Radiation oncology specialists analyzing imaging reports interpreted by artificial intelligence (AI), patients visiting outpatient clinics showing arrhythmia alerts from their smartwatches, endocrinology consultations that finely adjust insulin dosage based on blood glucose measurement data….

Medical settings are already in the midst of a massive wave of digital transformation. Despite such technological advances, the questions that remain are still fundamental: “Can these data and AI be used with legal and ethical certainty?”

The recently discussed amendments to the Digital Healthcare Act and the Bio-Data Act in the National Assembly are institutional responses to these questions. They also represent an effort to organically integrate a fragmented legal framework—spanning the Medical Service Act, the Bioethics and Safety Act, and the Personal Information Protection Act—to define what is permitted and what must be protected. They can be described as a “Clarity Act” for regulation in the bio-medical data domain.

The core of the amendment to the Digital Healthcare Act can be summarized in three main points. First, it defines digital healthcare as “activities in which technology and medical information are combined.” This is intended to reduce the regulatory gaps and overlapping regulations that have arisen with each new technology and to present a common standard that anyone can rely on.

Second, it clarifies the standards and procedures for data utilization. It sets out procedures for using anonymized information, from which personally identifiable information has been removed, for research purposes; it includes the right of patients to request transmission of their own medical records; and it provides for exceptional use of information in emergency situations.

Third, it establishes a national-level governance framework for digital healthcare. By forming a policy deliberation committee and drawing up a basic plan, digital healthcare will become a key pillar of health and medical policy with a long-term strategy, rather than a one-off pilot project. The introduction of a regulatory sandbox that enables relevant ministries, the medical community, and industry to work together to apply AI medical technologies in real-world settings is also being promoted.

The question now faced is no longer whether to accept the technology. The technology is already present in the field. The more important task has shifted to determining “according to what standards and procedures this technology should be used safely and effectively.”

At this point, designing a reliable institutional framework is more important than uncertain competition driven by speed. Many medical professionals, researchers, and companies are already participating in the fields of medical AI and digital healthcare. Those who first understand the rules and apply them to clinical practice, research, and industry will secure more than 10 years of competitiveness. Now is the time for medical professionals, researchers, and patients alike to take an interest in designing the rules. This is no longer a matter of choice, but a shared responsibility that everyone must bear together.

Popular News