Smart Healthcare Forum: Urgent Need for Amendments to Healthcare Medical Device Laws

It is pointed out that the 'smart healthcare' industry, one of the promising businesses of the Fourth Industrial Revolution era, remains stagnant due to being held back by domestic laws and regulations and insufficient standardization.

At the forum on 'Response Measures for the Healthcare Industry to Prepare for the 4th Industrial Revolution,' held on the 12th and hosted by the Korea u-Health Association and the Korea Testing Laboratory, participants voiced a consensus that legal systems must be improved and the market expanded through private sector leadership to expand smart healthcare services.

In the presentations preceding the discussion, Attorney Koo Tae-eon of Tech & Law spoke about the current framework of the Health Information Protection Act and the issues regarding legal and institutional improvements needed to expand healthcare services, while Professor Shin Soo-yong of the Department of Computer Engineering at Kyung Hee University introduced the 'Standardization Roadmap for Healthcare Artificial Intelligence.' At the event, Professor Shin emphasized the importance of standardization, stating, “We need to combine the healthcare data we possess, and to do so, standardization is essential. We must unify data storage methods and make them publicly available.”

During the expert panel discussion, a more in-depth discussion took place regarding the obstacles hindering the revitalization of the smart healthcare industry.

Voices were reiterated emphasizing that legal frameworks and technical standards must be resolved for healthcare technology to create new markets. Attorney Gu pointed out that the government's policy to eliminate regulations is merely lip service. He noted that while legal and technical experts should collaborate to research how to modify regulations, such efforts have not been consistently made. He urged that countermeasures must be devised jointly by the public and private sectors, as government-led efforts alone are insufficient to keep pace with technological advancements.

The issue of standardization has also come under scrutiny again. Professor Shin emphasized that standards are a matter of how data is handled. He noted that standards are not being used because data cannot be shared within the domestic medical system, and viewed it as the government's role to "ensure compliance with standards." The problem is that there are as many as five or six healthcare committees, making it chaotic, and since each ministry proceeds independently, it is difficult to share information with one another. It has also been argued that due to such strict regulations and insufficient standardization, it is difficult for B2C (Business to Consumer) to thrive in the healthcare sector.

Hong Seung-yong, Vice President of Neofect, expressed the difficulties of the domestic B2C healthcare market. He pointed out the reality that while it is legal for physical therapists and rehabilitation therapists to provide home visits in the United States, medical practice in Korea is illegal outside of hospitals because therapists are subordinate to doctors. Furthermore, he noted that due to privacy concerns regarding personal medical information, it is difficult to access and utilize accumulated patient data in Korea. For these reasons, he stated that despite being a domestically based company, they have no choice but to apply their services to the U.S. first and then seek market opportunities there.

Professor Shin argued, speaking on the premise that this is his personal opinion, that it is appropriate to abandon B2C in the medical field in Korea due to the Medical Act. To make this possible, we must move toward B2B2C, but there is another obstacle. Since it takes 3 to 4 years to obtain certification, one inevitably misses the timing for market launch.

Vice President Hong also agreed that doing so in Korea would not be easy. He suggested a solution, stating that too much influence in healthcare is currently concentrated in doctors and that the power held by doctors must be transferred to private companies.

Fortunately, there is a hopeful atmosphere regarding the fact that many regulations surrounding artificial intelligence have been relaxed following the Go match between Lee Sedol and AlphaGo last year, as interest in the field has grown. For instance, medical data can be collected and used with individual consent, and the scope of utilization expands even further if the cloud storage for this data is located in Korea. Opinions were also expressed that large corporations, rather than startups, should take the lead in establishing precedents for the healthcare business.

As the fact that the new government is putting the Fourth Industrial Revolution at the forefront is also being seen as a positive sign, more attention is being focused on solutions for smart healthcare regulations.