Interoperability standards enabling cross-border patient summary exchange

Abstract. 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 healthcare. 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. The Trillium Bridge project supports international standards development by extending the EU PS Guideline to meet MU-II C-CDA in the transatlantic exchange of Electronic Health Records (EHRs). 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

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Developing an infrastructure for secure patient summary exchange in the EU context: Lessons learned from the KONFIDO project

Background: The increase of healthcare digitalization comes along with potential information security risks. Thus, the EU H2020 KONFIDO project aimed to provide a toolkit supporting secure cross-border health data exchange. Methods: KONFIDO focused on the so-called “User Goals”, while also identifying barriers and facilitators regarding eHealth acceptance. Key user scenarios were elaborated both in terms of threat analysis and legal challenges. Moreover, KONFIDO developed a toolkit aiming to enhance the security of OpenNCP, the reference implementation framework. Results: The main project outcomes are highlighted and the “Lessons Learned,” the technical challenges and the EU context are detailed. Conclusions: The main “Lessons Learned” are summarized and a set of recommendations is provided, presenting the position of the KONFIDO consortium toward a robust EU-wide health data exchange infrastructure. To this end, the lack of infrastructure and technical capacity is highlighted, legal and policy challenges are identified and the need to focus on usability and semantic interoperability is emphasized. Regarding technical issues, an emphasis on transparent and standards-based development processes is recommended, especially for landmark software projects. Finally, promoting mentality change and knowledge dissemination is also identified as key step toward the development of secure cross-border health data exchange services

Developing an infrastructure for secure patient summary exchange in the EU context: Lessons learned from the KONFIDO project:

Background: The increase of healthcare digitalization comes along with potential information security risks. Thus, the EU H2020 KONFIDO project aimed to provide a toolkit supporting secure cross-border health data exchange. Methods: KONFIDO focused on the so-called "User Goals", while also identifying barriers and facilitators regarding eHealth acceptance. Key user scenarios were elaborated both in terms of threat analysis and legal challenges. Moreover, KONFIDO developed a toolkit aiming to enhance the security of OpenNCP, the reference implementation framework. Results: The main project outcomes are highlighted and the "Lessons Learned," the technical challenges and the EU context are detailed. Conclusions: The main "Lessons Learned" are summarized and a set of recommendations is provided, presenting the position of the KONFIDO consortium toward a robust EU-wide health data exchange infrastructure. To this end, the lack of infrastructure and technical capacity is highlighted, legal and policy challenges are identified and the need to focus on usability and semantic interoperability is emphasized. Regarding technical issues, an emphasis on transparent and standards-based development processes is recommended, especially for landmark software projects. Finally, promoting mentality change and knowledge dissemination is also identified as key step toward the development of secure cross-border health data exchange services

Big data and ICT solutions in the European Union and in China: A comparative analysis of policies in personalized medicine

Introduction: Several countries are either planning or implementing national strategies for the development and integration of Personalized Medicine (PM) into their healthcare systems. Personalized Medicine is an undisputed priority of the European Commission (EC), which has funded the project "Integrating China into the International Consortium for Personalized Medicine" (IC2PerMed), in order to ensure a common basis for Sino-European collaborations. By mapping the current PM landscape in the European Union (EU) and in China, IC2PerMed aims to provide key solutions toward a synergistic and coordinated approach in the field of PM. Methods: An extensive desk research was conducted, aimed at identifying documents on PM-related policies, programs, and action plans in the EU and in China, published up to November 2020. The search was conducted by exploring scientific and gray literature, and official institutional repositories. A descriptive summary condensed the information retrieved for both. Results: Since 2013, the year of publication of the first PM policy by the EC "Use of omics technologies in PM development," several documents have been published. PM is a key element of the policy agenda also in China, which in 2016 integrated PM into the 13th National Five-Year Plan, followed by the publication of several policies on technology infrastructure and big data. Both in the EU and China, especially in recent years, these policies addressed in detail the issues of big data, data interoperability and exchange, while defining the standards of information and communication infrastructures. Conclusions: In order to allow optimal collaboration, it is essential to understand similarities and differences between the respective policy strategies, with particular attention to data management and adopted infrastructures. The results of this project may enable the development of joint Sino-European research and innovation initiatives, promoting developments in the field of PM

A systematic review on the European legislation and policy of cross-border health care: barriers and facilitators

ABSTRACT - Background and Objectives: The legal basis of cross border health services in Europe is based on the Subsidiarity principle, which does not allow further integration of health or harmonization between Member States’ health systems. Even though there are instruments that address legal issues, governments remain responsible for health in their territory. The purpose of this systematic review is to identify and analyze the barriers and clarify facilitators of cross border collaboration and care in the European legal framework. To date, the evidence on strengths and weaknesses shows the difficulty to overcome legal and organizational barriers. However prior authorization of care abroad is against the European Union’s free movement and internal market principles, it is justified by the need for treatment and can be compensated through a reimbursement. Data Sources: A systematic review was built through an electronic search on PubMed, Web of Science, Scopus, Google Scholar, and grey literature. Study Eligibility Criteria and Methods: The aim was to include all legible articles in the English language, which connect legislation to barriers or facilitators, from 2009 to 2019. Two hundred and eighty (n=280) records were screened through the titles and abstracts and a final list of 21 papers was selected for the review. Primary data was the content of 9 studies and 12 studies used secondary data. Barriers and facilitators are linked and the second is a possible solution to the first. Results: The eight most influential barriers are connected to eHealth interoperability; member states' resistance to cooperate and exchange information; legal barrier and countries' political agenda; data protection legislation and liability and the economic barrier. The eight influential facilitators are related to possible solutions to the barriers, such as eHealth as a single market for healthcare; tools of Health Technology Assessment (HTA); European Public Health Program, and funded projects and research. Conclusions and implications of key findings: This review allows a legal and graphical analysis of the existing tools that can facilitate and improve cross borders health services. Evidence shows that the collaboration and receptivity of Member States can lead to better technology assessment, quality and common standards in health, liability, and a friendly single market for patients, that could give efficient answers in critical situations

CDC global digital health strategy

Lack of timely, accurate data has long hampered global efforts to combat and prevent disease. The global response to COVID-19 has brought greater attention to these challenges, underscoring the global community\u2019s vulnerability to infectious disease.To better prepare for response to future threats, CDC has launched the Data Modernization Initiative (DMI), to improve the quality, availability, and use of pandemic and response-related data. While DMI\u2019s main focus is domestic, DMI\u2019s principles, products, and impacts will apply globally. The best way to stop diseases from spreading globally is to detect and contain them early, in the countries in which they originate. One way to support this effort is to have accurate and timely data generated by country health systems, as part of routine individual and public health service delivery. Many countries are pursuing this goal under the title of \u201cdigital transformation\u201d or \u201cdigital health\u201d and these efforts are being actively supported by global organizations and other donors.While the application of digital tools to health service delivery has been undertaken for several years in lower- and middle-income countries, large-scale success and uses have been limited. Health systems are complex and constantly adapting. They are composed of chains of many linked services and digitally \u201cfixing\u201d one broken link in a chain of multiple broken links is not going to yield success. In recognition of this complexity, many countries are now taking an \u201centerprise approach\u201d to health systems, looking at the health system more holistically, addressing key issues including digital literacy and data governance, and organizing and allocating resources more effectively across the entire system. This enterprise approach is also being supported by global stakeholders as part of the digital transformation paradigm.The essence of this document then, is a collective roadmap shared by CDC and other global partners, to better align efforts and support countries in deploying enterprise approaches to realize the digital transformation or digital enablement of health services. This will not only benefit incountry health service delivery, reducing morbidity and mortality, but also provide disease experts globally with additional data sources to more effectively combat and control future outbreaks.GDHS_Strategy2022_REV_508.pd

Proposal for an eHealth Based Ecosystem Serving National Healthcare

The European Union (EU)'s keen concern about citizens' health and well-being advancement has been expressed at all levels. It has been understood that at present, these can only be achieved through coordinated actions at the individual member states' level based on EU directives, as well as through promoting and funding R&D and expanding the use of eHealth technologies. Despite the diversities and particularities among member states, common values such as universal access to good quality healthcare, equity, and solidarity have been widely accepted across EU. That demanded the adoption of policies and follow directives, which streamlined actions to bridge healthcare gaps, and facilitate cross-border healthcare. This paper articulates a framework for deriving a national healthcare system, based on interoperable Electronic Health Record (EHR) with safeguarding healthcare quality, enabling quadruple helix (Public, Academia, Industry, NGOs) driven R&D and guided by a patient-centered approach. A methodology to develop an integrated EHR at National level is proposed as a prerequisite for eHealth and put into perspective. Recommendations are given for the steps needed, from the managerial, legal, technical, and financial concerns in developing an open access, patient-centered national healthcare system based on the context and constraints of a country. The example of a small country to apply the proposed methodology is demonstrated. Stakeholders, including citizens, healthcare professionals, academia, and the industry are mobilized, enabled, and incentivized for implementing the methodology. Experiences are aspired to be offered as lessons learned for other countries to adapt on their environment