The European medical information framework: A novel ecosystem for sharing healthcare data across Europe

Abstract

Introduction: The European medical information framework (EMIF) was an Innovative Medicines Initiative project jointly supported by the European Union and the European Federation of Pharmaceutical Industries and Associations, that generated a common technology and governance framework to identify, assess and (re)use healthcare data, to facilitate real-world data research. The objectives of EMIF included providing a unified platform to support a wide range of studies within two verification programmes-Alzheimer's disease (EMIF-AD), and metabolic consequences of obesity (EMIF-MET).Methods: The EMIF platform was built around two main data-types: electronic health record data and research cohort data, and the platform architecture composed of a set of tools designed to enable data discovery and characterisation. This included the EMIF catalogue, which allowed users to find relevant data sources, including the data-types collected. Data harmonisation via a common data model were central to the project especially for population data sources. EMIF also developed an ethical code of practice to ensure data protection, patient confidentiality and compliance with the European Data Protection Directive, and GDPR.Results: Currently 18 population-based disease agnostic and 60 cohort-based Alzheimer's data partners from across 14 countries are contained within the catalogue, and this will continue to expand. The work conducted in EMIF-AD and EMIF-MET includes standardizing cohorts, summarising baseline characteristics of patients, developing diagnostic algorithms, epidemiological studies, identifying and validating novel biomarkers and selecting potential patient samples for pharmacological intervention.Conclusions: EMIF was designed to provide a sustainable model as demonstrated by the sustainability plans for EMIF-AD. Although network-wide studies using EMIF were not conducted during this project to evaluate its sustainability, learning from EMIF will be used in the follow-on IMI-2 project, European Health Data and Evidence Network (EHDEN). Furthermore, EMIF has facilitated collaborations between partners † The EMIF consortium comprised 56 institutions including academic and industry partners. The names of the institutions, and writers who contributed to the design, drafting, editing, reviewing, and final approval of the manuscript are acknowledged in the acknowledgment section of the manuscript.

Quality of Hospital Electronic Health Record (EHR) Data Based on the International Consortium for Health Outcomes Measurement (ICHOM) in Heart Failure: Pilot Data Quality Assessment Study

“…IMASIS contains clinical information from approximately 1.5 million patients who have used the services of this health care system since 1989, across different settings such as admissions, outpatient consultations, emergency room visits, and major ambulatory surgery appointments. IMASIS-2 is the anonymized relational database of IMASIS that was created during the European Medical Information Framework (EMIF) project [ 32 ] and is the data source used for research purposes. It contains structured data related to diagnosis, procedures, drug administration, and laboratory tests and clinical annotations in a free-text format.…”

Common Problems, Common Data Model Solutions: Evidence Generation for Health Technology Assessment

“…A limited number of European datasets are of sufficient quality for use in decision making, particularly in Eastern and Southern Europe [40]. Furthermore, it can be difficult to identify datasets containing relevant information or to understand the quality of the data with respect to a planned application [41]. When relevant, high-quality data are identified, it may not be accessible because of governance restrictions on data sharing, lack of patient consent, or prohibitively high access costs.…”

“…A large and diverse data network facilitates the identification of relevant data sources and allows for an understanding of their quality [60]. To support the timely generation of high-quality and relevant evidence, a well-maintained, high-quality register with detailed and substantial meta-data about each dataset is essential [41].…”

Is the quality of hospital EHR data sufficient to evidence its ICHOM outcomes performance in heart failure? A pilot evaluation

“…IMASIS contains clinical information from approximately 1.5 million patients who have used the services of this healthcare system since 1989, across different settings such as admissions, outpatient consultations, emergency room visits and major ambulatory surgery appointments. IMASIS-2 is the anonymized relational database of IMASIS, that was created during the European Medical Information Framework (EMIF) project 37 , being the data source used for research purposes. It contains structured data related to diagnosis, procedures, drug administration and laboratory tests, and clinical annotations in a free text format.…”