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Expertise

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Digital Health

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.
Expertise
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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