JMIR Publications

ABSTRACT

Background:

Health services face growing demand and limited capacity. Using health data beyond the purpose for which they were collected is increasingly seen as one way to close this gap. However, the General Data Protection Regulation (GDPR) and similar regulations classify health data as a special category of personal data, and their secondary use remains contested. Separate disciplines have studied barriers to their use, but no overview maps the reported barriers and how they relate.

Objective:

This review aimed to identify the barriers to the use of health data reported in the literature, describe their distribution across political, economic, societal, technological, and legislative dimensions, and identify the gaps in the evidence base they reveal.

Methods:

We conducted a scoping review following the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist. In August 2025, we searched DTU Findit, which indexes Scopus, Web of Science, PubMed, and other sources, using the string (“Health data”) AND (“Barrier” OR “Limit”) AND (“Access” OR “Sharing”). We included peer-reviewed English-language articles that described barriers to the use of health data and excluded clinical studies, technology or solution descriptions, and reviews. We coded barriers inductively, assessed thematic saturation by recording new categories per article, and grouped them deductively under 5 headlines adapted from the PESTEL (Political, Economic, Social, Technological, Environmental, Legal) framework: Economic, Societal, Legislation/Regulation, Politics and policy making, and Technology

Results:

The search identified 2634 records. After removing 43 duplicates, we screened 2591 titles and abstracts, assessed 102 articles in full text, and included 46 articles published between 2010 and 2025. We identified 29 barrier categories; all had emerged after 33 articles. Legislation/Regulation was the most widespread headline (43/46 articles), followed by Technology (40), Societal (38), Politics and policy making (36), and Economic (34). Legislative barriers concerned fragmented rules across jurisdictions, regulation poorly calibrated to its uses, consent requirements, and unclear data ownership. Barriers rarely occurred in isolation: almost three-quarters of the articles (33/46) addressed all 5 headlines, a share that rose from half of the articles published in 2010-2018 (7/14) to four-fifths of those published in 2019-2025 (26/32).

Conclusions:

Barriers to the use of health data are multifaceted and interdependent. Legislative barriers are the most frequently reported, but they arise as much from uncertainty about which rules apply and how to interpret them as from the law itself. Together with societal and technological barriers, they converge on one issue: maintaining individuals’ trust that their data are protected. Gaps remain in knowledge of how barriers interact and how legislation is applied in practice, and no previous inventory spans the period since the GDPR. Initiatives such as the European Health Data Space must address more than legal or technical barriers.