Health data governance is essential for optimal processing of data collection, sharing, and reuse. Although the World Health Organization (WHO) has proposed practical guidelines for managing health data during the pandemic, the Organization for Economic Cooperation and Development (OECD) found that many countries still lack the use of health data for decision-making. Therefore, this research aimed to identify and assess the challenges faced by health organization in implementing health data governance from various countries based on research articles. The challenges were assessed based on key components of health data governance from practitioner and scientist perspectives. These components include stakeholder, policy, data management, organization, data governance maturity assessment, and goals. The method used followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for collecting and reporting. Data were collected from several databases online with large repositories of academic studies, including IEEE Xplore, ScienceDirect, National Library of Medicine, ProQuest, Taylor and Francis Group, Scopus, and Wiley Online libraries. Based on the 41 papers reviewed, the results showed that policy was found to be the biggest challenge for health data governance. This was followed by data management such as quality, ownership, and access, as well as stakeholders and data governance organization. However, there were no challenges regarding maturity assessment and data governance goals, as the majority of research focused on implementation. Policy and policymaker awareness were identified as major components for the implementation of health data governance. To address challenges in data management and governance organization, creating committees focused on these components proved to be an effective solution. These results provided valuable recommendations for regulators and leaders in a healthcare organization to optimally implement health data governance.

Abraham, R., Schneider, J., & vom Brocke, J. (2019). Data governance: A conceptual framework, structured review, and research agenda. International Journal of Information Management, 49, 424–438. https://doi.org/10.1016/j.ijinfomgt.2019.07.008

Alhassan, I., Sammon, D., & Daly, M. (2018). Data governance activities: a comparison between scientific and practice-oriented literature. Journal of Enterprise Information Management, 31(2), 300–316. https://doi.org/10.1108/JEIM-01-2017-0007

Ali, S. R., Bryce, J., Hytiris, M., et al. (2021). Supporting international networks through platforms for standardised data collection - the European Registries for Rare Endrocrine Conditions (EuRRECa) model. Endocrine, 71(3), 555–560. https://doi.org/https://doi.org/10.1007/s12020-021-02617-0

Allen, C., Des Jardins, T. R., Heider, A., et al. (2014). Data Governance and Data Sharing Agreements for Community-Wide Health Information Exchange: Lessons from the Beacon Communities. EGEMs (Generating Evidence & Methods to Improve Patient Outcomes), 2(1), 5. https://doi.org/10.13063/2327-9214.1057

Alshahrani, A., Stewart, D., & MacLure, K. (2019). A systematic review of the adoption and acceptance of eHealth in Saudi Arabia: Views of multiple stakeholders. International Journal of Medical Informatics, 128, 7–17. https://doi.org/10.1016/j.ijmedinf.2019.05.007

Benfeldt, O., Persson, J. S., & Madsen, S. (2020). Data Governance as a Collective Action Problem. Information Systems Frontiers, 22(2), 299–313. https://doi.org/10.1007/s10796-019-09923-z

Bienassis, de K., Fujisawa, R., Hashiguchi, T. C. O., et al. (2022). Health data and governance developments in relation to COVID-19: How OECD countries are adjusting health data systems for the new normal. OECD Health Working Papers, 138. https://doi.org/https://dx.doi.org/10.1787/aec7c409-en

Boyd, M., & Tennison, J. (2021a). Data Governance maturity and best practices. In World Health Organization (Issue June).

Boyd, M., & Tennison, J. (2021b). The health data landscape. In Health Data Governance Summit (Issue June).

Cambridge Dictionary. (n.d.). Available online: https://dictionary.cambridge.org/dictionary/english/policy (accessed on 19 June 2023).

Chen, Y., & Song, L. (2018). China: concurring regulation of cross-border genomic data sharing for statist control and individual protection. Human Genetics, 137(8), 605–615. https://doi.org/10.1007/s00439-018-1903-2

Dagliati, A., Malovini, A., Tibollo, V., & Bellazzi, R. (2021). Health informatics and EHR to support clinical research in the COVID-19 pandemic: An overview. Briefings in Bioinformatics, 22(2), 812–822. https://doi.org/10.1093/bib/bbaa418

DAMA International. (2017). Data Management Body of Knowledge. Angewandte Chemie International Edition, 6(11), 951–952.

De Freitas, C., Amorim, M., MacHado, H., et al. (2021). Public and patient involvement in health data governance (DATAGov): Protocol of a people-centred, mixed-methods study on data use and sharing for rare diseases care and research. J Open, 11(3), 1–7. https://doi.org/10.1136/bmjopen-2020-044289

Di Iorio, C. T., Carinci, F., Oderkirk, J., et al. (2021). Assessing data protection and governance in health information systems: A novel methodology of Privacy and Ethics Impact and Performance Assessment (PEIPA). Journal of Medical Ethics, 47(12), E23. https://doi.org/10.1136/medethics-2019-105948

Dodd, S. X., Manhas, K. P., Page, S., et al. (2017). Governance and Privacy in a Provincial Data Repository: A Cross-Sectional Analysis of Longitudinal Birth Cohort Parent Participants’ Perspectives on sharing Adults vs. Child Research Data. DATA 2017. https://doi.org/10.5220/0006430802080215

Espíndola, P. L., Junior, J. F. S., Rosa, F., & Juliani, J. P. (2018). Data governance applied to information science: Analysis of a scientific data system for the health area. Revista Digital de Biblioteconomia e Ciencia Da Informacao, 16(3), 274–298. https://doi.org/10.20396/rdbci.v16i3.8651080

Evans, E. A., Delorme, E., Cyr, K., & Goldstein, D. M. (2020). A qualitative study of big data and the opioid epidemic: recommendations for data governance. BMC Medical Ethics, 21(1), 1–14. https://doi.org/10.1186/s12910-020-00544-9

Foy, M., Martyn, D., Daly, D., et al. (2021). Blockchain-based governance model for COVID-19 digital health certificates: A legal, technical, ethical and security requirements analysis. Procedia Computer Science. https://doi.org/https://doi.org/10.1016/j.procs.2021.12.303

Gu, D., Khan, S., Khan, I. U., et al. (2021). Assessing the Adoption of e-Health Technology in a Developing Country: An Extension of the UTAUT Model. SAGE Open, 11(3). https://doi.org/10.1177/21582440211027565

Handayani, P. W., Hidayanto, A. N., & Budi, I. (2018). User acceptance factors of hospital information systems and related technologies: Systematic review. Informatics for Health and Social Care, 43(4), 401–426. https://doi.org/10.1080/17538157.2017.1353999

Hassan, S., Dhali, M., Zaman, F., & Tanveer, M. (2021). Big data and predictive analytics in healthcare in Bangladesh: regulatory challenges. Heliyon, 7(6). https://doi.org/10.1016/j.heliyon.2021.e07179

Hovenga, E. J. S., & Grain, H. (2013). Health data and data governance. Health Information Governance in a Digital Environment, 67–92. https://doi.org/10.3233/978-1-61499-291-2-67

Hripcsak, G., Bloomrosen, M., FlatelyBrennan, P., et al. (2014). Health data use, stewardship, and governance: Ongoing gaps and challenges: A report from AMIA’s 2012 health policy meeting. Journal of the American Medical Informatics Association, 21(2), 204–211. https://doi.org/10.1136/amiajnl-2013-002117

Jang, K., & Kim, W. J. (2021). Development of data governance components using DEMATEL and content analysis. Journal of Supercomputing, 77(4), 3695–3709. https://doi.org/10.1007/s11227-020-03405-9

Jones, K., Daniels, H., Heys, S., et al. (2020a). Toward a risk-utility data governance framework for research using genomic and phenotypic data in safe havens: Multifaceted review. Journal of Medical Internet Research, 22(5). https://doi.org/10.2196/16346

Jones, K., Ford, E. M., Lea, N., et al. (2020b). Toward the development of data governance standards for using clinical free-text data in health research: Position paper. Journal of Medical Internet Research, 22(6), 1–16. https://doi.org/10.2196/16760

Kariotis, T., Ball, M. P., Greshake Tzovaras, B., et al. (2020). Emerging health data platforms: From individual control to collective data governance. Data & Policy, 2. https://doi.org/10.1017/dap.2020.14

Katz, A., Enns, J., Wong, S. T., et al. (2018). Challenges Associated with Cross-Jurisdictional Analyses using Administrative Health Data and Primary Care Electronic Medical Records in Canada. International Journal of Population Data Science, 3(3). https://doi.org/10.23889/ijpds.v3i3.437

Khatri, V., & Brown, C. V. (2010). Designing data governance. Communications of the ACM, 53(1), 148–152. https://doi.org/10.1145/1629175.1629210

Khurana, N. (2021). Issue analysis: A use-driven approach to data governance can promote the quality of routine health data in India. Global Health Science and Practice, 9(2), 238–245. https://doi.org/10.9745/GHSP-D-20-00347

Kim, K. K., Browe, D. K., Logan, H. C., et al. (2013). Data governance requirements for distributed clinical research networks: triangulating perspectives of diverse stakeholders. Journal of the American Medical Informatics Association, 21(4), 714–719. https://doi.org/10.1136/amiajnl-2013-002308

Ladley, J. (2020). Data Governance How to Design, Deploy, and Sustain an Effective Data Governance Program. Elsevier.

Laurie, G., & Nayha, S. (2013). Towards principles-based approaches to governance of health-related research using personal data. European Journal of Risk Regulation, 4(1), 43–57. https://doi.org/10.1017/S1867299X00002786

Li, J., Yu, G., Ding, W., et al. (2021). Data governance system of the National Clinical Research Center for Child Health in China. Translational Pediatrics, 10(7), 1905–1913. https://doi.org/10.21037/tp-21-272

Li, Q., Lan, L., Zeng, N., et al. (2019). A Framework for Big Data Governance to Advance RHINs: A Case Study of China. IEEE Access, 7, 50330–50338. https://doi.org/10.1109/ACCESS.2019.2910838

Marelli, L., Lievevrouw, E., & Van Hoyweghen, I. (2020). Fit for purpose? The GDPR and the governance of European digital health. Policy Studies, 41, 5, 447–467). https://doi.org/10.1080/01442872.2020.1724929

Marelli, L., Testa, G., & Hoyweghen, I. (2021). Big Tech platforms in health research: Re-purposing big data governance in light of the General Data Protection Regulation’s research exemption. Big Data and Society, 8(1). https://doi.org/10.1177/20539517211018783

Martani, A., Egli, S. M., Geneviève, L. D., et al. (2022). A role-model for data policies? Qualitative study on the governance of health data in Denmark. Health Policy and Technology, 11(4). https://doi.org/10.1016/j.hlpt.2022.100683

Martani, A., Geneviève, L. D., Elger, B., & Wangmo, T. (2021). “It’s not something you can take in your hands”. Swiss experts’ perspectives on health data ownership: An interview-based study. BMJ Open, 11(4), 1–11. https://doi.org/10.1136/bmjopen-2020-045717

Micheli, M., Ponti, M., Craglia, M., & Berti Suman, A. (2020). Emerging models of data governance in the age of datafication. Big Data and Society, 7(2). https://doi.org/10.1177/2053951720948087

Milne, R., & Brayne, C. (2020). We need to think about data governance for dementia research in a digital era. Alzheimer’s Research and Therapy, 12(1), 10–13. https://doi.org/10.1186/s13195-020-0584-y

Milne, R., Sorbie, A., & Dixon-Woods, M. (2021). What can data trusts for health research learn from participatory governance in biobanks? Journal of Medical Ethics. https://doi.org/10.1136/medethics-2020-107020

Munung, N. S., Chi, P. C., Abayomi, A., et al. (2021). Perspectives of different stakeholders on data use and management in public health emergencies in sub-Saharan Africa: a meeting report [version 1; peer review: 1 approved, 1 approved with reservations]. Wellcome Open Research, 6, 1–13. https://doi.org/10.12688/WELLCOMEOPENRES.16494.1

Murtagh, M. J., Blell, M. T., Butters, O. W., et al. (2018). Better governance, better access: Practising responsible data sharing in the METADAC governance infrastructure. Human Genomics, 12(1), 1–12. https://doi.org/10.1186/s40246-018-0154-6

National Cyber and Crypto Agency. (2020). Buku Putih Keamanan Siber Sektor Kesehatan.

Ndlovu, K., Mauco, K. L., Chibemba, S., et al. (2023). Assessment of Stakeholder Perceptions and Attitudes Toward Health Data Governance Principles in Botswana: Web-Based Survey. JMIR Formative Research, 7, e41408. https://doi.org/10.2196/41408

Nomura, S., Sakamoto, H., Ishizuka, A., et al. (2020). Ongoing debate on data governance principles for achieving Universal Health Coverage: A proposal to post-G20 Osaka Summit meetings Ongoing debate on data governance principles for achieving Universal. https://doi.org/10.1080/16549716.2020.1859822

OECD. (n.d.). Health Data Governance: Privacy, Monitoring and Research. Available online: https://read.oecd-ilibrary.org/social-issues-migration-health/health-data-governance_9789264244566-en#page15 (accessed on 29 June 2021).

OECD. (2010). Improving Health Sector Efficiency. OECD. https://doi.org/10.1787/9789264084612-en

OECD. (2015). Health Data Governance: Privacy, Monitoring and Research.

Oktaviana R, S., Handayani, P. W., & Hidayanto, A. N. (2022). Health Data Governance Issues in Healthcare Facilities: Perspective of Hospital Management, 1–5. https://doi.org/10.1109/icoict55009.2022.9914865

Osakede, U. A. (2021). Public health spending and health outcome in Nigeria: the role of governance. International Journal of Development Issues, 20(1), 95–112. https://doi.org/10.1108/IJDI-10-2019-0169

Page, M. J., Moher, D., Bossuyt, P. M., et al. (2021). PRISMA 2020 explanation and elaboration: Updated guidance and exemplars for reporting systematic reviews. The BMJ, 372. https://doi.org/10.1136/bmj.n160

Paparova, D., Aanestad, M., Vassilakopoulou, P., & Bahus, M. K. (2023). Data governance spaces: The case of a national digital service for personal health data. Information and Organization, 33(1), 100451. https://doi.org/10.1016/j.infoandorg.2023.100451

Piasecki, J., & Cheah, P. Y. (2022). Ownership of individual-level health data, data sharing, and data governance. BMC Medical Ethics, 23(1), 1–9. https://doi.org/10.1186/s12910-022-00848-y

Pinto, F., Rahulamathavan, Y., & Skinner, J. (2022). Blockchain for Doping Control Applications in Sports: A Conceptual Approach. Future Internet, 14(7). https://doi.org/10.3390/fi14070210

Rivera, D. R., Gokhale, M. N., Reynolds, M. W., et al. (2020). Linking electronic health data in pharmacoepidemiology: Appropriateness and feasibility. Pharmacoepidemiology and Drug Safety, 29(1), 18–29. https://doi.org/10.1002/pds.4918

Rosenbaum, S. (2010). Data governance and stewardship: Designing data stewardship entities and advancing data access. Health Services Research, 45(5 PART 2), 1442–1455. https://doi.org/10.1111/j.1475-6773.2010.01140.x

Sethi, N., & Laurie, G. T. (2013). Delivering proportionate governance in the era of eHealth: Making linkage and privacy work together. In Medical Law International (Vol. 13, Issues 2–3). https://doi.org/10.1177/0968533213508974

Shah, N., Viberg Johansson, J., Haraldsdottir, E., et al. (2021). Governing health data across changing contexts: A focus group study of citizen’s views in England, Iceland, and Sweden. International Journal of Medical Informatics. https://doi.org/https://doi.org/10.1016/j.ijmedinf.2021.104623

Shah, Nisha, Coathup, V., Teare, H., et al. (2019). Sharing data for future research—engaging participants’ views about data governance beyond the original project: a DIRECT Study. Genetics in Medicine, 21(5), 1131–1138. https://doi.org/10.1038/s41436-018-0299-7

Shaw, J., & Sekalala, S. (2023). Health data justice: building new norms for health data governance. Npj Digital Medicine, 6(1), 1–5. https://doi.org/10.1038/s41746-023-00780-4

Shaw, T., McGregor, D., Brunner, M., et al. (2017). What is eHealth (6)? Development of a conceptual model for eHealth: Qualitative study with key informants. Journal of Medical Internet Research, 19(10). https://doi.org/10.2196/jmir.8106

Shidhaye, R., Huang, K., & Kumar, M. (2022). A mixed-methods protocol for the feasibility of global digital mental health studies in young people. The MindKind Consortium. https://doi.org/10.12688/wellcomeopenres.17167.2

Sleigh, J., & Vayena, E. (2021). Public engagement with health data governance: the role of visuality. Humanities and Social Sciences Communications, 8(1), 1–12. https://doi.org/10.1057/s41599-021-00826-6

Sofaer, S. (1999). Qualitative Methods: What Are They and Why Use Them? Health Services Research, 34(5), 1101–1119. https://doi.org/10.1557/proc-756-ee5.9

Tekieh, M. H., Raahemi, B., & Benchimol, E. I. (2017). Leveraging applications of data mining in healthcare using big data analytics: An overview. Handbook of Research on Data Science for Effective Healthcare Practice and Administration, 345–358. https://doi.org/10.4018/978-1-5225-2515-8.ch015

The Data Governance Institute. (2020). Data Governance Frameworks. In The Data Governance Institute. https://doi.org/10.1108/978-1-78973-567-320201005

Thiel, R., Stroetmann, K. A., & Singleton, P. D. (2014). Clinical data governance: Legal and ethical challenges. 2014 IEEE-EMBS International Conference on Biomedical and Health Informatics, BHI, 597–600. https://doi.org/10.1109/BHI.2014.6864435

Thompson, N., Ravindran, R., & Nicosia, S. (2015). Government data does not mean data governance: lessons learned from a public sector application audit. Government Information Quarterly. https://doi.org/https://doi.org/10.1016/j.giq.2015.05.001

Tiffin, N., George, A., & Lefevre, A. E. (2019). How to use relevant data for maximal benefit with minimal risk: Digital health data governance to protect vulnerable populations in low-income and middle-income countries. BMJ Global Health, 4(2), 1–9. https://doi.org/10.1136/bmjgh-2019-001395

Tse, D., Chow, C. K., Ly, T. P., et al. (2018). The Challenges of Big Data Governance in Healthcare. Proceedings—17th IEEE International Conference on Trust, Security and Privacy in Computing and Communications and 12th IEEE International Conference on Big Data Science and Engineering, Trustcom/BigDataSE, 1632–1636. https://doi.org/10.1109/TrustCom/BigDataSE.2018.00240

Vayena, E., & Blasimme, A. (2017). Biomedical Big Data: New Models of Control Over Access, Use and Governance. Journal of Bioethical Inquiry, 14(4), 501–513. https://doi.org/10.1007/s11673-017-9809-6

Vayena, E., Haeusermann, T., Adjekum, A., & Blasimme, A. (2018). Digital health: meeting the ethical and policy challenges. Swiss Medical Weekly, 148, w14571. https://doi.org/10.4414/smw.2018.14571

Walji, M. F., Spallek, H., Kookal, K. K., et al. (2022). BigMouth: Development and maintenance of successful dental data repository. AMIA. https://doi.org/10.1093/jamia/ocac001

Walters, K. M., Jojic, A., Pfaff, E. R., et al. (2022). Supporting research, protecting data: One institution’s approach to clinical data warehouse governance. Journal of the American Medical Informatics Association, 29(4), 707–712. https://doi.org/10.1093/jamia/ocab259

Wang, M., Li, S., Zheng, T., et al. (2022). Big Data Health Care Platform with Multisource Heterogeneous Data Integration and Massive High-Dimensional Data Governance for Large Hospitals: Design, Development, and Application. JMIR Medical Informatics, 10(4), 1–15. https://doi.org/10.2196/36481

Wang, Z., Shi, X., & Li, H. (2021). Difficulties and solutions for public health data governance under the normalization of epidemic prevention and control. IOP Conference Series: Earth and Environmental Science, 692(3). https://doi.org/10.1088/1755-1315/692/3/032045

Wende, K., & Otto, B. (2007). A contingency approach to data governance. Proceedings of the 2007 International Conference on Information Quality, ICIQ 2007, November 2007. https://doi.org/http://doi.acm.org/10.1145/1515693.1515696.

Were, V., & Moturi, C. (2017). Toward a data governance model for the Kenya health professional regulatory authorities. TQM Journal, 29(4), 579–589. https://doi.org/10.1108/TQM-10-2016-0092

Whiting, P., Savović, J., Higgins, J. P. T., et al. (2016). ROBIS: A new tool to assess risk of bias in systematic reviews was developed. Journal of Clinical Epidemiology, 69, 225–234. https://doi.org/10.1016/j.jclinepi.2015.06.005

WHO. (2005). The Forty-eighth World Health Assembly. In WHO (Vol. 11, Issue 3). https://doi.org/10.1016/0266-6138(95)90030-6

WHO. (2016). Global diffusion of eHealth: Making universal health coverage achievable Report of the third global survey on eHealth Global. Available online: http://who.int/goe/publications/global_diffusion/en/ (accessed on 19 June 2023).

WHO SEAR. (2015). Regional Strategy for Strengthening eHealth in the South-East Asia Region, WHO (2014–2020).

Wieland-Jorna, Y., Verheij, R. A., Francke, A. L., et al. (2023). Setting up a Governance Framework for Secondary Use of Routine Health Data in Nursing Homes: Development Study Using Qualitative Interviews. Journal of Medical Internet Research, 25. https://doi.org/10.2196/38929

Winter, J. S., & Davidson, E. (2017). Investigating values in personal health data governance models. AMCIS 2017 - America’s Conference on Information Systems: A Tradition of Innovation. 1–10.

Winter, J. S., & Davidson, E. (2019a). Big data governance of personal health information and challenges to contextual integrity. Information Society, 35(1), 36–51. https://doi.org/10.1080/01972243.2018.1542648

Winter, J. S., & Davidson, E. (2019b). Governance of artificial intelligence and personal health information. Digital Policy, Regulation and Governance, 21(3), 280–290. https://doi.org/10.1108/DPRG-08-2018-0048

World Bank. (2021). World Development Report 2021: Building trust. Available online: https://wdr2021.worldbank.org/stories/building-trust/ (accessed on 19 June 2023).

Yao, K., & Park, M. K. (2020). Strengthening Data Governance for Effective Use of Open Data and Big Data Analytics for Combating COVID-19. Available online: https://www.un.org/development/desa/dpad/wp-content/uploads/sites/45/publication/PB_89.pdf (accessed on 19 June 2023).

Zorrilla, M., & Yebenes, J. (2022). A reference framework for the implementation of data governance systems for industry 4.0. Computer Standards & Interfaces, 81, 103595. https://doi.org/10.1016/j.csi.2021.103595