The government needs to establish a separate reimbursement registration frame for digital treatment devices that secure high-level clinical grounds from the approval stage, according to industry experts.

They made these and other points at a workshop organized by the Korea Venture Business Association at the National Assembly on Monday.

I & I Research CEO Lee Jin-su presented the results of a study on regulations facing the digital healthcare industry and how to cope with them. As the policy task to develop the digital healthcare sector, Lee cited, among others, providing health insurance for digital treatment devices.

“Medical practices can enter new technology territory only with cohort studies and experts’ opinions. However, digital treatment devices have higher levels of clinical grounds than other medical technology because they can prove minimal absolute effects with clinical trials from the stage of winning approval from the Ministry of Food and Drug Safety,” Lee said.

Lee stressed that the government should consider providing insurance coverage for all digital treatment devices designated as innovative technology.

“In foreign countries where digital treatment devices are used widely, these devices do not have intermediary distribution process (wholesaling) unlike other medical devices and medicinal products,” he said. “Delivering digital treatment devices to medical institutions and recovering costs is most realistic.”

To examine the reimbursement of digital treatment devices, it is necessary to determine to which reimbursement item they belong in the first place. Still, the current classification does not entirely suit digital devices, Lee pointed out.

Lee noted that given that the food and drug safety ministry regulated digital treatment devices as “software medical devices” and that the newly developed digital treatment devices replace existing medical practices, it is appropriate to classify them as medical practices or treatment materials.

“Considering the gradual expansion of the digital health domain, the authorities concerned might as well establish a separate reimbursement registration frame from the initial stage,” Lee said. “This is because by including digital treatment devices with fundamentally different characteristics in the category of medical practices and medicinal products, they can even harm the coherence of existing reimbursement system.”

Government officials and business executives discussed various related issues in the next debate.

At the debate, one of the bones of contention was the food and drug safety ministry’s guideline on “wellness products,” referring to goods for personal health management. Some participants pointed out that the guideline’s ambiguity hinders the development of related goods and services.

“At a meeting to hear the industry’s grievances, business executives say a clearer guideline will likely speed up developing wellness products and businesses,” said Song Young-jin, director of the Bio Convergence Department at the Ministry of Trade, Industry, and Energy. “This is because while the guideline explains wellness by taking examples, new products and services keep appearing in the market.”

Song hoped that revised guidelines or new laws would reflect such points.

“The draft bill of the Digital Medical Product Act classifies convergence products into digital medical devices, digital convergence medical products, and digital treatment-health support devices. The third category is similar to wellness products. From now on, we will manage them as products designated by the minister of food and drug safety,” said Ju Seon-tae, director of the Medical Device Policy Department at the Ministry of Food and Drug Safety.

Ju added that the ministry would try to minimize the industry’s confusion by listening to its opinions.

Some business executives also proposed the discussion should not stop at approvals and permissions but extend to how to help them enter markets.

“Thanks to efforts from the executive and legislative branches, the approval and permission system regarding digital treatment devices has improved much to affect no fewer than 100 products,” said Song Seung-jae, chairperson of the Digital Healthcare Policy Committee in the association and CEO of LifeSemantics, a digital health software developer.

Song expected future discussions not to be limited to development or permission but to prolong how to make people enjoy benefits from them.