JMIR Publications

ABSTRACT

Background:

The European Health Data Space (EHDS) will substantially increase cross-border health data sharing in the EU, tasking Health Data Access Bodies (HDABs) with the legal and ethical assessment of health data access requests. However, ethical evaluation of data access is often criticized as an opaque, inconsistent and difficult to operationalize, relying on list of principles with limited procedural guidance. As data access requests increase, the lack of standardized and actionable ethics review processes risks undermining transparency, consistency, and trust in health data governance.

Objective:

This scoping review (ScR) aimed to identify, map and synthesize existing tools and frameworks designed to operationalize ethical evaluation of health data access. It focused on tools moving beyond conceptual reflection by providing standardized, repeatable, or quantifiable processes that support actionable decision-making.

Methods:

The ScR was conducted in accordance with PRISMA-ScR guidelines, searching both academic databases and grey literature. Search results were imported into Covidence for screening when possible. For sources incompatible with Covidence, screening and data extraction were conducted manually, using Excel sheets. Two reviewers independently screened titles, abstracts and full texts, with disagreements resolved by consensus. To minimize bias, reviewers were aware of each other’s involvement but could not see each other’s decisions during the initial screening phase. Data were extracted and thematically analyzed to examine tool characteristics, intended users, evaluative criteria, patient involvement, use of quantification, and real-world applications.

Results:

The ScR retrieved 2215 results, of which 1887 were unique (82.15%). A total of 13 full text studies were included and analysed based on the following criteria: the type of tool, the actor meant to use it, what it measured, its actionable components, whether it contained quantified or quantifiable components compatible with (partial) automation, and real-life applications. These 13 tools differed in their approaches, varying from multiple choice questionnaires (n=5), qualitative questionnaires (n=3) and decision aids, frameworks or matrixes (n=5). Most of these tools were directed at data users (n=10) and mainly aimed at guiding reflection or generating reports for further ethics assessment (n=7). Very few directly involved the public or patients in their development (n=3). Some provided means to classify data use into risk categories with an associated lower or higher level of ethical scrutiny (n=5), at times incorporating quantification (n=5) in the review process. Finally, most tools had limited or no documented real-world implementation (n=9).

Conclusions:

An increasing number of tools and frameworks aiming at standardizing and operationalizing ethical assessment in data access are being developed in recent years, however their effectiveness remains untested in most cases. As data flows increase in the EHDS, and consequently, the need for streamlined ethics becomes more apparent, hybrid models incorporating both quantitative and deliberative components may play an important role in tackling the challenges associated with ethical data access management. Clinical Trial: N.A.