Representative Baek Jong-heon and others jointly proposed
Combined related bills pass National Assembly as alternative
Supporting development of digital health including DTx and AI
Amid growing interest in digital medical products such as digital therapeutics (DTx) and artificial intelligence (AI) medical devices, the 'Digital Medical Products Act,' which supports related systems, has passed the plenary session of the National Assembly.
On the 20th, the National Assembly passed the Digital Medical Products Act in the plenary session, aiming to establish a new legal framework specialized for digital medical products to enhance public accessibility and reliability of digital medical products and improve administrative efficiency. The bill was overwhelmingly approved with 178 votes in favor (96.2%), 3 against, and 4 abstentions out of 185 members present.
The bill passed on this day was a committee substitute combining two bills: the 'Digital Medical Products Act' originally proposed by Baek Jong-heon of the People Power Party, the 'Act on Digital Medical Products' proposed by Seo Young-seok of the Democratic Party, and the 'Partial Amendment to the Medical Devices Act' proposed by Kang Ki-yoon of the People Power Party. It was submitted to the plenary session and passed in this combined form.
The Ministry of Food and Drug Safety, the competent authority, stated regarding the enactment of this law, "It is meaningful in that it has established a regulatory system covering clinical trials, approval, and post-market management to evaluate the safety and effectiveness of digital medical products more efficiently and systematically." They also emphasized, "An integrated evaluation system for clinical trials and approval has been established for ‘digital convergence pharmaceuticals,’ which combine digital medical devices or digital medical and health support devices with pharmaceuticals to enhance the efficacy and safety of drugs."
The Digital Medical Products Act reflects the characteristics of digital medical products, including digital medical devices utilizing digital technologies such as AI and big data, digital convergence pharmaceuticals, and digital medical and health support devices. To ensure safety management and support product development, it includes ▲a regulatory system specialized for clinical trials and approval of digital medical devices and digital convergence pharmaceuticals to support rapid development and use of products, ▲the introduction of voluntary reporting, performance certification, and management systems for digital medical and health support devices to foster industrial development and a sound distribution environment, and ▲the designation and operation of a Digital Medical Products Regulatory Support Center to support the development of digital medical products, as well as government efforts for international regulatory harmonization.
With the passage of this bill, disease management for patients using digital innovation technologies is expected to become much easier. Kim Mi-young, president of the Korea Type 1 Diabetes Patient Association, said, “Type 1 diabetes is a disease that uses various digital medical products, but related laws were unclear, and regulations could not keep up with the speed of technology, leaving patients frustrated.” She added, "With the enactment of this law, regulations for digital medical products have been concretely established, enabling the safe and effective development and use of products.”
Baek Jong-heon, who previously proposed the related bill, said, "As we stand at the starting line of the global digital health era, the development and use of digital medical products can be activated based on Korea’s strength in the digital industry within a regulatory environment suited to its characteristics." He added, "The specialized regulatory system for digital medical products will support new industrial growth and promote a healthy life for the public through changes in the medical paradigm enabled by digital technology."
Yoo Cheol-wook, president of the Korea Medical Devices Industry Association, also said, “Digital medical devices such as Software as a Medical Device (SaMD) have limitations under traditional medical device regulatory systems, so it is time to establish a safety management and regulatory support system specialized for digital medical devices.” He added, “The passage of the Digital Medical Products Act, which stipulates necessary matters for handling, managing, and supporting manufacturing and importation specialized for digital medical products, will promote product safety, effectiveness, and quality improvement, and strengthen international competitiveness. The industry is very pleased with this development.”
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