[헬스코리아뉴스 / 박민주] As the digitalization of medical care is rapidly progressing due to COVID-19, Digital Therapeutics (DTx) is rapidly growing and attracting attention as a new paradigm for the next-generation medical market.
According to the Global Health Industry Trend No. 409 published by the Korea Health Industry Development Institute, software medical devices are products for the purpose of diagnosis, treatment, prevention and relief based on evidence. It is called ‘digital therapy’ (DTx).
Unlike health promotion apps for general consumers, AI-based diagnostic support, and online medical apps, DTx directly ‘treats’ patients, so the effectiveness of treatment intervention must be proven, and approval or insurance as a medical device It should be developed taking into account the application, etc.
DTx has a therapeutic effect through a new digital action that cannot be realized with only chemical and physical actions. It is characterized by relatively easy data collection and analysis and the ability to improve functions through data aggregation and SW update. △Improvement of treatment effect through individualized continuous intervention △Contribute to individual optimization of treatment effects such as obtaining and understanding patient information, △Reducing burden on doctors and △Reducing costs such as economic effect of medical care.
Through digital treatment, the patient’s daily data can be acquired and the precision of treatment can also be improved. In addition, it has the advantage of being able to establish a medical care system that allows patients to receive appropriate medical care without having to visit the hospital every time during the COVID-19 situation.
The application of DTx in the actual medical field is expected to be soon, so the issue of insurance benefit application is also emerging as a hot topic. Japan, the United Kingdom, Germany, etc. set up policies according to the circumstances of each country, and apply insurance benefits to some products.
JapanWhile the elderly population is increasing, the working-age population is decreasing. Based on the current estimate of the number of employed people in the medical welfare field, it is likely that the medical demand may not be sufficiently met in 2040. Accordingly, there is a need for a medical care system that can respond to the increase in medical demand due to an aging population.
In relation to digital therapeutics, the Japanese government stated in its health and medical strategy announced in March last year that it will continue to review pharmacist regulation methods, including evaluation methods, when reviewing medical device programs using advanced technologies such as AI. In the growth strategy action plan announced in June, it was mentioned that ‘the overall review system will be reviewed to promote the development and commercialization of medical devices, such as therapeutic apps, and to improve the predictability of developing companies’.
In Japan, CureApp’s ‘CureApp SC nicotine addiction treatment app and CO checker’ was approved for the first time in Japan in November last year, and insurance benefits are being applied for the first time.
Englandprovides information on ‘standard evidence’ and ‘how the National Medical Technology Evaluation Organization (NICE) will determine the insurance coverage of a therapeutic app through the National Health Service (NHS).’ From the point of view of development and evaluation of therapeutic apps, the NHS and NICE have come up with measures to enhance the effectiveness of guidance through mutual linkage.
The UK Ministry of Health published an appropriate guide for digital and data health technology in January, and evaluated △convenience △ ethical principles for data use △ product value △ technology assurance △ clinical safety △ data safety △ data management and protection △ cyber security. We have secured a timing and legal guidance.
UK NICE is in the process of establishing the Medical Technology Evaluation Program (MTEP), and the UK Medicines and Healthcare Products Regulatory Authority (MHRA) has issued guidance to comply with the definition and legal requirements of a SW app medical device that performs a single function in 2014. , and was updated this year.
Germanyis applying a fast-track system for therapeutic apps. If the registration requirements are met, the applied application within 3 months of application is registered in the national DB as a prescribeable therapeutic application, and the insurance price is also determined.
The system is highly predictable because companies can determine the price in the first year. Even if there is insufficient evidence of clinical effect at the time of application, temporary registration is possible if certain requirements are met. It is characterized by the ability to collect evidence and reapply after insurance is applied.
The application of Germany’s fast-track system also includes device-less therapeutic apps. Multiple sclerosis malaise app, depression treatment app, insomnia treatment app, and anxiety disorder app have been registered.
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