Ethics and Law of Personal Data Protection for Smartwatches in the Healthcare Sector
Abstract
The rapid adoption of smartwatches in the healthcare sector presents a fundamental duality between the potential for medical innovation and systemic risks to the right to privacy. This research aims to critically analyze the juridical-ethical gap between the health data governance practices of the smartwatch industry and the normative standards mandated by Law Number 27 of 2022. Using a normative legal research method and a gap analysis approach, this study dissects how industry practices systematically create a transparency deficit and devalue the meaning of informed consent into an illusory agreement. The analysis reveals a diametrical opposition between the regulatory ideal (das sollen), which prioritizes user autonomy, and the reality of industry practices (das sein), which are driven by commercial interests and formalistic compliance. This gap not only exposes users to data exploitation but also challenges the effectiveness of Law Number 27 of 2022 in addressing the complexity of wearable technology. Therefore, this research recommends a paradigm shift from the fragile consent-based model to a rights-based model. Furthermore, it urges the formulation of specific implementing regulations for the health technology sector to bridge the existing gap and build a fair and accountable digital ecosystem.
Downloads
References
The 1945 Constitution of the Republic of Indonesia. https://www.dpr.go.id/dokumen/jdih/undang-undang-dasar
Batista, E., Moncusi, M. A., López-Aguilar, P., Martínez-Ballesté, A., & Solanas, A. (2021). Sensors for Context-Aware Smart Healthcare: A Security Perspective. Sensors, 21(20), 1-60. https://doi.org/10.3390/s21206886
Brönneke, J. B., Müller, J., Mouratis, K., Hagen, J., & Stern, A. D. (2021). Regulatory, Legal, and Market Aspects of Smart Wearables for Cardiac Monitoring. 21(14), 1-19. https://doi.org/10.3390/s21144937
Cheng, L., Han, J., & Nasirov, J. (2024). Ethical Considerations Related to Personal Data Collection and Reuse: Trust and Transparency in Language and Speech Technologies. International Journal of Legal Discourse, 9(2), 217-235. https://doi.org/10.1515/ijld-2024-2010
Cilliers, L. (2020). Wearable Devices in Healthcare: Privacy and Information Security Issues. Health Information Management Journal, 49(2-3), 150-156. https://doi.org/10.1177/1833358319851684
Compagnucci, M. C., Wilson, M. L., Fenwick, M., Forgó, N., & Bärnighausen, T. (Eds.). (2022). AI in eHealth: Human Autonomy, Data Governance and Privacy in Healthcare. Cambridge University Press. https://doi.org/10.1017/9781108921923
Damayanti, M., & Priyono, E. A. (2022). Legal Consequences for LDMO Disclosing Personal Data of Transacting Parties: A Study of Legal Protection. SIGn Jurnal Hukum, 4(2), 221-232. https://doi.org/10.37276/sjh.v4i2.217
Elngar, A., Pawar, A., & Churi, P. (Eds.). (2021). Data Protection and Privacy in Healthcare: Research and Innovations. CRC Press. https://doi.org/10.1201/9781003048848
Fornasier, M. D. O. (2019). The Applicability of the Internet of Things (IoT) between Fundamental Rights to Health and to Privacy. Revista de Investigacoes Constitucionais, 6(2), 297-321. https://doi.org/10.5380/RINC.V6I2.67592
Hassanaly, P., & Dufour, J. C. (2021). Analysis of the Regulatory, Legal, and Medical Conditions for the Prescription of Mobile Health Applications in the United States, the European Union, and France. Medical Devices: Evidence and Research, 14, 389-409. https://doi.org/10.2147/MDER.S328996
Ioannidou, I., & Sklavos, N. (2021). On General Data Protection Regulation Vulnerabilities and Privacy Issues, for Wearable Devices and Fitness Tracking Applications. Cryptography, 5(4), 1-19. https://doi.org/10.3390/cryptography5040029
Irwansyah. (2020). Penelitian Hukum: Pilihan Metode & Praktik Penulisan Artikel. Mirra Buana Media.
Jiang, D., & Shi, G. (2021). Research on Data Security and Privacy Protection of Wearable Equipment in Healthcare. Journal of Healthcare Engineering, 2021(1), 1-7. https://doi.org/10.1155/2021/6656204
Karrouk, Y., Debasa, F., & Sanchez, L. M. F. (2025). The Digital Transformation of Smart Hospitals: Challenges and Opportunities. In M. Ouaissa et al. (Eds.), Utilizing AI of Medical Things for Healthcare Security and Sustainability (pp. 1-54). IGI Global Scientific Publishing. http://doi.org/10.4018/979-8-3373-0690-2.ch001
Law of the Republic of Indonesia Number 27 of 2022 on Personal Data Protection (State Gazette of the Republic of Indonesia of 2022 Number 196, Supplement to the State Gazette of the Republic of Indonesia Number 6820). https://www.dpr.go.id/dokumen/jdih/undang-undang/detail/1814
Mone, V., & Shakhlo, F. (2023). Health Data on the Go: Navigating Privacy Concerns with Wearable Technologies. Legal Information Management, 23(3), 179-188. http://doi.org/10.1017/S1472669623000427
Nelissen, L., & Funk, M. (2022). Rationalizing Dark Patterns: Examining the Process of Designing Privacy UX Through Speculative Enactments. International Journal of Design, 16(1), 75-92. https://doi.org/10.57698/v16i1.05
Papa, A., Mital, M., Pisano, P., & Giudice, M. D. (2018). E-Health and Wellbeing Monitoring Using Smart Healthcare Devices: An Empirical Investigation. Technological Forecasting and Social Change, 153, 1-10. https://doi.org/10.1016/j.techfore.2018.02.018
Predel, C., & Steger, F. (2021). Ethical Challenges with Smartwatch-Based Screening for Atrial Fibrillation: Putting Users at Risk for Marketing Purposes? Frontiers in Cardiovascular Medicine, 7, 1-7. https://doi.org/10.3389/fcvm.2020.615927
Princi, E., & Krämer, N. C. (2020). Out of Control – Privacy Calculus and the Effect of Perceived Control and Moral Considerations on the Usage of IoT Healthcare Devices. Frontiers in Psychology, 11, 1-15. https://doi.org/10.3389/fpsyg.2020.582054
Qamar, N., & Rezah, F. S. (2020). Metode Penelitian Hukum: Doktrinal dan Non-Doktrinal. CV. Social Politic Genius (SIGn).
Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the Protection of Natural Persons with Regard to the Processing of Personal Data and on the Free Movement of Such Data, and Repealing Directive 95/46/EC (General Data Protection Regulation). http://data.europa.eu/eli/reg/2016/679/oj
Sampara, S., & Husen, L. O. (2016). Metode Penelitian Hukum. Kretakupa Print.
Smart, S., & McManus, A. C. (2022). Closing the Gap between UNGPS and Content Regulation/Moderation Practices. Revista de Direito Internacional, 19(2), 269-293. https://doi.org/10.5102/rdi.v19i2.8380
Soemitro, D. P., Wicaksono, M. A., & Putri, N. A. (2023). Penal Provisions in the Personal Data Protection Law: A Comparative Legal Study between Indonesia and Singapore. SIGn Jurnal Hukum, 5(1), 155-167. https://doi.org/10.37276/sjh.v5i1.272
Sui, A., Sui, W., Liu, S., & Rhodes, R. (2023). Ethical Considerations for the Use of Consumer Wearables in Health Research. Digital Health, 9, 1-7. https://doi.org/10.1177/20552076231153740
Sun, N., Esom, K., Dhaliwal, M., & Amon, J. J. (2020). Human Rights and Digital Health Technologies. Health and Human Rights, 22(2), 21-32. Retrieved from https://www.hhrjournal.org/2020/12/08/human-rights-and-digital-health-technologies
Tom, E., Keane, P. A., Blazes, M., Pasquale, L. R., Chiang, M. F., Lee, A. Y., & Lee, C. S. (2020). Protecting Data Privacy in the Age of AI-Enabled Ophthalmology. Translational Vision Science and Technology, 9(2), 1-7. https://doi.org/10.1167/tvst.9.2.36
United States Code: Title 21 - Food and Drug, Section 393 - Food and Drug Administration. https://www.govinfo.gov/app/details/USCODE-2023-title21/USCODE-2023-title21-chap9-subchapX-sec393
Copyright (c) 2025 Hartono Tasir Irwanto, Wiranti Wiranti, Muhammad Fitratallah Dahlan, Nadiah Khaeriah Kadir
This work is licensed under a Creative Commons Attribution 4.0 International License.
