Lee & Ko’s Digital Health Team provides comprehensive legal services focusing on healthcare and privacy regulations to clients including pharmaceutical companies, medical device companies, healthcare institutions, IT companies, health insurers, startups, etc.

Lee & Ko’s Digital Health Team includes top-notch experts who have outstanding expertise and know-know accumulated through their advisory services catered to numerous clients in Korea and abroad in the field of digital health. In addition, Our Digital Health Team has former advisors and research fellows from the Ministry of Health and Welfare (MOHW), the Ministry of Food and Drug Safety (MFDS), the Health Insurance Review and Assessment Service (HIRA), multinational pharmaceutical companies, and Korea Information Society Development lnstitute (KISDI).

Our members are working in close liaison and partnership with competent authorities and stakeholders including government agencies, public institutions, Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), Korean Research-based Pharma Industry Association (KRPIA), Korea Medical Device Industry Association (KMDIA), Korea Health Industry Development Institute (KHIDI), Korea Medical Devices Industrial Cooperative (KMDIC), Korea Cosmetic Association (KCA), and Korea Digital Health Industry Association (KoDHIA).

Having extensive expertise and manpower, Lee & Ko’s Digital Health Team offers a comprehensive “one-stop” service to clients in digital health at every stage from the materialization of ideas for new technology and projects, permits and approvals, legal interpretation, response measures or persuasion strategies against regulatory bodies, consultation on legislation, international market expansion, VC, M&A, and IPO along the way.

主要业务方向

Healthcare and Privacy Regulations & Cybersecurity
To ensure the rapid market entry of state-of-the-art digital health products and services, astute analysis of and finding solutions to the risks of various regulatory issues in terms of healthcare and privacy regulations will be a prerequisite. In this regard, our Digital Health Team provides the highest level of legal advice to enable our clients to preemptively respond to legal issues, based on the expertise in regulatory matters, cybersecurity issues and deep understanding of their products and services.

Healthcare Services
Conventionally, medical fields are strictly subject to the Medical Service Act, the Pharmaceutical Affairs Act, the Bioethics and Safety Act, the Personal Information Protection Act, etc. Our Digital Health Team regularly provides counsel to leading healthcare institutions in Korea on interpretations of the Medical Service Act, the Pharmaceutical Affairs Act, the Bioethics and Safety Act, and the Personal Information Protection Act as well as legal concerns related to Korea's three main privacy and data security laws: the Personal Information Protection Act, the Act on the Promotion of the Use of the Information Network and Information Protection, and the Credit Information Use and Protection Act. In addition, we offer the foremost professional services in the fields of medical compliance, global expansion, and IT technology convergence.

Health Insurance and Medical Devices
Recently, medical devices of a kind never before existed such as digital therapeutics (DTx), mobile applications for medical diagnosis and treatment, and wearable devices have been developed and introduced to the consumer market. These new types of medical devices can successfully take root in the market only with an in-depth understanding of the entire system from R&D, clinical trials, authorization, application of fee-for-service in health insurance, registration process, and to security threats to the digital healthcare devices after they are launched.
Our Digital Health Team regularly consults clients on a wide variety of matters related to the authorization, distribution, and clinical trials of conventional medical devices as well as the authorization, clinical trial, demonstration, legal issues relating to Korea's three main privacy and data security laws, any breach of the Medical Service Act and the Pharmaceutical Affairs Act, and new market entry of the novel types of medical devices.

License and Patent Protection
In digital health, successful management of products and services can be secured by the establishment of a comprehensive strategy with full-spectrum coverage for healthcare and privacy regulations and IP rights. With regard to this, our Digital Health Team offers a full service to our clients on license matters including licensing, patents, and trademark rights. Our clients may also seek assistance from us in protecting their patents and other IP rights.

Intellectual Property Infringement
Our Digital Health Team advised clients proactively, based on good communication, on ways to detect and prevent any act of infringement in advance. Furthermore, diverging from a one-sided approach, we fully understand both products and services of our clients and exert our efforts to maintain their integrity and minimize any risk of IP rights violations.

Global Expansion, Merger and Acquisition (M&A), and Restructuring
A brisk level of global expansion, M&A, and restructuring in this fast-growing sector will likely be seen as never before. With decades of experience in these fields, our Digital Health Team advises clients on matters related to advancement into new businesses, corporate M&A, and the establishment of subsidiaries for the successful landing of their services and products in the market.

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代表性案例

Healthcare and Privacy Regulations & Cybersecurity

Advised on the deregulation of innovative medical devices
Advised on the deregulation of medical devices using big data and AI
Advised on the deregulation of mobile applications for measuring diabetes and high blood pressure
Advised on matters related to the deregulation of genetic testing
Advised on the projects for digital healthcare solutions
Advised on the Bioethics and Safety Act, Guidelines for Utilization of Healthcare Data, etc.
Advised on the matters related to the Guidelines for Utilization of Healthcare Data

Healthcare Services

Advised a large hospital in Korea on its medical big data platform
Advised on the promotion of the medical data-related partnership between a healthcare analytics company and a large hospital in Korea
Advised on the digital healthcare service for disease management jointly invested by an IT company and a large hospital in Korea.
Advised a large hospital in Korea on forging a “knowledge bank” diagnostic system for precision medicine
Advised a large hospital in Korea on the establishment of a joint venture to implement a new project utilizing its medical data.

Health Insurance and Medical Devices

Advised on matters related to the designation of innovative medical technology and new medical technology
Advised on the application of the Ministry of Food and Drug Safety regulations to various issues related to digital treatment devices
Advised on insurance benefits regarding digital treatment devices
Advised a digital treatment device company on its violations of medical laws, etc.
Advised a medical device company on genetic sample testing

Intellectual Property (IP) Rights

Advised on the legal protection of digital products such as patent, trademark, and design applications, copyright registration, and the establishment of a trade secret protection system
Patent application for AI-based companies in Korea and abroad.
Advised on the ownership and license of data resulting from a research project
Advised on matters related to the joint ownership of intellectual property
Advised on the intellectual property matters of a medical center for precision medicine
Advised on the ownership of intellectual property rights
Advised on matters related to intellectual property rights such as patents, trademarks, design rights, copyrights, trade secrets, and acts of unfair competition for the protection and utilization of digital health products.
Advised on the ownership of data resulting from various joint R&D

Global Expansion, Merger and Acquisition (M&A), and Restructuring

Advised a Korean digital healthcare company on legal concerns related to overseas investment to enter the US healthcare service market
Advised an IT company affiliated with a large hospital in Korea on the export of a hospital information system to the overseas market
Advised a Korean company on the global expansion of its cancer detection and diagnosis services based on machine learning
Advised a Korean EMR solution company on the entry into a new business of genetic testing, etc.
Advised a large company in Korea on the provision of new digital healthcare platform services
Advised a large bank in Korea on the acquisition of digital healthcare services
Advised a foreign big data analysis company on the expansion of its business to the medical big data market in Korea.