Ministry of Health and Welfare and National Assembly seek balance between utilization and protection at June 22 public hearing… Basic law framework including right to transmission and regulatory sandbox unveiled, while controversies over 're-identification and consent rights' remain at an impasse

How to safely utilize and simultaneously protect 'health and medical information,' which has emerged as the core fuel for medical AI and precision medicine, has become a pressing question. Legislative discussions to solve this long-standing puzzle officially surfaced at the National Assembly on June 22, 2026. The Ministry of Health and Welfare, jointly with the office of Democratic Party lawmaker Seo Young-seok at the National Assembly Members' Office Building that afternoon, held a public hearing for the enactment of the 'Act on Supporting the Use of Digital Healthcare and Health and Medical Information' (hereinafter referred to as the Digital Healthcare Act) and began gathering opinions from experts and various sectors. This public hearing served as a venue where stakeholders—including the medical and pharmaceutical sectors, civil society, patient advocacy groups, academia, and the industry—gathered to openly debate contentious issues regarding the bill currently pending in the 22nd National Assembly.

The bill in question is a lawmaker-initiated legislative proposal representative-sponsored by Democratic Party lawmaker Seo Young-seok on November 24, 2025. Until now, health and medical information has been regulated and dispersed across multiple laws such as the Medical Service Act, the Bioethics and Safety Act, and the Personal Information Protection Act, but a separate foundational law considering both the sensitivity of data and the necessity of its utilization has been absent. Through this legislation, the government and the sponsoring lawmaker intend to elevate utilization standards, which have previously remained at the level of administrative guidelines and manuals, into formal law.

Overview of the Public Hearing — Government, National Assembly, and Experts Gather

During the public hearing, Choi Kyung-il, Director General for Medical Information Policy at the Ministry of Health and Welfare, explained the key details of the bill, and Kim Jae-sun, a professor of law at Dongguk University, gave a presentation on the theme of 'Legal Issues and Legislative Tasks for Medical Data Utilization.' Subsequently, Professor Yang Sung-il of Seoul National University Bundang Hospital chaired the session, and 11 panelists representing the medical and pharmaceutical sectors, civil society organizations, academia, and industry (based on the public hearing guidelines) engaged in a debate.

Lee Hyung-hoon, Vice Minister of Health and Welfare, emphasized, "Major countries around the world are rapidly revising laws and systems to safely protect medical data while expanding its public-interest utilization. Based on a protection system that the public can trust, we must safely utilize personal health and medical information and achieve social consensus so that the outcomes return to the health and benefits of all citizens." The Ministry of Health and Welfare has held consecutive meetings with civil society, patient groups, labor unions, the medical sector, and industry since last May to gather opinions, and this public hearing is a continuation of that public discussion process.

Framework of the Bill — Simultaneous Design of 'Utilization Foundations' and 'Protective Safeguards'

The proposed bill contains four main categories of institutional safeguards. First, it establishes the legal concepts of digital healthcare and health and medical information and stipulates the responsibilities of the national and local governments. In addition, it requires the Minister of Health and Welfare to establish basic and implementation plans for supporting the use of digital healthcare and health and medical information, and provides the basis for establishing a policy deliberation committee to deliberate and resolve on them, as well as conducting social impact assessments.

Second, the bill legalizes the 'right to demand transmission,' which strengthens individuals' information utilization rights. This system allows patients to directly check their medical and health information and utilize it proactively for integrated inquiries or customized services. To support this, the legal basis for designating specialized institutions for personal health and medical information management and establishing and operating a health and medical information transmission request support system is also included. This corresponds to the legal foundation of so-called medical MyData.

Third, the bill clarifies the procedures for deliberating on the appropriateness and safety of pseudonymization, which had previously been regulated under subordinate statutes and guidelines of the Personal Information Protection Act. The bill stipulates pseudonymization procedures and requires each institution to undergo review by an 'Institutional Health and Medical Information Review Committee' to ensure their appropriateness and safety. Fourth, it includes the basis for promoting pilot projects for new digital healthcare products, services, and technologies, and the establishment of a regulatory sandbox system specialized in this field. Another feature is the specification of criteria for designating utilizing companies to ensure that services by companies utilizing medical MyData align with utilization purposes such as public health promotion.

Core Controversies — Clash Between 'Predictability' and 'Control'

The biggest controversy at the public hearing was where to strike a balance between the scope of utilizing health and medical information and the level of protection. According to reports, the industry stated that predictability in data utilization procedures must be secured to develop medical AI and digital healthcare services and foster related industries. On the other hand, the medical community and civil society raised prudent opinions that protection-related tasks must be resolved first, including the risk of re-identification of pseudonymized information, the possibility of sensitive information leakage, the guarantee of patient consent and control, the burden of liability on medical institutions, and the definition of the scope of 'public interest purposes.'

Professor Kim Jae-sun, who delivered the keynote presentation, reportedly presented a view that a 'paradigm shift' is needed regarding medical data businesses. While focus has hitherto been placed on individual institutional improvements, the perspective moving forward should be approached from the standpoint of national infrastructure building and national security in the bio and medical fields, according to his intent. Furthermore, he reportedly stated that continuous system refinement is required across various areas such as data combination and linkage, valuation, joint research, overseas transfer, and federated learning, alongside pseudonymization. In particular, inter-ministerial cooperation involving the Ministry of Health and Welfare, the Personal Information Protection Commission, and the Ministry of Science and ICT is required to establish legal grounds for medical AI utilization and federated learning.

Global Trends — "Major Countries Have Already Revised Special Laws"

The presentation also pointed out that South Korea's legislative pace is slower compared to major countries. According to Professor Kim Jae-sun's presentation, Japan established special laws or systems related to health and medical data in 2018, Finland in 2019, Germany in 2024, and the European Union (EU) in 2025, whereas South Korea has remained at the bill submission stage despite pursuing legislation since around 2016. Such cross-country comparisons of legislative timelines and benchmark years are based on the presenter's compilation, and the detailed characteristics and scopes of application of each country's systems (e.g., the EU's European Health Data Space (EHDS), Japan's Next-Generation Medical Infrastructure Act) differ by issue, requiring separate verification.

However, this international comparison suggests that health and medical data governance is expanding beyond simple domestic regulatory reform into issues of global medical AI competition and data sovereignty. Given that countries vary greatly in the proportions with which overseas legislation combines 'utilization promotion' and 'strong protection,' discussions surrounding the balance point of the Korean model are expected to continue for some time.

Industry and Business Implications — Expectations for Resolving 'Legal Uncertainty' in Medical AI and MyData Markets

The following content consists of analysis and forecasts based on the intent of the bill and industry trends, and is distinct from confirmed facts. If enacted, the fields directly falling into the sphere of influence are new industries that utilize health and medical data as core assets, such as medical AI, digital therapeutics, personal health information platforms, and precision medicine. It has been repeatedly pointed out that these industries have been exposed to uncertainties during the commercialization process because the legal basis for data utilization has remained at the level of guidelines. Analysts suggest that once utilization standards, review procedures, and requirements for designating utilizing companies are arranged by law, the procedural predictability for companies from data acquisition to service launch could increase.

In particular, the foundation of the right to transmission and medical MyData is evaluated as capable of serving as an institutional footing for B2C and B2B business models such as healthcare subscription services, chronic disease monitoring, and personalized healthcare management. There are also expectations that the establishment of a regulatory sandbox could provide verification opportunities for early-stage startups and small-to-medium medical device and software companies. However, concerns are concurrently raised that pseudonymization-related review procedures and the operation of institutional review committees could increase data processing costs and compliance burdens, meaning that the perceived impact may vary by company size. The specific scale of these costs and burdens remains an area that has not yet been quantitatively confirmed.

Legislative Outlook — Still at the 'Public Hearing Stage,' Serious Deliberation Begins Now

It should be noted that this bill is currently in the early legislative stage of passing through a public hearing following a lawmaker proposal, rather than being a government announcement or passing the plenary session. The bill still has several procedures ahead, including review by the 소관 standing committee, systematic and wording review by the Legislation and Judiciary Committee, and resolution at the plenary session. If differences of opinion regarding the balance between utilization and protection are not narrowed, the possibility of an extended deliberation schedule cannot be ruled out. In the 22nd National Assembly, bills with similar intent—such as the 'Digital Healthcare Promotion and Health and Medical Data Utilization Promotion Act' representative-sponsored by People Power Party lawmaker Ahn Sang-hoon on October 31, 2024—also exist, leaving open the possibility that the process of coordinating a single bill could become a variable. In the previous 21st National Assembly, related bills were proposed but failed to be processed before the term ended.

The Ministry of Health and Welfare stated, "We will faithfully review the opinions presented at the public hearing and continuously consult with related organizations to establish a health and medical information utilization system that the public can safely use and trust." As medical data establishes itself as a 'strategic asset of the AI era,' how the two values of utilization and protection are incorporated into statutory language remains the core task that will determine the success or failure of this legislation.