Legal Certainty in the Use of Artificial Intelligence for Healthcare and Medical Diagnosis
DOI:
https://doi.org/10.54518/rh.5.6.2025.855Keywords:
Artificial Intelligence, Healthcare, Legal Certainty, Medical Diagnostics, Patient ProtectionAbstract
The integration of artificial intelligence into healthcare promises to revolutionize medical diagnostics and service delivery. However, rapid technological advancement has outpaced the development of a specific legal framework, creating significant legal uncertainty. This study aims to examine Indonesia’s legal framework for medical artificial intelligence, identify key regulatory gaps, and propose an adaptive legal model to ensure safe and ethical artificial intelligence adoption. Using a normative juridical approach with statutory, conceptual, and comparative analyses, the study finds that current regulations, including Law Number 17 of 2023 on Health and Law Number 11 of 2008 on Information and Electronic Transactions, provide general but insufficient guidance. Critical issues such as liability for artificial intelligence-induced errors, data governance, algorithmic transparency, and patient consent remain unresolved. This regulatory gap poses risks to patients, healthcare providers, and technology developers. The absence of a robust, adaptive legal framework undermines legal certainty and patient protection, limiting trust and safe adoption of artificial intelligence in healthcare. The study proposes a tiered regulatory model based on international best practices to ensure accountability and foster confidence in artificial intelligence-driven medical services.
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Ahuja, A. S. (2019). The impact of artificial intelligence in medicine on the future role of the physician. PeerJ, 7(7), 66-77.
Akzatria, F. S. (2023). Implementation of artificial intelligence in healthcare. Journal of Advanced Technology and Multidiscipline, 2(2), 1-10.
Amann, J., Blasimme, A., Vayena, E., Frey, D., Madai, V. I., & Precise, C.(2020). Explainability for artificial intelligence in healthcare: A multidisciplinary perspective. BMC medical informatics and decision making, 20(1), 310-312.
Brown, N. A., Carey, C. H., & Gerry, E. I. (2021). FDA releases action plan for artificial intelligence/machine learning-enabled software as a medical device. The Journal of Robotics, Artificial Intelligence & Law, 4(2), 65-67.
Caesar, M. K. (2025). Peran Artificial Intelligence (AI) dalam diagnostik radiologi: tinjauan terkini tentang aplikasi dan tantangan di Indonesia. Jurnal Adijaya Multidisplin, 3(2), 135-138.
Dalimunthe, W., Ismaidar, I., & Simarmata, M. (2025). Patient legal protection in the digital era and study of telemedicine services in Indonesia. De Lega Lata: Jurnal Ilmu Hukum, 10(1), 40-49.
Davenport, T., & Kalakota, R. (2019). The potential for artificial intelligence in healthcare. Future Healthcare Journal, 6(2), 94–98.
Ermita Ekalia, S. H., Gunadi, A., & Abdurrohim, M. (2024). Pengembangan regulasi penggunaan artifcial intelligence pada bidang kesehatan di Indonesia pada aspek hukum dan etika. Jurnal Ilmu Hukum, Humaniora dan Politik (JIHHP), 5(2), 110-125.
European Commission. (2021). Proposal for a regulation laying down harmonised rules on artificial intelligence (Artificial Intelligence Act). Brussels: European Commission.
Fauziah, Y. A., Alhadad, H., & Prawira Utama, Y. (2024). Etika dan tantangan penggunaan kecerdasan buatan dalam kedokteran gigi. Jurnal Hukum dan Etika Kesehatan, 4(1), 50-65.
Firza, A. D. C., Samudera, K., Saphira, A., & Hidayat, M. S. (2024). Legal framework for artificial intelligence in Indonesia: Challenges and opportunities. Jurnal Peradaban Hukum, 2(2), 34-35.
Foster, K. R., Vecchia, P., & Repacholi, M. H. (2000). Science and the precautionary principle. Science, 288(5468), 979–981.
Gerke, S., Minssen, T., & Cohen, G. (2020). Ethical and legal challenges of artificial intelligence-driven healthcare. In Artificial intelligence in healthcare (pp. 295-336). Elsevier: Academic Press.
Ghassemi, M., Oakden-Abbott, J., & Ranganath, R. (2021). The clinician and dataset shift in artificial intelligence. The Lancet Digital Health, 3(7), 416-418.
Habibi, A., & Haryati, R. T. S. (2021). Artificial intelligence in nursing: a literature review. Jurnal JKFT, 6(2), 8-16.
Hadjon, P. M. (1987). Perlindungan hukum bagi rakyat di Indonesia. Surabaya: Bina Ilmu.
Juang, N. A., Kaban, M., & Sembiring, R. (2025). Legal certainty regarding the rules for qualifying unlawful acts and defaults in the framework of civil law reform in Indonesia. Research Horizon, 5(3), 1019-1028.
Lamem, M. F. H., Sahid, M. I., & Ahmed, A. (2025). Artificial intelligence for access to primary healthcare in rural settings. Journal of Medicine, Surgery, and Public Health, 5(2), 100-103.
Librianty, N., & Prawiroharjo, P. (2023). Tinjauan etika penggunaan artificial intelligence di kedokteran. Jurnal Etika Kedokteran Indonesia, 7(1), 25-34.
Marelli, L., Finegan, O., & Vayena, E. (2021). The potential of artificial intelligence for healthcare in the European Union: A law and policy perspective. Journal of Medical Ethics, 47(2), 2-4.
Marzuki, P. M. (2017). Penelitian hukum (Edisi Revisi). Jakarta: Penerbit Kencana.
Mökander, J., Morley, J., Taddeo, M., & Floridi, L. (2021). Ethics-based auditing of automated decision-making systems: Nature, scope, and limitations. Science and Engineering Ethics, 27(4), 44-45.
Mutiah, F., Sibuea, H., & Candra, M. (2025). Telemedicine regulation in Indonesia: legal frameworks, challenges, and future directions. Jurnal Multidisiplin Indonesia, 4(4), 242-251.
Pasquale, F. (2019). A rule of persons, not machines: The limits of legal automation. George Washington Law Review, 87(1), 1-54.
Prawiroharjo, P., & Librianty, N. (2017). Tinjauan etika penggunaan media sosial oleh dokter. Jurnal Etika Kedokteran Indonesia, 1(1), 31.
Price, W. N., Gerke, S., & Cohen, I. G. (2019). Potential liability for physicians using artificial intelligence. JAMA, 322(18), 1765–1766.
Rayyan, R., & Simarmata, M. (2025). Kepastian hukum penggunaan artificial intelligence (ai) dalam pelayanan kesehatan dan diagnosa medis di Indonesia. Demokrasi: Jurnal Riset Ilmu Hukum, Sosial dan Politik, 2(3), 210-225.
Rayyan, R., & Siregar, A. R. M. (2025). Kepastian hukum dalam penerapan teknologi kesehatan: perlindungan data pasien dan malpraktik. Politika Progresif: Jurnal Hukum, Politik dan Humaniora, 2(1), 01-11.
Shneiderman, B. (2020). Human-centered artificial intelligence: Reliable, safe & trustworthy. International Journal of Human–Computer Interaction, 36(6), 495-504.
Simbolon, N. Y., & Sh, M. (2022). Pengantar ilmu hukum. Pengantar Ilmu Hukum. Bandung: Widina Bhakti Persada.
Syam, A. D. (2019). Manfaat dan hambatan dalam pelaksanaan sistem informasi keperawatan. Jurnal Keperawatan Muhammadiyah, 4(2), 121-127.
Topol, E. J. (2019). High-performance medicine: The convergence of human and artificial intelligence. Nature Medicine, 25(1), 44–56.
Wenang, S., Schaefers, J., Afdal, A., Gufron, A., Geyer, S., Dewanto, I., & Haier, J. (2021). Availability and accessibility of primary care for the remote, rural, and poor population of Indonesia. Frontiers in public health, 9(2), 721-723.
Wijayanti, R. I., Sutarno, S., & Panjaitan, T. (2024). Telepsikiatri dalam undang-undang nomor 17 tahun 2023 dan peraturan pemerintah nomor 28 Tahun 2024: Tinjauan hukum dan etika. Jurnal Cahaya Mandalika, 3(1), 773-783.
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