There was a consensus that healthcare data should be used more actively. However, differences remained over the process and methods. Experts who called for easing regulations clashed with those who advocated strengthening safety to prevent the leak of personal information. To build high-quality medical data in the medical field, some participants stressed the need to clarify the rights and roles of medical professionals and institutions and establish a compensation system.
A heated debate over how to utilize medical data occurred at the “Digital Healthcare Act Discussion” held by the Ministry of Health and Welfare and the Korea Healthcare Industry Development Institute at the Glad Hotel in Yeouido, Seoul, on Wednesday. While the event was designed to discuss the overall content of the Digital Healthcare Act introduced by Rep. Kang Ki-yoon of the People Power Party last October, the focus was on medical data. Rep. Kang and Rep. Koh Young-in of the Democratic Party of Korea co-hosted the debate.
Does Korea have high-quality medical data?
Professor Choi Byung-kwan, a neurosurgeon and the head of the Center for Medical Information and Computerization at Pusan National University Hospital, said that Apple, in partnership with Johns Hopkins Hospital, launched "Health Kit" in 2018, which works in connection with electronic medical records (EMRs). Still, it did not gain traction, showing the limitations of utilizing medical data.
"We can secure medical data, but we lack the technology to process and commercially utilize such huge medical data," Choi said. "To analyze and utilize medical data commercially, we need their standardization, but medical data in hospitals is not standardized."
Others pointed out that there is a lack of discussion on how to build quality medical data. Although medical data accumulates in the health insurance system, it is not the "quality data" the government and industry want.
"Korea is discussing how to utilize medical data under the assumption that the IT technology infrastructure is advanced and quality medical data exists," said Kim Chung-ki, director for policy at the Korean Medical Association. "We need to recognize the reality correctly."
Most medical institutions in Korea use EMRs and transmit medical data to the National Health Insurance Service or the Health Insurance Review and Assessment Service. So, data is accumulating, but their connectivity and systematicity are not high, Kim noted. He added that it is difficult to say it has high efficiency when trying to use it in practice.
He said that the roles and rights of doctors and medical institutions as producers of medical data should be clarified to improve this. Moreover, "compensation and support" measures should be discussed together so that doctors and medical institutions can actively participate in building standardized medical data.
Kim Sang-il, chairman of the Future Healthcare Committee of the Korean Hospital Association, agreed. He said the medical community is "willing to actively cooperate for the use of medical data instead of unconditionally opposing it or expressing concerns about it." However, there is a lot of resistance because the government does not recognize their rights.
"The Digital Healthcare Act deals with the subject of medical data by limiting their subjects to individuals while only stipulating and emphasizing the duties and responsibilities of medical institutions as data holding organizations," Kim said. "The problem with the Digital Healthcare Act is that it rarely specifies the definition, rights, and powers of organizations that generate and possess medical data.”
Kim stressed that the authority and rights of medical institutions as medical data production entities should be specified. Only the transmission cost is specified, but there is no additional compensation for data generation, extraction, management, manpower, facilities, and equipment, so it needs to be supplemented.
There were also opinions that the Ministry of Health and Welfare should take the lead in operating a regulatory sandbox specialized for the biohealth sector, including digital healthcare.
"The regulatory sandbox in the bio sector can be effectively operated if the health and welfare ministry runs it based on its expertise," said Jung Myung-jin, a professor at the Korea Advanced Institute of Science and Technology (KAIST) Graduate School of Bio-Innovation Management. "There are many opinions that the ministry should prioritize the removal of regulations and ease them in a top-down manner."
Concerns remain over personal information leakage
Jung Ji-yeon, secretary general of the Voice for Consumers, emphasized the right of consumers to have their medical data corrected and deleted.
"Consumers should have the right to stop providing information and demand its destruction due to their change of mind, accident, or death," she said. "The current bill allows for destruction, but there is no way to check whether it has been destroyed. This should be monitored."
Consumers are concerned about the damage caused by sensitive medical data leaks. She noted that they are also concerned about the damage caused by the leakage of sensitive medical data.
"There should be a section in the bill that can technically solve and authenticate these problems,” Jung added.
Ahn Ki-jong, president of the Korea Alliance of Patient Organizations, said obtaining consent to use medical data should be patient-friendly. The consent process should be designed for patients, "using clear and plain language in an easy-to-understand format," he said.
Jung Hyung-jun, chief policymaker of the Korean Federation of Medical Activist Groups for Health Rights, was negative about enacting the Digital Healthcare Act, saying that the digital healthcare industry cannot be promoted by deregulation.
"There is no point in allowing digital healthcare-related technologies to be evaluated differently from existing medical technologies by including temporary permits and demonstration exceptions in the bill," he said. "They will not be certified overseas anyway. I don't see much benefit in introducing them through deregulation."