Regulation of Mobile Technologies in Biomedical Systems: Data Governance, Compliance, and Digital Oversight
DOI:
https://doi.org/10.3991/ijoe.v22i08.62320Keywords:
Mobile Biomedical Systems, Data Governance, Compliance, Digital Oversight, System Performance, Regression AnalysisAbstract
This study examines the impact of data governance (DG), compliance (COM), and digital oversight (DO) on system performance (SP) and security within mobile biomedical systems in Indonesia’s healthcare sector. Employing Socio-Technical Systems Theory, the study investigates the role of regulations in enhancing operational efficiency and strengthening cybersecurity in digital healthcare. A quantitative cross-sectional design was utilised, with data collected from 200 healthcare and biomedical technology professionals through an online questionnaire. Relationships among variables were analysed using multiple linear regression. The results showed that DG had the greatest positive effect on both SP and security, followed by COM and DO. All these relationships were statistically significant (p < 0.001). This study shows that adopting integrated governance frameworks, complying with regulations and maintaining ongoing monitoring are important for making mobile biomedical technologies more reliable and secure. It also adds new evidence by examining operational performance and system security (SS) as distinct outcomes in mobile biomedical systems.
References
[1] Tsvetanov, F., & Pandurski, M. (2024). Delay of Transmitted Data in the Remote Patient Monitoring System through AMQP and CoAP. International Journal of Online and Biomedical Engineering (iJOE), 20(07), pp. 130–144. https://doi.org/10.3991/ijoe.v20i07.47661.
[2] Sharma, P. (2025). Healthcare Data Governance Ecosystems: Balancing Privacy, Innovation, and Compliance in Real-World Evidence Platforms. IPHO-Journal of Advance Research in Science and Engineering, 3(12), 08-16.
[3] Perez-Pozuelo, I., Spathis, D., Gifford-Moore, J., Morley, J., & Cowls, J. (2021). Digital phenotyping and sensitive health data: Implications for data governance. Journal of the American Medical Informatics Association, 28(9), 2002-2008.
[4] Bene, B. A., Ibeneme, S., Fadahunsi, K. P., Harri, B. I., Ukor, N., Mastellos, N., ... & Car, J. (2024). Regulatory standards and guidance for the use of health apps for self-management in Sub-Saharan Africa: Scoping review. Journal of Medical Internet Research, 26, e49163.
[5] Baig, M. M., GholamHosseini, H., & Connolly, M. J. (2015). Mobile healthcare applications: system design review, critical issues and challenges. Australasian physical & engineering sciences in medicine, 38(1), 23-38.
[6] Fitria, L., Eliza, R., & Sari, S. (2026). Impact of Social Media Advertising on Business Performance: Evidence from Micro, Small, and Medium Enterprises in Dumai City, Indonesia. International Journal of Management Thinking, 3(2), 16–31. https://doi.org/10.56868/ijmt.v3i2.101.
[7] Sarabdeen, J., & Mohamed Ishak, M. M. (2025). A comparative analysis: health data protection laws in Malaysia, Saudi Arabia and EU General Data Protection Regulation (GDPR). International Journal of Law and Management, 67(1), 99-119.
[8] Alnasser, H. (2025). Negligence and Data Breaches Under Saudi Arabian Personal Data Protection Law (PDPL): A Doctrinal Analysis Approach. Journal of Advances in Humanities Research, 4(3), 23–38. https://doi.org/10.56868/jadhur.v4i3.321.
[9] Kharisma, D. B., & Diakanza, A. (2024). Patient personal data protection: comparing the health-care regulations in Indonesia, Singapore and the European Union. International Journal of Human Rights in Healthcare, 17(2), 157-169.
[10] Vadisetty, R., & Polamarasetti, A. (2025). Regulatory Framework for Digital Health, Data Privacy, and Cybersecurity. In Sustainable Healthcare Systems in Africa (pp. 132-153). CRC Press.
[11] R. Jeya, Hezerul Abdul Karim, & Sarina Binti Mansor. (2024). Artificial Intelligence and Mobile Apps Support Intelligent Healthcare Systems for Mental Health Services . International Journal of Interactive Mobile Technologies (iJIM), 18(20), pp. 157–168. https://doi.org/10.3991/ijim.v18i20.50743
[12] Nastasa, I. V., Artamonov, A. R., Busnatu, Ș. S., Mincă, D. G., & Andronic, O. (2025, July). From Innovation to Regulation: Insights from a Bibliometric Analysis of Research Patterns in Medical Data Governance. In Informatics (Vol. 12, No. 3, p. 66). MDPI.
[13] Saporito, A., & Mrad Georgis, B. (2025). Healthcare Compliance and Data Governance. In Healthcare Services Management (pp. 391-406). Springer, Cham.
[14] Winter, J. S., & Davidson, E. (2022). Harmonizing regulatory regimes for the governance of patient-generated health data. Telecommunications Policy, 46(5), 102285
[15] Ashish, A., & Pal, R. R. (2025). Digital health and regulatory affairs: A comparative analysis of regulations in the USA, Europe, Canada, and Australia. Applied Drug Research, Clinical Trials and Regulatory Affairs, 11(1), E26673371404752.
[16] 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).
[17] Scheibner, J., Ienca, M., Kechagia, S., Troncoso-Pastoriza, J. R., Raisaro, J. L., Hubaux, J. P., ... & Vayena, E. (2020). Data protection and ethics requirements for multisite research with health data: a comparative examination of legislative governance frameworks and the role of data protection technologies. Journal of Law and the Biosciences, 7(1), lsaa010.
[18] Bernier, A., Molnár-Gábor, F., & Knoppers, B. M. (2022). The international data governance landscape. Journal of Law and the Biosciences, 9(1), lsac005.
[19] Zangana, H. M., Omar, M., & Al-Karaki, J. N. (2025). Regulatory Frameworks in Science, Technology, and Medical Innovation. In Navigating Law and Policy in STM Enterprises: Ethical Governance, Regulation, and Innovation Strategy (pp. 1-34). IGI Global Scientific Publishing.
[20] Anioke, S. C., & Atima, M. E. (2023). Public health governance models using process optimization and performance metrics for regulatory oversight. International Journal of Advanced Multidisciplinary Research and Studies, 3(6), 2534-2548.
[21] Fernandes, F. A., & Chaltikyan, G. V. (2020). Analysis of legal and regulatory frameworks in digital health: a comparison of guidelines and approaches in the European Union and United States. Journal of the International Society for Telemedicine and eHealth, 8, e11-1.
[22] Tettey, F., Parupelli, S. K., & Desai, S. (2024). A review of biomedical devices: classification, regulatory guidelines, human factors, software as a medical device, and cybersecurity. Biomedical Materials & Devices, 2(1), 316-341.
[23] Kamnoore, K., Venkatesh, M. P., Balamuralidhara, V., & Kumar, T. P. (2019). Regulatory Requirements for Mobile Medical Applications for USA, EU and Other Countries. Journal of Pharmaceutical Sciences and Research, 11(8), 2910-2914.
[24] Moshi, M. R., Parsons, J., Tooher, R., & Merlin, T. (2019). Evaluation of mobile health applications: is regulatory policy up to the challenge?. International journal of technology assessment in health care, 35(4), 351-360.
[25] Vincent, C. J., Niezen, G., O'Kane, A. A., & Stawarz, K. (2015). Can standards and regulations keep up with health technology?. JMIR mHealth and uHealth, 3(2), e3918.
[26] Karageorgos, G., Andreadis, I., Psychas, K., Mourkousis, G., Kiourti, A., Lazzi, G., & Nikita, K. S. (2018). The promise of mobile technologies for the health care system in the developing world: a systematic review. IEEE reviews in biomedical engineering, 12, 100-122.
[27] Tiwari, G., Kumar, S., & Sharma, S. (2025). Biomedical Applications Based on Mobile Phone Cell Network Systems. In Smart Electronic Devices and Systems for Biomedical and Healthcare Applications (pp. 155-187). Apple Academic Press
[28] Salameh, A. A., Abu-AlSondos, I. A., Abu, N. H., & Harun, A. N. (2023). Current Knowledge and Future Possibilities of Medical Digital Technologies based on Mobile Health. International Journal of Interactive Mobile Technologies, 17(17).
[29] Anklam, E., Bahl, M. I., Ball, R., Beger, R. D., Cohen, J., Fitzpatrick, S., ... & Slikker Jr, W. (2022). Emerging technologies and their impact on regulatory science. Experimental Biology and Medicine, 247(1), 1-75.
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Copyright (c) 2026 Ade Ikhlas Amal Alam, Khairunnisa Azrin, Fakhrul Indra Hermansyah, Syamsu Alam, Andi Raina Ananda Herdiyana

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