Points of View Utilization of Data Obtained in Daily Life ～The Living Lab's Approach

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Yasuhiko Nakatsuka, Senior Researcher, National Institute of Biomedical Innovation Policy

1. Introduction

In parallel with the technological evolution of the IoT, the evolution of communication technology, the development of communication environments, and the spread of SNS have led to the realization of mechanisms for the constant collection of biometric-related information from mobile and wearable devices and sensors, as well as the real-time collection of consumers' emotions and thoughts. Against this backdrop, during the COVID-19 infection epidemic, efforts to advance and streamline clinical trials using technology and solutions, such as the use of mobile and wearable devices and online medical care, began to make rapid progress.

In addition to genomic and omics data and electronic medical records obtained mainly at medical institutions and research institutes, the use of data obtained outside of medical institutions is also attracting increasing attention as data that can be obtained through such technological advances. For example, data from various health checkups, maternal and child health handbooks, vaccination records, etc., activity, sleep, QOL, and other data obtained by mobile applications, wearable devices, etc., as well as data posted on SNS, weather, temperature, OTC drug purchase records, and so on. Furthermore, there is a movement to utilize such data from non-medical institutions alone or in combination with data from medical ^{institutions1)}.

However, as the paradigm shift from "physician-led medicine" to "patient-centered medicine" ^progresses2), the need for a more detailed understanding of the patient's condition is increasing. 2) The need for a more detailed understanding of the patient's condition is increasing. Data from digital devices enables the collection of patient data in real time. As it becomes possible to obtain such data on patients in their daily lives, it is expected that it will also become possible to collect and analyze data that is more relevant to patients' real lives than the data obtained from medical institutions in clinical trials. In addition, it is expected that an environment will be created in which PHR (Personal Health Record) can be obtained not only from patients suffering from diseases but also from healthy people (citizens).

This paper discusses the Living Lab, an innovation activity involving users, as a proposal for how to establish contacts with citizens and how to utilize PHRs.

What is a Living Lab?

Living Labs began in the U.S. in the early 1990s and have been rapidly expanding since 2000, especially in the Nordic countries (e.g., Finland). In Europe, a network organization of living labs called the European Net Work of Living Labs (ENoLL) ³⁾ has been established, and as of September 2020, there are more than 150 living labs registered with ENoLL ^worldwide4), as shown in 2015, The countries with Living Labs registered with ENoLL are shown in Figure 1.

It can be seen that the countries with Living Labs registered with ENoLL are not only in Europe, but also in various other regions such as the United States, China, and India. In Japan, such places have already been created in various regions.

Living Labs are not only for users (citizens), but also for companies seeking to develop services, local governments and NPOs seeking to solve regional issues, universities and other research institutions conducting regional research, and a variety of other stakeholders. The percentage of Living Labs affiliated with ENoLL is as shown in Figure 2: universities (37%), research institutions (33%), government (7%), and corporations (23%).

The areas of activity of living labs were also reported in 2015 in a survey of living labs that are members of ENoLL. (Figure 3)

Health & Wellness was the most common area of activity at 52%, followed by Social Innovation (41%), Social Inclusion (39%), Smart Cities (33%), and Energy (20%). Health & Wellness is mainly for activities to improve the health care and lives of the elderly, while Social Innovation is aimed at commercialization of solutions to social problems on an ongoing basis. Currently, living labs tend to have the objective of solving local issues through the participation of users (citizens) rather than through the development of new products and services by companies.

There are several types of Living Lab activities, and this paper refers to five ^types5).

In the pharmaceutical industry, it is assumed that the cases (2) and (3) are of the type (2) and (3), where mobile devices and ICT technologies are tested to acquire and utilize various data on patients and consumers. For example, although the Living Lab name is not used, Pfizer and IBM are working in 2016 to understand the movements of Parkinson's disease patients in their homes and verify the effectiveness of therapeutic drugs. Inside the installed homes, from refrigerator handles and kitchen cupboards to chairs and beds, sensors that respond to subtle changes in patient movement, a key indicator of Parkinson's disease, will be installed to collect patient data in real time and monitor disease symptoms 24 hours a day. This initiative is testing whether the progression of Parkinson's disease and the efficacy of pharmaceuticals can be evaluated by analyzing data collected in real time in line with daily ^life6). This activity is similar to the type of (2).

3. Living Lab: Overseas Activities

In the Nordic city of Copenhagen, Denmark, with the background of academia such as the Technical University of Denmark (DTU) and the University of Copenhagen, and life science and healthcare-related clusters ^{such as} Medicon ^Valley7) and the Copenhagen Health Tech ^Cluster8), TestBed and Health There are many living labs specializing in TestBed and health tech innovation.

The "Living Healthtech Lab " ⁹⁾ is a collaboration of these living lab facilities in Copenhagen, and is an attempt to create innovation by involving citizens with high IT literacy in a test hub that combines personal registry (electronic health data), remote and home healthcare, e-health, etc. The city of Odense, also in Denmark, is trying to create innovation through the participation of citizens with high IT literacy.

The city of Odense, Denmark, is also promoting the implementation of CoLab, a living laboratory involving universities, businesses, and local residents. The city is planning to construct a large new hospital, which is expected to employ many new technologies related to healthcare and welfare, and the CoLab is a place to explore the technologies and services required in this new healthcare setting. Here, demonstrations of medical equipment and IoT devices are being ^conducted10).

In addition, three Nordic cities, Copenhagen, Helsinki, and Reykjavik, are participating in the Nordic Business and Living Lab Alliance, which aims to consolidate a strong network of living labs in the Nordic region specializing in the elderly and health and wellbeing ⁽ An international collaboration of living labs in the healthcare field is also ^underway11).

4. Living Lab: Activities in Japan

11) One of the domestic activities in the healthcare field is the "AIST Living Lab," an initiative of the National Institute of Advanced Industrial Science and Technology (AIST). The "AIST Living Lab" is conducting demonstration experiments to support the daily lives of people with functional changes in their daily lives by using artificial intelligence technologies such as (1) observation technology to clarify problems, (2) monitoring support technology, and (3) life system design support technology. The project is internationally unparalleled, seamlessly linking basic research that develops and verifies technologies in virtual experiments and virtual environments that simulate actual sites, to demonstration research that supports verification and effectiveness evaluation (impact evaluation) in actual environments in collaboration with sites such as nursing care facilities and hospitals, as well as actual communities. A living laboratory environment has been established.

Similarly, AIST's "Kashiwa Living Lab" has a simulated living environment including a kitchen, bath, and toilet, as well as an artificial climate control room where temperature and humidity can be adjusted. We are working on the safety, effectiveness, and performance evaluation of robots through providing development support to many manufacturers in projects to develop and introduce robotic nursing care devices. In order to gather diverse opinions, workshops are held with the participation of caregivers and residents in the Kashiwa area, in addition to caregiver robot ^{researchers12)}.

As a mechanism for bringing innovation to a wide variety of stakeholders, activities such as the Hirosaki University Center of Innovation Program (COI) can be viewed as similar to the Living Lab.

Hirosaki University COI is constructing a super-multiple-item health big data set of approximately 2,000 items against the backdrop of regional characteristics as a challenge area for healthy longevity, identifying disease risk factors for lifestyle-related diseases and dementia, developing disease prediction algorithms, and developing optimal prevention and support systems. This includes molecular biological data such as genome, physiological and biochemical data such as blood tests, personal life activity data such as sleep, diet, and smoking, and social environmental data such as working environment and economic power. Data on these very large test items have been accumulated over 14 years (total of 20,000 people) with the cooperation of approximately 1,000 community residents each year. Numerous companies in the pharmaceutical, medical device, food, healthcare, and insurance industries participate in this COI as collaborators, and the COI provides an opportunity for companies to incorporate additional items they wish to measure into the health checkups and to examine their relationship with other items1).

5. Advantages and disadvantages of Living Labs

Living Lab activities are being conducted in various regions, including Japan, and the benefits of working with Living Labs are described for each stakeholder.

On the other hand, there are also disadvantages in utilizing Living Labs. As mentioned above, the Living Lab involves a wide variety of stakeholders. The large number of stakeholders may make it difficult to reach a coherent conclusion. In addition, the information handled by companies often contains confidential information, and it may be difficult to control information leaks, etc. in a living laboratory where citizens participate.

6. Summary

Although we have discussed living lab initiatives thus far, living lab initiatives in the healthcare field are currently limited to health care and nursing care for the elderly. By actively intervening in such efforts, the pharmaceutical industry can go beyond the conventional information obtained from medical institutions to understand the signs of disease and physiological trends (e.g., vital data) of actual consumers, understand their behavior, collect outcome data (including Patient Reported Outcome), and analyze the results of these efforts. ), collection of outcome data (including Patient Reported Outcome), and feedback of the analysis results to the public. The development of IoT devices such as mobile devices and sensors will further accelerate this process.

In the development of ethical drugs, the pharmaceutical industry obtains information on treatment needs and efficacy through treatments provided by medical institutions, clinical trials, and clinical research, and direct contact with individual patients has been rare and unnecessary. However, considering that the pharmaceutical industry will be involved not only in therapeutic approaches but also in all aspects of healthcare for citizens, including preventive and proactive medicine and long-term care, it is necessary to effectively utilize not only patient data in medical institutions but also data on citizens, including healthy people. This will require the effective use of data not only from patients at medical institutions, but also from citizens, including healthy people. In the field of clinical trials, there is already an active movement to acquire data from patients close to their daily lives through the use of ePRO, etc. However, in utilizing data from healthy people, it will be important to consider "utilization of data in line with daily life" using a system such as a living laboratory, where participants (citizens) are highly involved in the research.

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