The Data Governance Act and the EU's move towards facilitating data sharing

Shabani, Mahsa

doi:10.15252/msb.202110229

Cited by 14 publications

(18 citation statements)

References 3 publications

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“…According to most sources Consent [A 4 , 14 , 15 , 36 , 39 , 41 – 47 , 50 – 54 , 56 – 60 , 64 , 65 , 67 , 71 – 90 ] to having a participant’s biomedical data used in research forms a basis for best practices and codes of conduct. Consent serves as the cornerstone of bioethics and is constantly reflected as a core principle in law and ethics of biomedical research promoting autonomy [A 36 ].…”

Section: Resultsmentioning

confidence: 99%

“…Although this is an adaptive process [A 43 ] it is heavy reliant on resources and may not favour data use for secondary purposes [A 15 ]. Altruistic consent involves consent by data subjects to process personal data relating to them, or authorisations of other data custodians to allow the use of their non-personal data without seeking a reward, for purposes of general interest, such as scientific research purposes or improving public services [A 90 ].…”

Section: Resultsmentioning

confidence: 99%

“…Sources pointed out that the collection, curation, processing and deletion of data should be done on the grounds of sufficient legal basis [A 38 , 53 , 60 , 74 , 81 , 90 ]. References to legal basis describe legal basis in governance as the foundation that ensures that appropriate legal frameworks, applicable laws, regulations, and standards are behind the reasons for certain data governance actions [A 38 ].…”

Section: Resultsmentioning

confidence: 99%

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The ethical and legal landscape of brain data governance

2022

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Neuroscience research is producing big brain data which informs both advancements in neuroscience research and drives the development of advanced datasets to provide advanced medical solutions. These brain data are produced under different jurisdictions in different formats and are governed under different regulations. The governance of data has become essential and critical resulting in the development of various governance structures to ensure that the quality, availability, findability, accessibility, usability, and utility of data is maintained. Furthermore, data governance is influenced by various ethical and legal principles. However, it is still not clear what ethical and legal principles should be used as a standard or baseline when managing brain data due to varying practices and evolving concepts. Therefore, this study asks what ethical and legal principles shape the current brain data governance landscape? A systematic scoping review and thematic analysis of articles focused on biomedical, neuro and brain data governance was carried out to identify the ethical and legal principles which shape the current brain data governance landscape. The results revealed that there is currently a large variation of how the principles are presented and discussions around the terms are very multidimensional. Some of the principles are still at their infancy and are barely visible. A range of principles emerged during the thematic analysis providing a potential list of principles which can provide a more comprehensive framework for brain data governance and a conceptual expansion of neuroethics.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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The ethical and legal landscape of brain data governance

2022

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“…However, the Data Governance Act could act as a mechanism to standardise general consent between different EU member states, ameliorating the challenges with cross border transfers of data. The Data Governance Act could also act to empower data subjects so that they can exercise greater control over how their data is used for research [ 63 ].…”

Section: Discussionmentioning

confidence: 99%

Health data privacy through homomorphic encryption and distributed ledger computing: an ethical-legal qualitative expert assessment study

2022

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Background Increasingly, hospitals and research institutes are developing technical solutions for sharing patient data in a privacy preserving manner. Two of these technical solutions are homomorphic encryption and distributed ledger technology. Homomorphic encryption allows computations to be performed on data without this data ever being decrypted. Therefore, homomorphic encryption represents a potential solution for conducting feasibility studies on cohorts of sensitive patient data stored in distributed locations. Distributed ledger technology provides a permanent record on all transfers and processing of patient data, allowing data custodians to audit access. A significant portion of the current literature has examined how these technologies might comply with data protection and research ethics frameworks. In the Swiss context, these instruments include the Federal Act on Data Protection and the Human Research Act. There are also institutional frameworks that govern the processing of health related and genetic data at different universities and hospitals. Given Switzerland’s geographical proximity to European Union (EU) member states, the General Data Protection Regulation (GDPR) may impose additional obligations. Methods To conduct this assessment, we carried out a series of qualitative interviews with key stakeholders at Swiss hospitals and research institutions. These included legal and clinical data management staff, as well as clinical and research ethics experts. These interviews were carried out with two series of vignettes that focused on data discovery using homomorphic encryption and data erasure from a distributed ledger platform. Results For our first set of vignettes, interviewees were prepared to allow data discovery requests if patients had provided general consent or ethics committee approval, depending on the types of data made available. Our interviewees highlighted the importance of protecting against the risk of reidentification given different types of data. For our second set, there was disagreement amongst interviewees on whether they would delete patient data locally, or delete data linked to a ledger with cryptographic hashes. Our interviewees were also willing to delete data locally or on the ledger, subject to local legislation. Conclusion Our findings can help guide the deployment of these technologies, as well as determine ethics and legal requirements for such technologies.

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“…The purpose is to ensure that data quality remains high throughout the lifecycle of the data, so that they are trustworthy, consistent, and not misused [ 6 ]. Moreover, any controls that are implemented should be compatible with an organization’s objectives as well as with current rules and regulations such as, e.g., the General Data Protection Regulation (GDPR) within the European Union [ 19 ].…”

Section: Good Health Literacy Data Governancementioning

confidence: 99%

From Project-Based Health Literacy Data and Measurement to an Integrated System of Analytics and Insights: Enhancing Data-Driven Value Creation in Health-Literate Organizations

Sørensen

2022

IJERPH

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Health literacy measurement is important to improve equity, health and well-being as part of health system transformation. However, health literacy data of good quality are often lacking or difficult to access for decision-makers. To better inform policy, research and practice, this paper discusses how to move from project-based health literacy data and measurement to an integrated system of analytics and insights enhancing data-driven value creation in health-literate organizations. There is a need for the development of health literacy data pipelines, data dashboards, and data governance mechanisms which are timely and trustworthy. Investing in health literacy data analytics and data governance can pave the way for the integration of health literacy as an acknowledged global health indicator in large-scale surveys, ventures, and daily business. Leadership and management buy-in are needed to steer the process. Lessons learned from decades of measurement research combined with strategic implementation of systematic use of health literacy monitoring may accelerate the progress.

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The Data Governance Act and the EU's move towards facilitating data sharing

Cited by 14 publications

References 3 publications

The ethical and legal landscape of brain data governance

The ethical and legal landscape of brain data governance

Health data privacy through homomorphic encryption and distributed ledger computing: an ethical-legal qualitative expert assessment study

From Project-Based Health Literacy Data and Measurement to an Integrated System of Analytics and Insights: Enhancing Data-Driven Value Creation in Health-Literate Organizations

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