12 research outputs found
Real-world data and patient-reported outcomes in diabetes in Emilia–Romagna (REWINDER): protocol of a federated cohort study for the regional evaluation of quality of care during and after COVID-19
No full textIntroduction Real-world data and patient-reported outcomes in diabetes in Emilia–Romagna is a multi-centric observational cohort study aimed at improving diabetes care in the Emilia–Romagna region, by exploring trends and predictors of clinical and psychological parameters in a large population of people with diabetes, during and after the COVID-19 pandemic.Methods and analysis The study has a mixed retrospective/prospective design. The retrospective component involves computerised data linkage of administrative and clinical data from the local health authorities of Romagna and Reggio Emilia, and the University Hospital of Parma, covering a population of approximately 100 000 prevalent cases with diabetes, followed throughout the years 2019–2024. The selection of data items collected in the reference time frame is based on the International Consortium for Health Outcomes Measurement (ICHOM) standard set for diabetes, including clinical, lifestyle, social and healthcare service measurements. The prospective component includes primary data collection of indicators of psychological well-being through the WHO-5 Well-Being Index, diabetes distress using the Problem Areas In Diabetes-Short Form and depression through the Patient Health Questionnaire-9, measured at 0–6 months in an overall sample of 455 people with type 2 diabetes. Statistical analysis will include descriptive analysis and multivariate logistic regression using a two-step federated approach.Ethics and dissemination The study has obtained ethics approval from the Ethics Committee of Romagna and the Ethics Committee of Area Vasta Emilia Nord. The results of the study will be published in scientific journals to evaluate quality and outcomes of diabetes care across the region.Trial registration number NCT06639100
Revision of the European Data Protection Directive: opportunity or threat for public health monitoring?
No full textThe link between public health monitoring on one hand and data protection legislation on the other may not be immediately clear to all. Nevertheless, it has a strong relation with the conditions required to build and correctly operate high quality, sustainable public health information systems.
The following public health goals are directly influenced by the data protection legislative framework:
•optimizing efficiency, through a detailed analysis of health services provided to specific categories of individuals;
•monitoring appropriateness, safety and quality of care, through a systematic assessment of processes and outcomes across different categories of users in the intermediate and long term;
•targeting equity, through the analysis of deprived individuals that otherwise would have been difficult to track in relation to specific interventions;
•ensuring the sustainability of systems of health indicators, through the intelligent use of the information available in large administrative databases;
•enhancing data completeness for evidence-based policy making, identifying ways to extend the secondary use of health data;
•enhancing data quality, through linkage of different databases at the subject level, which will prevent that events are missed or double counted; and
•enhancing the competitiveness of the European Union, through an increased ability in using health data and the routine performance assessment of health services and systems to support research and development for innovation
Using routinely collected health data for surveillance, quality improvement and research: Framework and key questions to assess ethics, privacy and data access
No full textBackground The use of health data for public health, surveillance, quality improvement and research is crucial to improve health systems and health care. However, bodies responsible for privacy and ethics often limit access to routinely collected health data. Ethical approvals, issues around protecting privacy and data access are often dealt with by different layers of regulations, making approval processes appear disjointed.Objective To create a comprehensive framework for defining the ethical and privacy status of a project and for providing guidance on data access.Method The framework comprises principles and related questions. The core of the framework will be built using standard terminology definitions such as ethics-related controlled vocabularies and regional directives. It is built in this way to reduce ambiguity between different definitions. The framework is extensible: principles can be retired or added to, as can their related questions. Responses to these questions should allow data processors to define ethical issues, privacy risk and other unintended consequences.Results The framework contains three steps: (1) identifying possible ethical and privacy principles relevant to the project; (2) providing ethics and privacy guidance questions that inform the type of approval needed; and (3) assessing case-specific ethics and privacy issues. The outputs from this process should inform whether the balance between public interests and privacy breach and any ethical considerations are tipped in favour of societal benefits. If they are then this should be the basis on which data access is permitted. Tightly linking ethical principles to governance and data access may help maintain public trust.</p
Data protection, interoperability and governance assessment tool: results from a proof-of-concept survey
No full textBackgroundThe Collaborative Health Information European Framework (CHIEF) supports consistent monitoring of quality of care and outcomes, through a cohesive information infrastructure aligned with legal and ethical standards, to ensure preparedness to the European Health Data Space (EHDS). We aimed to define, develop and apply a practical solution to help data controllers and data holders navigating the increasingly complex and rapidly evolving legal conditions for health data governance.MethodsWe designed and applied a modular questionnaire to enable Data Protection, Interoperability and Governance Assessment (DIGA). The tool combines quantitative and qualitative analysis to measure the level of institutional compliance with EU data protection laws, governance standards and the EHDS Regulation. The instrument has been designed to enhance its usability and flexible implementation, allowing users to focus on sections that are considered most relevant for their operational purposes. A test survey was run to test its applicability.ResultsThe study demonstrated the tool's effectiveness in capturing real-world practices and help data controllers and data holders in identifying both strengths and critical gaps. Survey results showed that users have already established solid foundations for data protection. Participating centres showed a moderate-to-high capacity to enable the secondary use of health data for both research and public health purposes, reflecting an encouraging level of preparedness for the EHDS Regulation. The user feedback collected alongside the survey confirmed the tool's relevance and usability.ConclusionsWe developed an ad-hoc tool to monitor and improve data protection, interoperability and governance, which may represent a strategic resource for disease registries and health information systems. The DIGA tool can support institutional self-assessment, fostering regulatory readiness and generating meaningful insights for the implementation of national and EU-level policies. Further studies are needed to assess the reliability of the tool under different conditions, and refine it accordingly for large-scale implementation. Validation across multiple networks and disease domains within CHIEF will allow strengthening its role in preparation of the EHDS
WP8 - D8.1 - Website Framework and Social Tools
No full textDetails regarding the creation of the website and social pages
Data protection, interoperability and governance assessment tool: results from a proof-of-concept survey
No full textBackground
The Collaborative Health Information European Framework (CHIEF) supports consistent monitoring of quality of care and outcomes, through the definition of a cohesive information infrastructure aligned with legal and ethical standards, to ensure preparedness to the European Health Data Space (EHDS). We aimed to define, develop and apply a practical solution to help data controllers and data holders of disease registries and health information systems navigate the increasingly complex and rapidly evolving legal conditions for the governance of health data.
Methods
We designed a tool for data protection, interoperability and governance assessment (DIGA) as a modular, self-assessment questionnaire with an integrated scoring system. The tool enables the application of a mixed-methods approach, combining quantitative and qualitative analytics to assess the level of institutional compliance with EU data protection laws, governance standards, and the EHDS Regulation. The tool has been designed to enhance usability and flexible implementation, allowing institutions to focus on sections that are considered most relevant for their operational purposes. A proof-of-concept survey was run to test and validate the capability of the tool in the field.
Results
The pilot study demonstrated the ability of the tool to capture real-world practices and help data controllers and data holders identify both strengths and critical gaps. The results of the survey showed that participating centres have already established solid foundations in several key areas of data protection. Participating centres showed a moderate-to-high ability to support the secondary use of health data for both research and public health purposes, reflecting an encouraging level of preparedness to the EHDS Regulation. The user feedback collected alongside the pilot study confirmed the relevance and usability of the tool.
Conclusions
We developed an ad-hoc tool to monitor and improve DIGA, as a strategic resource for disease registries and health information systems. The application on field showed that the DIGA tool can support institutional self-assessment, to foster regulatory readiness and generate meaningful insights on how to guide implementation of national and EU-level policies. Further studies are needed to assess the reliability of the tool under broader conditions and refine it accordingly for large-scale implementation. Validation across multiple networks and disease domains within CHIEF will allow strengthening its role in preparation of the EHDS.JRC.F.1 - Disease Preventio
UK National Data Guardian for Health and Care’s Review of Data Security: Trust, better security and opt-outs
No full textSharing health and social care data is essential to the delivery of high quality health care as well as disease surveillance, public health, and for conducting research. However, these societal benefits may be constrained by privacy and data protection principles. Hence, societies are striving to find a balance between the two competing public interests. Whilst the spread of IT advancements in recent decades has increased the demand for an increased privacy and data protection in many ways health is a special case.
UK, are adopting guidelines, codes of conduct and regulatory instruments aimed to implement privacy principles into practical settings and enhance public trust. Accordingly, in 2015, the UK National Data Guardian (NDG) requested to conduct a further review of data protection, referred to as Caldicott 3. The scope of this review is to strengthen data security standards and confidentiality. It also proposes a consent system based on an “opt-out” model rather than on “opt-in.
Across Europe as well as internationally the privacy-health data sharing balance is not fixed. In Europe enactment of the new EU Data Protection Regulation in 2016 constitute a major breakthrough, which is likely to have a profound effect on European countries and beyond. In Australia and across North America different ways are being sought to balance out these twin requirements of a modern society - to preserve privacy alongside affording high quality health care for an ageing population.
Whilst in the UK privacy legal framework remains complex and fragmented into different layers of legislation, which may negatively impact on both the rights to privacy and health the UK is at the forefront in the uptake of international and EU privacy and data protection principles. And, if the privacy regime were reorganised in a more comprehensive manner, it could be used as a sound implementation model for other countries
Assessing data protection and governance in health information systems: a novel methodology of Privacy and Ethics Impact and Performance Assessment (PEIPA)
No full textAssessing data protection and governance in health information systems: A novel methodology of Privacy and Ethics Impact and Performance Assessment (PEIPA)
No full textBackground:
Data processing of health research databases often requires a Data Protection Impact Assessment to evaluate the severity of the risk and the appropriateness of measures taken to comply with the European Union (EU) General Data Protection Regulation (GDPR). We aimed to define and apply a comprehensive method for the evaluation of privacy, data governance and ethics among research networks involved in the EU Project Bridge Health.
Methods:
Computerised survey among associated partners of main EU Consortia, using a targeted instrument designed by the principal investigator and progressively refined in collaboration with an international advisory panel. Descriptive measures using the percentage of adoption of privacy, data governance and ethical principles as main endpoints were used for the analysis and interpretation of the results.
Results:
A total of 15 centres provided relevant information on the processing of sensitive data from 10 European countries. Major areas of concern were noted for: data linkage (median, range of adoption: 45%, 30%–80%), access and accuracy of personal data (50%, 0%–100%) and anonymisation procedures (56%, 11%–100%). A high variability was noted in the application of privacy principles.
Conclusions:
A comprehensive methodology of Privacy and Ethics Impact and Performance Assessment was successfully applied at international level. The method can help implementing the GDPR and expanding the scope of Data Protection Impact Assessment, so that the public benefit of the secondary use of health data could be well balanced with the respect of personal privacy
