Implementation of data access and use procedures in clinical data warehouses. A systematic review of literature and publicly available policies

Abstract

Background: The promises of improved health care and health research through data-intensive applications rely on a growing amount of health data. At the core of large-scale data integration efforts, clinical data warehouses (CDW) are also responsible for data governance, managing data access and (re)use. As the complexity of the data flow increases, greater transparency and standardization of criteria and procedures are required in order to maintain objective oversight and control. Therefore, the development of practice oriented and evidence-based policies is crucial. This study assessed the spectrum of data access and use criteria and procedures in clinical data warehouses governance internationally. Methods: We performed a systematic review of (a) the published scientific literature on CDW and (b) publicly available information on CDW data access, e.g., data access policies. A qualitative thematic analysis was applied to all included literature and policies. Results: Twenty-three scientific publications and one policy document were included in the final analysis. The qualitative analysis led to a final set of three main thematic categories: (1) requirements, including recipient requirements, reuse requirements, and formal requirements; (2) structures and processes, including review bodies and review values; and (3) access, including access limitations. Conclusions: The description of data access and use governance in the scientific literature is characterized by a high level of heterogeneity and ambiguity. In practice, this might limit the effective data sharing needed to fulfil the high expectations of data-intensive approaches in medical research and health care. The lack of publicly available information on access policies conflicts with ethical requirements linked to principles of transparency and accountability. CDW should publicly disclose by whom and under which conditions data can be accessed, and provide designated

The ethical and legal landscape of brain data governance

“…Accountability also demands that an organisation or a research body clearly identifies and discloses who is accountable for the management of data [A 43 ]. Some of the sources present accountability in terms of data use [A 44 – 46 , 48 ] while some highlight accountability in terms of organisational accountability [A 43 , 46 ]. Some sources also reference how the principle is reflected in data laws, for example, the GDPR’s principle of accountability of data controllers moves the onus of proof onto data controllers, thereby reducing the need for data subjects to demonstrate causation in many contexts [A 47 ].…”

“…Furthermore, accountability provides mechanisms for communicating health relevant information to data subjects [A 45 ]. Sources also agree that accountability can increase public trust in situations such as data reuse [A 48 , 49 ]. One author pointed out that it is necessary as a good governance practice to establish an accountable decision-making body that can provide assurances that data are being used and linked appropriately and responsibly [A 44 ].…”

Supporting research, protecting data: one institution’s approach to clinical data warehouse governance

“…Data governance practices will necessarily vary by institution. Our governance approach has commonalities with the spectrum of criteria and procedures described in Pavlenko et al 11 including requirements for human subjects protection training, IRB approval, and data sharing agreements, and attention to patients’ perspectives and institutional reputation when reviewing requests. Notably, however, the spectrum in Pavlenko does not include an explicit focus on whether a request is limited to the minimum necessary data.…”

“… 10 A recent systematic review on data access and use in clinical data warehouses found a lack of in-depth information on data governance and criteria used for reviewing requests. 11 This article seeks to fill that void by describing the governance approach at the University of North Carolina at Chapel Hill for research uses of the Carolina Data Warehouse for Health (CDW-H), the central repository for electronic health record (EHR) data for UNC Health.…”

The Challenges of Implementing Comprehensive Clinical Data Warehouses in Hospitals

“…As the complexity of the data flow increases, greater transparency and standardization of criteria and procedures are required to maintain objective oversight and control. The development of practice-oriented and evidence-based policies in this field is crucial [ 26 , 27 ]. On this point, it is interesting to note the recent initiative of the National Commission for Data Protection and Liberties in France (CNIL).…”