Data Harmonization Research Articles

Sharing sensitive data in life sciences: an overview of centralized and federated approaches.

Biomedical data are generated and collected from various sources, including medical imaging, laboratory tests and genome sequencing. Sharing these data for research can help address unmet health needs, contribute to scientific breakthroughs, accelerate the development of more effective treatments and inform public health policy. Due to the potential sensitivity of such data, however, privacy concerns have led to policies that restrict data sharing. In addition, sharing sensitive data requires a secure and robust infrastructure with appropriate storage solutions. Here, we examine and compare the centralized and federated data sharing models through the prism of five large-scale and real-world use cases of strategic significance within the European data sharing landscape: the French Health Data Hub, the BBMRI-ERIC Colorectal Cancer Cohort, the federated European Genome-phenome Archive, the Observational Medical Outcomes Partnership/OHDSI network and the EBRAINS Medical Informatics Platform. Our analysis indicates that centralized models facilitate data linkage, harmonization and interoperability, while federated models facilitate scaling up and legal compliance, as the data typically reside on the data generator's premises, allowing for better control of how data are shared. This comparative study thus offers guidance on the selection of the most appropriate sharing strategy for sensitive datasets and provides key insights for informed decision-making in data sharing efforts.

Resting state functional brain connectivity in child and adolescent psychiatry: where are we now?

Approaching the 30th anniversary of the discovery of resting state functional magnetic resonance imaging (rsfMRI) functional connectivity, we reflect on the impact of this neuroimaging breakthrough on the field of child and adolescent psychiatry. The study of intrinsic functional brain architecture that rsfMRI affords across a wide range of ages and abilities has yielded numerous key insights. For example, we now know that many neurodevelopmental conditions are associated with more widespread circuit alterations across multiple large-scale brain networks than previously suspected. The emergence of population neuroscience and effective data-sharing initiatives have made large rsfMRI datasets publicly available, providing sufficient power to begin to identify brain-based subtypes within heterogeneous clinical conditions. Nevertheless, several methodological and theoretical challenges must still be addressed to fulfill the promises of personalized child and adolescent psychiatry. In particular, incomplete understanding of the physiological mechanisms driving developmental changes in intrinsic functional connectivity remains an obstacle to further progress. Future directions include cross-species and multimodal neuroimaging investigations to illuminate such mechanisms. Data collection and harmonization efforts that span multiple countries and diverse cohorts are urgently needed. Finally, incorporating naturalistic fMRI paradigms such as movie watching should be a priority for future research efforts.

A Choir Without Harmony Is Just Noise: Accepting the Challenge of Data Harmonization in Transplantation.

A Choir Without Harmony Is Just Noise: Accepting the Challenge of Data Harmonization in Transplantation.

Harmonizing data on correlates of sleep in children within and across neurodevelopmental disorders: lessons learned from an Ontario Brain Institute cross-program collaboration.

There is an increasing desire to study neurodevelopmental disorders (NDDs) together to understand commonalities to develop generic health promotion strategies and improve clinical treatment. Common data elements (CDEs) collected across studies involving children with NDDs afford an opportunity to answer clinically meaningful questions. We undertook a retrospective, secondary analysis of data pertaining to sleep in children with different NDDs collected through various research studies. The objective of this paper is to share lessons learned for data management, collation, and harmonization from a sleep study in children within and across NDDs from large, collaborative research networks in the Ontario Brain Institute (OBI). Three collaborative research networks contributed demographic data and data pertaining to sleep, internalizing symptoms, health-related quality of life, and severity of disorder for children with six different NDDs: autism spectrum disorder; attention deficit/hyperactivity disorder; obsessive compulsive disorder; intellectual disability; cerebral palsy; and epilepsy. Procedures for data harmonization, derivations, and merging were shared and examples pertaining to severity of disorder and sleep disturbances were described in detail. Important lessons emerged from data harmonizing procedures: prioritizing the collection of CDEs to ensure data completeness; ensuring unprocessed data are uploaded for harmonization in order to facilitate timely analytic procedures; the value of maintaining variable naming that is consistent with data dictionaries at time of project validation; and the value of regular meetings with the research networks to discuss and overcome challenges with data harmonization. Buy-in from all research networks involved at study inception and oversight from a centralized infrastructure (OBI) identified the importance of collaboration to collect CDEs and facilitate data harmonization to improve outcomes for children with NDDs.

New Tools for Data Harmonization and Their Potential Applications in Organ Transplantation.

In organ transplantation, accurate analysis of clinical outcomes requires large, high-quality data sets. Not only are outcomes influenced by a multitude of factors such as donor, recipient, and transplant characteristics and posttransplant events but they may also change over time. Although large data sets already exist and are continually expanding in transplant registries and health institutions, these data are rarely combined for analysis because of a lack of harmonization. Promoted by the digitalization of the healthcare sector, effective data harmonization tools became available, with potential applications also for organ transplantation. We discuss herein the present problems in the harmonization of organ transplant data and offer solutions to enhance its accuracy through the use of emerging new tools. To overcome the problem of inadequate representation of transplantation-specific terms, ontologies and common data models particular to this field could be created and supported by a consortium of related stakeholders to ensure their broad acceptance. Adopting clear data-sharing policies can diminish administrative barriers that impede collaboration between organizations. Secure multiparty computation frameworks and the artificial intelligence (AI) approach federated learning can facilitate decentralized and harmonized analysis of data sets, without sharing sensitive data and compromising patient privacy. A common image data model built upon a standardized format would be beneficial to AI-based analysis of pathology images. Implementation of these promising new tools and measures, ideally with the involvement and support of transplant societies, is expected to produce improved integration and harmonization of transplant data and greater accuracy in clinical decision-making, enabling improved patient outcomes.

Cross-continental environmental and genome-wide association study on children and adolescent anxiety and depression.

Anxiety and depression in children and adolescents warrant special attention as a public health concern given their devastating and long-term effects on development and mental health. Multiple factors, ranging from genetic vulnerabilities to environmental stressors, influence the risk for the disorders. This study aimed to understand how environmental factors and genomics affect children and adolescents anxiety and depression across three cohorts: Adolescent Brain and Cognitive Development Study (US, age of 9-10; N=11,875), Consortium on Vulnerability to Externalizing Disorders and Addictions (INDIA, age of 6-17; N=4,326) and IMAGEN (EUROPE, age of 14; N=1888). We performed data harmonization and identified the environmental impact on anxiety/depression using a linear mixed-effect model, recursive feature elimination regression, and the LASSO regression model. Subsequently, genome-wide association analyses with consideration of significant environmental factors were performed for all three cohorts by mega-analysis and meta-analysis, followed by functional annotations. The results showed that multiple environmental factors contributed to the risk of anxiety and depression during development, where early life stress and school support index had the most significant and consistent impact across all three cohorts. In both meta, and mega-analysis, SNP rs79878474 in chr11p15 emerged as a particularly promising candidate associated with anxiety and depression, despite not reaching genomic significance. Gene set analysis on the common genes mapped from top promising SNPs of both meta and mega analyses found significant enrichment in regions of chr11p15 and chr3q26, in the function of potassium channels and insulin secretion, in particular Kv3, Kir-6.2, SUR potassium channels encoded by the KCNC1, KCNJ11, and ABCCC8 genes respectively, in chr11p15. Tissue enrichment analysis showed significant enrichment in the small intestine, and a trend of enrichment in the cerebellum. Our findings provide evidences of consistent environmental impact from early life stress and school support index on anxiety and depression during development and also highlight the genetic association between mutations in potassium channels, which support the stress-depression connection via hypothalamic-pituitary-adrenal axis, along with the potential modulating role of potassium channels.

Pioneering a multi-phase framework to harmonize self-reported sleep data across cohorts.

Harmonizing and aggregating data across studies enables pooled analyses that support external validation and enhance replicability and generalizability. However, the multidimensional nature of sleep poses challenges for data harmonization and aggregation. Here we describe and implement our process for harmonizing self-reported sleep data. We established a multi-phase framework to harmonize self-reported sleep data: (1) compile items, (2) group items into domains, (3) harmonize items, and (4) evaluate harmonizability. We applied this process to produce a pooled multi-cohort sample of five US cohorts plus a separate yet fully harmonized sample from Rotterdam, Netherlands. Sleep and sociodemographic data are described and compared to demonstrate the utility of harmonization and aggregation. We collected 190 unique self-reported sleep items and grouped them into 15 conceptual domains. Using these domains as guiderails, we developed 14 harmonized items measuring aspects of satisfaction, alertness/sleepiness, timing, efficiency, duration, insomnia, and sleep apnea. External raters determined that 13 of these 14 items had moderate-to-high harmonizability. Alertness/Sleepiness items had lower harmonizability, while continuous, quantitative items (e.g. timing, total sleep time, and efficiency) had higher harmonizability. Descriptive statistics identified features that are more consistent (e.g. wake-up time and duration) and more heterogeneous (e.g. time in bed and bedtime) across samples. Our process can guide researchers and cohort stewards toward effective sleep harmonization and provide a foundation for further methodological development in this expanding field. Broader national and international initiatives promoting common data elements across cohorts are needed to enhance future harmonization and aggregation efforts.

A multi-source change detection algorithm supporting user customization and near real-time deforestation detections

The abundance of free and accessible satellite data has revolutionized our ability to study deforestation with remote sensing. Recent advances have enabled us to monitor deforestation in near real-time (NRT), and a number of operational NRT alert systems using both optical and synthetic aperture radar (SAR) data have been developed. Yet despite their success, there are three primary issues with current systems. First, alerts often require multiple observations to confirm deforestation, which does not help enforcement if deforestation events are short-lived. Second, the methods can be computationally intensive and often focus on presenting binary detection alerts. Third, results are often reported as static accuracies or temporal lags, with relatively little discussion about how either could be improved for different use-cases. We therefore propose a novel, multisource NRT monitoring algorithm that addresses these issues by quickly achieving high-accuracy detections, using simple data harmonization to combine data sources while yielding probabilities of deforestation, and can be customized to meet management goals where users can explicitly change the algorithm to prioritize latency or accuracy in their detections based on their chosen data inputs. To demonstrate the algorithm's potential, we used combined Landsat-8, Sentinel-2, and Sentinel-1 SAR data in northern Myanmar to monitor areas with contrasting forest types. When testing all possible parameterizations, we achieved comparable results to previous studies, with median false positive rates and false negative rates under 10% and 25%, respectively, and median F1 scores consistently above 75% across the sensor combinations. Median post-data acquisition detection times were faster than other studies and ranged from 2 to 8 days, though the majority were between 2 and 5 days. In attempting to optimize the algorithm for our demonstrated region, we discovered there was no optimal parameterization that simultaneously provided the best accuracy and detection. In addition, we found that including Sentinel-1 data did not improve latency or accuracy, most likely due to relatively high levels of noise in our monsoonal study system that experienced high seasonal precipitation variation. We finally chose an example parameterization to create daily landscape maps of deforestation at 10 m resolution in two regions within the study area (∼60,000 ha). We assert this new, customizable method with the quantification of accuracy and latency trade-offs represents a clear advance for NRT change detection and can improve current operational systems.

Variations in Using Diagnosis Codes for Defining Age-Related Macular Degeneration Cohorts

Data harmonization is vital for secondary electronic health record data analysis, especially when combining data from multiple sources. Currently, there is a gap in knowledge as to how studies identify cohorts of patients with age-related macular degeneration (AMD), a leading cause of blindness. We hypothesize that there is variation in using medical condition codes to define cohorts of AMD patients that can lead to either the under- or overrepresentation of such cohorts. This study identified articles studying AMD using the International Classification of Diseases (ICD-9, ICD-9-CM, ICD-10, and ICD-10-CM). The data elements reviewed included the year of publication; dataset origin (Veterans Affairs, registry, national or commercial claims database, and institutional EHR); total number of subjects; and ICD codes used. A total of thirty-seven articles were reviewed. Six (16%) articles used cohort definitions from two ICD terminologies. The Medicare database was the most used dataset (14, 38%), and there was a noted increase in the use of other datasets in the last few years. We identified substantial variation in the use of ICD codes for AMD. For the studies that used ICD-10 terminologies, 7 (out of 9, 78%) defined the AMD codes correctly, whereas, for the studies that used ICD-9 and 9-CM terminologies, only 2 (out of 30, 7%) defined and utilized the appropriate AMD codes (p = 0.0001). Of the 43 cohort definitions used from 37 articles, 31 (72%) had missing or incomplete AMD codes used, and only 9 (21%) used the exact codes. Additionally, 13 articles (35%) captured ICD codes that were not within the scope of AMD diagnosis. Efforts to standardize data are needed to provide a reproducible research output.

The National Sleep Research Resource: making data findable, accessible, interoperable, reusable and promoting sleep science.

This paper presents a comprehensive overview of the National Sleep Research Resource (NSRR), a National Heart Lung and Blood Institute-supported repository developed to share data from clinical studies focused on the evaluation of sleep disorders. The NSRR addresses challenges presented by the heterogeneity of sleep-related data, leveraging innovative strategies to optimize the quality and accessibility of available datasets. It provides authorized users with secure centralized access to a large quantity of sleep-related data including polysomnography, actigraphy, demographics, patient-reported outcomes, and other data. In developing the NSRR, we have implemented data processing protocols that ensure de-identification and compliance with FAIR (Findable, Accessible, Interoperable, Reusable) principles. Heterogeneity stemming from intrinsic variation in the collection, annotation, definition, and interpretation of data has proven to be one of the primary obstacles to efficient sharing of datasets. Approaches employed by the NSRR to address this heterogeneity include (1) development of standardized sleep terminologies utilizing a compositional coding scheme, (2) specification of comprehensive metadata, (3) harmonization of commonly used variables, and (3) computational tools developed to standardize signal processing. We have also leveraged external resources to engineer a domain-specific approach to data harmonization. We describe the scope of data within the NSRR, its role in promoting sleep and circadian research through data sharing, and harmonization of large datasets and analytical tools. Finally, we identify opportunities for approaches for the field of sleep medicine to further support data standardization and sharing.

Enhancing Dementia Risk Mitigation: Standardized Digital Monitoring in Clinical Trials and Platform Design for At-Risk Elderly Individuals.

Dementia is becoming a significant public health concern, affecting approximately 130,000 individuals in Austria, whereby nearly 40% of the cases are attributed to modifiable risk factors. Multidomain lifestyle interventions have thereby demonstrated significant effects in reducing the risk of dementia. The goal was to define an interoperability framework to conduct standardized monitoring in clinical trials for enhancing dementia risk mitigation. In addition, the identified standards should be integrated into the components of the project. A step-by-step approach was used, where initially data collection, aggregation and harmonization was carried out with retrospective data from various clinical centers. Afterwards, the interoperability framework was defined including the prospective data that is gathered during a clinical trial. A guideline for integrating healthcare standards was developed and incorporated into the technical components for the clinical trial. The interoperability framework was designed in a scalable way and will be regularly updated for future needs.

Semantic Interoperability of Electronic Health Records: Systematic Review of Alternative Approaches for Enhancing Patient Information Availability.

Semantic interoperability facilitates the exchange of and access to health data that are being documented in electronic health records (EHRs) with various semantic features. The main goals of semantic interoperability development entail patient data availability and use in diverse EHRs without a loss of meaning. Internationally, current initiatives aim to enhance semantic development of EHR data and, consequently, the availability of patient data. Interoperability between health information systems is among the core goals of the European Health Data Space regulation proposal and the World Health Organization's Global Strategy on Digital Health 2020-2025. To achieve integrated health data ecosystems, stakeholders need to overcome challenges of implementing semantic interoperability elements. To research the available scientific evidence on semantic interoperability development, we defined the following research questions: What are the key elements of and approaches for building semantic interoperability integrated in EHRs? What kinds of goals are driving the development? and What kinds of clinical benefits are perceived following this development? Our research questions focused on key aspects and approaches for semantic interoperability and on possible clinical and semantic benefits of these choices in the context of EHRs. Therefore, we performed a systematic literature review in PubMed by defining our study framework based on previous research. Our analysis consisted of 14 studies where data models, ontologies, terminologies, classifications, and standards were applied for building interoperability. All articles reported clinical benefits of the selected approach to enhancing semantic interoperability. We identified 3 main categories: increasing the availability of data for clinicians (n=6, 43%), increasing the quality of care (n=4, 29%), and enhancing clinical data use and reuse for varied purposes (n=4, 29%). Regarding semantic development goals, data harmonization and developing semantic interoperability between different EHRs was the largest category (n=8, 57%). Enhancing health data quality through standardization (n=5, 36%) and developing EHR-integrated tools based on interoperable data (n=1, 7%) were the other identified categories. The results were closely coupled with the need to build usable and computable data out of heterogeneous medical information that is accessible through various EHRs and databases (eg, registers). When heading toward semantic harmonization of clinical data, more experiences and analyses are needed to assess how applicable the chosen solutions are for semantic interoperability of health care data. Instead of promoting a single approach, semantic interoperability should be assessed through several levels of semantic requirements A dual model or multimodel approach is possibly usable to address different semantic interoperability issues during development. The objectives of semantic interoperability are to be achieved in diffuse and disconnected clinical care environments. Therefore, approaches for enhancing clinical data availability should be well prepared, thought out, and justified to meet economically sustainable and long-term outcomes.

Data-Driven Enterprise Architecture for Pharmaceutical R&D

This paper addresses the research gap in the realm of data-driven transformation by leveraging the Resource-Based View (RBV) theory and the dynamic capabilities concept to the contours of a data-driven enterprise. It confronts the limitations of conventional digital and data transformation programs, which often prioritize technological enhancements over crucial organizational and cultural shifts. Proposing a more holistic perspective, the Data-Driven Enterprise Architecture Framework (DDA) is introduced, emphasizing the domain decomposition and productization of an architecture, distributed ownership, and federated governance, while ensuring the continuous harmonization of data, application, and business architecture. A case study featuring a leading pharmaceutical company illustrates the practical implementation of the DDA framework as a pillar of their Digital Transformation Strategy. By integrating scalable and distributed data architecture into the overarching Enterprise Architecture landscape, the company has initiated their data-driven transformation journey, showcased through their initial and very early results. This research not only offers valuable insights for pharmaceutical organizations navigating the complexities of data-driven transformations, but also addresses a research gap in the field.

Healthcare systems collaborating to implement a shared decision-making tool in the electronic health record and build evidence on its adoption and use.

Shared decision-making (SDM) is a method of care by which patients and clinicians work together to co-create a plan of care. Electronic health record (EHR) integration of SDM tools may increase adoption of SDM. We conducted a "lightweight" integration of a freely available electronic SDM tool, CV Prevention Choice, within the EHRs of three healthcare systems. Here, we report how the healthcare systems collaborated to achieve integration. This work was conducted as part of a stepped wedge randomized pragmatic trial. CV Prevention Choice was developed using guidelines for HTML5-based web applications. Healthcare systems integrated the tool in their EHR using documentation the study team developed and refined with lessons learned after each system integrated the electronic SDM tool into their EHR. CV Prevention Choice integration populates the tool with individual patient data locally without sending protected health information between the EHR and the web. Data abstraction and secure transfer systems were developed to manage data collection to assess tool implementation and effectiveness outcomes. Time to integrate CV Prevention Choice in the EHR was 12.1 weeks for the first system, 10.4 weeks for the second, and 9.7 weeks for the third. One system required two 1-hour meetings with study team members and two healthcare systems required a single 1-hour meeting. Healthcare system information technology teams collaborated by sharing information and offering improvements to documentation. Challenges included tracking CV Prevention Choice use for reporting and capture of combination medications. Data abstraction required refinements to address differences in how each healthcare system captured data elements. Targeted documentation on tool features and resource mapping supported collaboration of IT teams across healthcare systems, enabling them to integrate a web-based SDM tool with little additional research team effort or oversight. Their collaboration helped overcome difficulties integrating the web application and address challenges to data harmonization for trial outcome analyses.

Impaired topology and connectivity of grey matter structural networks in major depressive disorder: evidence from a multi-site neuroimaging data-set.

Major depressive disorder (MDD) has been increasingly understood as a disruption of brain connectome. Investigating grey matter structural networks with a large sample size can provide valuable insights into the structural basis of network-level neuropathological underpinnings of MDD. Using a multisite MRI data-set including nearly 2000 individuals, this study aimed to identify robust topology and connectivity abnormalities of grey matter structural network linked to MDD and relevant clinical phenotypes. A total of 955 MDD patients and 1009 healthy controls were included from 23 sites. Individualised structural covariance networks (SCN) were established based on grey matter volume maps. Following data harmonisation, network topological metrics and focal connectivity were examined for group-level comparisons, individual-level classification performance and association with clinical ratings. Various validation strategies were applied to confirm the reliability of findings. Compared with healthy controls, MDD individuals exhibited increased global efficiency, abnormal regional centralities (i.e. thalamus, precentral gyrus, middle cingulate cortex and default mode network) and altered circuit connectivity (i.e. ventral attention network and frontoparietal network). First-episode drug-naive and recurrent patients exhibited different patterns of deficits in network topology and connectivity. In addition, the individual-level classification of topological metrics outperforms that of structural connectivity. The thalamus-insula connectivity was positively associated with the severity of depressive symptoms. Based on this high-powered data-set, we identified reliable patterns of impaired topology and connectivity of individualised SCN in MDD and relevant subtypes, which adds to the current understanding of neuropathology of MDD and might guide future development of diagnostic and therapeutic markers.

Health data space nodes for privacy-preserving linkage of medical data to support collaborative secondary analyses.

The potential for secondary use of health data to improve healthcare is currently not fully exploited. Health data is largely kept in isolated data silos and key infrastructure to aggregate these silos into standardized bodies of knowledge is underdeveloped. We describe the development, implementation, and evaluation of a federated infrastructure to facilitate versatile secondary use of health data based on Health Data Space nodes. Our proposed nodes are self-contained units that digest data through an extract-transform-load framework that pseudonymizes and links data with privacy-preserving record linkage and harmonizes into a common data model (OMOP CDM). To support collaborative analyses a multi-level feature store is also implemented. A feasibility experiment was conducted to test the infrastructures potential for machine learning operations and deployment of other apps (e.g., visualization). Nodes can be operated in a network at different levels of sharing according to the level of trust within the network. In a proof-of-concept study, a privacy-preserving registry for heart failure patients has been implemented as a real-world showcase for Health Data Space nodes at the highest trust level, linking multiple data sources including (a) electronical medical records from hospitals, (b) patient data from a telemonitoring system, and (c) data from Austria's national register of deaths. The registry is deployed at the tirol kliniken, a hospital carrier in the Austrian state of Tyrol, and currently includes 5,004 patients, with over 2.9 million measurements, over 574,000 observations, more than 63,000 clinical free text notes, and in total over 5.2 million data points. Data curation and harmonization processes are executed semi-automatically at each individual node according to data sharing policies to ensure data sovereignty, scalability, and privacy. As a feasibility test, a natural language processing model for classification of clinical notes was deployed and tested. The presented Health Data Space node infrastructure has proven to be practicable in a real-world implementation in a live and productive registry for heart failure. The present work was inspired by the European Health Data Space initiative and its spirit to interconnect health data silos for versatile secondary use of health data.

Exploring Data Collection Priorities of Community Partners in Early Psychosis Care.

Learning health care networks can significantly improve the effectiveness, consistency, and cost-effectiveness of care delivery. As part of a data harmonization process, incorporation of the perspectives of community partners to maximize the relevance and utility of the data is critical. A mixed-methods focus group study was conducted with early psychosis program providers, leadership, service users, and family members to explore their priorities regarding data collection in early psychosis care. Focus group transcripts were analyzed through thematic analysis. Twenty-two focus groups comprising 178 participants were conducted across 10 early psychosis programs. Participants considered functioning, quality of life, recovery, and symptoms of psychosis as key outcomes to assess, although variation by participants' roles was also evident. Participants emphasized the clinical utility of assessing a broad range of predictors of care outcomes, favored a broad conceptualization of the constructs assessed, and indicated a preference for client-reported measures. Participants also emphasized the importance of surveys adopting a recovery-oriented, strengths-based approach. Large-scale aggregation of health care data collected as part of routine care offers opportunities for research and may have a positive impact on care delivery and quality improvement activities. However, these benefits are contingent on the data being both relevant and accessible to those who deliver and receive such care. This study highlights an approach that may inform the development of core assessment batteries used, optimizing the utility of such data for all community partners.

Public data homogenization for AI model development in breast cancer.

Developing trustworthy artificial intelligence (AI) models for clinical applications requires access to clinical and imaging data cohorts. Reusing of publicly available datasets has the potential to fill this gap. Specifically in the domain of breast cancer, a large archive of publicly accessible medical images along with the corresponding clinical data is available at The Cancer Imaging Archive (TCIA). However, existing datasets cannot be directly used as they are heterogeneous and cannot be effectively filtered for selecting specific image types required to develop AI models. This work focuses on the development of a homogenized dataset in the domain of breast cancer including clinical and imaging data. Five datasets were acquired from the TCIA and were harmonized. For the clinical data harmonization, a common data model was developed and a repeatable, documented "extract-transform-load" process was defined and executed for their homogenization. Further, Digital Imaging and COmmunications in Medicine (DICOM) information was extracted from magnetic resonance imaging (MRI) data and made accessible and searchable. The resulting harmonized dataset includes information about 2,035 subjects with breast cancer. Further, a platform named RV-Cherry-Picker enables search over both the clinical and diagnostic imaging datasets, providing unified access, facilitating the downloading of all study imaging that correspond to specific series' characteristics (e.g., dynamic contrast-enhanced series), and reducing the burden of acquiring the appropriate set of images for the respective AI model scenario. RV-Cherry-Picker provides access to the largest, publicly available, homogenized, imaging/clinical dataset for breast cancer to develop AI models on top. We present a solution for creating merged public datasets supporting AI model development, using as an example the breast cancer domain and magnetic resonance imaging images. • The proposed platform allows unified access to the largest, homogenized public imaging dataset for breast cancer. • A methodology for the semantically enriched homogenization of public clinical data is presented. • The platform is able to make a detailed selection of breast MRI data for the development of AI models.

Abstract LB141: Harmonization and integration of regional based prospective cohorts: A preliminary report of the African Caribbean Cancer Consortium

Abstract Introduction: The promise of achieving cancer control both nationally and globally rest on rigorous data collection, data harmonization and data sharing to catalyze scientific knowledge and understanding to more quickly advance our progress to addressing cancer disparities. In response, the LIFE Project aimed to establish a cancer-focused robust, functional platform for data harmonization and sharing across national and international studies with a focus on low-resourced settings and LMIC. Methods: Established in 2022, the integrated database platform hosts data collected from the ongoing Jamaican LIFE and US CAP3 projects. Both studies focus on investigating biologic and socioecologic risk factors for non-communicable chronic diseases (NCDs) and cancers. Participants self-reported data via REDCap. A one-to one mapping of the variables from both questionnaires was conducted and stored in the integrated REDCap file. An automated REDCap Application Programming Interface (API) script weekly imports the new entries into the integrated database. To ensure data accuracy, on a weekly schedule, data importation and data integration are monitored and assessed by random sampling of original source data entries and the corresponding entries in the integrated database. Any additional errors in data integration are resolved via consultations with the programming team. Results: As of June 2023, 3,369 participants were enrolled - 2,561 enrolled from the LIFE study and 808 from the CAP3 study. Overall, the combined participants were 89% Afro-Caribbean or African American, and comprised 40% males with a median age of 54 years and 60% females with median age being 51 years. For the LIFE study, median age is 50 years, and for the CAP3 the median age is 55. The prevalence of self-reported health conditions are as follows: diabetes - 13% LIFE, 13% CAP3; hypertension - 37% LIFE, 19% CAP3; dyslipidemia - 15% LIFE, 21% CAP3. Conclusion: With the continuing need for precision public health, there is a dire need to address disparities through innovative ways that promote comprehensive data linkage and analyses. This platform can be used in mapping individual cohort data with demonstrated success for the LIFE and CAP3 studies. Our web-based query tool to interface that interfaces with our REDCap database also allows us to query the available variables in both the separate and combined cohort databases and will facilitate hypothesis development. The impact of our study goes beyond the data harmonization, and robust data integration platform that links the LIFE and CAP3 studies. This allows for US comparative studies. Novel. We will also have the ability to harmonize with large US cohort studies, as well as interrogate research questions examining commonalities and differences among African Americans, Afro-Caribbean Americans and Afro-Caribbeans in the Caribbean. These comparative studies will help to elucidate the causes increased health risks, and accelerate the science to remedy the global Black NCD and cancer disparities. Citation Format: Camille C. R. Ragin, Janeil Williams, Olga Tchuvatkina, Joette Mckenzie, Kimlin Ashing, Marshall Tulloch-Reid. Harmonization and integration of regional based prospective cohorts: A preliminary report of the African Caribbean Cancer Consortium [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(7_Suppl):Abstract nr LB141.

Data Flows and Data Protection in the Greater Bay Area: The Need for a Coordinated Legal Framework

Abstract The ambitious Greater Bay Area (GBA) agenda pursues deeper cooperation among Guangdong, Hong Kong, and Macau for further regional development. The integration of the digital economies across the GBA cities depends on effective cross-boundary data flows. However, the free flow of data between Mainland China, Hong Kong, and Macau is currently hampered by stark differences in data protection and cyber security regimes. While the Mainland restricts data exports outside its jurisdiction, Hong Kong does not specifically regulate cross-border data exchanges. This article explores the potential for greater coordination and harmonization of data privacy laws between Hong Kong, Macau, and Mainland China. It proposes to explore the potential of facilitating inter-regional data transfers through a coordinated data export framework. The article also explains why this is likely a more realistic medium-term objective than a full harmonization of the data protection regimes in the three jurisdictions.