Bioethics and Legal Regulation of the Use of Artificial Intelligence (AI) in Healthcare Services in Indonesia - Arina Shiva Official Website

Achmad Shiva’ul Haq Asjach

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The development of modern health technology has brought significant changes to the healthcare system, one of which is the use of Artificial Intelligence (AI) in medical diagnosis and clinical decision-making processes. AI technology is capable of analyzing large volumes of health data rapidly and accurately, thereby assisting medical personnel in detecting diseases, predicting patient conditions, and determining therapeutic recommendations. In modern healthcare practice, AI has been applied in radiological analysis, cancer detection, laboratory result interpretation, digital medical record systems, and application-based telemedicine services (FDA, 2023).

Although it offers substantial benefits in terms of efficiency and accuracy in healthcare delivery, the use of AI in the medical field also raises various bioethical issues and legal regulatory challenges. This is because the use of AI is directly related to patient safety, the protection of health data, the legal responsibility of medical personnel, and the respect for human values in healthcare services. Therefore, the development of AI technology requires an adaptive legal and ethical framework to ensure that technological innovation progresses without neglecting the protection of patient rights.

From a bioethical perspective, the use of AI in medical diagnosis raises several fundamental issues. One of the main concerns is patient autonomy. In bioethical principles, patients have the right to obtain clear and comprehensible information regarding any medical procedures performed on them, including the use of AI technology in diagnostic and treatment processes. However, in practice, AI systems often operate through complex algorithms that are difficult to understand, even for medical professionals themselves. This condition may result in patients not fully understanding how medical decisions are made, thereby making the implementation of informed consent difficult to optimize (Nasution, 2013).

In addition, the use of AI also raises concerns related to the principle of non-maleficence, namely the obligation to “do no harm” to patients. Although AI systems may offer high levels of diagnostic accuracy, they still carry the potential for errors due to data bias, algorithmic flaws, or limitations in training data. For instance, AI systems developed using health data from a specific population may produce inaccurate results when applied to populations with different characteristics. If a diagnostic error leads to patient harm, legal questions arise regarding liability—whether it should be attributed to the physician, the hospital, the AI system developer, or the technology provider.

Another bioethical issue relates to the principle of justice. The use of AI technology in healthcare services has the potential to create disparities in access to healthcare between groups of people who can afford advanced technologies and those living in remote areas or facing economic limitations. This condition may widen inequalities in healthcare delivery if the state does not implement policies that ensure equitable access to health technologies.

In addition, the use of AI in healthcare is closely related to the protection of patients’ personal data. AI systems require large volumes of health data to improve analytical accuracy and algorithmic learning. However, health data is classified as sensitive personal data because it contains information about physical conditions, medical history, and patient identity. If such data is misused or exposed in a data breach, it may result in violations of patients’ privacy rights and potential discrimination against individuals (Law of the Republic of Indonesia Number 27 of 2022 concerning Personal Data Protection).

In the Indonesian legal context, regulations governing the use of AI in healthcare services have not yet been specifically and comprehensively established. Nevertheless, several existing laws provide a legal basis for the protection of health data and technology-based medical services. Law of the Republic of Indonesia Number 17 of 2023 concerning Health stipulates that healthcare services must be conducted based on patient safety principles, professional standards, and the responsible utilization of health technologies (Law of the Republic of Indonesia Number 17 of 2023 concerning Health).

However, the current regulatory framework still has several weaknesses. First, there are no specific provisions governing the security standards and diagnostic accuracy of medical AI systems. Second, there is a lack of clarity regarding legal liability in cases of diagnostic errors produced by AI. Third, there is no established mechanism for supervision and certification of AI usage in healthcare services. As a result, the use of AI technology in Indonesia still has the potential to create a legal vacuum when technology-based medical disputes arise.

When compared with several other countries, Indonesia is still lagging behind in developing regulatory frameworks for AI in healthcare. The European Union, for instance, has developed the Artificial Intelligence Act, which classifies AI in the healthcare sector as a high-risk AI system. As such, its use must comply with strict standards of transparency, safety, human oversight, and the protection of human rights (European Union, 2024). This regulation also requires risk assessment and auditing of AI systems before they can be widely deployed in public services.

Meanwhile, the United States, through the Food and Drug Administration (FDA), has implemented regulatory mechanisms for AI-based medical devices, including evaluations of the safety and effectiveness of digital health algorithms. The FDA has also developed a specific regulatory framework for AI-based medical software capable of continuous learning and adaptation (machine learning medical devices) (FDA, 2023). These approaches demonstrate that developed countries increasingly regard AI in healthcare as a strategic technology that requires specific legal oversight to ensure patient safety.

Based on these developments, Indonesia needs to undertake more adaptive health law reforms in response to advancements in AI technology. First, it is necessary to establish a specific regulation governing the use of AI in healthcare services, covering standards of safety, algorithmic transparency, technology certification, and mechanisms for supervising medical AI systems. Second, there must be clear legal provisions regarding liability in cases of AI-based diagnostic errors, including the allocation of responsibility between medical professionals, hospitals, and technology developers.

Third, the state needs to strengthen the protection of digital health data by implementing strict cybersecurity standards and robust monitoring mechanisms for the use of patient data by AI systems. Fourth, the implementation of AI in healthcare must continue to position medical personnel as the primary decision-makers, ensuring that AI functions only as a supporting tool rather than a full replacement of human roles in healthcare services.

Fifth, it is necessary to establish an independent supervisory body tasked with evaluating the use of AI technology in healthcare services to ensure that such technology complies with bioethical principles, patient safety standards, and human rights. In addition, the development of healthcare AI in Indonesia must also take into account social, cultural, and humanitarian values so that technology does not eliminate the element of empathy in the relationship between medical personnel and patients.

Based on the foregoing discussion, it can be understood that the use of AI in healthcare services offers significant benefits in improving the quality and efficiency of medical diagnosis. However, it also raises complex bioethical issues and legal challenges. Therefore, Indonesia requires a comprehensive, adaptive regulatory framework oriented toward the protection of patient rights to ensure that the utilization of AI technology can be implemented safely, ethically, and responsibly in the future.

References

European Parliament. (2024). Artificial Intelligence Act. European Union.

Food and Drug Administration (FDA). (2023). Artificial intelligence and machine learning in software as a medical device.

Marzuki, P. M. (2021). Pengantar ilmu hukum. Kencana.

Nasution, B. J. (2013). Hukum kesehatan: Pertanggungjawaban dokter. Rineka Cipta.

Law of the Republic of Indonesia Number 17 of 2023 concerning Health.

Law of the Republic of Indonesia Number 27 of 2022 concerning Personal Data Protection.