS: A technological architecture based on the use of Health Level Seven International (HL7) FHIR (fast health care interoperability resources) resources is proposed to support the revised FAIRification workflow. DISCUSSION: Research funding agencies all over the world increasingly demand the application of the FAIR guiding principles to health research output. Existing tools do not fully address the identified needs for health data management. Therefore, researchers may benefit in the coming years from a common framework that supports the proposed FAIRification workflow applied to health datasets. CONCLUSION: Routine health care datasets or data resulting from health research can be FAIRified, shared and reused within the health research community following the proposed FAIRification workflow and implementing technical architecture.

A Privacy Management Analysis (PMA) of Exchanging International Patient Summary.

This paper provides a summary of the Privacy Management Analysis method followed for the analysis of the International Patient Summary exchange use cases of Trillium II Project. The objective is to recommend the required security and privacy measures by providing traceability from Regulations/Principles/Preferences to the recommended Security & Privacy Measures that needs to be implemented in pilots.

Interoperability Assets for Patient Summary Components: A Gap Analysis.

The International Patient Summary (IPS) standards aim to define the specifications for a minimal and non-exhaustive Patient Summary, which is specialty-agnostic and condition-independent, but still clinically relevant. Meanwhile, health systems are developing and implementing their own variation of a patient summary while, the eHealth Digital Services Infrastructure (eHDSI) initiative is deploying patient summary services across countries in the Europe. In the spirit of co-creation, flexible governance, and continuous alignment advocated by eStandards, the Trillum-II initiative promotes adoption of the patient summary by engaging standards organizations, and interoperability practitioners in a community of practice for digital health to share best practices, tools, data, specifications, and experiences. This paper compares operational aspects of patient summaries in 14 case studies in Europe, the United States, and across the world, focusing on how patient summary components are used in practice, to promote alignment and joint understanding that will improve quality of standards and lower costs of interoperability.

Interoperability standards enabling cross-border patient summary exchange.

In an increasingly mobile world, many citizens and professionals are frequent travellers. Access during unplanned care to their patient summary, their most essential health information in a form physicians in another country can understand can impact not only their safety, but also the quality and effectiveness of care. International health information technology (HIT) standards such as HL7 CDA have been developed to advance interoperability. Implementation guides (IG) and IHE profiles constrain standards and make them fit for the purpose of specific use cases. A joint effort between HL7, IHE, and HealthStory created Consolidated CDA (C-CDA), a set of harmonized CDA IGs for the US that is cited in the Meaning Use II (MU-II) regulation. In the EU, the Patient Summary (PS) Guideline recently adopted, cites the epSOS IG also based on HL7 CDA, to support cross-border care in the EU and inform national eHealth programs. Trillium Bridge project supports international standards development by extending the EU PS Guideline and MU-II in the transatlantic setting. This paper presents preliminary findings from comparing patient summaries in the EU and US and reflects on the challenge of implementing interoperable eHealth systems in the cross-border or transatlantic setting.