Explanation of the 'Digital Medical Products Act' for pharmaceutical industry practitioners... Background and significance of enactment

Attorney Lee Il-hyung of Daeryun Law Firm, “Evaluation of the Digital Medical Products Act as legislation that well reflects the trends of the times.”
“We cannot neglect the development of digital medical products...a country that falls behind the trend of the times and loses corporate competitiveness.”

In January of last year, the world's first ‘Digital Medical Products Act’ was enacted and went into full effect in January of this year, attracting keen industry interest. The reason for enacting this law is related to the emergence of the digital therapeutics and digital medical device software markets.

According to the Ministry of Food and Drug Safety, digital therapeutics (commonly referred to as DTx and, despite its name, are subject to the Medical Device Act in Korea) refer to ‘software medical devices that provide evidence-based therapeutic intervention to patients to prevent, manage or treat medical disorders or diseases.’ In other words, unlike simple health management apps, digital therapeutics refer to software with proven disease treatment effects. In fact, some digital therapeutics are classified as medical devices that require a doctor's prescription.

The digital therapy market began to bloom in earnest in 2017 when the U.S. FDA approved ‘reSET’, an application for treating drug and alcohol addiction, as the world’s first digital therapy. Since then, in 2020, Akili Interactive’s ‘EndeavorRx’ and Pear Therapeutics’ ‘Somryst’ have received FDA approval, and this market continues to attract attention. In Korea, ‘Somzz’ developed by Aimmed was approved for the first time in February 2023.

When explaining digital therapeutics using ‘EndeavorRx’ as an example, in this game, players must control a spaceship during several stages to perform various tasks such as finding collectibles or catching animals. This game encourages children and patients with ADHD to improve their multitasking ability by repeating tasks that require concentration. ‘EndeavorRx’ was proven to be effective in improving ADHD symptoms as a result of actual clinical trials, and its status as a treatment was recognized.

Meanwhile, digital medical device software began to receive attention in earnest after the IMDRF proposed the concept of ‘SaMD (Software as a Medical Device)’ in 2013.

The Digital Medical Products Act defines ‘digital medical device software’ as software that forms part of a digital medical device or is itself a digital medical device, and is divided into ‘independent software’ and ‘dependent software’. However, in practice, when we think of ‘digital medical device software’, we tend to think of ‘standalone software’ first.

Diagnostic assistance software that utilizes images and vital signs continues to be released, and the digital medical device software market continues to attract attention. ‘Lunit’, well known to the general public, is a representative company in this field and is developing ‘detection and diagnosis assistance software’.

As such, the concepts of digital therapeutics, digital medical devices, and digital medical device software have been around for a long time, and they have many characteristics that distinguish them from existing medical devices, so a separate regulatory system was absolutely necessary.

In practice, there were various difficulties and confusion as digital medical products were regulated by the Medical Device Act, which was enacted a long time ago. Meanwhile, as social interest in digital technology rapidly increased after the introduction of AI technologies such as ChatGPT, our government became the first in the world to enact the 'Digital Medical Products Act'.

The recently enacted Digital Medical Products Act was created in consideration of the unique characteristics of ‘digital,’ and is a welcome example of legislation for related companies. The fact that the level of harm to the human body is much lower than that of medical devices, and that it is possible to resolve the situation that hinders industrial development by excessively regulating digital medical products that have characteristics different from medical devices, can be evaluated positively from the manufacturer's perspective.

According to promotional materials and policy briefing materials from the Ministry of Food and Drug Safety regarding the contents of the Digital Medical Product Act, it appears that new regulations such as licensing procedures, quality control systems, clinical trial procedures, and advertising and sales regulations have been prepared to reflect digital characteristics.

If you look at the actual legal provisions, there are many parts that have a unique system that is different from the Medical Device Act or the Pharmaceutical Affairs Act. For example, this law includes component performance evaluation regulations, relaxes regulations so that medical devices can be provided to medical personnel and medical institution workers for actual use evaluation, and also eases GMP inspection. In addition, there are unique regulations unique to the Digital Medical Products Act. Specific details on this will be covered in the following contribution.

Although this is a bit off topic, the contributor also felt that the introduction of ‘digital’ and ‘AI technology’ was an unavoidable trend of the times while using ChatGPT, and came to think that the development of digital medical products could not be neglected. As the contributor, who is a lawyer, is experiencing this trend, practitioners at the forefront of the pharmaceutical industry will be experiencing even more changes and trends.

Countries and companies that fall behind this trend will eventually lose their competitiveness, and the Digital Medical Products Act, which takes effect this year, is evaluated as legislation that well reflects this trend of the times.

I hope that practitioners in pharmaceutical and bio companies will study this law well in the future and create many business opportunities, and I would like to conclude this article.

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