Susmed, Inc., hereinafter referred to as “Susmed”*1, is a
Japanese leading digital therapeutics startup and is focusing on the
research and development of smartphone applications as software medical
devices for treatment of diseases such as insomnia. It today announced
that “Regulatory Sandbox System”*2, pilot projects led by
Japanese government, on the “Demonstration of Clinical Data Monitoring
System Using Blockchain Technology”, hereinafter referred to as “the
pilot project”, has been certified by the Ministry of Health, Labor, and
Welfare and the Minister of Economy, Trade and Industry.
Susmed is developing a Clinical Data Managing System, hereinafter
referred to as “the system”*3, leveraging its
experience in developing smartphone treatment applications as software
medical devices. In addition to functioning as a platform system for
smartphone application for treatment of various diseases, this system
will implement the blockchain technology that has been extensively
researched and developed by Susmed, enabling the system to reliably
secure quality data for clinical development. This will radically reform
current labor-intensive monitoring operations and streamline clinical
development while contributing to the sustainability of social security.
In this pilot project, the system uses blockchain technology, which is
expected to be more cost-effective than conventional methods in
monitoring of clinical researches and ensuring data accuracy during
monitoring. In collaboration with the National Cancer Research Center,
Susmed will conduct a clinical research to develop an exercise program
that promotes behavioral change for cancer survivors who do not
habitually exercise. Through this pilot project, they aim to prove that
the reliability of data can be ensured even if monitors do not visit to
check the source data and the report material.
Research title: Effect of home-based high intensity intermittent
training and behavioral modification using information and communication
technology on cardiorespiratory fitness and exercise habits among
sedentary breast cancer survivors: habit-B study protocol for a
randomized controlled trial
*1 About Susmed
Susmed aims to find solutions that match IoT
technology to medical needs, striving to achieve sustainable medical
care at an affordable cost for society while ensuring that we secure
quality medical care. Medical treatment with IoT is expected to
contribute to the sustainability of social security costs and the
improvement of productivity, and these developments in medical devices
are facilitated through dialogues between doctors and engineers. For
more information, visit us at https://www.susmed.co.jp/en
*2 About New Technology Pilot Project “Regulatory Sandbox System”
In
order to promote business activities using new technologies and business
models based on the Productivity Improvement Special Measures Act, which
came into effect on June 6, 2018, Japanese government started to lead
the “New Technology Demonstration System”, so-called ” Regulatory
Sandbox System “. In this system, prompt demonstrations can be enabled
through limiting duration and participants, as well as preparing an
environment where demonstrations of new technologies can be conducted
without being subject to the application of existing regulations. This
is a system that promotes regulatory reform by making it possible to
actually utilize the information and materials obtained in the
demonstration.
http://www.kantei.go.jp/jp/singi/keizaisaisei/regulatorysandbox.html
*3 Background on Clinical Development Support System Development using
Blockchain Technology
In clinical development since the
implementation of Good Clinical Practice, GCP, in 1998, outsourcing
costs to contracted development agencies such as the CRO (Contract
Research Organization) or SMO (Site Management Organization) have
continued to increase. In order to ensure the quality and reliability of
data in clinical trials, the cost of monitoring work has also increased,
and the cost of development has increased due to the costs of the direct
review of raw materials. This is expected to further increase the cost
of clinical development, which may lead to delays in clinical
development. In order to address these problems, Susmed is developing
this new system using blockchain technology. In addition, it conducts
research and development by applying this system to mobile medical
treatment, along with obtaining multiple related patents and publishing
papers in international medical journals (see below). The efficiency of
clinical development reduces the costs of developing new medical
technologies and creates an ecosystem through increase on products of
pipelines of pharmaceutical companies and medical startup companies.
Through these steps it can reduce the high costs of new medical
technology and contribute to the balance between sustainable social
security costs and technological innovation.
Published Paper: Tamper-Resistant Mobile Health Using Blockchain
Technology
Ichikawa et al., JMIR mHealth uHealth 2017 https://www.ncbi.nlm.nih.gov/pubmed/28747296
View source version on businesswire.com: https://www.businesswire.com/news/home/20190422005269/en/