Korea Plays Catch-Up In Digital Therapeutics
New Deals, Legislation Paving The Way
Executive Summary
Despite its broad connectivity and fast internet speeds, South Korea has been lagging in the adoption of digital therapeutics. But the pandemic situation is highlighting the increasing need to catch up with other areas such as the US and Europe to adopt this burgeoning technology in the healthcare space.
Amendments to the country’s key data privacy laws earlier this year are also making the conditions ripe for more robust development activities. In fact, the government has placed a strategic focus on data, networks and AI in three industries, including biohealth, this year, raising hopes for a growth in data-based digital therapeutics and other innovative medical technologies.
South Korean authorities currently expect to come up with approval and review guidelines and other regulatory frameworks for the area later this year.
Early Alliance For Pear's reSET
As one of the country’s first tangible attempts to adopt new developments, the National Center for Mental Health, which operates under the health ministry, and Welt Corp. have inked an agreement to bring in mental health-related digital therapeutics developed by US prescription digital health product venture Pear Therapeutics, Inc.
The partners are initially seeking to bring in products that have demonstrated safety and efficacy and likely to have high domestic demand, in order to speed up the introduction of such products. Welt, which also focuses on digital healthcare, has developed a smart waist belt intended to lower fall risk in the elderly or infirm. The embedded sensors and algorithms accurately calculate fall risk from abnormal gait patterns and also measure activity and waist size.
Welt is now aiming to bring in Pear's reSET, a software product that received US FDA approval in 2018 for the treatment of substance use disorder, a relapsing condition caused by the recurrent use of alcohol and/or drugs. It was the first software to receive a label to treat any human disease from the US regulator. This June, the Health Science Authority of Singapore also authorized reSET for the same indication.
The digital therapeutic is used as a 12-week (90-day) prescription treatment in conjunction with out-patient, clinician-delivered care. reSET offers interactive treatment modules that deliver cognitive behavioral therapy, fluency training to reinforce proficiency and contingency management, all of which can be useful in treating the disorder.
Within a digital dashboard, clinicians can follow patient-reported substance use, cravings and triggers, to facilitate transparency and encourage deeper interaction with patients at face-to-face meetings.
Higher Demand For 'Untact' Healthcare
“Demand for 'untact' [non-personal contact] treatment and healthcare methods is rising, rather than traditional face-to-face methods, because of the prolonged COVID-19 situation,” explained Young Moon Lee, president of National Center for Mental Health. “Continuous management is crucial in mental health. We hope the latest collaboration will largely help preventing and managing the nation’s mental health in this difficult era.”
Through the alliance, the center says it is aiming for a leading role in becoming the foundation and test bed for the introduction of digital therapeutics in the mental health area, in line with global trends.
Welt CEO Seong-Ji Kang said that “development of digital healthcare technology and market entry are accelerating worldwide. In particular, a substantial number of digital therapeutics are being developed and launched for the treatment of mental diseases and their efficacy is being verified.”
The products can be broadly divided into two approaches – medication replacement or as a complement to conventional therapeutics. Digital therapeutics have so far been developed or launched largely for chronic disorders such as diabetes and asthma, as well as various neurological diseases.
Among South Korean companies already developing pipeline digital therapeutics, LifeSemantics is progressing products for the management of cancer and stroke in the form of mobile and web apps, while Welt has begun to develop a product for sarcopenia
Boost From Privacy Law Amendments?
Meanwhile, the passage of amendments to data privacy laws in South Korea early this year is enabling the digital healthcare industry to speed up development activities.
The National Assembly passed the amendments to the three main laws on the topic - the Personal Information Protection Act, the Act on the Promotion of the Use of the Information Network and Information Protection, and the Credit Information Use and Protection Act. The changes clearly distinguished personal data, pseudonymized data and anonymized data and enacted detailed provisions on the processing of pseudonymized data.
The Korean Pharmaceutical And Bio-Pharma Manufacturers Association noted that the country’s health and medical big data initiatives have been blocked by the "excessive" protection of personal information, and saw the change in the privacy laws as a turning point for healthcare innovation that will bring forward an era of new drug development using big data and AI, as well as customized precision medicine.
The global digital therapeutics market is still in the early stages, and South Korea has only just begun to develop its own products, with relevant regulations still needing to be enacted.
Need To Resolve Grey Zones Amid Growth
Some forecasts see the global digital therapeutics market growing by an annual average of 20-30%, thanks to regulatory improvements and policy support in individual countries. The South Korean market is also expected to grow sharply from next year, backed by regulatory support as well as social and economic need.
The country is preparing for a tailor-made regulatory system to implement a revised medical device law, according to a report by the Korea Evaluation Institute of Industrial Technology.
To introduce digital therapeutics in South Korea, the report suggested it is necessary to resolve "grey zones", such as the need to establish a clear concept and definition of digital therapeutics, verify clinical efficacy, establish a regulatory system that meets the technological characteristics, and build a clear medical charges system.
The country must preemptively come up with rules to enable rapid approvals and the clinical development of products to gear up for potential rapid growth in the sector, the institute recommended.