Lunit to join U.S. project on regulatory standards for digital healthcare

[Courtesy of Lunit]

South Korean medical AI startup Lunit Inc. will join a U.S. regulatory program to develop a guideline for novel digital health products (DHPs).

According to sources familiar with the healthcare industry on Wednesday, Lunit has been selected as one of the organizations joining the Integrated Evidence Plans (IEP), a project led by the U.S. Digital Medicine Society (DiMe) to align best practices between regulatory requirements and decision-making with downstream payers and purchasers.

Lunit is the only Korean company on the list of participants.

DiMe, established in 2019, is a non-profit organization that conducts various research on digital healthcare and develops clinical solutions.

Digital health companies have had difficulties proving the safety of their products due to the lack of evidence for DHPs, forcing them to rely on the existing regulatory requirements for medicines instead.

According to Lunit officials, the project aims to streamline the pathways to successful commercialization of high-value, evidence-based digital health products.

The IEP project will be joined by the U.S. government agencies, both healthcare and regulatory, including the Food and Drug Administration (FDA) and the U.S. Centers for Medicare & Medicaid Services (CMS), in addition to global pharmaceutical companies such as Takeda Pharmaceutical Co. and Genentech Inc.