Rep. Kwon Chil-seung of the Democratic Party of Korea introduced a bill Monday that provides a legal basis for using the medical data of deceased patients.
Kwon said he was the lead sponsor of a proposed act on promoting digital healthcare and supporting the use of health and medical information. The bill elevates the issue of using deceased patients' health and medical information to law, establishing a clear legal basis, and includes provisions to designate a "secondary utilization support body" dedicated to the practical research use of such data.
While the medical data of deceased patients is usefully applied in areas such as verifying the effects and limitations of new drugs, critics have noted that its use in Korea has been difficult due to barriers under the Medical Service Act, the Bioethics Act, and the Personal Information Protection Act.
Kwon has taken a leading role in related activities to improve regulations that hinder the growth of the digital healthcare industry. Through the "Strategic Meeting on Rationalizing Core Regulations" presided over by President Lee Jae-myung last year and during parliamentary questioning of the government, he proposed the need for institutional improvements to enable the use of deceased patients' medical data.
The bill also directly defines in law the operational basis for "non-medical digital healthcare services," which until now had relied on the regulatory sandbox. Companies that had been pursuing their businesses through exception clauses are expected to secure legal predictability.
"For the digital healthcare industry to establish itself as a key future growth engine, guidelines or fundamental legislation on the 'use of deceased patients' medical data' and 'non-medical digital healthcare services' are urgently needed," Kwon said. "Through this bill, I will focus on resolving bottlenecks in industry development and creating a predictable innovation ecosystem."
Meanwhile, Kwon's office held a "National Assembly Seminar on Legislative Directions for Promoting Digital Healthcare and Utilizing Health and Medical Data" that day at the National Assembly Members' Office Building, together with the Cross-Ministerial Integrated Healthcare Association and the Korea AI Medical Healthcare Research Institute, discussing effective legislative directions.
