Regulatory framework for health information systems in Ethiopia: A qualitative document analysis

<b>Background:</b> The regulatory and legal contexts of health information systems (HIS) play a crucial role in the generation and utilisation of health information. However, in many low- and middle-income countries, the regulatory framework for HIS remains underdeveloped, often hindering effective data management and system implementation. <b>Objective:</b> To evaluate how HIS policies, strategy and protocols guide the use of the health management information system (HMIS) for HIV and AIDS monitoring and evaluation (M&E) in Ethiopia. <b>Method:</b> An evaluation study using qualitative document analysis was adopted. Purposive criterion sampling was used to select government policy documents. Data extraction tool and management strategy were implemented. Atlas.Ti version 8 was used for content analysis. <b>Results:</b> Ten documents met the required criteria. The guidelines in the documents emphasised data quality assessment through data quality assurance techniques, data quality tracking of completeness and timeliness logbook and District Health Information System Version 2 (DHIS2) checks. Evidence from documents revealed broad guidance in terms of the implementation of M&E processes. Content showed clear definitions of information use at different levels and strategies to promote culture of data use. <b>Conclusion:</b> The study revealed that Ethiopia has an adequate regulatory framework for HIS to support the implementation of the HMIS in M&E of the HIV and AIDS program. However, the documents also acknowledge challenges with the implementation of these guidelines. <b>Implications for health information management practice:</b> This work highlights the importance of HIS and HMIS to the entire health system, and the vital role played by health information managers (HIMs) in managing the resources, people, protocols, and datasets essential for a functional information system, and for ensuring secure access to data for evidence-based decision-making.