The First Step Toward Institutionalizing Digital Health... Proposal of the 'Digital Medical Device Act'

Representative Proposal by Baek Jong-heon, Member of the People Power Party

[Image source=Pixabay]

A bill titled the 'Digital Medical Device Act (Draft)', which stipulates the establishment of regulatory and support systems for digital medical products such as digital therapeutics (DTx), has been proposed.

On the 16th, Baek Jong-heon, a member of the Health and Welfare Committee of the National Assembly from the People Power Party, announced that he had introduced the Digital Medical Device Act to promote the safety and quality improvement of digital medical products, expand treatment opportunities for patients through digital innovation, and contribute to the improvement of public health.

Rep. Baek explained the reason for proposing the bill, saying, "Recently, our society has seen increasing demand and interest in disease prevention and personal health due to population aging and other factors. Digital medical products utilizing digital technologies such as artificial intelligence (AI), big data, and the Internet of Things (IoT) are expected to provide not only disease prevention and health management but also new diagnostic and treatment opportunities."

In this regard, he referred to the United States' '21st Century Cures Act' and Germany's 'Digitale-Versorgung-Gesetz (DVG)', explaining the background by stating that overseas, "regulatory systems are being restructured to actively utilize digital medical products in healthcare according to their characteristics." On the other hand, regarding Korea, he pointed out that "our legal system is structured only for existing hardware-based medical devices, limiting the development and total product lifecycle (TPLC) management of new medical products based on digital technology, and it is difficult to efficiently manage the safety of digital medical products."

Therefore, he said, "The bill was prepared to establish a safety management and regulatory support system specialized for digital medical products so that various and new digital medical products can be developed and used more safely and rapidly in a rational and predictable regulatory environment."

This bill defines digital medical products into categories such as ▲digital medical devices (medical devices applied with digital technologies such as intelligent information technology, robotics technology, and information and communication technology), ▲digital medical and health support devices (products applied with digital technology for medical support or health maintenance and improvement but not classified as digital medical devices), and ▲digital convergence pharmaceuticals (products combining pharmaceuticals with digital medical devices or digital medical and health support devices). In particular, in terms of purpose, it encompasses not only disease treatment but also diagnosis and prognosis observation, thereby covering prevention and management beyond treatment.

Specifically, from a policy perspective, the bill requires the Minister of Food and Drug Safety to establish and implement a 'Comprehensive Plan for Support and Management of Digital Medical Products' every three years. It also includes concrete support measures such as establishing a Digital Medical Device Committee responsible for reviewing the establishment and implementation of this plan, classification and designation of digital medical products, and real-world evaluation. Additionally, a Digital Medical Product Comprehensive Support Center will be designated to support product commercialization, information collection and provision, and quality improvement.

The bill also includes provisions such as ▲establishing regulatory systems specialized for clinical trials and approvals of digital medical devices and digital convergence pharmaceuticals, ▲introducing voluntary performance certification and distribution management for digital medical and health support devices, ▲electronic infringement protection of digital medical products, and ▲strengthening international cooperation and training of specialized personnel for the advancement of digital medical products.

Baek Jong-heon, Member of the People Power Party [Photo by Baek Jong-heon’s Office]

Rep. Baek said, "Now standing at the starting line of a global paradigm shift in digital healthcare, under a regulatory environment suited to its characteristics, the development and use of digital medical products can be revitalized based on Korea's strength in the IT industry." He added, "This bill is essential to support advanced medical benefits and the healthy lives of the people through digital medical products."

This content was produced with the assistance of AI translation services.