Regulator Meets With Digital Healthcare Firms To Discuss Industrial Promotion

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By Kim Chan-hyuk    

Representatives of the nation’s largest digital healthcare companies, including Kakao Healthcare, Welt, and Vuno, put their heads together to induce better and more extensive policy support from the government.

The Ministry of Food and Drug Safety held a policy consultative meeting with the representatives of 13 digital healthcare companies at the itx3 conference room in Yongsan Railway Station on Thursday.

The Ministry of Food and Drug Safety held a policy consultative meeting with the representatives of 13 digital healthcare companies at the itx3 conference room in Yongsan Railway Station on Thursday.

They did so at a meeting organized by the Ministry of Food and Drug Safety for digital healthcare venture businesses on Wednesday.

The participants represented 13 companies. They are Life Semantics, JLK, Bagel Labs, Ybrain, Seers Technology, 3L Labs, Onions, Claripi, Neurophet, Kakao Healthcare, Welt, Neofect, and Vuno. They are members of the Korea Venture Business Association’s Digital Healthcare Policy Committee.

The ministry explained that it had organized the meeting to discuss major policy trends, including the Digital Healthcare Product Act bill pushed jointly by the National Assembly and the government, and how to reform regulations on digital healthcare products. Rep. Baek Jong-heon of the ruling People Power Party has proposed the bill.

The bill aims to define and categorize digital healthcare products, establish a comprehensive plan for digital healthcare products, prepare regulatory systems specific for digital medical devices and digital fusion medical products, such as clinical trial and approval, introduce autonomous certification of functions and distribution management, protect electronic infringement on digital healthcare products, and foster personnel specialized in strengthening international cooperation to develop digital healthcare products.

It mainly calls for establishing a digital medical product committee and operating a comprehensive support center for digital medical products to help develop and commercialize such products and improve their quality. The proposed committee will also enhance its policy deliberation and advisory function and strengthen technological support for developers regarding clinical trials and approval procedures.

If the bill becomes a law, it will define and categorize digital products into three types – “medical devices applied by digital technology,” such as intelligence information technology, robotics technology, and IT technology, and “digital medical and health supporting devices” used to support healthcare and maintain or improve health, and “digital fusion medical products,” which are the combination of digital medical devices or digital healthcare, health support devices to medical products.

Upon proposing the bill, Rep. Baek explained its background, saying it aimed to improve the safety and quality of digital medical products by establishing regulatory and support systems specialized for digital medical products and expanding treatment opportunities for patients through digital innovation.

Rep. Seo Young-seok of the opposition Democratic Party of Korea also has proposed a bill titled “Act on digital medical products.”

The bill includes content that calls for substantive support for the industry, including preferential treatment in health insurance coverage so that digital medical products worth improving public health can better contribute to national competitiveness.

It also calls for transparently disclosing information on digital medical products so they can be used safely and effectively while clarifying the responsibility of health and medical professionals who sue them.

“We will work out regulatory supports to reinvigorate the development of digital healthcare products by continuously listening to the opinions of the fields, including IT businesses,” said  director-general of the ministry’s Medical Equipment Safety Bureau, Chae Kyu-han,. “We will do our best to support the digital medical product industry to help them exert great influence as a global standard and lead the global market armed with K-medical devices based on cutting-edge technology.”

CEO of Life Semantics, who doubles as the chair of the association’s policy committee, Song Jeung-jae said, “If the government provides clear regulatory standards on digital medical products, a pillar of the digital healthcare industry, it will be of great help for the industry’s rapid development of products and market advance. Venture businesses also will do their best to build a foothold for Korea to emerge as a digital healthcare powerhouse.”

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