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

Abstract

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.

Ethical Use of Electronic Health Record Data and Artificial Intelligence: Recommendations of the Primary Care Informatics Working Group of the International Medical Informatics Association

“…The IMIA PCIWG has conducted a series of Delphi groups to research the ethical dimension of informatics and data curation initiatives in primary care since 2011 9 10 11 12 . Our 2016 Privacy, Ethics, and Data Access Framework for Real World EHR Data was the starting point for this work.…”

The role of ethics in data governance of large neuro-ICT projects

“…One example with far-reaching implications is data access policy. 44 , 45 This determines who may access which data for which purposes. The definition of such an access policy requires further detail, including the definition of user types, which we would expect to find in the documentation to be analyzed.…”

Examination and diagnosis of electronic patient records and their associated ethics: a scoping literature review

“…Ethical considerations required a favourable benefits/risks balance of EPRs [30,76,[132][133][134][135][136] and many saw this balance as a challenge [30,58,80,94,123,[136][137][138]. Some discussed EPR technology in terms of harm to the patient [30,39,62,64,66,80,118,123,131,137] or mentioned patient safety [57,122,138]. Concepts of 'quality' and 'efficiency', instruments to obtaining the benefits from EPR systems, were also explored [65,122,139,140].…”

“…Apart from one article reporting the first steps in establishing a framework using a privacy and ethics consensus development process [30], no fully developed EPR ethics framework was uncovered during this scoping review. An ethical framework formulated to inform the design, development, implementation and use of EPR systems would aid healthcare organisations and should describe the roles and responsibilities of diverse stakeholders.…”