Childhood Cancer Survivorship Passport Challenges in the European Health Data Space.

Innovation in cancer therapy has increased childhood cancer survival rates. However, survivors are still at risk of developing late effects. In the digital transformation of the health sector, the Survivorship Passport (SurPass) can support long-term follow-up care plans. Gaps in seamless connectivity among hospital departments, primary care, combined with the time of health professionals required to collect and fill-in health data in SurPass, are barriers to its adoption in daily clinical practice. The PanCareSurPass (PCSP) project was motivated to address these gaps by a new version of SurPass (v2.0) that supports semi-automatic assembly from organizational Electronic Health Record (EHR) systems of the treatment summary data using HL7 FHIR, to create SurPass, and to link it to regional or national digital health infrastructures in six European countries. In this paper we present the methodology used to develop the SurPass technical implementation strategy with special focus on the European Health Data Space (EHDS). The recently provisionally approved EHDS regulation instruments a digital health data ecosystem with opportunities for cost-effective SurPass implementation across Europe. Moving forward, a European HL7 FHIR SurPass Implementation Guide along with synthetic data sets, and validation tools can enrich the European Electronic Health Record Exchange Format (EEHRxF) with use cases on health & wellness of childhood cancer survivors.

Transforming Ontology Web Language Elements into Common Terminology Service 2 Terminology Resources.

Communication and cooperation are fundamental for the correct deployment of P5 medicine, and this can be achieved only by correct comprehension of semantics so that it can aspire to medical knowledge sharing. There is a hierarchy in the operations that need to be performed to achieve this goal that brings to the forefront the complete understanding of the real-world business system by domain experts using Domain Ontologies, and only in the last instance acknowledges the specific transformation at the pure information and communication technology level. A specific feature that should be maintained during such types of transformations is versioning that aims to record the evolution of meanings in time as well as the management of their historical evolution. The main tool used to represent ontology in computing environments is the Ontology Web Language (OWL), but it was not created for managing the evolution of meanings in time. Therefore, we tried, in this paper, to find a way to use the specific features of Common Terminology Service-Release 2 (CTS2) to perform consistent and validated transformations of ontologies written in OWL. The specific use case managed in the paper is the Alzheimer's Disease Ontology (ADO). We were able to consider all of the elements of ADO and map them with CTS2 terminological resources, except for a subset of elements such as the equivalent class derived from restrictions on other classes.

HL7 Fast Healthcare Interoperability Resources (HL7 FHIR) in digital healthcare ecosystems for chronic disease management: Scoping review.

BACKGROUND: The prevalence of chronic diseases has shifted the burden of disease from incidental acute inpatient admissions to long-term coordinated care across healthcare institutions and the patient's home. Digital healthcare ecosystems emerge to target increasing healthcare costs and invest in standard Application Programming Interfaces (API), such as HL7 Fast Healthcare Interoperability Resources (HL7 FHIR) for trusted data flows. OBJECTIVES: This scoping review assessed the role and impact of HL7 FHIR and associated Implementation Guides (IGs) in digital healthcare ecosystems focusing on chronic disease management. METHODS: To study trends and developments relevant to HL7 FHIR, a scoping review of the scientific and gray English literature from 2017 to 2023 was used. RESULTS: The selection of 93 of 524 scientific papers reviewed in English indicates that the popularity of HL7 FHIR as a robust technical interface standard for the health sector has been steadily rising since its inception in 2010, reaching a peak in 2021. Digital Health applications use HL7 FHIR in cancer (45 %), cardiovascular disease (CVD) (more than 15 %), and diabetes (almost 15 %). The scoping review revealed that references to HL7 FHIR IGs are limited to âˆ¼ 20 % of articles reviewed. HL7 FHIR R4 was most frequently referenced when the HL7 FHIR version was mentioned. In HL7 FHIR IGs registries and the internet, we found 35 HL7 FHIR IGs addressing chronic disease management, i.e., cancer (40 %), chronic disease management (25 %), and diabetes (20 %). HL7 FHIR IGs frequently complement the information in the article. CONCLUSIONS: HL7 FHIR matures with each revision of the standard as HL7 FHIR IGs are developed with validated data sets, common shared HL7 FHIR resources, and supporting tools. Referencing HL7 FHIR IGs cataloged in official registries and in scientific publications is recommended to advance data quality and facilitate mutual learning in growing digital healthcare ecosystems that nurture interoperability in digital health innovation.

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.

Standardization Proposal for the Transmission of Waiting List Data in Italy.

Each Italian region is required to manage and disclose data relating to waiting times for healthcare services which are provided by both public and private hospitals and local health units accredited to the Sistema Sanitario Nazionale (SSN - in English, National Healthcare System). The current law governing data relating to waiting times and their sharing is the Piano Nazionale di Governo delle Liste di Attesa (PNGLA - in English National Government Plan for Waiting Lists). However, this plan does not propose a standard to monitor such data, but only provides a few guidelines that the Italian regions are required to follow. The lack of a specific technical standard for managing sharing of waiting list data and the lack of precise and binding information in the PNGLA make the management and transmission of such data problematic, reducing the interoperability necessary to have an effective and efficient monitoring of the phenomenon. The proposal for a new standard for the transmission of waiting list data derives from these shortcomings. This proposed standard promotes greater interoperability, is easy to create with an implementation guide, and has sufficient degrees of freedom to assist the document author.

CTS2 OWL: Mapping OWL Ontologies to CTS2 Terminology Resources.

The advancement of healthcare towards P5 medicine requires communication and cooperation between all actors and institutions involved. Interoperability must go beyond integrating data from different sources and include the understanding of the meaning of the data in the context of concepts and contexts they represent for a specific use case. In other words, we have to advance from data sharing through sharing semantics up to sharing clinical and medical knowledge. According to the Good Modeling Best Practices, we have to start with describing the real-world business system by domain experts using Domain Ontologies before transforming it into an information and communication technology (ICT) system, thereafter specifying the informational components and then transforming the system into an implementable solution. Any representation style - in the system development process acc. to ISO 10746 called system view - is defined by a related ontology, to be distinguished from real-world domain ontologies representing the knowledge spaces of involved disciplines. The system enabling such representational transformation shall also support versioning as well as the management of historical evolutions. One of such systems is the Common Terminology Service Release 2 (CTS2), which is a standard that allows the complete management of terminological contents. The main objective of this work is to present the choices we made to transform an ontology, written in the standard Ontology Web Language (OWL), into the CTS2 objects. We tested our transformation approach with the Alzheimer's Disease Ontology. We managed to map all the elements of the considered ontology to CTS2 terminological resources, except for a subset of elements such as the equivalentClass derived from restrictions on other classes.

A NLP Pipeline for the Automatic Extraction of a Complete Microorganism's Picture from Microbiological Notes.

The Italian "Istituto Superiore di Sanità" (ISS) identifies hospital-acquired infections (HAIs) as the most frequent and serious complications in healthcare. HAIs constitute a real health emergency and, therefore, require decisive action from both local and national health organizations. Information about the causative microorganisms of HAIs is obtained from the results of microbiological cultures of specimens collected from infected body sites, but microorganisms' names are sometimes reported only in the notes field of the culture reports. The objective of our work was to build a NLP-based pipeline for the automatic information extraction from the notes of microbiological culture reports. We analyzed a sample composed of 499 texts of notes extracted from 1 month of anonymized laboratory referral. First, our system filtered texts in order to remove nonmeaningful sentences. Thereafter, it correctly extracted all the microorganisms' names according to the expert's labels and linked them to a set of very important metadata such as the translations into national/international vocabularies and standard definitions. As the major result of our pipeline, the system extracts a complete picture of the microorganism.

A NLP Pipeline for the Automatic Extraction of Microorganisms Names from Microbiological Notes.

According to the "Istituto Superiore di Sanita'" (ISS), hospital infections are the most frequent and serious complication of health care. This constitutes a real health emergency which requires incisive and joint action at all levels of the local and national health organization. Most of the valuable information related to the presence of a specific microorganism in the blood are written into the notes field of the laboratory exams results. The main objective of this work is to build a Natural Language Processing (NLP) pipeline for the automatic extraction of the names of microorganisms present in the clinical texts. A sample of 499 microbiological notes have been analysed with the developed system and all the microorganisms names have been extracted correctly, according to the labels given by the expert.

Semantics Management for a Regional Health Information System in Italy by CTS2 and FHIR.

An infrastructure for the management of semantics is being developed to support the regional health information exchange in Veneto - an Italian region which has about 5 million inhabitants. Terminology plays a key role in the management of the information fluxes of the Veneto region, in which the management of electronic health record is given great attention. An architecture for the management of the semantics of laboratory reports has been set up, adopting standards by HL7. The system has been initially developed according to the common terminology service release 2 (CTS2) standard and, in order to overcome complexities of CTS2 is being revised according to the Fast Healthcare Interoperability Resources (FHIR) standard, which has been subsequently introduced. Aspects of CST2 and of FHIR have been considered in order to retain most suitable aspects of both. This integration can be regarded as most worthwhile.

Healthcare Associated Infections: An Interoperable Infrastructure for Multidrug Resistant Organism Surveillance.

Prevention and surveillance of healthcare associated infections caused by multidrug resistant organisms (MDROs) has been given increasing attention in recent years and is nowadays a major priority for health care systems. The creation of automated regional, national and international surveillance networks plays a key role in this respect. A surveillance system has been designed for the Abruzzo region in Italy, focusing on the monitoring of the MDROs prevalence in patients, on the appropriateness of antibiotic prescription in hospitalized patients and on foreseeable interactions with other networks at national and international level. The system has been designed according to the Service Oriented Architecture (SOA) principles, and Healthcare Service Specification (HSSP) standards and Clinical Document Architecture Release 2 (CDAR2) have been adopted. A description is given with special reference to implementation state, specific design and implementation choices and next foreseeable steps. The first release will be delivered at the Complex Operating Unit of Infectious Diseases of the Local Health Authority of Pescara (Italy).

The Ligurian HIV Network: How Medical Informatics Standards Can Help Clinical Research.

Integrating evidence from systematic research in daily clinical practice is one of the pillars of evidence-based medicine. Electronic data capture tools simplify data collection from different centers and supports the management of multicenter clinical trials. The Ligurian HIV Network (LHN) is one such tool, originating from a regional effort to integrate clinical trial capabilities for HIV and other chronic infectious diseases. In order to manually collect a complete report of all clinical tests on patients enrolled in a trial, a strenuous human effort and the allocation of great resources would be necessary. Moreover, the risk of error in a manual system is very high. The proposed system automatically extracts clinical data from the EHR of three hospitals of the LHN in a standardized way, and enhance their re-use in clinical trials. Through dedicated questionnaires, physicians reported a strongly positive feedback about the efficacy of the platform in supporting clinical research.

A SOA Based Solution for MDRO Surveillance and Improved Antibiotic Prescription in the Abruzzo Region.

Prevention and control of hospital and community acquired infections caused by multi drug resistant organisms (MDROs) are one major priority nowadays for health care systems worldwide. To improve actions and plans to tackle this problem, the creation of automated regional, national and international MDRO surveillance networks is a mandatory path for international health Institutions and Ministries. In this paper, the authors report on the surveillance system designed for the Abruzzo Region (Central Italy) to monitor the prevalence of MDROs in both infected and colonized patients, to verify appropriateness of antibiotic prescription in hospitalized patients and to interact with other national and sovra-national networks. Service Oriented Architecture (SOA) approach, different Healthcare Service Specification Project (HSSP) standards, local, national and international terminology and Clinical Document Architecture Release 2 (CDA R2) were adopted to design the overall architecture of this regional surveillance system. The Authors discuss the state of implementation of the project, itemizing specific design and implementation choices adopted so far and sketching next steps and reasons of some design and implementation choices, and indicate the next steps.

Information Technology System Including Patient Generated Health Data for Cancer Clinical Care and Research.

This paper presents the extension of a service-oriented architecture framework for precision oncology to the management of patient generated health data from wearables. The solution follows the indication provided by the Health Level 7 (HL7) and Object Management Group (OMG) initiative Healthcare Service Specification Project (HSSP) and is compliant to Retrieve Locate and Update Service (RLUS) Release 1 standard adopting Clinical Document Architecture Release 2 (CDA R2) as semantic signifier. The system which has been developed supports the management of visits, the setting up of a clinical diary and a comprehensive view of the patients from the wearables data for improve clinical care and for research. The system structure is highly modular and the parameters relating to wearables data are only present in one module. Extension of the systems to other aspects, such as genomics and immune therapy, are planned following the same modular design criteria.

Cancer precision medicine today: Towards omic information in healthcare systems.

INTRODUCTION:: This article focuses on the integration of omics data in electronic health records and on interoperability aspects relating to big data analysis for precision medicine. METHODS:: Omics data integration methods for electronic health record and for systems interoperability are considered, with special reference to the high number of specific software tools used to manage different aspects of patient treatment. This is an important barrier against the use of this integrated approach in daily clinical routine. RESULTS:: The correct use of all three levels of interoperability (technical, semantic, and process interoperability) plays a key role in order to achieve an easy access to a significant amount of data, all with correct contextualization, which is the only way to obtain a real value from data for precision medicine. CONCLUSIONS:: The proposed architecture could improve the potentialities of data routinely collected in many health information systems to form a real patient center information environment.

A SOA-Based Solution to Monitor Vaccination Coverage Among HIV-Infected Patients in Liguria.

Vaccination in HIV-infected patients constitutes an essential tool in the prevention of the most common infectious diseases. The Ligurian Vaccination in HIV Program is a proposed vaccination schedule specifically dedicated to this risk group. Selective strategies are proposed within this program, employing ICT (Information and Communication) tools to identify this susceptible target group, to monitor immunization coverage over time and to manage failures and defaulting. The proposal is to connect an immunization registry system to an existing regional platform that allows clinical data re-use among several medical structures, to completely manage the vaccination process. This architecture will adopt a Service Oriented Architecture (SOA) approach and standard HSSP (Health Services Specification Program) interfaces to support interoperability. According to the presented solution, vaccination administration information retrieved from the immunization registry will be structured according to the specifications within the immunization section of the HL7 (Health Level 7) CCD (Continuity of Care Document) document. Immunization coverage will be evaluated through the continuous monitoring of serology and antibody titers gathered from the hospital LIS (Laboratory Information System) structured into a HL7 Version 3 (v3) Clinical Document Architecture Release 2 (CDA R2).

I-Maculaweb: A Tool to Support Data Reuse in Ophthalmology.

This paper intends to present a Web-based application to collect and manage clinical data and clinical trials together in a unique tool. I-maculaweb is a user-friendly Web-application designed to manage, share, and analyze clinical data from patients affected by degenerative and vascular diseases of the macula. The unique and innovative scientific and technological elements of this project are the integration with individual and population data, relevant for degenerative and vascular diseases of the macula. Clinical records can also be extracted for statistical purposes and used for clinical decision support systems. I-maculaweb is based on an existing multilevel and multiscale data management model, which includes general principles that are suitable for several different clinical domains. The database structure has been specifically built to respect laterality, a key aspect in ophthalmology. Users can add and manage patient records, follow-up visits, treatment, diagnoses, and clinical history. There are two different modalities to extract records: one for the patient's own center, in which personal details are shown and the other for statistical purposes, where all center's anonymized data are visible. The Web-platform allows effective management, sharing, and reuse of information within primary care and clinical research. Clear and precise clinical data will improve understanding of real-life management of degenerative and vascular diseases of the macula as well as increasing precise epidemiologic and statistical data. Furthermore, this Web-based application can be easily employed as an electronic clinical research file in clinical studies.

IANUA: a regional project for the determination of costs in HIV-infected patients.

HIV treatment is based on combined antiretroviral therapy (cART) which has substantially improved survival, thus resulting in an increase in patient life expectancy as well as in the cost of HIV-related medical care. Therefore, several cost effectiveness studies were implemented worldwide, with one specifically in the Liguria region (Italy), to compare the annual economic expense in this area for HIV services, and the related improvement in patients' health. The IANUA project is intended to implement both cost-effectiveness and cost-utility analysis, therefore data related to clinical indicators and perceived health status were collected, the latter using a questionnaire based on the EQ-5D-3L. Information about the antiretroviral drugs and the relative quantity that a patient withdraws from the hospital pharmacy every month were extracted from the regional "F-file". All data gathered were stored in the Ligurian HIV Network, a web platform developed by the DIBRIS - Medinfo laboratory. More than eight hundred questionnaires were collected, and data will be elaborated by economists and psychologists. The first statistical elaborations showed that, as expected, costs increased as the number of therapeutic lines increased. Moreover, the average annual costs for patients whose last CD4 values were below 200 cells/mmc corresponded to the maximum expense recorded, however, the cost for patients with final CD4 counts above 500 cells/mmc was not, as expected, the lowest found. This can be explained by the fact that stabilized patients, who had CD4 values below 500 cells/mmc, did not need very expensive care, while patients with CD4 counts above 500 cells/mmc improved their health status thanks to cART.

A standardized SOA for clinical data interchange in a cardiac telemonitoring environment.

Care of chronic cardiac patients requires information interchange between patients' homes, clinical environments, and the electronic health record. Standards are emerging to support clinical information collection, exchange and management and to overcome information fragmentation and actors delocalization. Heterogeneity of information sources at patients' homes calls for open solutions to collect and accommodate multidomain information, including environmental data. Based on the experience gained in a European Research Program, this paper presents an integrated and open approach for clinical data interchange in cardiac telemonitoring applications. This interchange is supported by the use of standards following the indications provided by the national authorities of the countries involved. Taking into account the requirements provided by the medical staff involved in the project, the authors designed and implemented a prototypal middleware, based on a service-oriented architecture approach, to give a structured and robust tool to congestive heart failure patients for their personalized telemonitoring. The middleware is represented by a health record management service, whose interface is compliant to the healthcare services specification project Retrieve, Locate and Update Service standard (Level 0), which allows communication between the agents involved through the exchange of Clinical Document Architecture Release 2 documents. Three performance tests were carried out and showed that the prototype completely fulfilled all requirements indicated by the medical staff; however, certain aspects, such as authentication, security and scalability, should be deeply analyzed within a future engineering phase.