International Interoperability Research Articles

Fostering the international interoperability of clinical research networks to tackle undiagnosed and under-researched rare diseases.

Clinical research is an essential component to advance diagnosis and therapeutic development. In 2022, the International Rare Diseases Research Consortium (IRDiRC) and the European Joint Programme on Rare Diseases (EJP RD) brought together key stakeholders from across the globe to discuss common themes in clinical research networks (CRNs) for rare diseases. Various topics were raised during discussions including current state of CRNs, the need for new CRNs, multi-stakeholder perspectives on value of CRNs, and ways to collaborate on a global scale. Communication and coordination between various groups, taking advantage of existing experiences, can expedite establishment and execution of complex collaborations that will be necessary for CRNs. In this perspective, we discuss opportunities and highlight key considerations for developing successful collaborative CRNs across the globe.

Validation of an acute respiratory infection phenotyping algorithm to support robust computerised medical record-based respiratory sentinel surveillance, England, 2023.

IntroductionRespiratory sentinel surveillance systems leveraging computerised medical records (CMR) use phenotyping algorithms to identify cases of interest, such as acute respiratory infection (ARI). The Oxford-Royal College of General Practitioners Research and Surveillance Centre (RSC) is the English primary care-based sentinel surveillance network.AimThis study describes and validates the RSC's new ARI phenotyping algorithm.MethodsWe developed the phenotyping algorithm using a framework aligned with international interoperability standards. We validated our algorithm by comparing ARI events identified during the 2022/23 influenza season in England through use of both old and new algorithms. We compared clinical codes commonly used for recording ARI.ResultsThe new algorithm identified an additional 860,039 cases and excluded 52,258, resulting in a net increase of 807,781 cases (33.84%) of ARI compared to the old algorithm, with totals of 3,194,224 cases versus 2,386,443 cases. Of the 860,039 newly identified cases, the majority (63.7%) were due to identification of symptom codes suggestive of an ARI diagnosis not detected by the old algorithm. The 52,258 cases incorrectly identified by the old algorithm were due to inadvertent identification of chronic, recurrent, non-infectious and other non-ARI disease.ConclusionWe developed a new ARI phenotyping algorithm that more accurately identifies cases of ARI from the CMR. This will benefit public health by providing more accurate surveillance reports to public health authorities. This new algorithm can serve as a blueprint for other CMR-based surveillance systems wishing to develop similar phenotyping algorithms.

From Clinical Information Systems to Personalized Health Knowledge Graphs.

This paper presents a versatile solution to formally represent the contents of electronic health records. It is based on the knowledge graph paradigm, and semantic web standards RDF and OWL. It employs the established semantic standards SNOMED CT and FHIR, which warrant international interoperability. A graph-based form is not only useful to feed different target visualizations, but it can also be subject to AI-powered services such as (fuzzy) retrieval and summarization.

'SNOMEDizing' Questionnaires for Standardizing Stroke Registry Data.

International interoperability of healthcare and research data requires a commitment to standards. To this end, SNOMED CT was evaluated for representing questionnaire items of the European Registry of Stroke Care Quality using a complex annotation protocol. The agreement between validators and annotators was 72.4%. At least 64% of the information could be represented by using SNOMED CT only, including complex post-coordinations. 9% of the information would require an information model, and 14% the addition of new content to SNOMED CT. Next steps will be the creation of an annotation guideline for questionnaires, a specific reference set, and the combination of both with an information model such as HL7 FHIR.

Design, implementation and usability analysis of patient empowerment in ADLIFE project via patient reported outcome measures and shared decision making

IntroductionThis paper outlines the design, implementation, and usability study results of the patient empowerment process for chronic disease management, using Patient Reported Outcome Measurements and Shared Decision-Making Processes.BackgroundThe ADLIFE project aims to develop innovative, digital health solutions to support personalized, integrated care for patients with severe long-term conditions such as Chronic Obstructive Pulmonary Disease, and/or Chronic Heart Failure. Successful long-term management of patients with chronic conditions requires active patient self-management and a proactive involvement of patients in their healthcare and treatment. This calls for a patient-provider partnership within an integrated system of collaborative care, supporting self-management, shared-decision making, collection of patient reported outcome measures, education, and follow-up.MethodsADLIFE follows an outcome-based and patient-centered approach where PROMs represent an especially valuable tool to evaluate the outcomes of the care delivered. We have selected 11 standardized PROMs for evaluating the most recent patients’ clinical context, enabling the decision-making process, and personalized care planning. The ADLIFE project implements the "SHARE approach’ for enabling shared decision-making via two digital platforms for healthcare professionals and patients. We have successfully integrated PROMs and shared decision-making processes into our digital toolbox, based on an international interoperability standard, namely HL7 FHIR. A usability study was conducted with 3 clinical sites with 20 users in total to gather feedback and to subsequently prioritize updates to the ADLIFE toolbox.ResultsUser satisfaction is measured in the QUIS7 questionnaire on a 9-point scale in the following aspects: overall reaction, screen, terminology and tool feedback, learning, multimedia, training material and system capabilities. With all the average scores above 6 in all categories, most respondents have a positive reaction to the ADLIFE PEP platform and find it easy to use. We have identified shortcomings and have prioritized updates to the platform before clinical pilot studies are initiated.ConclusionsHaving finalized design, implementation, and pre-deployment usability studies, and updated the tool based on further feedback, our patient empowerment mechanisms enabled via PROMs and shared decision-making processes are ready to be piloted in clinal settings. Clinical studies will be conducted based at six healthcare settings across Spain, UK, Germany, Denmark, and Israel.

Scaling up and implementing the digital Survivorship Passport tool in routine clinical care – The European multidisciplinary PanCareSurPass project

BackgroundChildhood cancer survivors (CCS), of whom there are about 500,000 living in Europe, are at an increased risk of developing health problems [1–6] and require lifelong Survivorship Care. There are information and knowledge gaps among CCS and healthcare providers (HCPs) about requirements for Survivorship Care [7–9] that can be addressed by the Survivorship Passport (SurPass), a digital tool providing CCS and HCPs with a comprehensive summary of past treatment and tailored recommendations for Survivorship Care. The potential of the SurPass to improve person-centred Survivorship Care has been demonstrated previously [10,11]. MethodsThe EU-funded PanCareSurPass project will develop an updated version (v2.0) of the SurPass allowing for semi-automated data entry and implement it in six European countries (Austria, Belgium, Germany, Italy, Lithuania and Spain), representative of three infrastructure healthcare scenarios typically found in Europe. The implementation study will investigate the impact on person-centred care, as well as costs and processes of scaling up the SurPass. Interoperability between electronic health record systems and SurPass v2.0 will be addressed using the Health Level Seven (HL7) International interoperability standards. ResultsPanCareSurPass will deliver an interoperable digital SurPass with comprehensive evidence on person-centred outcomes, technical feasibility and health economics impacts. An Implementation Toolkit will be developed and freely shared to promote and support the future implementation of SurPass across Europe. ConclusionsPanCareSurPass is a novel European collaboration that will improve person-centred Survivorship Care for CCS across Europe through a robust assessment of the implementation of SurPass v2.0 in different healthcare settings.

Towards the international interoperability of clinical research networks for rare diseases: recommendations from the IRDiRC Task Force

BackgroundMany patients with rare diseases are still lacking a timely diagnosis and approved therapies for their condition despite the tremendous efforts of the research community, biopharmaceutical, medical device industries, and patient support groups. The development of clinical research networks for rare diseases offers a tremendous opportunity for patients and multi-disciplinary teams to collaborate, share expertise, gain better understanding on specific rare diseases, and accelerate clinical research and innovation. Clinical Research Networks have been developed at a national or continental level, but global collaborative efforts to connect them are still lacking. The International Rare Diseases Research Consortium set a Task Force on Clinical Research Networks for Rare Diseases with the objective to analyse the structure and attributes of these networks and to identify the barriers and needs preventing their international collaboration. The Task Force created a survey and sent it to pre-identified clinical research networks located worldwide.ResultsA total of 34 responses were received. The survey analysis demonstrated that clinical research networks are diverse in their membership composition and emphasize community partnerships including patient groups, health care providers and researchers. The sustainability of the networks is mostly supported by public funding. Activities and research carried out at the networks span the research continuum from basic to clinical to translational research studies. Key elements and infrastructures conducive to collaboration are well adopted by the networks, but barriers to international interoperability are clearly identified. These hurdles can be grouped into five categories: funding limitation; lack of harmonization in regulatory and contracting process; need for common tools and data standards; need for a governance framework and coordination structures; and lack of awareness and robust interactions between networks.ConclusionsThrough this analysis, the Task Force identified key elements that should support both developing and established clinical research networks for rare diseases in implementing the appropriate structures to achieve international interoperability worldwide. A global roadmap of actions and a specific research agenda, as suggested by this group, provides a platform to identify common goals between these networks.

Integrating geological data in Europe to foster multidisciplinary research

The European Plate Observing System (EPOS, www.epos-eu.org) is a multidisciplinary pan-European research infrastructure for solid Earth science. It integrates a series of domain-specific service hubs (Thematic Core Service, TCS) such as the Geological Information and Modelling, which provides access to data, data products and services on European boreholes, geological maps, mineral occurrences, mines and 3D models. TCS GIM services are hosted by a group of European Geological Surveys and a couple of national research organizations. This paper presents novel data discovery and integration, facilitated using borehole logging information with on-demand web services to produce 3D geological structures. This domain interoperability across EPOS was created for the purpose of research, but it is also highly relevant for the response to societal grand challenges such as natural hazards and climate change. European and international interoperability implementation frameworks are well described and used (e.g., INSPIRE, ISO, OGC, and IUGS/CGI). It can be difficult for data providers to deploy web services that support the full semantic data definition (e.g., OGC Complex Feature) to expose several millions of geological entities through web-enabled data portals as required by pan-European projects. The TCS GIM group implemented and innovatively extended two standardized descriptions, i.e. GeoSciML-Lite and EarthResourceML-Lite, with an important reuse of content from Linked Data Registries. This approach was applied to design and implement the European Borehole Index and associated web services (View-WMS and Discovery-WFS), extended to 3D models, geological maps as well as mineral occurrences and mines. Results presented here apply the Linked Data approach ensuring optimal semantic description and enriching the data graphs, with complex descriptions and contents. In this way, it is now possible to traverse from one Borehole Index instance to linked richer information such as the borehole geological log, groundwater levels, rock sample description, analyses, etc. All this detailed information is served following international interoperability standards (Observations & Measurements, GroundWaterML 2.0, GeoSciML4, amongst others).

Dentistry and Interoperability

Information has become the vital commodity of exchange in recent decades. Medicine is no exception; the importance of patient information in the digital form has been recognized by organizations and health care facilities. Almost all patient information, including medical history, radiographs, and feedback, can be digitally recorded synchronously and asynchronously. Nevertheless, patient information that could be shared and reused to enhance care delivery is not readily available in a format that could be understood by the systems in recipient health care facilities. The systems used in medical and dental clinics today lack the ability to communicate with each other. The critical information is stagnant in isolated silos, unable to be shared, analyzed, and reused. In this article, we propose enabling interoperability in health care systems that could facilitate communication across systems for the benefit of patients and caregivers. We explain in this article the importance of interoperable data, the international interoperability standards available, and the range of benefits and opportunities that interoperability can create in dentistry for providers and patients alike.

PharmActa: Personalized pharmaceutical care eHealth platform for patients and pharmacists.

Community pharmacists are critically placed in the patient care chain being an extended frontline within primary healthcare networks across Europe. They are trained to ensure safe and effective medication use, a crucial and responsible role, extending beyond the common misconception limited to just providing timely access to medicines for the population. Technology-wise, eHealth being committed to an effective, networked, patient-centered and accessible healthcare would prove a real asset in this direction by achieving improved therapy adherence with better outcomes and direct contribution to a cost-effective healthcare system. In this work, we present PharmActa, a personalized eHealth platform that addresses key features of pharmaceutical care and enhances communication of pharmacists with patients for optimizing pharmacotherapy. PharmActa empowers patients by providing pharmaceutical care services, such as drug interactions tools, reminders for assisting adhesion and compliance, information regarding adverse drug reactions, as well as pharmacovigilance along with related tools for healthcare management. In addition, it allows the pharmacists to review the medication history in order to provide personalized pharmaceutical care services; thus enhancing their role as healthcare providers. Finally, a mechanism allowing such a system to be interconnected with a developed medical repository following European and International interoperability standards, is also presented. Thus far, the evaluation results presented in this work indicate that PharmActa can be of great benefit to healthcare professionals, especially pharmacists and patients.

Standardisation of Naval Containerised Modules - Enabling Interoperability Across NATO

This paper explores the work carried out by the Naval Design Partnering (NDP) team to propose a new North Atlantic Treaty Organisation (NATO) standard covering naval containerised modules outfitted with mission systems. The purpose of the Standard is to facilitate interoperability of naval modules across NATO navies, and to future proof the design process both for supply-chain and vessel designers. Drawing upon the experience of the offshore world in using containerised modules, as embodied in the current certification standards, the Standard provides a uniform set of safety-related construction requirements, standardised interfaces, and guidance for platforms to enable the deployment of naval modules. The paper covers the overall philosophy behind the Standard, the background research conducted, and the rationale behind the requirements chosen. Finally, it explores the impact of the Standard on platform design, the key enablers for the deployment of naval modules, and the future work to develop international inter-operability.

People of Collections: Facilitators of Interoperability?

In March 2019, the Muséum national d’histoire naturelle, Paris (MNHN) launched the datapoc.mnhn.fr project, funded by the French research infrastructures CollEX-Persée and E-recolnat. This proof of concept was imagined and is supported by a group of partners coming from different communities working at the Muséum (specimen collection curators, librarians, researchers, data scientists, publishers). The initial motivation of this team for getting together was to imagine a way to link the massive data produced and preserved in the heterogeneous institutional collection databases and repositories of the Muséum in order to improve global access and visibility for the benefit of end-users as well as data curation processes. After a year of sharing and deliberating, the group concluded that focusing on people’s names and identification, could be a promising way to explore interoperability and alignment solutions in order to match data hosted in the different systems. The project has thus two main goals: first, to improve biodiversity and taxonomic data quality for the qualification of personal identities, publications and scientific names by resolving frequent ambiguities and issues in people’s names assignment ; second, to develop and assess machine-driven linking strategies between specimen and authorship metadata and resources derived from various institutional datasilos of interest to the research community. In order to test this idea and to experiment innovative data computing and visualization technologies, all parties involved in the project agreed to develop a proof of concept focused on a dataset of 500 names of major MNHN naturalists from its foundation until nowadays. This proof of concept will consist in building a structured authority file for people's names, which could be shared by all services producing and using biodiversity data at MNHN, as well as reusable as open data by external stakeholders and international partners. This structured file will strengthen data and databases production and maintenance workflows, but could also help improving the quality of end-user experience by allowing individuals or machines to match, link or otherwise compute and analyse data that is still difficult to handle because of the diversity of IT applications and limited standardisation practises. It is key to the project that this structured file should somehow comply with international interoperability and semantic web standards so to facilitate global access and data exchanges with similar institutions around the world. Linked datasets and related resources derived from this work will be displayed on a public website designed for researchers as well as for the public via diverse applications and formats (API, RDF). The project will be run from April 2019 to April 2020 by the core team of partners who initiated it, with the support of a private IT and data computing service called Logilab. Some of the challenges of this project include finding an efficient way for building the structured file and then succeed in aligning and disambiguising names already present existing databases. A way to approach this issue is to confront and consolidate MNHN biodiversity datasets with external repositories by using people identifiers systems like ISNI, VIAF, IdREF, which are already familiar to libraries, archives and other cultural institutions. How can those various people identifiers systems be profitable to parse MNHN "people of collections" and help disambiguise them? Is there a particular people identifier system which will prove to be most relevant for all types of collections? Which parsing method will give the best results, and how could it scale up and possibly be reused by other institutions or even future European taxonomic infrastructures? Those are some of the questions the MNHN team is eager to deal with and to share and discuss at the Biodiversity Next Symposium.

An openEHR Approach to Detailed Clinical Model Development: Tobacco Smoking Summary Archetype as a Case Study.

Data modeling for electronic health records (EHRs) is complex, requiring technological and cognitive sophistication. The openEHR approach leverages the tacit knowledge of domain experts made explicit in a model development process aiming at interoperability and data reuse. The purpose of our research was to explore the process that enabled the aggregation of the tacit knowledge of domain experts in an explicit form using the Clinical Knowledge Manager (CKM) platform and associated assets. The Tobacco Smoking Summary archetype is used to illustrate this. Three methods were used to triangulate findings: (1) observation of CKM discussions by crowdsourced domain experts in two reviews, (2) observation of editor discussions and decision-making, and (3) interviews with eight domain experts. CKM discussions were analyzed for content and editor discussions for decision-making, and interviews were thematically analyzed to explore in depth the explication of tacit knowledge. The Detailed Clinical Model (DCM) process consists of a set of reviews by domain experts, with each review followed by editorial discussions and decision-making until an agreement is reached among reviewers and editors that the DCM is publishable. Interviews revealed three themes: (1) data interoperability and reusability, (2) accurate capture of patient data, and (3) challenges of sharing tacit knowledge. The openEHR approach to developing an open standard revealed a complex set of conditions for a successful interoperable archetype, such as leadership, maximal dataset, crowdsourced domain expertise and tacit knowledge made explicit, editorial vision, and model-driven software. Aggregated tacit knowledge that is explicated into a DCM enables the ability to collect accurate data and plan for the future. The process based on the CKM platform enables domain experts and stakeholders to be heard and to contribute to mutually designed standards that align local protocols and agendas to international interoperability requirements.

Mobile App for Simplifying Life With Diabetes: Technical Description and Usability Study of GlucoMan.

BackgroundPatients with diabetes can be affected by several comorbidities that require immediate action when occurring as they may otherwise cause fatal or consequential damage. For this reason, patients must closely monitor their metabolism and inject insulin when necessary. The documentation of glucose values and other relevant measurements is often still on paper in a diabetes diary.ObjectiveThe goal of this work is to develop and implement a novel mobile health system for the secure collection of relevant data referring to a person’s metabolis and to digitize the diabetes diary to enable continuous monitoring for both patients and treating physicians. One specific subgoal is to enable data transmission of health parameters to secure data storage.MethodsThe process of implementing the system consists of (1) requirements analysis with patients and physicians to identify patient needs and specify relevant functionalities, (2) design and development of the app and the data transmission, and (3) usability study.ResultsWe developed and implemented the mobile app GlucoMan to support data collection pertaining to a person’s metabolism. An automated transfer of measured values from a glucometer was implemented. Medication and nutrition data could be entered using product barcodes. Relevant background knowledge such as information on carbohydrates was collected from existing databases. The recorded data was transmitted using international interoperability standards to the MIDATA.coop storage platform. The usability study revealed some design issues that needs to be solved, but in principle, the study results show that the app is easy to use and provides useful features.ConclusionsData collection on a patient’s metabolism can be supported with a multifunctional app such as GlucoMan. Besides monitoring, continuous data can be documented and made available to the treating physician. GlucoMan allows patients to monitor disease-relevant parameters and decide who accesses their health data. In this way, patients are empowered not only to manage diabetes but also manage their health data.

How Do You Know When You Have Interoperability?

This paper first looks at the several definitions of the word interoperability. Next, the paper addresses several of the distinct components that are factors in accomplishing interoperability: semantic interoperability, functional interoperability, stakeholder interoperability, consumer interoperability, business interoperability, privacy and security interoperability, and international interoperability. This paper discusses each of these components in terms of their current state relating to interoperability and suggests what changes might be made to achieve interoperability.

A case study of the introduction of the International Classification for Nursing Practice(®) in Poland.

The development of a nursing practice, improvements in nurses' autonomy, and increased professional and personal responsibility for the medical services provided all require professional documentation with records of health status assessments, decisions undertaken, actions and their outcomes for each patient. The International Classification for Nursing Practice is a tool that meets all of these needs, and although it requires continuous evaluation, it offers professional documentation and communication in the practitioner and researcher community. The aim of this paper is to present a theoretical critique of an issue related to policy and experience of the current situation in Polish nursing - especially of the efforts to standardize nursing practices through the introduction and development of the Classification in Poland. Despite extensive promotion and training by International Council of Nurses members worldwide, there are still many countries where the Classification has not been implemented as a standard tool in healthcare facilities. Recently, a number of initiatives were undertaken in cooperation with the local and state authorities to disseminate the Classification in healthcare facilities. Thanks to intense efforts by the Polish Nurses Association and the International Council of Nurses Accredited Center for ICNP(®) Research & Development at the Medical University of Łódź, the Classification is known in Poland and has been tested at several centres. Nevertheless, an actual implementation that would allow for national and international interoperability requires strategic governmental decisions and close cooperation with information technology companies operating in the country. Discussing the barriers to the implementation of the Classification can improve understanding of it and its use. At a policy level, decision makers need to understand that use Classification in eHealth services and tools it is necessary to achieve interoperability.

Empirical and Practical Implementation Methodology for Clinical Integration of E-Health Iot Technology

This paper structures empirical and practical implementation methodologies for clinical integration of eHealth IoT smart device technology embedded in Cloud service architecture. The results and findings of this two-year research program are summarized from mathematical, system architectural and software engineering perspective. The research takes place in the European Union, in Hungary. The program is the manifestation of the trilateral industry-university collaboration of the University of Debrecen Faculty of Informatics, T-Systems Healthcare Competence Center Central and Eastern Europe and Semmelweis University 2nd Pediatric Clinic Department of Pulmonology. The paper presents the mathematical model for the system architecture optimization. Selected system-architectural solution plans are mapped into directed graphs and converted into adjacency and availability matrices for optimization. Adequate technologies are collected and identified for the research based on industry megatrends. The experiment establishes multidirectional interoperability among eHealth smart devices, telemedicine instruments and clinical information systems. The Open Telemedicine Interoperability Hub, interoperability core module, was developed and embedded into Cloud service architecture. This module transposes and transmits the captured bio-sensory data stream from the eHealth IoT smart-devices and from the telemedicine instrument into the clinical information system. Dominant international healthcare interoperability standards are reviewed and selected for the research. The research program defined different interoperability levels and mapped these against the open systems interconnection model layers. The international interoperability standard, Health Level Seven, was selected for the research. The research explicitly tested interoperability among eHealth consumer electronic sensor-enabled smart-device, spirometer telemedicine instrument and cloud-based hospital information test system. The research proved that universal interoperability between IoT eHealth smart devices and clinical information system technology is from technical perspective absolutely possible. The paper describes the lessons learned, drawbacks and achievements of this research program. An insight is also given into the forthcoming research phase.

Environmental data gaps in Black Sea catchment countries: INSPIRE and GEOSS State of Play

Abstract This paper presents the results of a large analysis of environmental data gaps in countries of the Black Sea catchment performed in the context of the FP7 enviroGRIDS project in 2010. We also assessed the level of compatibility of the data to the European directive establishing an Infrastructure for Spatial Information in the European Community (INSPIRE) and to the international standards of data interoperability as advocated by the Group on Earth Observations (GEO) and implemented in the Global Earth Observation System of Systems (GEOSS). Many environmental datasets were analyzed at different scales (national, regional, European, and global) and the analysis revealed gaps in spatial and temporal environmental data coverage and problem of data compatibility at different scales. The analysis enabled the identification of areas where further efforts are needed to reinforce the existing observation systems in the region, such as monitoring systems to provide data on water quality in rivers, on the state of marine environments, or on pollution and nutrients loads from land based sources. A significant proportion of environmental datasets is not accessible or has limited access, so further efforts are needed to make them available to decision makers and scientists following the GEO data sharing principles. Compatibilities of many data sets and observation systems to international interoperability standards are low in this region, and we discuss what further efforts are needed to improve the situation and how this is relevant to environmental policies.

Biobanking and international interoperability: samples

In terms of sample exchange, international collaborations between biobanks, or between biobanks and their research partners, have two important aspects. First, the donors' consent usually implies that the scope and purpose of any sample transfer to third parties is subject to major constraints. Since the legal, ethical and political framework of biobanking may differ substantially, even between countries of comparable jurisdictional systems, general rules for the international sharing of biomaterial are difficult, if not impossible, to define. Issues of uncertainty include the right to transfer the material, the scope of research allowed, and intellectual property rights. Since suitable means of international law enforcement may not be available in the context of biobanking, collaborators are advised to clarify any residual uncertainty by means of bilateral contracts, for example, in the form of material transfer agreements. Second, biobank partners may rightly expect that the biomaterial they receive for further analysis attains a certain level of quality. This implies that a biobank has to implement stringent quality control measures covering, in addition to the material transfer itself, the whole process of material acquisition, transport, pre-analytical handling and storage. Again, it may be advisable for biobank partners to claim contractual warranties for the type and quality of the biomaterial they wish to acquire.

Stem cell banking: between traceability and identifiability.

Stem cell banks are increasingly seen as an essential resource of biological materials for both basic and translational research. Stem cell banks support transnational access to quality-controlled and ethically sourced stem cell lines from different origins and of varying grades. According to the Organisation for Economic Co-operation and Development, advances in regenerative medicine are leading to the development of a bioeconomy, 'a world where biotechnology contributes to a significant share of economic output'. Consequently, stem cell banks are destined to constitute a pillar of the bioeconomy in many countries. While certain ethical and legal concerns are specific to the nature of stem cells, stem cell banking could do well to examine the approaches fostered by tissue banking generally. Indeed, the past decade has seen a move to simplify and harmonize biological tissue and data banking so as to foster international interoperability. In particular, the issues of consent and of traceability illustrate not only commonalities but the opportunity for stem cell banking to appreciate the lessons learned in biobanking generally. This paper analyzes convergence and divergence in issues surrounding policy harmonization, transnational sharing, informed consent, traceability and return of results in the context of stem cell banks.