Points of View Ripple Effects of the Utilization of Medical Information

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Natsuko Watanabe, Senior Researcher, Pharmaceuticals and Industrial Policy Research Institute
Hōdai Okada, Senior Researcher, Pharmaceuticals and Industrial Policy Research Institute

SUMMARY

1. Introduction

Modern healthcare is undergoing a major transformation due to advances in information technology and sophistication of data analysis. Diverse medical information, including electronic medical records, genome data, clinical trial data, and data obtained from wearable devices and health apps, is collected in enormous volumes every day and plays an important role in all areas of medicine. Effective utilization of this vast amount of data has the potential to bring about not only innovative changes across the entire healthcare field, but also broad social ripple effects.

In Japan, as the aging of society brings to light issues such as rising healthcare costs, uneven regional distribution of healthcare delivery, and an increasing burden on healthcare workers, there is also a need to utilize data to provide efficient healthcare and improve the quality of healthcare. In order to address these complex and multifaceted issues, there are limits to the conventional operation of decentralized and individually managed data, and it is necessary to utilize a wide range of information through a more integrated data infrastructure. As part of this effort, the construction of a national medical information ^platform1) is currently under consideration in Japan. Since the introduction of such a large-scale system will require technical and institutional challenges and high investment, it is important to evaluate the benefits that these investments will bring to society as a whole, as well as the losses that will result from not implementing such a system.

Looking at developments outside of Japan, the European Health Data Space (EHDS) ²⁾ initiative being promoted by Europe is attracting attention as a leading example. In an impact assessment ^report3) prepared by the European Commission, the social and economic impact of the EHDS was assessed in detail in advance of its introduction, and the economic benefits were converted into monetary terms, indicating that the long-term benefits will exceed the initial investment and operational costs. Similarly in Japan, when establishing a national medical information platform, preliminary impact assessment and estimation of the economic benefits of implementation can serve as a basis for decision-making for policy makers. This will not only show the appropriateness of support for initial investment and operational costs, but also promote the development of appropriate support measures and infrastructure based on this information, thereby promoting the introduction of the platform. In addition, through such evaluations, it is expected that diverse stakeholders will deepen their understanding of the utilization of medical information, and more proactive use of the platform will be encouraged.

This paper introduces part of the EHDS Impact Assessment Report and summarizes the scope and impact on a wider range of stakeholders, not only in the medical field, based on the movement toward the establishment of a national medical information platform in Japan. By doing so, we aim to further promote discussion on the utilization of medical information in Japan and lay the groundwork for future quantitative analysis as we move forward with a comprehensive analysis that includes the challenges and risks associated with its introduction.

2. Ripple Effects of Domestic Medical Information Sharing

Currently, a large-scale national medical information platform is being considered in ^Japan4).

A national medical information platform is "a nationwide platform for sharing and exchanging information on all aspects of medical care (including nursing care), such as immunizations, electronic prescriptions, municipal health checkups, and electronic medical records, in addition to information on receipts, specified medical checkups, etc., by expanding the network of online eligibility verification systems, etc." This is ^a nationwide platform for sharing and exchanging information on all aspects of medical care (including nursing care), such as immunizations, electronic prescriptions, municipal health checkups, electronic medical records, etc., in addition to information on health diagnoses, etc. The publicized concept envisages a medical information infrastructure that shares patient information with other medical institutions, etc., and also links this with a nursing care information infrastructure and administrative and municipal information infrastructure, with a view to secondary use of the information shared on this platform. In order to realize these concepts, initial investments and institutional reforms will be required. This section, as part of the items to be organized to evaluate their appropriateness, will provide a broad overview of the scope of the ripple effects that are expected to occur when a national medical information platform is established and the information is used for secondary purposes in addition to primary uses. This report will organize a wide range of perspectives. For the purpose of organizing the contents that have been reported academically so far, this time we surveyed papers that mention the exchange of medical information among medical institutions (HIE: Health Information Exchange), using multiple search sites or papers cited and cited by each paper. From these, we extracted articles ^{5, 6, 7, 8, and 9)} that mentioned the benefits arising from the primary or secondary use of medical information. Based on the overall organization of the papers based on the content and frequency of the references, it is considered that the majority of the range of possible impacts can be divided into three main areas: "optimization of medical care," "improvement of health and public health," and "promotion of innovation. It should be noted that the scope of impact included in this arrangement is not limited to what can be achieved by sharing medical information alone, and that realization will require not only the establishment of a medical information infrastructure, but also investment in systems, cooperation from each stakeholder, and institutional design for personal information protection and other measures. Based on the organization of related papers, Figure 1 shows the spread of ripple effects that are expected to occur when system investment in medical DX and reform of related regulations, etc., for the utilization of medical information are assumed to proceed in parallel with the establishment of a national medical information platform infrastructure, and the benefits that each stakeholder is expected to enjoy. Table 1 summarizes the benefits expected to be enjoyed by each stakeholder.

First, regarding the optimization of medical care, the major impact can be summarized as the optimization of treatment and diagnosis by the patients themselves who provided the information, mainly through the primary use of information, and the effective allocation of medical cost resources expected from the development of medical technology and personalized medicine through secondary use and the refinement of cost-effectiveness assessment. From the perspective of medical institutions, nursing care providers, and medical personnel, the typical benefits are the reduction of administrative burdens due to the computerization of medical and nursing care records and the formation of an information management infrastructure, the improvement of operational efficiency through the development of IT infrastructure, and the provision of appropriate medical and nursing care services through the analysis of accumulated information. Furthermore, as medical information can be shared with other medical institutions, etc., it is expected to lead to more efficient use of medical resources in regional healthcare and reduction of duplicated tests. The utilization of such medical information is expected to help medical institutions reduce costs and improve profitability, and is expected to lead to the development of an environment in which medical care is provided continuously through synergistic effects with other operational improvements. From the patient's perspective, the medical institutions available in the region will continue to exist along with the benefits that will accrue to the medical institutions and healthcare professionals mentioned above, and it will be possible to continue to receive optimal medical care. In addition, the ability to access one's own health and medical information via MyNa Portal is also expected to lead to a better understanding of one's health status, which will be useful for health management and disease prevention, and to more prompt access to appropriate treatment. From the perspective of payers of health care costs, the increase in information available for the evaluation of medical technology is expected to further promote the economic optimization of medical services by enabling more precise analysis. The increasing social security burden on the working-age population due to the aging of society has become an issue, and if the appropriate allocation of medical expenses becomes possible, it will help to reduce the burden on the citizens who bear the insurance premiums.

Next, with regard to health promotion and improvement of public health, analysis of the accumulated information is expected to lead to detection of trends in disease outbreaks and infectious disease outbreaks, as well as adverse events of pharmaceuticals and medical devices. This would work effectively from the perspective of policy makers, regulators, etc. Based on this information, it would be possible to improve the health of the public, raise awareness of risks, and take countermeasures quickly. Such a national response is fresh in the memory of the need for informed decision-making, such as in the case of the number of people infected with the new type of coronavirus infection and the public funding of vaccines. In the aspect of national crisis management, it would be a great advantage to have a system that enables comprehensive collection of medical information.

Finally, regarding the promotion of innovation, from the perspective of researchers at universities and private companies, the most significant benefit will be easier access to medical information, which used to require enormous amounts of time and effort to obtain. Patient-derived information plays a very important role in life science research, especially in the development of pharmaceuticals and medical devices, and understanding the treatment outcomes and actual use of existing pharmaceuticals and medical devices is extremely important in the development of new products and improvement of existing products. Furthermore, with the recent practical application of artificial intelligence, it is becoming possible to handle larger scale information and derive highly accurate analysis results. Easier access to such information will lead to more accurate conclusions in a shorter period of time, and will enable the early introduction of new drugs and medical devices to the market. Another benefit to the public will be that the availability of Japanese information for these studies will lead to development that is more in line with the actual conditions of medical practice in Japan. From the perspective of holders of existing information for research, such as disease registries and biobanks, if it becomes possible to develop an infrastructure and system that allows linkage with information held by their own organizations, they will be able to use some of the medical information that they have been required to collect entirely by their own organizations from a national infrastructure, leading to an increase in the value of the information held by their own organizations. This will lead to an increase in the value of the information held by the organization, and the number of users is expected to increase. The stabilization of the economic situation of these organizations that collect detailed biological and medical information for research and development purposes will enable them to collect even more information, which is expected to create a more desirable cycle in terms of innovation.

In this way, the system investment in medical DX and the reform of regulations, along with the establishment of a national medical information platform, will not only directly benefit medical institution workers and patients, but will also comprehensively benefit all citizens via a large number of stakeholders, ultimately leading to a great deal of benefit to all citizens. The following section discusses the benefits of a national medical information platform.

3. Utilization of medical information in specific cases

In the previous section, we organized the ripple effects that a national medical information platform could bring by classifying them into three areas: optimization of medical care, improvement of health and public health, and promotion of innovation. These effects are expected to bring a wide range of benefits to Japanese society, but at this stage there are only a limited number of examples in Japan, so we have sought and organized examples of specific ripple effects from overseas. In this chapter, we introduce how the utilization of medical information has brought about results in each of the overseas cases, and discuss the possibility that similar effects can be expected in Japan as well.

(1) Optimization of medical care

Optimization of medical care through the use of medical information brings significant benefits, especially to medical institutions and healthcare professionals. According to a systematic review and meta-analysis of English-language articles conducted at an Italian university on the impact of electronic health records on the quality of medical care, the introduction of electronic health records and other ICTs has, on average, reduced documentation time by 22.4%, improved adherence to guidelines, as well as reported reductions in medication errors and adverse ^events10). In addition, a Massachusetts, U.S., medical institution reported a 10.2% reduction in hospital length of stay due to the introduction of a regional coordination system for electronic ^{information11)}. In the U.S. state of South Carolina, the number of medical institutions implementing regional collaborative systems is increasing, with 82% actually operating such ^systems12). On the other hand, some reports indicate that there is no clear improvement in direct effects on patient outcomes, such as patient mortality and ^morbidity13). This is due to the fact that few studies have directly measured the impact of HIE use in clinical practice, making it difficult to assess causality, and also because the outcomes are diverse, making it difficult to draw consistent conclusions. One of the studies mentioned in this report found significant reductions in readmission rates when medical information was exchanged between single-vendor EHR platforms, while no significant reductions were found when linkages were made between different platforms. Although this is only one example, it suggests that the impact of HIE may be influenced by the form of its introduction and the environment in which it is used. In order to actively introduce these medical information collaboration platforms to medical institutions in Japan in the future, it is necessary to develop specific measures to improve the operations of medical institutions and healthcare professionals and to improve the quality of healthcare without adversely affecting patient outcomes. In order to actively introduce these medical information collaboration infrastructures to medical institutions in Japan, it is necessary to clarify more elaborate arguments regarding specific conditions and methods of introduction, in order to contribute to the improvement of operations of medical institutions and healthcare professionals and the quality of healthcare without adversely affecting patient outcomes.

(2) Improvement of health and public health

The use of medical information also contributes to improving the health and public health of the country as a whole. in introducing the COVID-19 vaccine, Israel made effective use of the digital health infrastructure and unified data management with a single ID that had been in place for 20 years. This enabled the continuous collection of data on vaccination prioritization, vaccine doses, and number of vaccinations, making it the first country in the world to vaccinate the majority of its population. In addition, Clalit, Israel's largest health organization, conducted a large-scale study of 600,000 vaccinated and unvaccinated people each to evaluate the effectiveness of vaccination, and by utilizing a wealth of medical information, was the first in the world to obtain evidence-based research ^results14). Similarly, in the United Kingdom, an NHS-led vaccination program was rolled out nationwide; NHS Digital utilized a system that integrated EHR and health data to continuously monitor vaccination progress, efficacy, and safety. The system automated the management and data collection of vaccination eligibility and ensured that vaccinations across the United Kingdom proceeded quickly and effectively. In addition, studies using NHS data provided important insights into identifying risk factors associated with COVID-19 ^deaths15). These examples demonstrate how important the use of a unified national infrastructure and the collection of information on a large scale is in maximizing the effectiveness of national public health policies and protecting the health of the population as a whole.

(iii) Promotion of innovation

The utilization of medical information will also bring about major innovations in the development of drugs and medical devices. In particular, real world data (RWD) and the real world evidence (RWE) derived from it play an important role. In the U.S. and Europe, laws and guidance have been developed to promote the use of RWD, and its use is supported at the national level. According to a survey by the European Medicines Agency (EMA), RWE was included in approximately 40% of new marketing authorization applications and 20% of expanded indications submitted in 2018 and 2019, primarily as data to support product safety and ^efficacy16). Furthermore, the use of RWE in clinical development planning has optimized trial size and reduced costs. For example, a recent study reported that RWE reduced the number of patients in a phase III multiple sclerosis clinical trial by more than 40% and shortened the duration of the trial by more than 6 ^months17). Another study attempted to reassess trial eligibility criteria in a non-small cell lung cancer trial by using a combined RWE and AI ^approach18). In this study, data from 61,094 EHRs were used to mimic previously conducted clinical trials, and simulations were performed regarding the relationship between trial eligibility criteria settings and trial outcomes. The results suggested that eligibility criteria for clinical trials could be relaxed without significantly impacting trial outcomes, and concluded that as a result, approximately twice as many patient populations could have been included in the trials as were eligible under the previous criteria. In order to utilize RWE for the development of more drugs and medical devices, it is essential to expand the information available. For this purpose, it is important to link diverse information, and the establishment of a unified national infrastructure will increase the compatibility of information and further improve the value of information use. At the present stage, the national medical information platform is being considered mainly as a framework for public information sharing, but the overall vision (image) of the national medical information platform suggests the possibility of linking private-sector information from "private healthcare services, etc." as well. In the future, it is expected that linkage with private-sector data will progress, leading to an even wider utilization of information.

These overseas examples show how much the utilization of medical information can contribute to optimizing medical care, improving health and public health, and promoting innovation. In Japan, however, the framework for extensive data linkage and secondary use as seen in overseas cases has not yet been developed. In the future, as data linkage based on a national medical information platform is strengthened in Japan, it is expected that medical DX will be promoted in line with advanced overseas cases, but for this to happen, it is important to establish a more flexible data collection and utilization framework.

4. Economic analysis as seen in the EHDS Impact Assessment Report

As the overseas cases discussed so far show, the utilization of medical information has brought about significant effects in the optimization of medical care, public health, and the promotion of innovation. Quantitative analysis is essential to objectively evaluate these effects and make use of them in policy making. In particular, assessing the benefits of the use of medical information from an economic perspective is an important guideline in understanding the balance between implementation costs and the decisions that support platform implementation.

In Europe, the EHDS is being promoted as an important initiative to enhance accessibility, interoperability, and reuse of medical data, and the concept has many implications for Japan The purpose of the EHDS is to integrate medical data managed in different EU member states, allowing individuals to manage their own health data and to put in place the infrastructure that will allow researchers, ^{innovators19)}, policy makers, regulators, and others to access this data securely and efficiently.

The EHDS Impact Assessment Report, published to accompany the EHDS legislative bill, provides the basis for a comprehensive assessment of the social and economic impacts expected from its implementation. The report shows that the benefits and costs are carefully compared and appropriately balanced as a policy, and this approach can be very helpful for infrastructure development in Japan.

The report outlines the 10-year benefits envisioned from the introduction of the EHDS (Table 2), and estimates that it will bring economic benefits in excess of 11 billion euros over the first 10 years of implementation.

Of these, the most significant economic benefit is "cost reduction and efficiency gains in the healthcare sector," with the introduction of telemedicine shown to be a particularly significant contributor. Compared to traditional face-to-face care, telemedicine has the potential to save significant time and money for both patients and providers, which contributes significantly to overall healthcare efficiency gains. The total cost savings from this efficiency improvement over a 10-year period are expected to reach 5.4 billion euros. This impact can be attributed to reduced patient travel costs, shorter clinic times, and more efficient patient management.

In addition, "cost savings from the reuse of health data access" is also estimated to bring significant economic benefits: the implementation of EHDS will make access to necessary medical information faster and easier, while at the same time significantly reducing access costs. This is achieved by eliminating the need for data users to directly access each data subject to obtain consent, and instead accessing information through national health data access organizations. This is expected to streamline the access process and reduce the burden on data users. The initiative is expected to result in cost savings in the order of 3.4 billion euros over 10 years, benefiting data users such as researchers, innovators, regulators, and policy makers.

The economic benefits from the use of RWEs have also been greatly appreciated: the use of RWEs has led to more accurate data on the effectiveness and safety of drugs, which has contributed to more efficient drug price renegotiations and regulatory processes. The projected economic benefits are approximately EUR 800 million, including cost savings from renegotiated drug costs in key disease areas such as cancer, diabetes, cardiovascular disease, and respiratory disease.

The EHDS Impact Assessment Report shows that a properly developed health information framework is an important foundation not only for contributing to the efficiency of health care delivery, but also for fostering innovation and contributing to economic development through improved quality of care. In particular, the estimates of each of the economic benefits presented in the report translate the benefits of utilizing medical information into monetary values, show the rationality of the implementation costs, and provide concrete examples of the impact of utilizing medical information through EHDS. Such estimates will be very helpful in the construction of a nationwide medical information platform in Japan, and suggest the importance of quantitatively evaluating the economic impact and concretely showing the benefits of its utilization in Japan in the future, which will serve as an indicator to support decision making for its introduction.

Summary and Discussion

In this paper, we have organized the wide-ranging ripple effects of the utilization of medical information with a view to establishing a nationwide medical information platform in Japan. As a result, the utilization of medical information sharing and collaboration based on the concept of a national medical information platform in Japan was categorized into three areas: optimization of medical care, improvement of health and public health, and promotion of innovation. In fact, in Europe and the U.S., the effects of cases in which the centralized management and secondary use of medical information has led to more efficient patient care, enhanced public health risk response, and even promoted research and development have been estimated, and these examples could be applied to initiatives in Japan.

Although there are great expectations for the introduction of a national medical information platform, its implementation will involve technical and institutional challenges and high investment. In order to overcome these challenges and ensure long-term success, it is helpful to conduct an impact assessment and estimate the economic benefits prior to implementation. As shown in the EHDS impact assessment report, quantitative evaluation of the economic benefits of the utilization of medical information is indispensable to strike an appropriate balance between implementation costs and benefits. It is expected that a similar impact assessment will be conducted in Japan to concretely demonstrate the economic benefits, thereby assisting policy makers in their decision making and promoting the smooth introduction and effective operation of a national medical information platform.

Furthermore, it is also important to conduct economic analysis adapted to Japan's unique economic environment and healthcare system. In addition to the development of a data infrastructure, investment and regulatory reforms to promote medical DX are essential, and these comprehensive efforts are the key to maximizing the utilization of medical information. We strongly hope that the promotion of these measures will improve the quality of medical services for society as a whole and promote the health of the people. Finally, it is important that diverse stakeholders work together as one to deepen discussions and promote further concrete initiatives for the establishment of a national medical information platform and its effective utilization. We hope that this report will help in this endeavor.

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