Demonstration of Clinical Data Managing System Using Blockchain Technology

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TOKYO–(BUSINESS WIRE)–Apr 22, 2019–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

*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.

*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

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Taro Ueno, Representative Director/Doctor



SOURCE: Susmed, Inc.

Copyright Business Wire 2019.

PUB: 04/22/2019 03:36 AM/DISC: 04/22/2019 03:36 AM

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