1. Reason for proposal

With digital technologies such as AI, big data, cloud computing, IoT (Internet of Things), mobile, 5G, metaverse, etc. maturing owing to the recent acceleration of the 4th industrial revolution, and with the extension and improvement of individual life through health management translating into socioeconomic changes, the digital healthcare industry wherein digital technology and health management are fused attracts attention as the core power to determine the survival and development of enterprises and industrial competitiveness of a country.

  Especially, it is essential to develop digital health technology and apply it to industries to solve pending issues including acceleration of aging of populations and chronic diseases with the recognition of the new reality that rapid changes and limited medical support in the living environment caused by the COVID-19 pandemic wield significant influence on people’s health and all industries.

  As such various issues cannot be solved by treatment-focused health/medicine support system only, there is a need to provide the foundation of the digital healthcare industry focused on prevention, management, and monitoring and to focus support on the activation of industries and gain competitiveness.

  In the current legal system, however, as it is difficult to combine different industries such as medicine, non-medicine, software, hardware, AI, data, etc. based on digital technology with services and to reflect the structural properties of the digital healthcare industry to form an ecosystem of new industries based on fusion-type business models such as services of products or commercialization of services, and as the basis for supporting the digital healthcare industry is distributed in many laws and guidelines such as the Industrial Convergence Promotion Act, Software Promotion Act, Act on Nurturing Medical Devices Industry and Supporting Innovative Medical Devices, Non-medical institution health management service guidelines, and Guidelines for use of health and medical data, etc., systematic cultivation and support of the digital healthcare industry are limited.

  Moreover, even though the industry is a rapidly growing one with a bright future, enterprises belonging to the digital healthcare industry have major difficulties and uncertainty in investments due to insufficiency in connection & collaboration, policy implementation systems, and support systems among parts such as R&D, manpower cultivation, demand generation, business change, etc.

  Therefore, the aim is to define the concept of digital healthcare not handled in other laws, alleviate the legal uncertainty of enterprises in handling digital healthcare technology through the establishment of principle on the cultivation, protection, and use of industrial ecosystem in relation to the same, promote the use of advanced digital healthcare technology in all industries, and provide the legal basis of support and implementation system for the integrated establishment and execution of policies related to the digital healthcare industry; especially, the aim is to provide strong support for the activation of the private digital healthcare industry by establishing an integrated support center, etc. to improve the technical capability of digital healthcare industries.

2. Main contents

A. The Act seeks to strengthen the competitiveness of the digital healthcare industry and to contribute to the improvement of people’s health and economic development by prescribing matters needed for the formation of basis for cultivating, supporting, and developing the digital healthcare industry (Draft for Article 1).

B. The Act defines the industries related to R&D, production, distribution of devices, software, systems, and platforms to collect and analyze information on personal health and to provide tailored health management services as a digital healthcare industry and prescribes the digital healthcare enterprises to be supported under the Act (Draft for Article 2).

C. The Minister of Trade, Industry, and Energy shall establish an integrated digital healthcare industry cultivation & support plan every five years through discussions with the heads of related central administrative agencies and review by the Digital Healthcare Industry Committee in order to achieve efficiently and systematically the purpose of the Act (Draft for Article 6).

D. The Act prescribes the establishment of the Digital Healthcare Industry Committee at the Ministry of Trade, Industry, and Energy to review policies related to the digital healthcare industry and to check the implementation, including the configuration and operation of the committee (Draft for Article 8).

E. The Minister of Trade, Industry, and Energy may authenticate excellent digital healthcare enterprises to cultivate digital healthcare enterprises and enhance industrial competitiveness, and the basis of various support measures such as preferential treatment including national R&D projects and special taxation and preferred purchase for excellent digital healthcare enterprises is provided (Draft for Article 11 through Article 19).

F. The Minister of Trade, Industry, and Energy may provide the measures needed to cultivate and employ professional manpower related to the digital healthcare industry and may operate education/training programs with the designation of agencies to cultivate professional manpower of the digital healthcare industry (Draft for Article 20).

G. The Minister of Trade, Industry, and Energy may support related industries in order to encourage international cooperation and overseas launching of digital healthcare industry and may perform foreign market launching support work with the designation of the integrated digital healthcare industry support centers (Draft for Article 22 and Article 23).

H. A basis is provided for digital healthcare business operators, etc. to establish an association with authentication by the Minister of Trade, Industry, and Energy for the promotion of distribution of digital healthcare products and services (Draft for Article 25).