Accelerating Digital Healthcare Innovation... 'What Regulations Should Be Established?'

With the emergence of 1st and 2nd class digital therapeutic devices (DTx) and ongoing innovation in the digital healthcare sector, a forum was held to discuss directions for innovating regulations, which serve as the 'road' for this progress.

The Ministry of Food and Drug Safety approved digital therapeutic devices (DTx) Aimmed's 'Somz' and Welt's 'PillowRx' (from left)
[Photo by each company]

On the 18th, the Ministry of Food and Drug Safety announced that it held a meeting to discuss major policy trends, including bills related to 'digital medical products' being promoted jointly by the National Assembly and the government, and to explore directions for regulatory innovation regarding digital medical products, together with venture companies in the digital medical field. Since discussions on digital healthcare regulatory innovation are underway, such as the 'Digital Medical Products Act' proposed by Baek Jong-heon of the People Power Party and the 'Act on Digital Medical Products' proposed by Seo Young-seok of the Democratic Party in March, this meeting was held to gather opinions on the matter.

At the meeting, from the Ministry of Food and Drug Safety, Chaegyu Han, Director of the Medical Device Safety Bureau, and Kang Young-gyu, Director of the Digital Health Regulatory Support Division, participated. From the industry, representatives from 13 companies belonging to the Digital Healthcare Policy Committee of the Korea Venture Business Association attended, including LifeSemantics (347700), Kakao Healthcare, Welt, JLK, VUNO, Bagel Labs, Ybrain, Seers Technology, ThreeL Labs, Onions, Clarify, Neurofit, and Neofact.

Chaegyu Han, Director of the Medical Device Safety Bureau, stated, “We will continuously listen to opinions from the field, including IT venture companies, and actively prepare regulatory support measures to revitalize the development of digital medical products.” He added, “We will do our best to ensure that our regulatory system for digital medical products gains influence as a global standard and that, based on this, innovative new technology K-medical devices can lead the global market.”

Song Seung-jae, Chairman of the Digital Healthcare Policy Committee of the Korea Venture Business Association and CEO of LifeSemantics, also said, “If a clear regulatory system for digital medical products, a pillar of the digital health industry, is established, it will greatly help rapid development and market entry.” He added, “Our venture companies will do their best to become a stepping stone for Korea to leap forward as a digital healthcare powerhouse.”