Regulations and standards as barriers to innovation in open-source software for healthcare systems : a systematic literature review
Alam, Sheikh Rabiul (2025)
Diplomityö
2025
School of Engineering Science, Tuotantotalous
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Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi-fe20251201113037
https://urn.fi/URN:NBN:fi-fe20251201113037
Tiivistelmä
Open-Source Software (OSS) is often more cost-effective and adaptable than proprietary software, which is why healthcare organisations are interested in using it. However, they continue to encounter obstacles. Moreover, regulations have not been developed to account for OSS, technical integration is not as straightforward as it should be, and most hospitals lack the necessary expertise.
A systematic literature review (SLR) was conducted in accordance with the PRISMA guidelines. Papers published from 2015 to 2025 in academic databases were searched, and those that analysed OSS adoption in healthcare settings were included. The 38 included documents were analysed using the methodology of narrative synthesis, and their findings were organised in the following research questions: barriers (RQ1) and regulatory frameworks (RQ2).
The study of 20 papers has identified five categories of barriers: interoperability issues (60%), regulatory compliance challenges (55%), resource and technical issues (50%), privacy and security issues (35%), and geographic and contextual issues (20%). 18 papers provided four categories of frameworks, namely standards selection and implementation (33%), process reforms and regulatory updates (44%), compliance validation methodologies (39%), and context-specific adaptation (33%). Interoperability issues have close empirical connections to standards frameworks and regulatory compliance issues with process reforms.
A systematic literature review (SLR) was conducted in accordance with the PRISMA guidelines. Papers published from 2015 to 2025 in academic databases were searched, and those that analysed OSS adoption in healthcare settings were included. The 38 included documents were analysed using the methodology of narrative synthesis, and their findings were organised in the following research questions: barriers (RQ1) and regulatory frameworks (RQ2).
The study of 20 papers has identified five categories of barriers: interoperability issues (60%), regulatory compliance challenges (55%), resource and technical issues (50%), privacy and security issues (35%), and geographic and contextual issues (20%). 18 papers provided four categories of frameworks, namely standards selection and implementation (33%), process reforms and regulatory updates (44%), compliance validation methodologies (39%), and context-specific adaptation (33%). Interoperability issues have close empirical connections to standards frameworks and regulatory compliance issues with process reforms.