Key Ethical Challenges in the European Medical Information Framework

Floridi, Luciano; Luetge, Christoph; Pagallo, Ugo; Schäfer, Burkhard; Valcke, Peggy; Vayena, Effy; Addison, Janet; Hughes, Nigel; Lea, Nathan; Sage, Caroline; Vannieuwenhuyse, Bart

doi:10.1007/s11023-018-9467-4

Cited by 26 publications

(32 citation statements)

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“…In developing the ECoP, several pre‐existing codes and policies were examined during 2014‐2015 to evaluate whether component parts of these should be adopted by EMIF. EMIF adheres to the IMI code on data privacy, which contains many high‐level principles that the ECoP could extend with more operational detail . Successive drafts of the ECoP were developed during 2014‐2016, primarily by a core team of academic, healthcare, pharma industry and legal experts, with periodic wider consultation within the consortium comprising many data custodians, research users and patient organisations across Europe.…”

Section: Challenges In the Projectmentioning

confidence: 99%

“…The most important challenges the ECoP team faced were: how to define, control and monitor the purposes (kinds of research) for which federated health data are used; the kinds of organisations that should be permitted to conduct research; and how to monitor this . This ECoP will also be adopted in EHDEN, which intends to harmonise ~100 million EU records to the OMOP common data model, to facilitate—outcome‐based research .…”

Section: Challenges In the Projectmentioning

confidence: 99%

“…This ECoP will also be adopted in EHDEN, which intends to harmonise ~100 million EU records to the OMOP common data model, to facilitate—outcome‐based research . Details about ECoP and the challenges involved in ECoP have been explained in detail in a paper by Floridi et al…”

Section: Challenges In the Projectmentioning

confidence: 99%

“…Standardizing these data to a common platform would provide uniform representation and architecture thereby enabling the standardisation of data and allowing the use of common analytical tools . This would maximise the research value of the scientific information and allow researchers to make significant advancements in medical research and drug development leading to improved quality of care through data discovery and analysis . Therefore, there is a need for a unified platform that allows researchers to find, assess and (re)use healthcare data on a wider scale, bringing together data from different populations.…”

Section: Emif—introductionmentioning

confidence: 99%

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

Lovestone

2019

Learning Health Systems

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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.

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Section: Challenges In the Projectmentioning

confidence: 99%

Section: Challenges In the Projectmentioning

confidence: 99%

Section: Challenges In the Projectmentioning

confidence: 99%

Section: Emif—introductionmentioning

confidence: 99%

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

Lovestone

2019

Learning Health Systems

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“…These criteria overlap and even go somewhat further than the criteria for 'bona fide research' and the departments which perform the research as discussed by Floridi et al [49]. The background of that article is the Innovative Medicines Initiative (IMI) [50] projects where academia and industry cooperate in approved, often very-large-scale projects.…”

Section: Research and The Public Interestmentioning

confidence: 99%

Observational health research in Europe: understanding the General Data Protection Regulation and underlying debate

Veen¹

2018

European Journal of Cancer

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Insights into the incidence and survival of cancer, the influence of lifestyle and environmental factors and the interaction of treatment regimens with outcomes are hugely dependent on observational research, patient data derived from the healthcare system and from volunteers participating in cohort studies, often non-selective. Since 25th May 2018, the European General Data Protection Regulation (GDPR) applies to such data. The GDPR focusses on more individual control for data subjects of 'their' data. Yet, the GDPR was preceded by a long debate. The research community participated actively in that debate, and as a result, the GDPR has research exemptions as well. Some of those apply directly; other exemptions need to be implemented into national law. Those exemptions will be discussed together with a general outline of the GDPR. I propose a substantive definition of researchdabsent in the GDPRdwhich can warrant its special status in the GDPR. The debate is not over yet. Most legal texts exhibit ambiguity and are interpreted against a background of values. In this case, those could be subsumed under informational self-determination versus solidarity and the deeper meaning of autonomy. Values will also guide national implementation and their interpretation. The value of individual control or informational selfdetermination should be balanced by nuanced visions about our mutual dependency in healthcare, as an ever-learning system, especially in the European solidarity-based healthcare systems. Good research governance might be a way forward to escape the consent or anonymise dichotomy.

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The AI Act’s Research Exemption: A Mechanism for Regulatory Arbitrage?

Colonna

2023

YSEC Yearbook of Socio-Economic Constitutions

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Key Ethical Challenges in the European Medical Information Framework

Cited by 26 publications

References 1 publication

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

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

Observational health research in Europe: understanding the General Data Protection Regulation and underlying debate

The AI Act’s Research Exemption: A Mechanism for Regulatory Arbitrage?

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