The European Health Data Space

Marcus, J. Scott; Martens, Bertin; Carugati, Christophe; Bucher, Anne; Godlovitch, Ilsa

doi:10.2139/ssrn.4300393

Cited by 11 publications

(5 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Chapter II of the EHDS proposal focuses on rights and mechanisms that complement existing data subject rights. These mechanisms will enable natural persons to obtain better care by reducing information asymmetries between providers and users of health services, and by facilitating informed choice ( Marcus et al, 2022 ). An important example pertains to data portability, which will be significantly enhanced.…”

Section: Discussionmentioning

confidence: 99%

“…Namely, it will be possible to exercise the right irrespective of the legal bases on which the original data processing took place, as well as to transmit not only individually provided data, but also inferred and derived data (e.g., medical examinations). 29 Enhancing the portability of data stored in electronic health records will presumably contribute to, e.g., patients obtaining more meaningful specialist opinions or second opinions on their disease and treatment ( Marcus et al, 2022 ). Such a consequence is in line with one of the key positive outcomes of individual data control identified in the survey, i.e., “benefits for individual patients”.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Patients’ knowledge, preferences, and perspectives about data protection and data control: an exploratory survey

Lalova-Spinks,

Saesen,

Silva

et al. 2024

Front. Pharmacol.

View full text Add to dashboard Cite

Background: In the European Union, the General Data Protection Regulation (GDPR) plays a central role in the complex health research legal framework. It aims to protect the fundamental right to the protection of individuals’ personal data, while allowing the free movement of such data. However, it has been criticized for challenging the conduct of research. Existing scholarship has paid little attention to the experiences and views of the patient community. The aim of the study was to investigate 1) the awareness and knowledge of patients, carers, and members of patient organizations about the General Data Protection Regulation, 2) their experience with exercising data subject rights, and 3) their understanding of the notion of “data control” and preferences towards various data control tools.Methods: An online survey was disseminated between December 2022 and March 2023. Quantitative data was analyzed descriptively and inferentially. Answers to open-ended questions were analyzed using the thematic analysis method.Results: In total, 220 individuals from 28 European countries participated. The majority were patients (77%). Most participants had previously heard about the GDPR (90%) but had not exercised any of their data subject rights. Individual data control tools appeared to be marginally more important than collective tools. The willingness of participants to share personal data with data altruism organizations increased if patient representatives would be involved in the decision-making processes of such organizations.Conclusion: The results highlighted the importance of providing in-depth education about data protection. Although participants showed a slight preference towards individual control tools, the reflection based on existing scholarship identified that individual control holds risks that could be mitigated through carefully operationalized collective tools. The discussion of results was used to provide a critical view into the proposed European Health Data Space, which has yet to find a productive balance between individual control and allowing the reuse of personal data for research.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Patients’ knowledge, preferences, and perspectives about data protection and data control: an exploratory survey

Lalova-Spinks,

Saesen,

Silva

et al. 2024

Front. Pharmacol.

View full text Add to dashboard Cite

show abstract

“…Adopting common data standards, such as FHIR, and establishing governance and orchestration mechanisms, like the consent management system presented, can facilitate the exchange and integration of health data, leading to better clinical decision-making, research, and patient outcomes. Additionally, the data access policies can contain more constraints [8] (e.g., geo-locational), allowing a cross-border exchange in line with the European Commission proposal of a European Health Data Space [9].…”

Section: Benefits Of Governance Mechanisms For Facilitating Health Da...mentioning

confidence: 99%

Consent Management System on Patient-Generated Health Data

Randine,

Salant,

Muzny

et al. 2024

Studies in Health Technology and Informatics

View full text Add to dashboard Cite

We consent to many things in life, but sometimes we do not know what we consent to. When discussing data protection in Europe, consent has been associated with permission under the GDPR, and health data are highly sensitive. Patients cannot make an informed decision without being provided with the information they need upfront: no informed decision, no informed consent. This paper presents a consent management system for patient-generated health data stored with HL7 FHIR specification, tested on Type 1 diabetes synthetic data. This architecture, based on using FHIR as an unequivocal data exchange format, can lead to individuals (patients) taking control of their data, enabling potential data exchange and reuse of health data across countries and organisations, in line with the European Commission proposal of a European Health Data Space.

show abstract

“…[12,13] Furthermore, from a European perspective, there have been significant developments such as the establishment of a European Health Data Space (EHDS) during the last years. [14,15] Overall, much good is expected from the developments taking place regarding routine healthcare data.…”

Section: Introductionmentioning

confidence: 99%

The impact of data extraction and processing on outcomes of research based on routine healthcare data from general practices: an observational study (Preprint)

van Essen,

Twickler,

Weesie

et al. 2024

Preprint

View full text Add to dashboard Cite

BACKGROUND Further use of routinely recorded data in electronic health records (EHR) is increasingly more common, for example in epidemiological research. However, data need to be processed and prepared to allow for this further use. Within this process, different choices can be made, which could have significant consequences for research outcomes. OBJECTIVE The aim of this study was to investigate the influence of data processing steps involved in the secondary use of EHR data on research outcomes. METHODS This study used EHR data from eight Dutch general practices from 2019. These practices contributed data to two research databases: the Academic General Practitioner Development Network (AHON) registry and the Nivel Primary Care Database (Nivel-PCD). Data were extracted and processed using distinct data processing pipelines. This allowed for the evaluation of the impact of different processing methods by comparing the two datasets in a three-step approach: 1) patient demographics, 2) epidemiology of concordant patients, 3) health service utilization of patients with three diagnoses. We compared a number of indicators of similarity between the two databases, including number of contacts, regular consultations and visits, prescriptions, and episodes. Subsequently, for these three diagnoses (diabetes mellitus (DM), urinary tract infection (UTI), cough) we calculated the prevalence, number of prescriptions and number of regular consultations and visits per 1000 patient years. The outcomes were compared by performing two sample t-tests using 99% confidence intervals. RESULTS There was a difference in the number of enrolled patients between the two datasets (AHON registry N= 47,517, Nivel-PCD N=44,247). However, the patient demographics were similar. We found differences between all indicator outcomes of the concordant patients in both databases, i.e., the number of contacts, prescriptions and episodes per patient, except for the number of regular consultations and visits (P=.46). Differences in the indicator outcomes varied between the three diagnosis groups, whereas the number of regular consultations and visits was similar between databases for all diagnoses (DM P=<.55, UTI P=.73, cough P=.73) CONCLUSIONS The results illustrate the importance of awareness of researchers and other users of routine health data of the different steps in processing these data and making them available for research. Data processors should share their knowledge about these choices and researchers and policymakers should invest in their knowledge of this type of metadata. This transparency is all the more important in light of a European Health Data Space and the ever-increasing secondary use of routinely recorded health data. Future research should focus on the role of transparency and joint decision making, to minimize effects of data processing steps and to gain insight into the individual influence of processing steps on research outcomes. This could stimulate a common approach among data processors and researchers resulting in increased data interoperability.

show abstract

The European Health Data Space

Cited by 11 publications

References 0 publications

Patients’ knowledge, preferences, and perspectives about data protection and data control: an exploratory survey

Patients’ knowledge, preferences, and perspectives about data protection and data control: an exploratory survey

Consent Management System on Patient-Generated Health Data

The impact of data extraction and processing on outcomes of research based on routine healthcare data from general practices: an observational study (Preprint)

Contact Info

Product

Resources

About