The Complete Guide to Using AI in the Healthcare Industry in South Korea in 2025

South Korea’s new AI Basic Act – enacted January 21, 2025 and effective with a one‑year transition starting January 22, 2026 – puts healthcare squarely in a high‑impact category, meaning AI used in health care services and digital medical devices must meet transparency, risk‑management and human‑oversight rules (with special timing for digital medical devices), and even foreign vendors serving Korean patients may need a domestic representative; regulators can investigate and impose fines up to KRW 30 million for noncompliance.

This matters for hospitals, medtech and startups using AI‑powered imaging diagnostics or generative tools because they’ll need clear user notices, documentation of training data and lifecycle monitoring.

For clinical teams and healthcare product managers who must adapt quickly, focused training like Nucamp’s 15‑week AI Essentials for Work bootcamp can teach practical prompt skills and workplace AI governance to help meet these new obligations – see the AI Basic Act overview at Araki Law and CSET’s translation for implementation details.

“The purpose of this Act is to protect human rights and dignity, and to contribute to enhance the quality of life, while strengthening national competitiveness by establishing essential regulations for the sound development of artificial intelligence (AI) and the establishment of trust.”

South Korea’s regulatory landscape for healthcare AI now centers on the AI Basic/Framework Act: promulgated January 21, 2025 and carrying a one‑year transition that makes most obligations enforceable from January 22, 2026, with a narrow earlier start date for certain digital medical device rules – details and thresholds will arrive via Presidential Decree and Enforcement Decrees, so watch those timelines closely (FPF: South Korea AI Framework Act timeline and definitions; Araki Law: medical device rule timing under South Korea’s AI Framework).

The law takes a risk‑based approach: healthcare tools deemed “high‑impact” must implement risk management, human oversight, explanation materials and user notices, generative AI outputs must be labelled, and offshore vendors that meet user/revenue thresholds may need a local representative.

MSIT is the primary regulator with broad investigatory powers and the ability to compel records; administrative fines – limited but real – can reach KRW 30 million (≈ USD 20,700) for key breaches (Debevoise: analysis of scope, extraterritoriality, and penalties under South Korea’s AI Act).

Healthcare teams should treat the year before enforcement as a single runway to map systems to the Act, align with PIPC privacy guidance, and identify which products might be classified as high‑impact.

“AI is defined as “an electronic implementation of human intellectual abilities such as learning, reasoning, perception, judgment and language comprehension.”

Common AI Healthcare Use Cases in South Korea (2023–2025)

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Across South Korea from 2023–2025, AI has moved from pilot projects into everyday clinical workflows with clear hotspots: automated image diagnostics and cancer screening, predictive analytics for patient deterioration, telemedicine and remote monitoring, and workflow automation that trims administrative time and dosing errors.

Hospital and startup collaborations led by Samsung, VUNO and Lunit power many imaging and oncology tools, while smartphone‑based skin cancer screening (e.g., LifeSemantics’ CanoPMD SCAI) shows how consumer devices can feed clinically useful models – a striking example is clinicians triaging suspicious lesions from patient photos in outpatient settings.

Early adopters also include AI for neuroimaging and dementia assessment that has already secured national insurance access, highlighting a path from validation to reimbursement.

Market studies underline rapid expansion: broader AI in medical diagnostics and imaging is growing fast, driven by government digital‑health programs, strong IT infrastructure and aging population needs; see the market forecast and company landscape in South Korea Healthcare AI Market report – MarketResearchFuture, the diagnostic market breakdown in South Korea AI in Medical Diagnostics Market – Markets and Data, and explore practical imaging use cases in Nucamp AI Essentials for Work bootcamp syllabus – AI-powered imaging diagnostics overview.

These trends create real operational gains – and a practical imperative for teams to pair technical pilots with clinical evidence and payer strategies to scale safely.

Data, Privacy and Model Training Rules in South Korea

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Data in South Korea’s healthcare AI roadmap is governed by two complementary strands: the strengthened Personal Information Protection Act (PIPA) and the AI Framework/Basic Act, so teams must design models with both privacy and AI‑specific rules in mind.

PIPA already tightened consent, pseudonymization and breach rules (notably 72‑hour breach notification thresholds and expanded CPO duties after the 2023 amendments), while the AI Framework Act (promulgated Jan 21, 2025; enforceable Jan 22, 2026) layers on risk‑based obligations – transparency, lifecycle documentation of training data, human oversight and even a domestic‑representative requirement for some foreign operators – and directs MSIT to build shared AI data infrastructure and standards to support safe model training (see the AI Framework Act analysis at FPF analysis of South Korea’s AI Framework Act).

Parallel tracks matter in practice: proposed amendments flagged by Kim & Chang would explicitly ease some barriers to using personal data for AI training if safeguards and PIPC confirmation are met, but teams should still plan for pseudonymization, strict access controls, and cross‑border transfer notices under PIPC guidance.

A clear local contact, documented data lineage and a 72‑hour incident playbook are practical musts for any healthcare AI rollout in Korea.

Law / Authority	Key data & training rules	Timing / status
South Korea Personal Information Protection Act (PIPC) – PIPA details	Pseudonymization, consent limits, CPO duties, 72‑hour breach notification, strict cross‑border rules	Amended effective Sept 15, 2023 (Enforcement Decree actions in 2024)
FPF analysis of South Korea’s AI Framework Act (MSIT)	Risk management, documentation of training data, user notices, domestic representative for foreign operators, data center support	Promulgated Jan 21, 2025; enforceable Jan 22, 2026
Kim & Chang analysis of proposed AI data amendments	Potential carveouts to ease securing training data for AI development subject to safeguards and PIPC confirmation	Proposed – monitor for implementation details

Safety, Standards and Technical Requirements in South Korea

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Safety and technical standards for healthcare AI in South Korea have moved from abstract principles to concrete, enforceable rules: the MFDS published the world’s first Guidelines on the Review and Approval of Generative AI‑based Medical Devices (setting submission and usability documentation expectations and asking developers to map intended use to risk level), and followed with Good Machine Learning Practice (GMLP) principles that mirror international norms like ISO 14971/AAMI and demand lifecycle risk management, representative training data, bias mitigation and clinician‑centric system design – see a concise MFDS guidelines editorial overview (Korean Journal of Radiology).

The MFDS also set a high bar for cybersecurity: Korea’s Digital Medical Device Electronic Intrusion Security Guidelines require encryption, access controls and continuous vulnerability monitoring so devices are not just accurate but resilient in the wild (detailed in recent regulatory updates).

Practically, that means design teams must bake in explainability, comprehensive technical documentation, quality‑management systems, post‑market surveillance and clear clinician override paths from day one – and treat the six named hazard categories (performance, data quality, bias, user, adaptive system and others) as concrete checkpoints rather than theoretical risks.

Approval, Clinical Evidence and Reimbursement Pathways in South Korea

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Navigating approval and reimbursement in South Korea means pairing early regulatory dialogue with rigorous clinical evidence and a clear payer strategy: the MFDS’s updated pre‑consultation program (4th revision, June 2025) now explicitly covers digital medical devices and offers non‑binding written feedback that can clarify classification, trial design and documentation expectations before costly studies begin (MFDS pre-consultation guideline for digital medical devices | RegDesk).

Clinical trials and device studies must align with MFDS and IRB requirements, be registered with regulators, and protect sensitive subject data under PIPA, while MFDS approval dossiers increasingly demand lifecycle evidence about training data, bias mitigation and post‑market monitoring consistent with the agency’s generative AI and GMLP guidance (MFDS generative AI and GMLP guidance overview | Korean Journal of Radiology).

Marketing authorisations run on a five‑year cycle, and MFDS retains the power to probe safety and efficacy over a four‑to‑seven‑year window, so build real‑world monitoring from day one; expedited tracks exist for priority drugs and orphan/innovative devices, and Korea’s integrated review can align approval with insurance assessment to shorten market entry (MFDS, HIRA and reimbursement pathways in South Korea | Life Sciences 2025 (Chambers Practice Guides)).

For reimbursement, HIRA/NHIS and MOHW evaluate clinical efficacy, cost‑effectiveness (positive listing for drugs) and whether a device’s cost is billed separately or bundled into a service – practical success depends on stitching regulatory strategy, robust Korean or bridged clinical data, and early payer engagement into one plan.

Governance, Oversight and Enforcement in South Korea

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Governance in South Korea couples active promotion with enforceable oversight: the Ministry of Science and ICT (MSIT) and the National AI Committee will set national plans, standards and inspections, while MSIT gains broad investigatory powers to compel records, conduct on‑site probes and issue corrective orders during the law’s one‑year transition to enforcement on January 22, 2026.

The AI Basic Act reaches beyond borders – systems that affect Korean users can trigger MSIT review – and foreign operators meeting user/revenue thresholds may need a domestic representative to handle compliance and reporting.

For healthcare, that means high‑impact tools must be backed by risk‑management plans, human oversight, user notices and lifecycle documentation so regulators can verify safety and reliability; failure to notify users, name a local rep or follow corrective orders carries administrative fines (up to KRW 30 million).

The net effect is practical: treat the transition year as a single runway to align privacy duties with the PIPC, document impact assessments and appointment chains, and be ready to demonstrate technical and governance controls when MSIT asks for evidence (see the FPF analysis and Debevoise overview for implementation detail).

“The Basic Act has very broad extraterritorial effect; it applies to all AI-related actions performed abroad that affect South Korea’s domestic market or users.”

Liability and Legal Risks for AI in South Korea Healthcare

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Liability and legal risk in South Korea’s healthcare AI landscape are concrete, immediate and multi‑layered: the AI Basic/Framework Act gives MSIT wide investigatory powers and administrative fines up to KRW 30 million for breaches like failing to label generative outputs or neglecting to appoint a domestic representative, while traditional product‑safety and product‑liability laws can trigger criminal exposure and mandatory recalls if a device or system causes harm (including imprisonment in severe recall cases under the FAPS) – so regulatory audits aren’t theoretical paper‑work but can involve on‑site inspections and compelled records.

Civil claims under the Product Liability Act impose strict liability for defective products and can create a presumption of defect when harm occurs during normal use, shifting heavy evidentiary pressure onto manufacturers, importers and dev‑ops in the AI stack; that legal mix means documentation of training data, clinical validation, post‑market surveillance and clear human‑oversight policies are not optional compliance niceties but frontline risk controls.

Because the AI Act reaches activities that affect Korean users even if performed abroad, foreign vendors should map exposure early, name a local representative, align device dossiers with MFDS/GMLP expectations and knit regulatory, clinical and legal evidence into a single lifecycle folder that can be produced to MSIT, courts or consumer agencies on short notice (see the AI Framework Act summary from the Future of Privacy Forum and product liability guidance from Kim & Chang for practical legal contours).

AI is defined as “an electronic implementation of human intellectual abilities such as learning, reasoning, perception, judgment and language comprehension.”

Market, Investment, Talent and National Programs in South Korea

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South Korea’s market push is no gentle nudge – it’s a full‑throttle national program that couples massive public spending with chaebol scale and clear workforce targets: MSIT’s AI blueprint backs a National AI Computing Center (budgeted up to KRW 2 trillion) and a build‑out to over 2 exaflops by 2030, while the plan expects KRW 65 trillion of private AI investment from 2024–2027 and a leap from 51,000 to 200,000 AI experts by 2030, signaling that hospitals and health‑tech startups can tap both computing capacity and talent pipelines as they scale AI diagnostics and screening programs (MSIT AI blueprint for the National AI Computing Center).

Ambitious GPU targets underline the urgency: reports cite efforts to secure 10,000 GPUs by year‑end and plans to deploy 15,000 advanced GPUs across the national center by 2027, while parallel R&D (the KRW 403.1 billion K‑Cloud project) aims to harden domestic AI‑semiconductor stacks and cloud tooling – concrete infrastructure that can cut model training times for clinical imaging and population‑screening pilots (Industry analysis of South Korea GPU and data‑center expansion; Coverage: South Korea targets 10,000 GPUs to boost national AI computing power).

For healthcare teams the takeaway is blunt but useful: national funding, semiconductors and GPU access are becoming available – treat them as levers to accelerate validated pilots into reimbursable, scalable services rather than mere grant‑funded experiments.

Program / Metric	Target / Budget	Timeline
National AI Computing Center (MSIT)	Up to KRW 2 trillion; >2 EF target	Full operations by 2027–2030
Private AI investment	KRW 65 trillion	2024–2027
GPU procurement targets	10,000 GPUs (2025); 15,000 GPUs (by 2027)	2025–2027
K‑Cloud R&D project	KRW 403.1 billion (total)	2025–2030
AI talent goal	200,000 AI experts	By 2030

“We are embarking on a national all-out effort to achieve our ambitious goal of becoming one of the top three global AI powerhouses (AI G3).”

Conclusion & Practical Compliance Checklist for Healthcare Teams in South Korea

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Wrap compliance into a short, action‑focused checklist: treat the AI Basic Act’s one‑year transition to enforcement (effective 22 Jan 2026) as a single runway – first inventory all AI systems and flag anything that touches diagnosis, medical devices, patient rights or automated decisions for “high‑impact” review; then draft a documented risk‑management plan that covers explainability (criteria and training‑data lineage), human oversight, bias mitigation and lifecycle monitoring as required by Article 34 (see FPF’s overview of the Framework Act and CSET’s translation for the Act text).

Align data handling with PIPA (pseudonymization, strict cross‑border controls and the 72‑hour breach playbook), be ready to appoint a domestic representative if thresholds are met, and label generative outputs and user notices per the transparency rules.

For digital medical devices, open early MFDS pre‑consultation, build clinical and post‑market evidence, and harden cybersecurity and clinician‑override paths; keep a producible evidence folder because MSIT can demand records and administrative fines can reach KRW 30 million.

Make training and governance concrete – upskill teams with targeted courses (for example, Nucamp’s 15‑week AI Essentials for Work teaches workplace prompt skills, governance and practical controls) and treat this checklist like a preflight inspection before submitting dossiers or scaling pilots.

“The purpose of this Act is to protect human rights and dignity, and to contribute to enhance the quality of life, while strengthening national competitiveness by establishing essential regulations for the sound development of artificial intelligence (AI) and the establishment of trust.”

Frequently Asked Questions

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