“AI medical devices and DTx, legal response capabilities determine global survival”

Understanding the US Federal Priority Principle and QMSR, requiring integrated legal risk management

The dawn of regulatory science innovation in 2026

The fact that the Korean Ministry of Food and Drug Safety has allocated 11.4 billion won in the 2026 budget for ‘Food and Drug Regulatory Science Innovation Support’ means that the domestic AI-based medical device and digital therapeutic device (DTx) industry has been upgraded to a national strategic export item. This large-scale budget investment goes beyond simple financial support and contains a strong policy will to standardize the technical effectiveness of domestic companies in line with international legal standards.

This heralds a major transformation in the industry. Now, companies must design a sophisticated legal roadmap that takes into account everything from the early stages of technology development to final licensing and health insurance fee registration. This will soon become a core competency directly related to survival in the global market.

Regulatory response based on technical understanding

Approval of digital healthcare devices is fundamentally different from the review of existing hardware-centered medical devices. The process of proving the effectiveness of the algorithm and the continued reliability of the data is essential.

Through my expertise as a pharmacist, practical experience at a global pharmaceutical company, and public service experience at the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service, I have experienced the entire process through which innovative technologies go through to settle in the market. Regulatory authorities focus on evaluating how the technology ensures ‘predictable safety’ within the current legal system rather than the innovation itself. Ultimately, the core of regulatory science is to explain complex scientific evidence in the language of laws and norms that authorities can accept. Translating technology into the language of law determines the success or failure of licensing.

Legal seat belts entering the US market

The legal concept that companies targeting the U.S. market must understand is the principle of ‘Federal Preemption.’

The U.S. Supreme Court's Riegel v. Medtronic, Inc (2008) case presents important implications for medical device companies.

At the time, the court ruled in the case that patients could be restricted from filing product liability lawsuits based on state law for medical devices that passed the U.S. Food and Drug Administration's (FDA) premarket approval (PMA) process. This shows that FDA approval goes beyond simple market entry permission and can be a legal shield that protects companies from the risk of large-scale civil litigation in the United States. Therefore, faithfully complying with the Quality System Regulation (QMSR), which has been fully implemented from 2026, is both a regulatory response and the strongest litigation defense strategy.

Expanding Cybersecurity and Product Liability

With the proliferation of software-based medical devices, security flaws have emerged as a new product liability issue. Global regulatory authorities and courts tend to interpret security flaws in software medical devices not as simple technical errors but as serious manufacturing errors that are directly linked to patient life.

The FDA mandates submission of a software bill of materials (SBOM) and establishment of a post-security patch process in the QMSR system. If this is neglected, a chain of legal risks may arise that can lead to not only cancellation of the license but also violation of the False Claims Act.

Companies must apply ‘Security by Design’ from the development stage. At the same time, a documentation system must be established to legally prove the design and management process.

Transparency demands and administrative response strategies

In Korea, the HIRA is closely examining expenditure reports using advanced data analysis techniques. The level of transparency demanded by companies continues to strengthen.

Looking back at past precedents of cases involving the Ministry of Health and Welfare's decision to lower drug prices or invalidate public notices, companies that failed to logically prove the ‘academic justification’ for providing economic benefits in the early stages of administrative investigations suffered a huge management blow. In particular, digital healthcare companies must integrate and manage data to prevent marketing activities from being mistaken for rebates. When expanding overseas, global compliance standards must be established that simultaneously meet Korea's expenditure report system and the U.S. Physician Payments Sunshine Act.

Integrated risk management creates leading companies

The success of the AI ​​and digital healthcare industries is not achieved through technological innovation alone. It must be accompanied by a solid legal defense mechanism to protect the technology and make it sustainable. Regulatory response, quality management, cybersecurity, and transparency should not be separate tasks but integrated into one strategy. We hope that the domestic medical device industry will lead global standards through preemptive regulatory strategies and institutional preparations commensurate with technological innovation.

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