Points of View Characteristics of the Global EHR/PHR Environment -Toward the Promotion of Utilization of Health and Medical Data in Japan

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Junya Tsujii, Senior Researcher, National Institute of Biomedical Innovation Policy

1. Introduction

64ZB (zettabytes). This is the amount of digital data generated worldwide in ²⁰²⁰¹⁾. When converted to the familiar GB (gigabyte), this means that an enormous 64 trillion GB of data was generated in just one year. Furthermore, with the imminent arrival of a digital society in which everything will be connected via the Internet through advances in communication technology and the sophistication of digital devices, some estimates suggest that the amount of data generated will increase to approximately 175 ZB by 2025. In particular, the healthcare sector is a prime example of this area, where data volume is expected to increase by an average of 36% per year (2018-2025) ²⁾.

In Japan, the 2020 edition of the White Paper on Science and Technology (Ministry of Education, Culture, Sports, Science and Technology) presents an "Image of Society in 2040. The white paper describes a future in which medical and healthcare services are optimized for each individual, utilizing technologies such as "a super-distributed hospital system that enables remote treatment and care for dementia and other conditions," and "wearable devices that monitor information inside the body ^.) The next generation of medical and healthcare services, which can be described as data-driven, will be supported by personal health and medical data obtained through medical institutions and digital devices. All kinds of data must be linked and analyzed on an individual basis, leading to prevention, health promotion, early detection of diseases, and appropriate therapeutic intervention, etc. Secondary use of data by industry, etc. (use outside the purpose of collection) is required to elucidate the causes of disease onset and develop new therapeutic agents, etc. In the future, it is expected that a wide variety of health and medical data will be acquired and accumulated against the backdrop of more sophisticated medical care, improved health checkups, advances in sensing technology, and the widespread use of mobile applications, etc. However, the data acquired by medical institutions and individuals are dispersed and stored in various locations, and are not sufficiently linked on an individual basis. In Japan, health data are stored in scattered locations. In order to appropriately link scattered health and medical data and promote effective utilization of such data in Japan, it is essential to establish a data infrastructure and mechanism that contributes to linkage. This paper provides an overview of global trends in the current status of the infrastructure and linkage (EHR-PHR linkage) of health and medical data obtained within and outside of medical institutions, and data utilization, as well as an in-depth look at issues and countermeasures in Japan.

Definition of terms in this paper

The terms used in this paper are defined as follows

Electronic Health Record (EHR) refers to a system for electronically recording an individual's medical information over a lifetime and sharing and utilizing that information across different medical ^{institutions4)}. 4) Target data includes medical information, laboratory data, medical history, allergy information, etc., and mainly includes data obtained at medical institutions.

In Japan, however, personal health records (PHRs) have not been strictly defined, and the interpretation and scope of data may differ depending on the position and situation of the person defining the term. In this paper, we define PHR as "a system that allows individuals and their families to accurately grasp and utilize data related to health and medical care in the form of electronic records, which are linked to the individual's life," based on materials provided by the Ministry of Health, Labor and ^Welfare5) and the Japan Council for the Promotion of ^PHR6). Target data includes not only medical data that can be shared with individuals, but also data obtained outside of medical institutions, such as information on medical checkups and examinations, vaccination history, and life log data (blood pressure, step count, sleep, etc.) obtained by wearable ^devices7). In addition, genomic and omics data are excluded from the scope of this paper, as it is expected to be linked within a framework different from that of EHR-PHR linkage, as it is separately aimed at establishing "an information infrastructure that links and incorporates clinical information with information such as the results of whole genome ^analysis8). Note that the terms EHR and PHR are also used to refer to the data itself handled in the above mechanisms (Figure 1).

3. expectations through the collaboration and utilization of health and medical data

Before referring to the current situation in each country, we would like to touch on the effects expected from the linkage and utilization of health and medical data from the perspective of each stakeholder.

The linkage of EHRs, which are data mainly obtained at medical institutions, and PHRs, which are data mainly obtained outside of medical institutions, will enable the construction of diverse and time-series health and medical data based on individuals. For example, when considering the use of such data from the perspective of individuals, such as citizens and patients, it is expected to contribute to disease prevention and health promotion, and to provide safe, secure, and high-quality medical care (early diagnosis, personalized medicine, etc.) through data sharing with medical providers. In addition, it is also expected that these data will be utilized to receive appropriate treatment in emergency situations when a person is unable to express his/her own will. From the perspective of medical institutions, government authorities, and insurers, the data can be used to improve the efficiency of medical care through the appropriate allocation of medical resources, and to implement highly accurate measures that contribute to the improvement of the health of citizens and the insured, thereby providing value directly or indirectly to the public and patients. In industry and academia, secondary use of various time-series data linked to individuals will accelerate efforts to elucidate factors that contribute to the onset and severity of diseases and to search for biomarkers that contribute to patient stratification. This will make it possible to efficiently and effectively find new evidence for prevention, early diagnosis, treatment, and prognosis. In particular, the pharmaceutical industry is expected to contribute to the enhancement of the quality of medical care and healthcare through the discovery of new drug targets and the development of new solutions that contribute to preventive and preemptive medicine.

4. infrastructure of healthcare data and current status of EHR-PHR linkage

4-1 Efforts by each country

This paper focuses on the United States, where many pioneering efforts, including those by the private sector, are underway; the United Kingdom and Finland, where the government is taking the lead in the development of EHRs and PHRs; the Netherlands, which is implementing distinctive public-private partnership measures; and Australia, where EHRs and PHRs are becoming increasingly popular among the population.

1) U.S.A.

In the United States, the Department of Veterans Affairs (VA) has established an EHR environment called "VistA" and a PHR environment called "My HealtheVet". The Veterans Health Administration (VHA), a division of the Department of Veterans Affairs, provides medical services to 9 million veterans each year at approximately 1,300 medical ^{facilities9), 10).} 10) VistA has been used since the 1990s as a system to link medical data acquired at those facilities. My HealtheVet" was launched in 2003 as a follow-up to VistA. ¹¹⁾ My HealtheVet is linked to VistA, allowing veteran patients to manage their own health and medical data and easily share their health status with healthcare professionals and family members. The most recent data (10 years to 2022) is available. In the most recent data (October-December 2022), there were approximately 4.7 million active users and more than 130,000 new registrants. In addition, nearly 1.6 million downloads of their own health care data had been ^made12). The data downloads were made using a program called "Blue Button," which was developed by the Department of Veterans Affairs in collaboration with the Markle Foundation, the Centers for Medicare & Medicaid Services (CMS), and the Department of Defense Through this functionality, patients can directly access (view and download files) their own healthcare ^data13). Currently, Blue Button is being adopted not only by My HealtheVet, but also by other government agencies (CMS Blue Button 2.0, US Department of Defense TRICARE Blue Button, etc.) and private companies. Accessible information includes medical records, test results (laboratory tests, radiology reports, etc.), medical history, allergy information, and medication history. In addition, patients can self-enter life log data (blood pressure, blood sugar, cholesterol, heart rate, body temperature, weight, pain, etc.) that they themselves have measured, track their progress, and share with medical institutions, thus promoting the linkage of health and medical data based on the ^{individual14)}. (Beginning in July 2020, longitudinal patient records can be created that aggregate health care data from outside health care providers in addition to those under the jurisdiction of the Veterans Health ^{Administration15} ). The system uses a special account linked to the Social Security Number (SSN) as the personal identification ^ID16), and also allows the sharing of information to healthcare professionals through VistA and My HealtheVet using an opt-out method (i.e., the provision of personal data to third parties can be stopped at the request of the person in question). ⁽ i.e., to stop the provision of personal data to a third party at the request of the ^{individual17)}.

My HealtheVet can also be accessed through applications such as smartphones. In addition, apps to support personal health management (chat apps with medical teams, mental health apps, etc.) are provided by VA agencies (Office of Connected Care) and VA-recommended private businesses (currently over 30 types) ¹⁸⁾. In addition to managing and sharing their own health and medical data, these apps also have functions such as medical appointments via My HealtheVet, management of electronic prescriptions, and communication with the VA healthcare team, and are increasingly being used as tools to improve patient access to medical and healthcare care.

2) United Kingdom

In the U.K., family physicians are institutionalized and, in principle, citizens receive primary medical care from a registered family physician. An EHR environment based on the family doctor system is the Summary Care Records (SCR) operated by the National Health Service (NHS) Digital (merged with NHS England on February 1, 2023). ¹⁹⁾ The SCR is a network of medical SCR is one of the "Spine" services, a collaborative network of healthcare-related data in the ^UK20), and is an electronic record for each individual that is automatically generated from the medical data of family physicians. The SCR contains an individual's medical record linked to an NHS number (a 10-digit personal number used by the NHS to manage medical information), as well as information on allergies, medications, and medications. The SCR includes information related to medical records, allergy information, medications, adverse reactions to medications, etc., but as a time-limited measure for COVID-19, important medical history, reasons for medications, care plan information, and immunization records are added.

Any human being with an NHS account (13 years of age or older with a family physician ^{registration21)} ) can access these medical information (EHR data) through an app (NHS App) provided by NHS ^Digital22). This is the basis of PHR services in the UK. In addition, there are general practices and hospitals that have partnered with private service providers to offer patients private PHRs that are linked to the NHS App, DrDoctor's PHRs are introduced as apps that can be linked to the NHS ^App23). For example, Patients Know Best allows patients not only to view medical information, etc. recorded in the NHS App, but also to upload their own lifelog data obtained from wearable devices to the portal and share it with healthcare professionals, family members, etc. ²⁴⁾ (see section 4-2 for details).

In addition, citizens themselves can choose whether or not to provide health care data to the research domain through the NHS App or other means. If the provision of research is permitted, the data is processed into a form in which individuals cannot be identified, and then used for research, etc. at universities, hospitals, and pharmaceutical ^companies25).

3) Finland

In Finland, an EHR environment called "Kanta" has been established to collect and share medical data centrally across regions, backed by a nearly 100% electronic medical record penetration rate. The Finnish Social Insurance Agency (Kela) is responsible for its operation, and medical institutions are required by law to provide patient data to Kanta ^.26) Data recorded in Kanta include medical records (treatment (including dental care), laboratory results (clinical laboratories, imaging tests, etc.), prescription drugs, immunization records ( COVID-19 vaccine), and self-entered lifelog data (expressed as wellbeing data in Kanta) from a dedicated application, and data related to social welfare is also being ^{aggregated27)}. Since these data are provided to Kanta by medical institutions nationwide with a unique number (personal identification number) associated with the individual, it is possible to link data across multiple institutions based on the individual. As of 2021, there will be approximately 3.8 million users (Finland's population is approximately 5.5 million), and more than 2.7 billion pieces of medical data for a total of 6.4 million people. The system has a world-class health and medical data base with over 2.7 billion medical data for a total of 6.4 million people and nearly 20 million social welfare data for 700,000 people. ²⁸⁾ Individuals can access their own data through "My Kanta Pages," a system that allows them to access their own data.

Individuals can access the above health and medical data through "My Kanta Pages " ²⁹⁾. My Kanta Pages also allows users to record their own lifelog data, including vital data such as blood glucose levels, blood pressure, and respiratory rate, as well as subjective symptoms. This function is called Kanta Personal Health Record (Kanta PHR) and was launched in ^201830). Furthermore, in accordance with the Act on the Electronic Processing of Client Data in Healthcare and Social Welfare (Client Data Act, 784/2021), which took effect on November 1, 2021, the Kanta PHR stores The Act on the Electronic Processing of Client Data in Healthcare and Social Welfare (Client Data Act, 784/2021 ⁾, which took effect on January 1, 2010, allows the sharing of healthcare data stored in Kanta PHRs with healthcare institutions and social welfare service providers (data sharing between individuals and providers and between providers) ^{26), 31)}. The law is being implemented in phases, with a transition period ending on January 1, 2024.

The recording of lifelog data, etc. into the Kanta PHR is done via private wellbeing apps developed for this purpose (approved by Kela's Kanta service, etc.), and four different products are currently available as available apps on Kela's ^website32). When developing a wellbeing app, it is necessary to follow the development process shown in Figure ²³³⁾. First, an understanding of data standards for data linkage and exchange (Kanta PHR uses HL7 FHIR (Fast Healthcare Interoperability Resource), which is being discussed for introduction in Japan) and domestic data content is required. If new data content is required, developers are encouraged to undergo review by the HL7 Finland Personal Health SIG development community, as well as independent testing in the sandbox environment provided by the Kanta service. Once the system, standards, and other technical requirements are met, joint testing is conducted with Kela on the developed ^product34). Joint testing consists of three stages: 1) testing between the developer and Kela, 2) testing between client organizations such as medical institutions and Kela, and 3) cross-testing by the developer, Kela, and client organizations. After the joint test, the product is added to the register of Valvira (a national organization under the Ministry of Social Affairs and Health) and can be used if it passes the information security evaluation by an evaluation organization accredited by Traficom (the Finnish Agency for Transport and Communications). The process is characterized by the fact that the government is heavily involved in the development and establishment of laws and regulations to ensure that only products of a certain level of quality are distributed, given the background of handling sensitive information in the form of health and medical data.

The government also promotes the secondary use of health and medical data stored in Kanta and other public databases; the Act on the Secondary Use of Health and Social Data, passed in April 2019, specifies the purposes for which secondary use is possible, and individual-level data for statistical and scientific research, education, knowledge management, regulatory guidance and supervision in social welfare and health care, and activities at the authorities, while statistical-level data are permitted to be used in addition to the above, in development and innovation related to public health or social ^security35). The data used include prescriptions, diagnostic names, laboratory values, procedures, etc. A data resource catalog (data sets and their descriptions) is made available to those considering their ^use36). (Date of death data and cause of death are held by different institutions but can be combined with Kanta ^data37 ). However, use for marketing activities, including advertising, is prohibited. In addition, as a characteristic measure, data use screening and permission, collection and processing of data across multiple institutions (pseudonymization, anonymization, etc.), and creation of statistical data are handled by Findata, a data use permission organization established under the National Institute for Health and Welfare (THL). (Figure 3). Until now, data conducive to secondary use had been dispersed and stored in various institutions and systems, requiring approval from each institution for data use and taking a long time before data use could begin. However, Findata now handles all cases involving multiple data sources and access to private data sources centrally, and is aiming for rapid data utilization, completing application processing (data availability decision) within 3 months and data delivery from data availability approval within 60 business days (38). According to the 2021 annual report, there were 312 applications per year, and the median processing time was 80 ^days39). In addition, Findata's activities are supervised by the Parliamentary Ombudsman and the Data Protection Ombudsman, both of which are third-party organizations, to ensure the transparency of its ^{activities40)}.

Perhaps as a result of these efforts, in a survey on the use of digital services published in 2019, "willingness to provide data on one's own or family members' health and genetics for scientific research" was the highest among the countries surveyed (Finland, Germany, the Netherlands, and ^France42).

4) The Netherlands

King Willem-Alexander, who ascended to the throne as the new King of the Netherlands in 2013, stated in his coronation speech that "the 20th century-style welfare state is over," and called for a shift to a new participatory society in which citizens limit social security support by the central government and take the initiative to maintain and improve their own health themselves ⁽⁴³⁾. The cornerstone of the new society aimed at "self-help and mutual aid" is health medical data, and the Netherlands is strongly promoting its use.

The digitization of medical data in the Netherlands has progressed from early on, and as in other Nordic countries, the penetration rate of electronic medical records has reached almost 100%. Based on this background, the government led the construction of an EHR system in the 2000s, but the plan was abandoned due to significant public opposition to centralized data management and opt-out methods of data ^{collection44)}. However, due to the importance of utilizing medical data, VZVZ, a private organization comprised of medical institutions, insurance companies, pharmacies, IT vendors, and other industry organizations, took the lead in developing and operating a medical data collaboration infrastructure, and by adopting an opt-in method (data use is permitted based on the consent of the individual), a new EHR The LSP is a medical information exchange system established for each region and does not accumulate medical data on specific servers. It is characterized by the adoption of a decentralized system in which users access data stored in each institution (family doctors, after-hours medical centers, pharmacies, etc.) via the LSP (network) based on their resident registration number (BSN), thereby securely linking the data of each institution (patients can check which medical provider has accessed their data). Medical data that can be shared through LSPs include current health status, test results, medications, and allergy information. The National Institute for Medical ICT (Nictiz), which initially led the construction of the EHR, has gained public understanding by working with VZVZ in the development and management of national standards and in the formulation of an overall ^vision46). ⁴⁷⁾.

While medical data linkage between medical institutions (EHR environment) has been promoted from early on as described above, a PHR environment for citizens and patients to utilize their own health medical data is the MedMij project, which was launched in ^201648). Like EHRs, this is a public-private partnership project involving various stakeholders, including the Ministry of Health, Welfare, and Sports, patient associations, and private insurance companies. In addition, the MedMij Foundation was set up in 2018 as the body to determine participation in MedMij, and its Board of Directors includes an Owners Council, half of which are patient representatives (such as the Dutch Patient Federation) and half of which are healthcare providers. The MedMij Foundation's activities are transparent because healthcare users and providers are involved in decision-making on an equal footing. Funding for the operation is provided by the Ministry of Health, Welfare, and Sports and Zorgverzekeraars Nederland (an industry association of private insurance companies).

MedMij is not a specific PHR service or data infrastructure, but rather a set of standard rules (technical specifications, security, interoperability, etc.) for the secure exchange of health care data between citizens/patients and health care providers in the Netherlands. In practice, data exchange between citizens/patients and health care providers takes place via a Personal Health Environment (PHE), which is an application or website that allows citizens/patients to view and manage their own health data as well as medical data obtained at medical institutions in one place. PHE allows citizens and patients to view and manage medical data obtained at medical institutions and their own health data in one place, as well as share data with their healthcare providers.

The PHE is provided by private service providers, and each supplier develops its PHR platform in compliance with the MedMij standards. In addition to developing the standards, MedMij also certifies suppliers that comply with the standards. (The review process also involves Nictiz (information standards-based review) and VZVZ (management of contracting systems). Currently, there are more than 20 PHEs that have been granted the MedMij label, which is published on the MedMij ^website49). One example is an application for health management based on lifelog data (blood glucose, blood pressure, heart rate, diet, sleep, etc.) acquired by wearable devices, etc. ( ^Selfcare50 ), ^Drimpy51), a medication data management application ( ^Zorgdoc52) ), a health maintenance and long-term care application for patients who need The public and patients are free to choose the service that best suits their disease and purpose of use from a high level of competitive products.

To obtain MedMij certification, compliance with NEN7510 (a Dutch information security standard based on ISO27001 that provides guidelines for healthcare organizations to finalize, enact, and maintain medical data protection and security ^measures54) ) and other supplementary security standards, etc. ⁵⁵⁾. In addition, they are required to pass a penetration test (a penetration test performed by an external independent body for the purpose of verifying vulnerabilities in systems, etc.). In addition, they are required to incorporate information standards (standards and interoperability for recording, retrieving, sharing, exchanging, and transferring medical data with appropriate quality) as specified by ^Nictiz56). For example, MedMij implements HL7 FHIR, an international standard for data linkage and exchange, and is working on standardization with a view to future international data linkage as well as ensuring data interoperability in Japan. In addition, the participation agreement at the time of MedMij certification prohibits the sale of data by PHR providers to third ^parties57).

Thus, in the Netherlands, the public and private sectors are working together to build a data infrastructure and establish a system for data linkage with an awareness of the need to protect the nation's health and medical data.

5) Australia

In Australia, the country established the Personally Controlled Electronic Health Records (PCEHR) in 2012 with the aim of creating a public PHR environment that allows individuals and healthcare providers to access important healthcare data when and where they need it. However, the number of people enrolled in the PCEHR, which was based on an opt-in system, did not increase, and instead, the My Health Record, which is based on an opt-out system, was considered. The My Health Record gradually gained public support over a period of about three years through steady efforts such as trial testing of the opt-out model on a scale of 1 million people (opt-out rate of 1.9%) ^{58) and} amendments to the law to address public concerns (ensuring the right of individuals to control data access from third parties, strengthening privacy and information security, etc.). After these efforts, based on the My Health Records (National Application) Rules 2017, the system has been transitioned to an opt-out system since January 31, ^201959), and as of December 2022, more than 90% of the Australian population, or 2, 3.5 million Over 3.5 million profiles have been ^created60). Data uploaded by healthcare providers include medical history, diagnostic imaging, discharge summary (a plan to support ongoing care after discharge), and allergy ^{information61)}. Almost 100% of general practitioners, public hospitals, and pharmacies have implemented and are using My Health ^Record60), and this platform also serves as a data sharing environment (EHR) among medical institutions, although the consent of the individual is required in advance. Information that can be added by the individual includes current medication status, allergy information, and personal health records, but at present there are only limited examples of linkage between lifelog data obtained by wearable devices and My Health ^Record62). Individuals can access (view) their data through myGov (a user information management website for accessing Australian government services) or PHR apps. Digital Health Agency introduces two PHR apps that can view My Health Record information: "healthdirect," which is government funded, and "HealthNow," which is a private ^{PHR63), 64).}

The information collected is anonymized and used for research aimed at improving future healthcare and public health, among other ^things65). Data provision requires the consent of the individual, which can be freely expressed through My Health Record. (Identifiable data can be used only with special consent of the individual.) However, the provision of data for commercial or non-health-related purposes, to insurance agents, or the sale of the data itself is prohibited.

Thus, in Australia, the national government is taking the lead in strongly promoting the establishment of a data infrastructure to promote individual health management based on health and medical data, data sharing among medical institutions, and secondary use for research that contributes to higher quality of medical care. According to the Annual Report (2021-22) issued by the Australian Digital Health Agency, the total number of accesses to My Health Record in the same year was approximately 9.8 million, an increase of 3.6 times from the previous ^year66). However, it has been pointed out that many of these accesses were due to the COVID-19 pandemic, such as obtaining vaccination certificates and test results via My Health ^Record67), and it cannot be assured that the utilization of health care data is making steady progress, but the number of registered users in January 2019 was approximately 5.39 million, and the total number of accesses in 2020-21 (The impact of the My Health Record on the 1919 pandemic is noted as 67).

6) Japan

Current EHR/PHR Environment

While the infrastructure for health and medical data is being developed in many countries, the penetration rate of electronic health records, which form the foundation of the EHR environment, in Japan as a whole was 50-60% (in 2020), which is still underdeveloped compared to countries such as Scandinavia, where the penetration rate reaches almost 100% (Table 1) ⁶⁸⁾. On the other hand, Japan has a long history of efforts to build an EHR environment, and around 2000, a "regional medical information collaboration network" was launched to share regional medical data through information and communication technology (ICT), with more than 200 networks currently in ^operation69). However, there are several issues to be addressed, such as the difficulty of sharing data beyond the framework of a "regional network" and the intensity of ^{activities70) ,} when looking at data collaboration covering the entire country. Under these circumstances, the "Basic Policies for Economic and Fiscal Management and Reform 2022" (Kotta Policy 2022), approved by the Cabinet on June 7, 2022, calls for the establishment of a nationwide infrastructure for sharing and exchanging information on all aspects of medical care (including long-term care), including information on receipts and specified medical examinations, vaccinations, electronic prescriptions, municipal medical examinations, and electronic medical records, as part of efforts to promote medical DX. The creation of a "national medical information platform," a nationwide platform for sharing and exchanging information on all aspects of medical care (including nursing care), including receipts, information on specified health checkups, immunizations, electronic prescriptions, municipal health checkups, and electronic medical records, was ^specified71). The National Medical Information Platform aims to develop and expand the network of online eligibility verification and other systems, and to achieve comprehensive data linkage beyond regional boundaries.

Meanwhile, the operation of MyNa Portal, a public PHR, began in 2017 and is being addressed based on a process chart regarding data health ^reform72). Currently, data that can be shared with medical institutions (EHR-PHR linkage based on the consent of the individual) via systems such as personal viewing and online eligibility verification include information on drugs, specified medical checkups, and medical treatment (history of consultations, medical records).

Current status of expansion and linkage of EHR/PHR data

An urgent issue for the development of an EHR environment is to increase the penetration rate of electronic medical records, which will serve as the foundation for data linkage. Currently, specific policies for the dissemination of electronic medical records have been set forth in the Kotta Policy 2022 and the Liberal Democratic Party's "Medical DX2030 ^Vision73), and the government is taking the initiative to introduce standardized electronic medical records to medical institutions that have not yet adopted them. In addition, standardization of electronic medical records is also being promoted to expand the data that can be linked, and studies are underway to standardize data for three medical data documents (medical information forms, discharge summaries, and health checkup reports) and six electronic medical record information (names of injuries and diseases, allergy information, infectious diseases, drug contraindications, tests, and prescriptions) ⁷⁴⁾.

In addition, looking at further utilization of medical data, the development of templates that contribute to structuring electronic medical record data and assisting data entry by physicians is also an important perspective. For example, Kyoto University Hospital and the New Medical Real World Data Research Organization (PRiME-R) are jointly developing templates for standardization, structuring, and input support of electronic medical record data in the field of oncology, which will be introduced at about 40 facilities nationwide from June 2022 to promote the wide use of data (e.g., treatment results and adverse event information within a medical institution). The templates will be introduced at approximately 40 facilities nationwide from June 2022, and will be used for a wide range of data applications (visualization of treatment results, adverse event information, etc. within each medical institution, and utilization of statistical data from each medical institution). ⁷⁵⁾ This is an initiative in the area of specific diseases, but further data linkage beyond the boundaries of medical institutions is required in the future.

On the other hand, regarding the PHR environment, private PHR providers are now able to handle information on medical examinations, etc. stored in MyNa Portal, etc. ⁷⁶⁾ and the expansion of PHR data that can be linked is under consideration (Figure 4) ⁷⁷⁾. In addition, based on the national policy that "it is essential to use the vitality of private PHR providers as well as to publicly provide a minimum environment for using PHRs, " ⁷⁸⁾ the "PHR Service Providers Association (tentative name)," consisting of 15 private companies, has begun activities to standardize data and improve service quality79 ⁾. ^79). However, according to the "Questionnaire Survey of Users of Private PHR Services" conducted by the Ministry of Health, Labor and Welfare (in early December 2020), the current PHR utilization rate (the percentage of those currently using PHR products) is not high, at around 10%, and the current utilization is not sufficiently ^advanced80). In addition, a systematic mechanism for sharing lifelog data acquired by private PHRs with medical institutions via MyNa Portal, etc. (i.e., linking with EHR data) is not yet in place, which is considered a challenge in promoting EHR-PHR data linkage (there are examples of individual linkage by private companies; see section 4-2. ).

As described above, various measures are being taken to expand and link EHR and PHR data, but Japan's efforts have only just begun.

Current status of secondary use of healthcare data

In Japan, the use of anonymized processed medical information based on the Next Generation Medical Infrastructure Act and the establishment of pseudonymized processed medical ^{information81)} have led to the development of medical data for research and other purposes. However, secondary use of anonymized processed medical information at present is limited to 23 ^{cases82), 83), 84).} This is largely due to the characteristics of anonymized processed medical information (such as the inability to match with original data, processing of specific values, and non-provision of information that is scarce), but also due to the difficulty in understanding the details of data held by medical institutions and authorized providers of anonymized processing, the time and effort required to collect data across multiple institutions, the complexity of applications for use, and the burden on medical institutions to obtain consent and provide data. The burden on medical institutions to obtain consent, provide data, etc. is also an issue in the promotion of secondary ^{use85), 86).} However, discussions for improvement are underway. For example, in the provision of data to third parties (for anonymous processing) based on the Next Generation Medical Infrastructure Act, prior notice (careful opt-out) from medical institutions to the public and patients is required, and issues regarding the bias toward consent have been pointed out. With regard to obtaining consent for data provision, the Japan Pharmaceutical Manufacturers Association (JPMA) has proposed a shift from entry regulation (consent principle) to exit regulation (use screening + opt-out), and similar proposals have been made by other ^{organizations87)}. Specifically, the following recommendations are made with reference to the European Health Data Space (EHDS), which clarifies in advance the purpose of secondary use (e.g., public, public health, research, innovation activities including drug discovery, etc.) and prohibited items, etc., and to enable secondary use in the form of usage screening and an opt-out system The bill also calls for the enactment of a special law on personal information protection in the medical field that would allow secondary use of diverse medical data on an opt-out basis.

In addition, with the aim of secondary use of diverse medical data, the linkage of anonymized processed medical information under the Next Generation Medical Infrastructure Act with other public databases (NDB, nursing care DB, etc.) is under ^{consideration81)}. Linkage by data users is envisioned under a common hashed ID (an ID that converts a numerical value or character string into an unrecoverable character string according to a certain conversion formula).

On the other hand, while primary use of PHR data for disease prevention and symptom management has begun to make progress, PHR data infrastructure and EHR-PHR linkage mechanisms that anticipate utilization in research and development are still under consideration, and secondary use, like medical data, has not progressed. In addition, the provision of data to third parties based on the will of individuals is currently being considered in the "information bank," which aims to distribute and utilize data with the effective involvement of individuals, but the handling of health and medical data, which contains much sensitive information, is still under ^{discussion88)}. However, the handling of health and medical data, which contain a large amount of sensitive information, is still under discussion88) . In addition, in the utilization of both EHRs and PHRs, it is an important perspective for promoting secondary use that citizens and patients, who are data providers, can check the status of secondary use of their own data in a timely and appropriate manner. However, in Japan, there is currently no systematic system in place that allows individuals to easily check the status of their data use. In Europe, the EHDS stipulates the right of individuals to check the usage status of their own ^data89), which may be a useful reference for Japan in ensuring transparency of secondary use for citizens and patients.

4-2 Initiatives by the private sector

While we have discussed trends in other countries toward the utilization of health and medical data, the private sector is also making progress.

One of the world's pioneering efforts is Apple's "Health Records," which stores and analyzes lifelog data (heart rate, falls, sleep time, exercise time, etc.) from iPhones, Apple Watches, and other wearable devices in the Health Records app. and analyze them within the Health Records app. In addition, through Health Records, information such as vaccination records, test results, and medications held by multiple medical institutions are being aggregated on an individual basis. Furthermore, in 2021, it will be possible to link the lifelog data obtained by the individual to the EHR of a partnering medical institution and share it with physicians, caregivers, and ^others90). This EHR-PHR linkage service is provided not only in the U.S., but also at medical institutions in Canada and the U.K. ⁹¹⁾.

In the United Kingdom, as noted above, there are private PHRs that are linked to the NHS App. One of these, Patients Know Best ("PKB"), is the first private PHR that has been approved to work with the NHS App, allowing access from the NHS App to health and medical data recorded in PKB. ⁹²⁾ PKB allows data from various wearable devices PKB allows data from various wearable devices (blood glucose, weight, heart readings, etc.) to be uploaded to the app and tracked over time, aiming to build and utilize a broader range of personal health and medical data than is covered by the NHS App ^alone93). In addition, the same functionality is available not only in the U.K. but also overseas, and is unique in that it allows access to one's own health and medical data anytime and anywhere. In addition, some companies are building their own data collaboration platforms between patients and medical institutions, such as Evergreen Life's "Evergreen Life app, " ⁹⁴⁾ which enables the display of NHS-guaranteed family doctors' medical records and the storage of life log data, and the "Evergreen Life app" by Evergreen Life, which allows patients to enter their personalized care plan for optimization of their individual care plans. ⁽ Evergreen Life app94 ⁾ and Huma's "hospital at home," which links and visualizes vital data entered by individual patients with clinical data from more than 3,000 medical ^{institutions95)} for the purpose of optimizing care plans for each individual patient.

In addition, as mentioned in section 4-1, Finland and the Netherlands are expanding private PHRs through government support for the development of private PHR providers and certification of PHR suppliers that reach a certain level.

Meanwhile, in Japan, EHR-PHR collaboration by some private sector providers is also progressing. For example, Fujitsu's electronic medical record system for clinics and Welby's PHR platform (Welby MyChart) will be linked in 2021 to utilize daily diet and exercise records and vital information for treatment and other ^purposes96). NOBORI, provided by PSP, is an application that allows individuals to view the results of imaging and blood tests, drug information, and other data provided by partner medical institutions, along with exercise, heart rate, and other healthcare information obtained by the patient, all in one place. In addition, it has begun to be linked with medical information stored in MyNa Portal, making it possible to share this information among patients, family members, and medical ^{institutions97)}.

Acceleration of Utilization of Health and Medical Data in Japan

Based on the survey results, Table 2 summarizes the health and medical data infrastructures, related systems, and the current status of data linkage (EHR-PHR linkage) in each country. Further measures are expected to be taken to establish a system for the systematic linkage of scattered data, to promote the use of PHRs including lifelog data, and to develop mechanisms and systems to accelerate the secondary use of data. In this context, it will be necessary to take measures in reference to the efforts of other countries that have taken the lead in developing EHR and PHR environments that will serve as the foundation for the utilization of healthcare data in Japan. Based on the current situation in Japan and overseas, the author discusses Japan's issues and measures for the utilization of health and medical data (see Table 3 for summary).

Development of mechanisms to expand EHR-PHR collaboration

In order to promote the utilization of health and medical data acquired in various ways for the improvement of one's health, the advancement of medical care, and the creation of innovative drugs through research and application, it is necessary to have an infrastructure and mechanism to systematically link data dispersed in various places. As mentioned above, EHR-PHR data is being linked among medical institutions through the National Medical Information Platform and the Regional Medical Information Collaboration Network, and between individuals and medical institutions through MyNa Portal (an online eligibility verification system). In addition, guidelines have been issued for private PHR providers to handle information on medical examinations stored in MyNa Portal and other such systems. On the other hand, a systematic mechanism for sharing lifelog data obtained from daily life with medical institutions (linkage with EHR data) is not yet in place, and there is a need to establish a highly comprehensive data linkage infrastructure based on the individual. Against this backdrop, at the first meeting of the Headquarters for Promoting Medical DX held on October 12, 2022, the Ministry of Internal Affairs and Communications (MIC) presented the "Project for Establishment of PHR Data Distribution Infrastructure Contributing to Advanced Medical Care" ¹⁰⁴⁾. This project aims to build a data distribution infrastructure necessary for PHR data utilization in the medical field, and a budget proposal of 550 million yen was submitted as "Promotion of Informatization of Healthcare" in the draft budget under the jurisdiction of the Ministry of Internal Affairs and Communications for ^FY2023105).

In this study, we confirmed that in Finland, the Netherlands, and other countries, a system for sharing lifelog data collected by individuals with healthcare professionals via public PHRs and certified private PHRs (EHR-PHR collaboration) has been established. In Japan, as well as promoting linkage between lifelog data stored in private PHRs and public PHRs, existing infrastructures such as online eligibility verification systems can be utilized to enable patients and medical institutions to share and link a wide range of health and medical data, including lifelog data (i.e., to provide medical institutions, etc., upon request by physicians, etc., with the We believe that it is necessary to establish a system that enables patients and medical institutions to share and collaborate on a wide range of health and medical data, including lifelog data (i.e., provide PHR data or grant data access rights to medical institutions upon request by physicians, etc.).

In doing so, rather than introducing the system at once, we should first conduct a trial of EHR-PHR linkage with the public, referring to the Australian policy, to verify its effectiveness, and make careful improvements to address the issues identified. In addition, it is important to verify the compatibility of the opt-in/opt-out model for data provision and linkage, the usefulness of a wide range of data linkage including those in fields other than healthcare, and other aspects of the data linkage infrastructure from the perspective of the public, together with the public concerned, to realize a data infrastructure and mechanism that is highly convincing to the public. It is important to realize a data infrastructure and mechanism that is highly convincing to the ^public106).

Toward the promotion of PHR utilization by citizens and patients: Introduction of a PHR certification system and expansion of development support

However, according to the aforementioned survey of private PHR service users, the current utilization rate of PHRs in Japan is not good, at around ^10%80). The survey pointed out the low level of PHR awareness (66.7% did not know the name of PHR at all), and it is assumed that one of the reasons for the low utilization rate is the lack of public understanding of PHRs themselves and their usefulness (issues of public understanding are discussed below). On the other hand, among those who have used PHRs in the past, functional dissatisfaction, such as the time and effort required for data registration and linkage, and issues related to product quality, such as concerns about information security, were cited as reasons for leaving the market. In particular, private PHR products and services that are outside the scope of pharmaceutical regulations are a mixed bag, and not all products guarantee the quality desired by the public and patients. In order to prevent the above-mentioned mismatch between users and PHR products and services, it is desirable to establish a system and framework to support the development of private PHRs with a certain level of quality assurance, and to establish a system that enables users to select such products appropriately.

In Japan, the "Basic Guidelines on the Handling of Health Examination Information by Private PHR Providers" issued by the Ministry of Internal Affairs and Communications, the Ministry of Health, Labor and Welfare, and the Ministry of Economy, Trade and Industry states that private sector providers must confirm the items to be observed when handling personal health examination information from MyNa Portal, etc. according to a check sheet and disclose the results themselves76), 107). In ^addition, the PICC has established the "Basic Guideline for Handling Information on Medical Checkups, etc. by Private Sector Entities.) In addition, the Council for the Promotion of PHR Dissemination has published a guideline that complements the above-mentioned guideline by organizing the rules and norms that PHR service providers should follow in more ^detail108). In a survey conducted by the Ministry of Health, Labour and Welfare in March 2022, some respondents stated that they were "unaware of the publication" or "did not have the time or money to compile and publish the results. The MHLW survey in March 2022 indicated that only a small number of providers (about 3% of 69 providers (including those who answered that their services are not covered by the check sheet)) have yet to publicize the check sheet in the basic guidelines due to reasons such as "not being aware of the publication" and "not being able to spend the time and money to compile and publish the results". ¹⁰⁹⁾ In order to promote the use of PHRs by the public and patients, the current issues include the lack of publicly available information, the low accessibility of information published by individual companies, and the difficulty for the public and patients themselves to fully understand such information and judge whether the product is good or bad.

To address this issue, it is necessary to improve the digital literacy and health literacy of the public and patients who are the users. From the perspective of PHR development, the author would like to establish and manage standard regulations (comprehensive standards for product functions, information security, data interoperability, etc.) that private operators should comply with, The author believes that it is important to establish and manage standard rules (comprehensive standards for product functions, information security, data interoperability, etc.) to be complied with by private companies, and to provide users with easy-to-understand information on products that meet these requirements. As a measure to achieve this, the author believes that the "MedMij" initiative in the Netherlands can serve as a useful reference. Specifically, the government or a specialized organization (third-party certification body) in cooperation with the public and private sectors is established to lead the development (including updating) of comprehensive standard rules to be followed by private PHRs that link public PHRs and data, and to grant certification marks such as the "MedMij label" to products of businesses that meet these standards. ⁽¹¹⁰⁾. Furthermore, it is expected that the list of certified products will be centrally managed and made publicly available to increase the accessibility of information by the public and patients, thereby enabling more appropriate product selection. It would also be important to ensure transparency of the activities of third-party certification bodies by establishing an oversight body composed of stakeholders such as medical institutions and the public (e.g., patient groups).

On the other hand, it was mentioned that one of the characteristics of the Dutch PHR policy is that citizens and patients can freely select services suited to their disease and purpose of use from among certified products that have been competed at a high level. This may be due to the support of public-private partnerships that encourage the development of various private PHRs. For example, to promote the development of private sector PHRs, the public and private sectors are investing a total of 20 million euros over four years in SMEs that develop excellent digital solutions (Fast Track eHealth Initiative) ¹¹¹⁾. In Finland, where government support is substantial, the national government is promoting the development of private PHRs that are linked to public PHRs by providing a sandbox environment to verify performance and security levels and by conducting joint performance tests. Conversely, in Japan, the Ministry of Health, Labour, and Welfare's "Study Group on the Promotion of PHRs for the Health Promotion of the Nation" has stated that "PHRs have various purposes of use, and ideally, PHRs should be developed to contribute to all purposes of use," and "In order for individuals to maximize the benefits of PHRs in accordance with their own needs, it is necessary to develop PHRs that are appropriate and broadly applicable. In order for individuals to maximize the benefits of PHRs according to their own needs, it is also necessary to create and utilize an appropriate and wide range of private PHR services" ^(112). Currently, for example, the InnoHub by the Ministry of Economy, Trade and Industry (METI) provides support to healthcare-related venture companies, etc., in terms of private sector financing and business promotion, ¹¹³⁾ but in light of the current state of PHR use, further support aimed at promoting PHR development in Japan should be expanded. Specifically, we believe that, with reference to the policies of the Netherlands and Finland, it will be possible to accelerate the development of private PHRs that meet the various purposes of use by citizens and patients by improving measures such as the push-type incentives provided by public and private funds and the development environment (sandbox environment, joint verification system for performance, etc.) by the national government. This will accelerate the development of private PHRs that meet the various purposes of use by the public and patients.

In light of the above, it is important to promote the use of PHRs through both institutional development and development support, which will ensure that products and services of a certain level of quality or higher are delivered to the public and patients, while encouraging free competition among private sector providers. In particular, since many of the players involved in PHR development are expected to be start-ups, it is important to balance support for development by the public and private sectors while taking care not to impose excessive regulations on developers. This measure will foster a sense of trust and security in PHRs among the public and patients, and enable them to freely and independently select a PHR that meets their own purposes from among multiple products of a certain level or higher, thereby promoting further accumulation and utilization of data.

Promotion of secondary use of healthcare data

In order to maximize the "value" of health and medical data, it is important to promote the secondary use of data for disease elucidation and drug discovery research, in addition to the primary use of data for health promotion and utilization in medical institutions. Looking overseas, in Finland, the purposes for which data can be used for secondary purposes are stipulated in advance by law, and data is processed in such a way that it cannot be linked to specific individuals, and then provided to companies under the judgment of Findata (a national organization), which is the centralized organization for data use. In the UK and Australia, a system has been established whereby citizens themselves can freely indicate whether or not they wish to provide their health and medical data to the research field, etc. via public PHRs, etc., for secondary use by pharmaceutical companies, academia, etc.

In section 4-1, the author mentioned the following issues in the secondary use of medical data in Japan: difficulty in understanding the details of data held by medical institutions and authorized business operators for anonymous processing, laborious data collection across multiple institutions, complicated applications for use, and the burden on medical institutions for obtaining consent and providing data. In light of these issues, the author believes that the establishment of a third-party organization that serves as a "hub" for secondary use of data, as in Finland (Findata), is a good idea for further promotion of secondary use of health and medical data. For example, a third-party organization could be responsible for cataloging and releasing data sets held by medical institutions, collecting data across multiple institutions, handling applications for secondary use of data for specific purposes (in principle, the consent of the individual is not required), and deciding whether or not to provide data. This will enable the visualization of data available for secondary use, appropriate matching of research purposes and data to be provided, and prompt start of data use (streamlining the collection of data from multiple institutions and screening for use), thereby promoting more efficient and effective secondary use. However, the large number of medical institutions from which medical data can be generated (8,238 in Japan and 249 in Finland in 2020) ¹¹⁴⁾, the dispersion of data against the background of free access to medical care, and the current situation in Japan where multiple public databases (NDB, DB for intractable diseases and small chronic diseases, national cancer registration DB, etc.) and regional medical information collaboration Considering the current situation in Japan where networks are in operation, the author believes that a decentralized system of data linkage with data stored in each organization or database, as in the Netherlands, may be more suitable for our country than centralized management of medical data by public databases, as in Finland. In any case, what is important is that the third-party organizations should be able to "accurately grasp the details of data stored in each organization, etc." and that "necessary data should be provided in a timely and appropriate manner or access rights should be granted to the data," and a data platform that contributes to these purposes should be constructed. A data platform that contributes to these purposes is required to be built.

In addition, a third-party organization that serves as a hub for secondary use of data is envisioned to be the national government or a neutral organization in public-private partnership. This will ensure that the secondary use of data is more satisfactory to the public and patients.

Furthermore, in order to promote the secondary use of health and medical data held by citizens and patients, a systematic mechanism is needed to allow all citizens and patients to freely express (select or change) their willingness to provide data (comprehensive willingness to provide data for specific purposes of use) via public PHRs, etc., with reference to measures in the UK and Australia. In particular, it is important to establish a mechanism for individuals to voluntarily provide data for secondary use in research and development of lifelog data that they have acquired and possess on their own initiative. Based on the information bank initiatives that are currently under consideration, measures should be taken to encourage citizens and patients to provide health and medical data for secondary use.

Raise public awareness of the use of health and medical data

In this paper, we have focused on environmental improvements related to data utilization, such as data infrastructures and legal systems, but we would also like to consider measures from the perspective of educating the public and fostering social thinking about the utilization of health and medical data. To repeat, the current utilization rate of PHRs in Japan is not high, at around ^10%80), and the number of accesses to personal drug information (drug information, specified medical checkups) via MyNa Portal is only 368,000 (as of August 7, 2022, approximately 2% of the 18,321,000 user folders ^opened115). In order to overcome the current situation in Japan, where data utilization is not necessarily active, it is an important perspective to educate the public and patients, who are both data providers and users.

In Finland, more than 80% of citizens were willing to provide their own health and medical data for the purpose of developing more effective treatments and new drugs, assuming that the data will be processed so that it cannot be linked to individuals, according to a 2016 ^survey116). In Japan, on the other hand, the Pharmaceutical Manufacturers Association of Japan (PMAJ) conducted the "16th Survey on Sei-katsu-sha Attitudes toward Drugs and the Pharmaceutical Industry," and found that 71.5% of respondents were willing to provide medical data for use by pharmaceutical ^{companies117)}. In addition, according to the Ministry of Internal Affairs and Communications' 2021 White Paper on Information and Communications, the percentage of respondents who are concerned about the provision of personal data, such as medical history and medical conditions, is lower than in other countries (the United States and Germany), and it would be no exaggeration to say that public expectations for data utilization in the medical and healthcare fields are comparable to those ^{overseas118).} On the other hand, the results also indicate that the percentage of respondents who are concerned about "not knowing" information such as data management systems, mechanisms for providing data to third parties, and who will use the data and for what purposes is higher than in other countries (the U.S., Germany, and China). ¹¹⁸⁾ Therefore, it is necessary for the public and private sectors to cooperate in implementing measures to improve public understanding and foster a society that is positive toward data utilization, such as communicating and educating the public about the mechanism of data linkage and utilization, and the value (advantages and disadvantages) that will be returned to individuals and society. The pharmaceutical industry will also be required to gain public understanding by further communicating the purpose of data utilization and the "value" that can be provided, and by providing opportunities to discuss secondary use of data with the public, patients, and healthcare professionals.

It is also important to introduce a system that allows citizens and patients, who are data providers, to check the status of their own health and medical data use at any time, and to foster a sense of security in data provision, referring to measures in Finland, the Netherlands, Europe (EHDS), and other countries. For example, in the aforementioned Finnish survey, while more than 90% of Finnish citizens answered that it is important to know the purpose and users of their own ^{information116)}, in this survey, a system was established to enable Finnish citizens to confirm who accessed their own health and medical data and for what purpose The survey confirmed that a system has been established to enable Finnish citizens to confirm who accessed their healthcare data and for what purpose. In Japan, this would be an indispensable measure when looking ahead to data sharing among medical institutions through a national medical information platform and the use of data for specific purposes for which the consent of the individual is not required in principle (through exit regulations). As an example, medical institutions and third-party organizations that serve as hubs for secondary use should disclose the status of use of personal health and medical data (who accesses the data, purpose of use, etc.), and introduce a system that allows citizens and patients to check the contents in a timely and appropriate manner via Mynaportal, etc. This will increase transparency of data use and make it more convincing to citizens and patients. This will enhance the transparency of data use and realize the utilization of health and medical data with a high level of acceptance by the public and patients.

Based on the proposed measures described above, the author's vision of a mechanism to promote the utilization of health and medical data is summarized in Figure 5 as a conceptual diagram, which requires interrelated measures such as the expansion of EHR-PHR data linkage, implementation of measures to promote PHR utilization, and the establishment of a hub organization to promote secondary use of data.

6. conclusion

This paper provides an overview of the current global EHR/PHR environment and data linkage (EHR-PHR linkage), etc., and discusses the efforts required to promote the utilization of health and medical data in Japan. As the nature of medicine and healthcare expands from a focus on treatment to the entire life course, including prevention, diagnosis, and prognosis, it will become increasingly important to establish the infrastructure and systems for appropriate linkage of data acquired in all situations and for all purposes, both within and outside of medical institutions. In the pharmaceutical industry, more and more companies are moving beyond the field of "treatment," which has contributed to the creation of innovative new drugs, to become "total healthcare companies" that cover all aspects of healthcare from prevention to prognosis. In order to enhance the environment for data utilization in Japan, we believe that it is necessary to promote effective initiatives with reference to the overseas measures presented in this report.

Japan's health and medical data, including abundant medical data accumulated based on a high-standard medical system, long-term health checkup information, and life log data, are substantial in both quality and quantity, and we have an environment that we can boast of to the world. In order to take advantage of this environment, discussions on the utilization of health and medical data are currently progressing rapidly throughout Japan, led by the government's "Medical DX Promotion Headquarters " ^119). It is necessary for the public and private sectors to work together to build a data utilization environment that contributes to the creation of new value, while backcasting from the future that should be envisioned by stakeholders in industry, government, academia, and the private sector. The pharmaceutical industry, which is expected to contribute to social change through the use of healthcare data, should play a central role in this discussion.

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