[Journalism Internship] Strict laws risk holding back Korea’s digital medicine industry, experts say

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[Journalism Internship] Strict laws risk holding back Korea’s digital medicine industry, experts say

Inha University Hospital utilizes a remote collaboration system and AI to provide advanced medical services. [INHA UNIVERSITY]

Inha University Hospital utilizes a remote collaboration system and AI to provide advanced medical services. [INHA UNIVERSITY]

 
Danu Kim, Hyein Lee, Riye Kim, Yu-an Jeon

Danu Kim, Hyein Lee, Riye Kim, Yu-an Jeon

 
Since the approval of Somzz, the first digital therapeutic device permitted for use in Korea, on Feb. 15, 2023, there has been a notable increase in the implementation and development of digital medical devices in Korea.
 
Digital medical devices, or digital therapeutics (DTx), are technologies that use software to prevent, treat and cure diseases.  
 
As DTx are globally adopted due to their convenient and straightforward nature, the technology allows patients to accurately examine their health. The digital medical device field is currently expected to yield $6.9 billion globally in 2025, more than triple the amount accrued in 2020, according to research institute Innopolis.
 
Such developments have led to increases in government regulations, and Korea is no exception.
 
The Ministry of Food and Drug Safety is responsible for engaging in regular inspections that assess the extent to which such devices comply with the controlled safety standards, said regulatory solutions company Freyr South Korea.  
 
The Food Ministry passed the Digital Media Products Act (DMPA) in January 2024, requiring permits and clearances from the ministry on DTx before granting public access to citizens. Within these standards, the devices are subject to risk-based classifications that determine whether they are at low risk, known as Class I, or moderate risk, Class II. All DTx are regulated at the national level based on these measures to ensure public safety.  
 
On June 4, the Symposium for Evaluating the Need for AI Medical Diagnosis Tools was held by Min Hyung-bae, a member of the National Assembly. Many Korean industry and medicine experts participated in the conference, including Dr. Yang Seung-bu from Nowon Eulji Medical Center and Oh Jun-ho, CEO of Otom, an AI software and X-ray company. Several benefits of DTx were discussed at the conference.
 
Dr. Yang said that AI can effectively assist in the field of radiology by efficiently managing the huge amount of radiology data collected daily, such as patient X-ray photos. This aids radiology staff by helping their work process flow more efficiently. He criticized the current policies in Korea, which, he says, “fail to keep up with the rapidly developing AI technologies.”
 
Otom CEO Oh mentioned that “Korea’s regulations regarding medical technologies are too strict, and that they are failing the domestic production of medical technologies.” He added that “by loosening the regulations, Korea could take control of the AI diagnosis technologies.”
 
The Food Ministry’s 2024 policy report shows that the Korean government has acquired 2.34 billion won ($1.59 million) to support the development of medical technologies, such as DTx.
 
Patients also benefit from DTx. The Korea Health Industry Development Institute (KHIDI) published the “KHIDI Brief,” featuring the results of clinical trials for ministry-approved DTx technologies. The report highlights a software called WELT-I, which was implemented as a mobile application that performs personalized cognitive therapy based on a patient’s sleep patterns. It proved effective in significantly improving the sleep efficiency of 120 insomnia patients.
 
However, these technologies now pose controversy, as barriers to the implementation of digital media devices exist, with a considerable portion of the industry desiring less strict regulation standards for DTx.  
 
Many health care facilities lack experts who can understand and apply the technologies to eligible patients.  
 
Prof. Kim Yoo-Shin from the Department of Sports Medicine at Cheongju University mentioned, "Even if we leave aside the performance of DTx devices as an area to be proven in the future, it is unclear whether the manpower to operate them will be realistically available,” according to HIT News.  
 
Elderly patients are often diagnosed with diseases that require long-term management and the use of unfamiliar technologies. If the intended users cannot effectively interact with digital therapeutics, the effectiveness of DTx is inevitably diminished.  
 
Another critical issue involves software stability and data privacy. DTx uses the private health data of individuals in Korea, which is protected strictly under the Personal Information Protection Act. Such use of information requires explicit informed consent from patients.  
 
“When using DTx, all software functional management measures, such as software stability and security and related regulations, such as clinical trials and medical laws, must be considered,” said Lee Byeong-il, CEO of health care company Doc.On.
 
Aside from Korea’s dilemma regarding DTx use, foreign countries have clear regulations for using DTx and privacy. Considering that DTx depend on the collection of personal data and processing, concerns regarding data leakage and privacy have become apparent.  
 
European countries acknowledge three negative impacts of DTx on data protection, according to the European Data Protection Supervisor (EDPS).  
 
The perpetual gathering of personal information is its primary concern. Critics question the ethics of continued patient information updates, as they create an environment similar to constant surveillance. The possibility of repurposing the personal information also raises concern.  
 
The EDPS also points out privacy infringement by gathering personal information about patients.  
 
The intricacy of the DTx system may lead to security problems where the information can be accessed by strangers or third-party organizations. The information can be transferred from device to device and from system to system, which may lead to data leakage or illicit access.  
 
The EDPS says DTx will have no positive impact on digital security, which puts emphasis on the need to regulate DTx. According to the Digital Therapeutic Alliance, Germany has been striving to regulate privacy regarding DTx.  
 
The Digital Health Applications Ordinance, the DTx regulation guide provided by Germany, illustrates this by covering data protection measures and digital safety. Other countries’ concerns regarding privacy are evident, yet they pose strong regulations and restrictions to control DTx.  
 
The Korean government also strives to protect personal privacy by acquiring the patient’s consent regarding the usage of personal information, according to Medipana.
 
Further action and regulations surrounding DTx are expected from the government.  
 
The Food Ministry is developing a DTx privacy policy for implementation in 2025.

BY DANU KIM, HYEIN LEE, RIYE KIM, YU-AN JEON [[email protected], [email protected], [email protected], [email protected]]
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