Cross-border flow of health information: is 'privacy by design' enough? Privacy performance assessment in EUBIROD

Iorio, Concetta Tania Di; Carinci, Fabrizio; Brillante, Massimo; Azzopardi, Joseph; Beck, Peter; Bratina, Nataša; Cunningham, Scott; Beaufort, Carine de; Debacker, N; Jarosz-Chobot, Przemysława; Jecht, M.; Lindblad, Ulf; Moulton, Tony; Metelko, Ž.; Nagy, Attila; Olympios, George; Prunǎ, S.; Röder, Michael; Skeie, Svein; Storms, F.; Benedetti, M. Massi

doi:10.1093/eurpub/cks043

Cited by 24 publications

(16 citation statements)

References 3 publications

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“…The sequel project, European Best Information through Regional Outcomes in Diabetes (EUBIROD), aimed 'at establishing a European Diabetes Register through the extension of the BIRO network and the use of related technology' [21]. Completed in March 2012, the system delivered fully versatile BIRO software that has been used to successfully collect data and deliver an international diabetes report from 19 countries.…”

Section: International Developments and Future Perspectivesmentioning

confidence: 99%

Standardized Information Exchange in Diabetes: Integrated Registries for Governance, Research, and Clinical Practice

Carinci¹,

Iorio²,

Benedetti³

2014

Frontiers in Diabetes

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To fight diabetes effectively, both local action and global engagement are needed. All of the potential stakeholders are necessary for collating complete data and using the information to improve policy and practice on a daily basis. A substantial contribution is required by those who deliver care regularly to people with diabetes, monitoring the status and progression of the disease with better knowledge of the problem and at a lower cost per contact. As an integral part of a long-term strategy, diabetes registers use information recorded at the point of care to improve quality of care through continuous monitoring of outcomes and prompt identification of subjects at increased risk of developing complications. Modern electronic diabetes registers substantially differ from simple electronic databases, as their role is at the core of a sophisticated network, where anything related to the condition of the individual can be measured with information on all the other levels of the healthcare system. In this chapter, we provide an overview of recent experiences in this field as well as challenges in the implementation of integrated registers, outlining roles and responsibilities of principal stakeholders and providing a snapshot of the best structure required to implement an integrated diabetes register. The chapter closes with a brief presentation of the relevant European legislation and the possible use of the recent achievements delivered by the European Union-funded public health projects BIRO and EUBIROD. The conclusions underpin the importance to follow up all recent experiences concluded positively, with consistent initiatives aimed at engaging governments, health professionals, and the whole community in the safe exchange of diabetes information, which is in everyone's interest.A modern diabetes register represents the fundamental pillar of regional/national strategies against diabetes. Through the standardized use of electronic medical records and the adoption of evidence-based definitions, registries can feed a con-

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Section: International Developments and Future Perspectivesmentioning

confidence: 99%

Standardized Information Exchange in Diabetes: Integrated Registries for Governance, Research, and Clinical Practice

Carinci¹,

Iorio²,

Benedetti³

2014

Frontiers in Diabetes

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“…The privacy and ethics framework provided could be used as means to reach a right balance between the right to privacy and the right to the higher attainable level of health. The approach is also in line with the latest work carried out by the OECD which developed key data governance mechanisms to minimize societal risks and maximise societal benefit [15].…”

Section: Contributionmentioning

confidence: 69%

“…[15] An appraisal of the tuberculosis programme in India using an ethical framework [16] What makes public health studies ethical? [17] Health data governance: privacy, monitoring, and research [18] …”

Section: Discussionmentioning

confidence: 99%

Building a Privacy, Ethics, and Data Access Framework for Real World Computerised Medical Record System Data: A Delphi Study

Liyanage¹,

Liaw²,

Iorio³

et al. 2016

Yearb Med Inform

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Summary Background: Privacy, ethics, and data access issues pose significant challenges to the timely delivery of health research. Whilst the fundamental drivers to ensure that data access is ethical and satisfies privacy requirements are similar, they are often dealt with in varying ways by different approval processes. Objective: To achieve a consensus across an international panel of health care and informatics professionals on an integrated set of privacy and ethics principles that could accelerate health data access in data-driven health research projects. Method: A three-round consensus development process was used. In round one, we developed a baseline framework for privacy, ethics, and data access based on a review of existing literature in the health, informatics, and policy domains. This was further developed using a two-round Delphi consensus building process involving 20 experts who were members of the International Medical Informatics Association (IMIA) and European Federation of Medical Informatics (EFMI) Primary Health Care Informatics Working Groups. To achieve consensus we required an extended Delphi process. Results: The first round involved feedback on and development of the baseline framework. This consisted of four components: (1) ethical principles, (2) ethical guidance questions, (3) privacy and data access principles, and (4) privacy and data access guidance questions. Round two developed consensus in key areas of the revised framework, allowing the building of a newly, more detailed and descriptive framework. In the final round panel experts expressed their opinions, either as agreements or disagreements, on the ethics and privacy statements of the framework finding some of the previous round disagreements to be surprising in view of established ethical principles. Conclusion: This study develops a framework for an integrated approach to ethics and privacy. Privacy breech risk should not be considered in isolation but instead balanced by potential ethical benefit.

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“…Consequently, European public health projects that rely on the existence of such registries to maintain secure platforms implementing “privacy by design”5 for cross-border information exchange, such as European Best Information through Regional Outcomes in Diabetes (EUBIROD),8 would also be undermined.…”

Section: Discussionmentioning

confidence: 99%

“…In the healthcare sector, the direct impact of these practices produced a substantially lower capacity to conduct effective research in specific MS,7 thus producing an imbalance between the right to privacy/data protection and the right to health 8…”

Section: Introductionmentioning

confidence: 99%

Health research and systems’ governance are at risk: should the right to data protection override health?

Iorio¹,

Carinci²,

Oderkirk

2013

J Med Ethics

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The European Union (EU) Data Protection Regulation will have profound implications for public health, health services research and statistics in Europe. The EU Commission's Proposal was a breakthrough in balancing privacy rights and rights to health and healthcare. The European Parliament, however, has proposed extensive amendments. This paper reviews the amendments proposed by the European Parliament Committee on Civil Liberties, Justice and Home Affairs and their implications for health research and statistics. The amendments eliminate most innovations brought by the Proposal. Notably, derogation to the general prohibition of processing sensitive data shall be allowed for public interests such as the management of healthcare services,but not health research, monitoring, surveillance and governance. The processing of personal health data for historical, statistical or scientific purposes shall be allowed only with the consent of the data subject or if the processing serves an exceptionally high public interest, cannot be performed otherwise and is legally authorised. Research, be it academic, government,corporate or market research, falls under the same rule.The proposed amendments will make difficult or render impossible research and statistics involving the linkage and analysis of the wealth of data from clinical,administrative, insurance and survey sources, which have contributed to improving health outcomes and health systems performance and governance; and may illegitimise efforts that have been made in some European countries to enable privacy-respectful data use for research and statistical purposes. If the amendments stand as written, the right to privacy is likely to override the right to health and healthcare in Europe.

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Cross-border flow of health information: is 'privacy by design' enough? Privacy performance assessment in EUBIROD

Abstract: The novel method of privacy performance assessment realized in EUBIROD may improve the respect of privacy in each data source, reduce overall variability in the implementation of privacy principles and favour a sound and legitimate cross-border exchange of high quality data across Europe.

Cited by 24 publications

References 3 publications

Standardized Information Exchange in Diabetes: Integrated Registries for Governance, Research, and Clinical Practice

Standardized Information Exchange in Diabetes: Integrated Registries for Governance, Research, and Clinical Practice

Building a Privacy, Ethics, and Data Access Framework for Real World Computerised Medical Record System Data: A Delphi Study

Health research and systems’ governance are at risk: should the right to data protection override health?

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