The promotion of value-based healthcare
through digital transformation
American Medical Devices and Diagnostics Association
Digital Health Committee

Research Project Report

Executive summary•

Maintaining a universal health insurance system and providing high-quality medical carerequires transitioning from the current fee-for-service-based system for health insurance tovalue-based healthcare (VBHC). Healthcare digital transformation (DX) is essential in thisprocess.

•

Linking and sharing data such as personal health records (PHR) and medical information
allow for early diagnosis and the prevention of disease aggravation, leading to an
improvement in healthcare value. These actions can also promote research anddevelopment and technology assessment, while helping to solve social problems (e.g., by
reducing social costs such as expenses for medical care and nursing and eliminating labor
shortages in clinical settings).

•

To link PHR and other medical information, it is necessary to establish a platform and policy
for shifting data ownership and management into the hands of individuals.

•

It is necessary to create an environment that will ensure the international interoperability of
PHR and other medical information, so that people can benefit from world-class medical
technology at the highest level.

•

Reasonably evaluating the value of digital health technology is difficult in current fee-based
medical systems. Enabling evaluation from new perspectives specific to digital healthtechnology such as burden reduction for healthcare professionals, the equalization andoptimization of technology, rapid development, and product improvement will requireestablishing a new system for evaluation with reference to foreign cases and the utilizationof the system for medical expenses combined with treatment outside insurance coverage.

•

Collaboration among stakeholders and the healthcare DX schema, as well as knowledgesharing, is essential for implementing healthcare DX amid significant environmental
changes and advances in technology. An information-sharing and discussion platform forgovernment and industry should be prepared for that purpose.

Table of contents

Executive summary
Introduction
Section 1 Overview of elements and direction of discussion on healthcare DX
1.1 Necessity of healthcare DX from perspective of value-based healthcare (VBHC)
1.2 Objectives of this proposal and issues regarding promotion of healthcare DX
1.3 Mapping of main stakeholders for healthcare DX
Section 2 Necessity of policies for shifting data ownership into the hands of individuals andsecondary use of data by companies. Necessity of linking and sharing healthcare data
2.2 Loss of opportunities to receive medical advice that would occur with personal dataobtained in a real-time manner (case of challenge related to [1] and [2] )2.3 Loss of opportunities for medical care due to insufficiency of database (case ofchallenges related to [2] ). Brief summary and challenges related to data privacy and their solutions.
2.5 Loss of opportunities to receive medical advice that would occur with personal dataobtained in a real-time manner (case of challenge related to [1] and [2] ). Data utilization with consideration for the work style reform
2.7 Loss of opportunities to receive medical advice that would occur with personal dataobtained in a real-time manner (case of challenge related to [1] and [2] )Section 3 Whole issue of digital health technology assessment and its perspectives
3.1 Digital health technology assessment/main challenges related to value assessment
3.1.1 Digital health technology assessment contributing to reduction of burden on
healthcare professionals, etc.
3.1.2 Assessment in line with speed of product development and improvement
3.1.3 Assessment of technology contributing to optimization of medical institutions andsystems

3.1.4 Assessment in Japanese health insurance system focused on fee-for-service
3.2 Overall aspects of evaluation of digital health technology and its perspectives
3.2.1 Reduction of the burden on healthcare professionals
3.2.1.1 Evaluation as special treatment material
3.2.1.2 Preliminary evaluation
3.2.1.3 DPC functional coefficients
3.2.2 Equalization and levelling of healthcare technology
3.2.2.1 Outcome assessment/reward success type
3.2.2.3 DPC functional coefficient
3.2.2.4 Selected treatment
3.2.3 Optimization
3.2.3.1 DPC functional coefficient
3.2.3.2 Assessment of premium for medical devices/management fee
3.2.4 Evaluation in line with speed of product development and improvement
3.2.4.1 Preliminary evaluation
3.2.4.2 Advanced medical care
3.2.5 Other issues
3.2.5.1 Primary and secondary prophylaxis
3.2.5.2 Continued development after product launch
Section 4 Arrangement of environment for digital health to ensure safety and security of users
and efficient utilization
4.1 Four principles for arrangement of environment for digital health4.1.1 Principle of open inclusion
4.1.2 Principle of pursuit of state-of-the-art and international compatibility

4.1.3 Principle of minimization of human load
4.1.4 Principle of arrangement for environment with safety and security
4.2 Three steps for arrangement of digital health environment
4.2.1 Digital health architecture
4.2.1.1 Necessity of arrangement of master data related to medical device logistics
4.2.1.2 Promotion of administrator function for safety management of medical information
system in medical institutions
4.2.2 Arrangement of laws and regulations
4.2.2.1 Introduction of cases demonstrating the necessity of legal arrangement to ensure
cyber security of medical devices
4.2.3 Implementation
4.2.3.1 Arrangement of environment where options are provided for patients and theirfamilies in an appropriate manner
4.4.3.2 Investigation of challenges related to implementation of online medical care and its
effectiveness4.3 Digital health conference between government and industry

Introduction
Given the declining birth rate in Japan, healthcare DX should be promoted to extend Japan shealthy life expectancy, improve operational efficiency in clinical settings, and ensure the efficiency
and effectiveness of medical service provision. Healthcare DX is designed to manage information anddata generated during processes related to healthcare, medical services, and nursing (e.g.,
prophylaxis, consultation, examination/treatment/prescription, medical certificate preparation,
medical fee claim, collaborative care, collaborative local medical service, and research anddevelopment) through an optimal platform, as well as the externalization and standardization ofsystems and data and the tasks performed by personnel involved in healthcare, medical services,and nursing. It is also intended to promote an awareness of preventive medicine and ensure theprovision of high-quality medical services. Japan was ranked 29th in global digital competitivenessin 2022 (according to an IMD survey) and is falling behind the rest of the international community on
digitalization and DX. Government promotion of digitalization in the medical field is urgently needed.
The government established a headquarters for healthcare DX promotion in the cabinet secretariat
in October 2022. This headquarters is fostering the establishment of a platform that will enable theoptimization of service and its quality improvement through healthcare DX to improve medical
services covered by health insurance and optimize medical care. This headquarters has establisheda system to address tasks interdepartmentally without the need for vertical government
administration and has created a policy emphasizing the need for collaboration between the medical
and industrial communities.
The American Medical Devices and Diagnostics Manufacturers Association (AMDD) is mainlycomprised of Japanese subsidiaries of US manufacturers of medical devices and in vitro diagnostics(IVD) and of Japanese manufacturers of medical devices and in vitro diagnostics (IVD) serving US
markets. The AMDD aims to achieve high-quality medical care and sound medical financing throughthe introduction of high-value medical technology. To this end, the organization is seeking to
implement VBHC. The AMDD considers that this will require a wide range of digital technology
applications in the medical field as well as the management and distribution of medical devices and
IVD. The promotion of healthcare DX is a core pillar of AMDD activities.
The AMDD Digital Health Committee initiated a research project in the context of the government s
commitment to promoting healthcare DX. This committee aims to create a better society through thedigitalization of medical and societal systems utilizing medical, information, and communication
technologies. It proposes to foster these systems by referring to advanced cases inside and outside
the country.

This proposal consists of the following.
Section 1 Overview of elements and direction of discussion on healthcare DX, which discusses
the necessity of healthcare DX from the perspective of VBHC pursued by AMDD, the direction of
future advances in medical devices and technology, the mapping of stakeholders who are assumed
to cooperate with AMDD for the implementation of healthcare DX, and issues related to work stylereform starting in 2024.
Section 2 Necessity of policies for shifting data ownership into the hands of individuals andsecondary use of data by companies , which discusses and introduces the cases how healthcare
DX can contribute to improvements, such as increasing opportunities for medical care utilizing realtime data, ensuring appropriate medical care by making a solid platform for sharing medical
information, promoting companies research and development/technology assessment
opportunities by increasing access to medical information, and contributing to work style reform ofhealthcare professionals via the use of medical information.
Section 3 Whole issue of digital health technology assessment and its perspectives, which
focuses on how to evaluate digital health technology for promoting healthcare DX for inclusion in
the health insurance system; and discusses issues related to assessment, including reducing
burdens on healthcare professionals, fostering technology equalization and optimization,
conducting assessments in line with rapid product development and improvement, and addressing
problems specific to digital health technology (such as programmed medical devices) that are
difficult to assess properly in the current medical fee system, with a presentation of foreign casesand proposals for the utilization of the system for medical expenses combined with treatment
outside insurance coverage.
Section 4 Creation of a digital health environment that ensures user safety and security andefficient utilization, which identifies four principles (open and inclusion, pursuit of state-of-the-art
and international compatibility, minimization of human load, and creation of an environment withsafety and security) and three issues (architecture, laws and regulations, and implementation) thatstakeholders should understand regarding the promotion of healthcare DX in the current situation,amid drastic environmental changes and in technological advances. This includes the need toestablish codes for medical device logistics to ensure a stable supply of medical devices and IVD,
which is currently recognized as an important issue.
In addition, the section proposes the necessity of an inclusive discussion involving all stakeholders
on the effective and efficient implementation of multidisciplinary digital health technology andappropriate policy assessments.

This report, based on the specialized knowledge of medical domain, is expected to be referred to by
government officials and members of the Diet in collaboration with the academic community andrelevant industrial associations to support their discussions. This will result in a collaboration
between government and industry in Japan, as well as with the US government and the US-based
Advanced Medical Technology Association (AdvaMed), which will help enhance healthcare in Japan.

References•

Version , Healthcare DX Reiwa Vision(August ,•(LDP: May,), MHLW Promotion Team) Material https://www.mhlw.go.jp/content/

IMD World Digital Competitiveness Ranking

/

.pdf

https://www.imd.org/centers/world-competitiveness-center/rankings/world-digital-competitiveness/•

Fiscal system subcommittee, fiscal system council (held on April ,) MOF document

https://www.mof.go.jp/about_mof/councils/fiscal_system_council/subof_fiscal_system/proceedings/material/zaiseia
•

.html

Cabinet Secretariat, Establishment of headquarters of healthcare DX promotion
https://www.cas.go.jp/jp/seisaku/iryou_dx_suishin/pdf/siryou .pdf•

AMDD HP

https://amdd.jp/about/leaders/Section 1: Overview of elements and direction of discussion on healthcare DX
This section discusses the necessity of healthcare DX in terms of the VBHC pursued by the AMDD,
the future direction of medical device and technology advances, the mapping of stakeholders who
are likely to cooperate with the AMDD in healthcare DX implementation, and issues regarding thework style reform starting in 2024.

1.1 Necessity of healthcare DX from perspective of value-based healthcare (VBHC)The aging population and increasing medical costs due to advances in medical technology areissues that affect the entire nation. However, the environment of medical settings is changing due
to advances in digital technology that can facilitate outcome measurements. In addition,
innovations have produced new beneficial functions for medical devices (various values). Voices,not only from Japan, but from many nations argue that medical reimbursement should be based on
the benefits provided rather than what is done. In this context, the AMDD considers that the current
fee-for-service system should be changed to a healthcare system centered on value (called valuebased healthcare, or VBHC in this proposal document) to maintain the universal healthinsurance system and provide better medical care.
In this document, value is defined as (1) the efficiency of a new technology (i.e., the extent towhich patients or the medical system can receive a benefit, such as efficacy and safety, from a newtechnology, against a certain cost), (2) the efficiency of improvements in the system and themechanism for medical fee claims and medical service provision, and (3) the concept of value usedby patients and their families in their decision-making in clinical settings.
The following issues are key factors for VBHC implementation: (1) the creation of an environment
where patients and their families can select the best medical technology option based on relevant
information, (2) healthcare DX, (3) the development of a database for data visualization enabling
the selection of the best medical technology option for healthcare providers and the promotion ofclinical outcome assessments in terms of medical fee points (basic fee and technical fee), (4) areview of the pricing (reimbursement calculation) for medical devices and technologies with theproper evaluation of the value and efficiency of individual technologies, (5) distribution
optimization and ensuring supply stability, (6) the creation of an environment that can reduce
development costs through global harmonization in the pharmaceutical affairs system, thefacilitation of evidence creation, and the realization of an efficient approval system through thejoint use of regulations and research results.
In this research project, (2) healthcare DX is discussed from a wide range of perspectives.

Figure 1: Six pillars of VBHC implementation

1.2 Objectives of this proposal and issues regarding promotion of healthcare DX
This report is published by the AMDD, which aims to help promote a better society through thedigitalization of healthcare/social systems by using the information and communication technology
of medical devices and techniques. The report proposes a system for enabling this process,environmental arrangements, and activities for stakeholder collaboration.
Based on discussions with the Healthcare Information and Management Systems Society (HIMSS),
a key academic society for medical information and healthcare digitalization, we speculate that
healthcare DX will produce four changes. It will
(1) diversify the medical system by enabling early diagnosis, the prevention of disease
aggravation, and VBHC
(2) enable changes in medical service provision (e.g., telemedicine, home care)(3) lead to the sharing of medical information and the resolution of silos (e.g., eliminate
barriers to sharing medical data among hospital staff and vendor lock-in)(4) allow technical collaboration with nonmedical companies and organizations, andfacilitate human resource acquisition to help promote healthcare DX
This research project identifies issues, presents successful cases, and offers proposals from thethree viewpoints described below to promote above mentioned four significant changes.

1. Policies for shifting data ownership into the hands of individuals and secondary use ofdata by companies (in Section 2 Necessity of policies for shifting data ownership into thehands of individuals and secondary use of data by companies ).
2. Digital health technology assessment and its perspectives (in Section 3 Whole Issue ofdigital health technology assessment and its perspectives )3. Arrangement of digital infrastructure for user safety and security and efficient utilization(in Section 4 Arrangement of environment for digital health to ensure safety and security ofusers and efficient utilization )1.3

Mapping of main stakeholders for healthcare DX

Many stakeholders (such as the government, academia, and industrial companies) are involved inhealthcare DX. The main stakeholders and themes are mapped as follows:

Figure 2: Mapping of stakeholders forhealthcare DX
References•

Makoto Tamura, Director of AMDD Medical Technology Policy Institute What value-based

healthcare means (Social Security Review, 1 December, 2018 https://amdd.jp/wpcontent/uploads/2021/01/mtpi_valuebase_healthcare.pdf•

AMDD HP New perspective: value-based health care https://amdd.jp/future/issue/2989/•

Yuji Yamamoto, Competition for improvement in quality and value of medical strategies

Section 2 Necessity of policies for shifting data ownership into the hand of individuals andsecondary use of data by companies

This section promotes the establishment of a system that will lead to the creation of new value
through data utilization with contributing to users health and medical care as essential elements.
This section does not focus on the profit-making of member companies, as it is assumed that theirprofits can be obtained through fair competition under an established system.
The most significant issue in data utilization is involved in the challenge of mutual data use, inwhich data are used by individuals and also for medical purposes or in which multiple kinds of
medical data are used for various medical purposes. This section describes the necessity ofmeasures to shifting data ownership in the hands of individuals to solve the above-mentioned
issue. In addition, the section discusses cases in which opportunities for research and development
or technology assessment are lost due to a company s lack of access authorization, and cases thatlead to potential disadvantages for patient, to emphasize the necessity of enabling the secondary
use of data. Finally, cases are presented in which data are utilized in order to effectively employ
limited resources as a way to address the reform of healthcare professionals work style andemphasize the overall necessity for data utilization.

. Necessity of linking and sharing healthcare data

The government has proposed Society . as a vision of an ideal society and has taken measures
to realize it. In Society . , all people and things are linked by the Internet of Things (IoT) and shareknowledge and information so that new values can be produced to overcome the challenges
mentioned above, particularly beneficial to health and medical care. The artificial intelligence (AI)analysis of big data (e.g., real-time data on physiological measurements, status of disease diagnosis
and treatment, presence or absence of infection, living environment, and medical/family history)
will enable real-time automatic health check-ups, leading to improved health and early diseasediagnosis; and physiological and medical data sharing, leading to optimal treatment regardless oflocation, in addition to reduced social costs (e.g., medical and nursing costs) and the solution tolabor shortages in clinical settings.
Various government agencies are advancing policies for establishing a platform for linking
medical and health data, promoting networking, and encouraging utilization of information andcommunication technology (ICT). The ministry of internal affairs and communications (MIC)
promotes networking and ICT utilization to resolve challenges (e.g., increasing medical and nursing

costs, the uneven distribution of medical resources) and improve services, emphasizing thepromotion of ICT utilization. The ministry of economy, trade and industry (METI), which promotes
the provision of medical services utilizing technology at the highest level in the world andcontributions to economic growth as part of the health/medical strategies proposed by thecabinet in, implements policies for advanced research and development and the creation of

new industries scheduled from FY
for data health reform into(five years). The MHLW established its headquarters. Based on the idea that the current scattered and disconnectednature of data does not produce benefits for academic industrial collaboration, patients, andsociety, the MHLW has implemented an intensive reform plan and other plans inspired by thenecessity of establishing a big data platform to handle a large amount of existing information
related to health, medical care, and nursing.
This is but one example of the action being taken by various government agencies. Numerous
other policies are being implemented to advance networking and data linking in manyorganizations. Although these measures vary, their main objective is to solve various problems
through data sharing. The keyword for these policies is data utilization (i.e., how to utilize both
existing data collected through various methods and data that will be collected in the future). Whatis the current situation regarding data utilization?
Data types can be classified in various ways. In this document, as one method, healthcare data
are classified into the following types:
1. Data that are independently stored and managed by ordinary people (i.e., who are nothealthcare providers) regardless of their intended use. These are called personally useddata and include medical records (such as records of health checkups for nursing women,
infants/children, schools, workplaces, and residents, as well as records of life-habit disease
monitoring), test results, medication records, and healthcare data obtained from selfmeasurement.
2. Health/medical data that are utilized by healthcare professionals or under instructions fromhealthcare professionals to help with medical procedures. These are called data on
healthcare use (e.g., data on a general practitioner s diagnosis, post-operative follow-up,
rehabilitation, nursing).
The inability of personally used data and data on healthcare use to be used mutually and theinability of diagnostic data and nursing data which having the same purpose (i.e., healthcare use
data types) to be used mutually are an example of the challenges associated with these kinds ofdata. The former challenge is related to the mutual use of personally used data and data on
healthcare use (i.e., related to points [ ] and [ ] above, as illustrated in Figure ), and the latter isrelated to the mutual use of multiple kinds of medical data used for various medical purposes (i.e.,related to point [ ], as illustrated in Figure ). This report discusses these challenges and theireffects, and presents specific cases involving them.

Figure 3: Challenge related to mutual use of personally used data and data on healthcare use(related to 1 and 2)

Figure 4: Challenge related to multiple kinds of medical data used for various medical purposes(related to 2)

2.2 Loss of opportunities to receive medical advice that would occur with personal dataobtained in a real-time manner (case of challenge related to [1] and [2] )Data that can be classified as either personally used data or data on healthcare use include
patient-reported outcomes (PRO). These data mainly include the EQ- D (comprehensive quality oflife scale), VAS Pain (disease-specific score), and PRO-CTCAE (used in oncology) and are increasingly
being used for assessment in research, clinical trials, and clinical settings.
Data for personal use (can be obtained daily) including number of daily steps, heart rate, meal
records, body weight; and data on healthcare use including blood pressure and othermeasurements made by medical devices such as a blood glucose meters are measured as PRO. Lifehabit diseases are one of the areas that may benefit from the visualization of records andcollaboration with a medical institution. A study involving ,patients with Typewhom patient monitoring technology was applied twice (inanddiabetes for) to record their PHR dataat an interval of three months found that HbA c improved in patients for whom this patientmonitoring technology was used more often during these periods. In addition, many cases havebeen reported that the recording, visualization, and sharing of personally used data that supportedchanges in patient behaviors and appropriate medical instruction also led to improvements inoutcomes.
In addition to lifestyle-related diseases, relevant cases have also been reported in the field of
oncology. A study titled Symptom Monitoring With Patient-Reported Outcomes During Routine
Cancer Treatment: A Randomized Controlled Trial published in the Journal of Clinical Oncology
found a change in the survival rate and health-related QOL (HRQL) in advanced solid tumor patients
undergoing chemotherapy, with 12 common symptoms being reported by the patients on a webbased Symptom Tracking and Reporting (STAR) system utilizing a tablet PC. The results are
summarized as follows:•

The one-year survival rates were

% and% in the intervention and standard therapy

groups, respectively.
•

For serious symptoms, which were reported by% of patients who received theintervention during the study period, nurses performed frequent clinical procedures in
response to e-mail alerts.
•

Scientific research has shown that approximately half of patients symptoms are overlooked
by clinicians during cancer treatment.

•The survival rate was improved by PRO monitoring due to an extension of the period during
which patients could tolerate cancer treatment, a decrease in the number of ER**consultations, and the early discovery of recurrence.
* PRO monitoring: continuous monitoring of various symptoms subjectively felt by
patients** ER: Emergency RoomFigure 5: Example of workflow in PRO monitoring

As shown in these cases, linking personally used data and data on healthcare use that are
employed mutually can lead to the visualization of records, which can help improve the quality of
medical care. In addition, the utilization of techniques for the entry, viewing, and management ofPRO data (mainly using a mobile application installed in a smartphone or tablet) for the treatmentof various diseases resulted in an improvement of treatment adherence (i.e., patients active
participation), according to a study report. This study reviewed 11 studies evaluating mobile
applications, and reported that improvements in treatment adherence were seen in seven studies.
In addition, efficacy has been reported with the use of mobile applications in patients with asthma,coronary heart disease, and acquired immunodeficiency syndrome (AIDS). The positive effect of apatient support program in which nurses support was combined with a mobile application for thetreatment of psoriasis has also been reported.
In the current treatment trends, hospitalization periods tend to be shorter, and hospital visits andhome care have been widely selected when possible. In addition, given the changes made in local
medical care, hospitals, clinics, care facilities, and home care in response to the 2025 problem,* ansystem for remotely monitor patient conditions and urgently respond them are urgently required tomake the best use of limited medical resources, reduce medical costs while preventing disease
aggravation, and build medical infrastructure that can help people to live healthy, safe, and secure
lives which is the essential element. A system enabling the real-time utilization of PRO that can beapplied in actual clinical settings is available. Further advancements in this system could accelerate
the efforts for digital health and data health in Japan.
*2025 problem: Various difficulties associated with a hyper-aging society, where 1 in 3.9
people will be aged 75 or older in Japan in 2025, when the baby boomers will comprisethe late elderly, defined as those aged 75 or older.
However, the real-time utilization of PRO faces challenges, including burdens on healthcare
professionals. In addition, the system and environment for PRO utilization are not well-organized(e.g., no assessment based on medical fee points is available for PRO utilization). Furthermore,
system standards vary among companies, depending on the main IT vendors in the region. It isnecessary to establish a system based on a vision for the future (such as the efficient utilization of
accumulated data).
For this purpose, it is necessary to establish the following:(1)

Clear definitions and standards for data entry(2)

Quality control system with periodic assessments of differences between devices and entry
systems(3)

System for data integration into an external system (such as a vendor-independent
electronic medical record system).

(4)Market systems with a platform for the development of a better medical services , leading tocompetition.

This section describes challenges and makes proposals regarding the mutual utilization of
personally used data and data for healthcare. Data that are difficult to classify as either personallyused data or data on healthcare use (such as PRO) may be produced indefinitely. This phenomenon
is typical of intangible data. Although it is important to classify such data, it is more important toproduce data that can be used for both purposes. It is thus necessary to establish a system in whichdata that can be used more frequently can be produced as a basis for new services and competition.

2.3

Loss of opportunities for medical care due to insufficiency of database (case ofchallenges related to [2] )This section describes a case of joint replacement generally requiring post-operative follow-up as
an example. After surgery, a digital device, including a product called the TracPatch (see Figure ),can be used for remote monitoring to improve clinical outcomes and care efficiency, ultimately
leading to cost reduction.
This product has two components that are attached to the leg of a patient who has undergone
knee joint replacement. Before surgery, this patch is applied above and below the knee for baseline
measurement. After surgery, patients often experience pain; therefore, they cannot move the leg as
is required to help their recovery. The TracPatch can be used to monitor the leg s range of motion,
the appropriate amount of exercise, and the temperature of the surgical wound; the information
can be used in follow-up examinations of disease status and to propose changes in the treatment
plan. The patient can also use the application to report problems such as pain or to ask their doctor
about recovery status and physical treatment plans. This product enables communication andmonitoring of patient status without requiring the patient to visit a hospital. This may lead to a more
rapid recovery. In addition, physicians can verify that the treatment is progressing as planned,
reducing the need for follow-up visits.

Figure : Example of model for optimization of post-operative outcome monitoring

However, other types of data on healthcare use face challenges (related toabove) is assumed tobe caused by the partial optimization of information drawn from the electronic medical record

system, etc. in individual facilities and the limited coverage of the network for local medical care.
The standardization of electronic medical record systems should be advanced in parallel with thestandardization of operations/procedures for treatment, medical terms, formats of medical records,
and other medical practices. Not enough has been done to enhance the collection and utilization of
medical records across medical facilities because medical record vendors have developed andmodified the systems designed and optimized to operate in individual medical facilities.
In the United States, the informatization of medical information is overseen by the Office of the
National Coordinator for Health Information Technology (ONC). Japan has fallen behind in theestablishment of an organization in charge of cross-sectional informatization for the future of ourhealthcare system. Given that the utilization of personally used data and data on healthcare use are
involved by multiple government agency departments, which are further divided into more
departments, it is difficult for companies and research facilities to identify contacts to whom they
could offer opinions or ask questions. Efforts should be made to establish a system in which, forexample, the digital agency serves as a control tower and information desk to respond rapidly toinquiries from stakeholders, including the key companies involved, and to perform overall control ofdata utilization.
As mentioned, it is necessary to shift data ownership and management into the hands ofindividuals and establish a system for the seamless handling of healthcare-related information
obtained from electronic medical record systems in order to resolve challenges related to themutual use of personally used data and data on healthcare use (challenges related toand ) andchallenges related to other types of data on healthcare use, thus promoting the secondary use ofhealthcare data by companies and organizations. An image of the achievement of challenges related
to the mutual use of personal data and data on healthcare use (related toand , as shown in

Figure ) and challenges related to other types of data on healthcare use (related to , as shown in
Figure ) is illustrated in Figure .

Figure 7: Plan for enabling individuals to own and manage their data

As we mentioned about ONC, US measures and the background are briefly described below. In
the United States, the right to have access to electronic PHR was defined in the HIPPA Act under the
Clinton administration. Subsequently, under the Bush administration, healthcare IT initiatives were
implemented to improve healthcare quality. Through these initiatives, which aimed to establish anenvironment in which people could access their own PHR, the ONC was established as anorganization to promote healthcare IT. Under the Obama administration, the HITECH Act wasenacted to reinforce efforts to promote healthcare IT. It offered subsidies/financing for infrastructure
and privacy protection, with the Blue Button system established to encourage the provision ofhealthcare information to patients. Blue Button allows patients to download their healthcare datafrom a medical institution s portal site. This system, which was initially used by veterans andMedicare users, was adopted by private insurance users. However, this system provided only asystem for downloading, without any standardization of data content or structure. In response,standard specifications for healthcare information and safe transfer methods were established to
improve the system and create Blue Button Plus. Subsequently, MyHealthData initiatives wereprepared under the Trump administration, with Blue Button . created to improve patients data
access and control capacity. Blue Button . employs the fast healthcare interoperability resource(FHIR) as a standard protocol for healthcare information exchange and OAuth (open standard forauthorization) as a tool to obtain authorization to access data.

A review of the implementation sequence for these US systems indicates what is required foraccess to healthcare data, including electronic medical record systems, and their utilization. An
example of the standalone-type system (similar to the initial version of the Blue Button system) is
shown on the left-hand side of Figure . The middle graphic illustrates a tether-type system similar
to Blue Button Plus, which includes a portal for accessing and registering patient information. In
these two systems, which include neither specifications for medical information exchange(standardized language) nor structures for data access authorization, data cannot be linked among
different medical institutions. The graphic on the right illustrates the integrated-type system, similar
to Blue Button . . It is equipped with FHIR and OAuth, which allows for the control of information(i.e., input of information from different medical institutions and information output) for patients.
Our issues to be addressed is insufficient standardization of healthcare information required toachieve this type of mutual interchangeability, which poses a challenge. The realization of a system
like Blue Button . should initially be pursued in Japan.
The Japanese government, which aims to encourage the mutual use of health information andother data by local governments and residents via the My Number Card, has been sought to ensurethat information on municipal health checkups, specific medical checkups, and prescriptions (notedon the health insurance claim form) can be provided by Mynaportal. However, the My Number Cardis not fully distributed in the country. Although a system for online qualification confirmation isrequired in principal for health insurance medical institutions and pharmacies after April, thisrequirement has not been fully met. Open-source, decentralized networks similar to Blue Button .
should be established as soon as possible under the leadership of the government so that patients
can access (and download) their health information data via the data portals of various medical
institutions and control them. This type of network would help put healthcare data management
and ownership in the hands of individuals.

Figure 8: Blue Button 2.0 with standard specifications.

Brief summary and challenges related to data privacy and their solutions.
We discussed and presented cases illustrating the challenges related to the mutual use of

personally used data and data on healthcare use (related toand) and challenges related to othertypes of data on healthcare use (related to ) and proposed ideas how to shift data management
and ownership into the hands of individuals. This requires a mechanism for the seamless handlingof healthcare-related information obtained from an electronic medical record system. Shifting data
management and ownership into the hands of individuals could enable the real-time utilization of
peripheral data and data tracing over time.
Data utilization is associated with privacy issues. Appropriate data privacy protection is a criticalchallenge when putting data management and ownership into the hands of individuals. This
challenge must be overcome for the system to be usable. However, excessive privacy protection is abarrier to data utilization. Therefore, a policy that both protects data privacy and encourages
utilization is necessary. A proposal and example of how to do this are provided below.

Figure : Current unorganized data privacy system in Japan

ApacMed, a medical device association located in the Asia-Pacific region, recently announced
recommendations about how to provide access to high-quality data. ApacMed emphasized thatdata access can promote patients understanding, accelerate access to the market, and support
development based on needs. In the ApacMed meeting, the following were recommended as meansof enabling effective data access:•Development of specifications for health data and harmonized format

•

Utilization of best practices developed by the International Standards Organization or othergovernment agency and models for reference•

Development of practice codes and a voluntary framework to promote the reliableutilization of and access to health data

Japan s Personal Information Protection Commission updated five guidelines for the Japanese
privacy system under the Act on the Protection of Personal Information in August 2021.
These guidelines include:•

General regulations•

Provision of personal information for a third party in foreign countries•

Obligation of review and recording of personal information provided for a third party•

Anonymized information•

Certified organization for personal information protection

In these revised guidelines, in which data privacy protection is significantly enhanced, ApacMed
requires further modifications in the areas described below:•

Expansion of individual rights•

Requirement for reporting of data leakage•

Use of pseudonymized information•

Reinforcement of penalties•

More strict regulations on the provision of data that can identify individuals to a third party•

Avoidance of personal data leakage across the border•

Expansion of extraterritorial application

Under the expansion of individual rights , a data subject can ask for data deletion in cases where. individual data are no longer necessary. significant data leakage occurs, or. the rights or profits of the subject may be violated.

In addition, the data subject can ask for the disclosure of individual data transfers. Furthermore,
the requirement for reporting has been strengthened to make the following compulsory:•

reporting to the regulatory authorities•

notification to the data subject who will be affectedData privacy is currently considered in many ways. However, policies for achieving both dataprivacy protection and data utilization have been insufficient. The above proposal by ApacMed does
not address every issue. However, regulations should be reorganized developing matrix
management structure as soon as possible to establish a system that achieves both data privacy
protection and actual implementation to prevent inappropriate privacy policies from hampering
data utilization. Therefore, complete privacy protection is not necessary to pursue. Instead, it isimportant to clarify first the limitations and responsibility boundary points so that providers andusers can understand both the responsibilities and risks of data utilization.
The MHLW announced its Digital Transformation (DX) Action Strategies in Healthcare for
SaMD(Software as a Medical Device) on November,, which set out a policy for developing

enhanced structure for promoting the practical use of programmed medical devices. Reducing thehurdles to data utilization will accelerate this policy. Factors that hamper data utilization include thefollowing:. the need to obtain consent from individuals to use their personal information. data integration difficulties due to differences in data format across electronic medical records. uncertainties regarding business models (e.g., medical fee claim) and regulations

However, data on healthcare use cannot be used mutually when patients receive checkups at
multiple medical institutions, which leads to a shortage of the information required for diagnoses.
In this situation, duplicate examinations may be necessary or diagnostic precision may be reduced.
To solve this problem, data should be managed uniformly, data ownership should be shifted to thehands of individual patients, data utilization should be promoted, patient convenience should be
improved, and medical costs resulting from unnecessary examinations should be reduced. In
addition, given that a factor

above cannot be easily resolved, data that can be mutually usedshould be identified. We propose that a roadmap for the realization of the mutual use of data should
be formulated, starting with data for which mutual use may be relatively easy (such as vital dataobtained from health checkups and wearable devices), subsequently expanding this work.
Theth

Basic Science and Technology Basic Plan decided by Cabinet in, describes Society .

as the kind of society that Japan should pursue. In this society, all generated data are aggregated as
big data to be analyzed by AI and are returned to the real world for use in economic development
and the resolution of social challenges. As an example, to embody this, the revision of medical feesin April

specified a policy by which health insurance would cover the costs of programmed

medical devices, which encouraged manufacturers. However, Japan has few medium- or smallscale medical institutions with fewer thanbeds (allowed under the medical law) and dedicatedstaff with IT expertise. Even where such dedicated staff are present, few medical institutions have

sufficient security measures to protect personal information due to their budget or knowledge level.
Medical fee was revised that imposes a medical fee premium for medical record management
systems at institutions with at least

beds that can submit a notification of the premium. In linewith this revision, improvements in the IT security levels of medical institutions should bemonitored so that policies can be reviewed and revised based on the monitoring results.
In addition, there is often no significant difference in medical fees between medical institutions
that do and do not use programmed medical devices. Companies may therefore give up introducing
such devices given the business risks involved. The evaluation measures for medical fees should beclarified in ways not limited to programmed medical devices. Encouraging their use requires
incentives of many kinds (in addition to medical fees for medical institutions) from a macroscopic
perspective. Furthermore, in addition to a system for medical fees for medical interventions using
programmed medical devices, another medical fee system is required for the application of dataobtained in clinical settings.
As mentioned, the contents and attributes of data items differ depending on the specifications ofelectronic medical record manufacturers, which prevents medical institutions from being able toutilize uniformly collected data without any processing. Thus, a public database should be prepared
under the leadership of the government to collect data for use and uniform management, followedby processing for anonymization and standardization. Sufficient security measures should be taken
for such a database, which would reduce the burden on medical institutions and promote its
utilization by companies. The future plan for shifting healthcare data management and ownership
into the hand of individuals described above with reference to Blue Button . and theestablishment of a public database under the leadership of the government could help achieve this.

2.5

Loss of opportunities for research and development/technology assessment due tocompany s lack of authorization to access data

The cost of new medical device development is increasing worldwide. Although insurance
reimbursements covering those costs may have been expected in the past, these that meet theinvestment are often difficult to obtain amid the severe insurance financing situation. The
introduction of new devices to the Japanese market may be abandoned when no recovery of theinvestment can be expected.
Data utilization in line with actual clinical settings may lead to significant optimization, cost
reduction, and acceleration in the development of medical devices, for which huge costs are
required. In particular, real-world data (RWD), in contrast to clinical trial data, can contributesignificantly to the early realization of innovative medical devices with low costs, increasing
investment in the Japanese market and investment priority.
The utilization of RWD is expected to occur during various phases of product development. The
utilization of RWD in the regulatory process is highly expected to accelerate the creation of evidence.
The Pharmaceutical and Medical Devices Agency (PMDA) announced notifications called Basic
Principles on Utilization of Registry for Applications and Points to Consider for Ensuring the
Reliability in Utilization of Registry Data for Application as a measure to create an environment for
the utilization of RWD, including data in databases (registries) managed by academic societies andother organizations.
Registry data employed for regulatory applications may be used for various purposes, such asexternal reference comparison and the supplementation of clinical studies. If data can be usedinstead of clinical studies, new medical devices and new indications can be rapidly provided topatients, leading to significant cost reduction. Given that applications for regulatory approval using
RWD are increasing worldwide, use standards that are more flexible and in line with real-world
conditions should be prepared with consideration given to the differences across databasereliability levels and the need for international regulatory harmonization (as methods of handlingpersonal information in Japan differ from those of other countries).
In Japan, many registries have been established through industry government academia
collaboration. Although many registries developed under the leadership of academic societies areavailable, they pose several challenges, such as the requirement for patient consent, limited accessfor companies, and a limited availability of information. Therefore, these databases are not utilized
extensively for the development of new products, algorithm improvement, or the submission of
applications for regulatory approval. Although many other types of registries have been establishedfor various purposes, no process for obtaining consent for company use has been designed, which
often causes accumulated data to remain unused. In one case, for example, only opt-in data can beused because the patient s consent for the submission of an application for regulatory approval isrequired even when consent has been obtained from the academic society that manages the data.
To address these problems, a scheme should be established to utilize the data extracted byprocessing, such as anonymization/pseudonymization, in such a way as to include only the
information necessary for the submission of the application for regulatory approval. Registry data,
which reflect the status of the clinical setting and include patient data that are more diverse thandata drawn from clinical studies conducted under controlled circumstances, can be used for clinicaldevelopment.

An example of the challenges posed by companies lack of authorization to access data is provided
below. This is a case in which utilization is prevented from improving an AI algorithm based on
patients RWD in program development.
The technology continuously records local field potential (LFP), a type of brain wave, provides an
AI-programmed auto-adjustment of the intensity of stimulation to the deep part of the brain
depending on the changes in the patient s condition related to treatment and other factors. This
technology is expected to reduce the incidence and degree of adverse reactions related to themaintenance of the on-status and excessive stimulation. Patient monitoring data collected via IoT
and remote monitoring system were used as training data in an effort to improve the quality of thealgorithm in the research and development department. In the actual clinical settings, algorithm
optimization of AI-programmed devices can be achieved using pseudonymized RWD information.
The following problems arose in Japan case:•Pseudonymized RWD information obtained from medical institutions can be usedsecondarily for research and development under the relevant regulations. However, datautilization is insufficient because of the absence of specific written procedures forpseudonymization in medical institutions•

There are no procedures for appropriate data processing in medical institutions using
patient data obtained from medical devices equipped with an AI program used as trainingdata•

The relevant regulations are unclear (e.g., the submission of raw data for quality assurance,
which must be submitted in applications for regulatory approval, may violate personal
information protection regulations)Figure: An example of challenges due to a lack of company s authority to access data

Companies cannot access data in Japan due to the complex regulations, as shown in Figure.

Therefore, data from Japanese patients cannot be used for research and development or
technology assessments to improve treatment performance.
The regulations at issue in this context include the prohibition of data provision to third parties
specified in the Next Generation Medical Infrastructure Act (Paragraph of Article
andof Article

and Paragraph). In this regard, the following matters should be clarified: ( ) the procedures forpseudonymization in medical institutions and ( ) the fact that the use of raw data for quality
assurance in the process of regulatory review (regarded as a part of research and development) is
acceptable under the Personal Information Protection Law. Industry government academia
collaboration should be conducted to achieve better results and foster utilization.

.

Data utilization with consideration for the work style reform

Japan has an excellent system for providing medical services, which is supported by thecommitment of healthcare professionals, including physicians. However, they have reached a limit
because of their excessive burden. Therefore, work style reforms for healthcare professionals arebeing discussed. An application of a regulation regarding the upper limit for extra work hours will bestarted in April. Given that many physicians have exceeded this upper limit of working hours,

the total supply of medical services will decline due to the application of this limit. Meanwhile, thedemand for medical services is expected to continually increase in most regions due to population
aging at least until between

and.

As mentioned, the promotion of data utilization can lead to improvements in patient outcomes
and the promotion of innovation by companies. Furthermore, it is likely to encourage work stylereforms among healthcare professionals. As one case in point, an increase in the efficiency ofhealthcare operations through data utilization is described below.
In an Asset Performance System (APM), a sensor is attached to ultrasound diagnostic equipment(mobile type) to identify and display its location using a receiving system in a hospital. In a largescale hospital with dozens of pieces of equipment of the same type, not all equipment is inoperation at any one time; thus, some equipment may be redundant. This requires a system that
could ensure a more efficient operation of the hospital s equipment and confirm that only what isnecessary and sufficient is purchased.
In addition, a system called a command center could visualize the status of physicians andnurses (e.g., their location) as well as the status of bed usage, prospects for admission anddischarge, and other issues. With this system, nurses in a ward with more than enough workers
could be sent timely to a ward that lacks staff, or the operation of beds could be optimized based on
the current bed situation and prospects for future admissions and discharge.

Figure: Efficient operation of medical assets and optimization of workflow

In such cases, the system does not perform optimization. Instead, data on status in the clinicalsetting are prepared for visualization. Based on the visualized data, the personnel in charge canconsider increasing efficiency for optimization. In these cases, data are utilized for the efficient
operation of limited medical resources, in addition to work style reforms for healthcare
professionals.
In addition, automation and optimization are expected for the processes of checking for medical
fee claims and preparing draft symptom specifics. If the standardization of information in medical
health records includes the integration of electronic medical health records and medical fee claims,
computer processing can be refined to allow for the identification of items required to calculate
medical procedure fees, making medical fee claim checks by physicians unnecessary. The
attachment of symptom specifics may be required for techniques newly covered by insurance. In
this case, the draft can be automatically prepared based on information drawn from electronic
medical health records, leading to a significant reduction in the desk work burden on healthcare
professionals. It is not difficult to imagine several scenarios based on the development of automatic
writing systems.
The introduction of an additional system may be required as infrastructure to allow datautilization to contribute to work style reform for healthcare professionals. However, a dilemma
often occurs when a new system cannot be introduced without a medical fee. Therefore, medical
institutions should appreciate the value of data utilization (e.g., cost reduction for medical
institutions and increased attractiveness due to an improved work environment, leading to new
personnel acquisition) and take the appropriate measures. The AMDD and its individual member
companies would like to support the efforts of medical institutions and personnel operating invarious work areas.

.

For future
We have described issues surrounding data utilization, pointing out the necessity of a policy

designed to shift data ownership into the hands of individuals, enable the secondary use of data bycompanies, and encourage data utilization with a consideration for work style reform. Important
challenges, including issues regarding data handling difficulties such as data quality assurance andthe transition of personally used data into data on healthcare use, will be discussed in detail in the
future. This document does not describe the dilemma posed by the conflict between the necessityof classifying data types and the difficulties associated with this classification. This will also be
discussed in the future.

References
・

Cabinet OfficeSociety .

https://www .cao.go.jp/cstp/society _ /・Office of Prime Minister Global Health Strategy
https://www.kantei.go.jp/jp/singi/kenkouiryou/suisin/ketteisiryou/kakugi/r

senryaku.pdf
・

MIC Homepage
https://www.soumu.go.jp/menu_seisaku/ictseisaku/ictriyou/iryou_kaigo_kenkou.html

・

METI Healthcare industry policy in METI
https://www.meti.go.jp/policy/mono_info_service/healthcare/01metihealthcarepolicy.pdf

・Homepage of Headquarters for promotion of data health reform in MHLW
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000148743.html

・

Dejung Su et al. Diabetes management through remote patient monitoring: the importanceof patient activation and engagement with the technology. Telemed J E Health. 2019
Oct;25(10):952-959.doi: 10.1089/tmj.2018.0205. Epub 2018 Oct 27

・

Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A
Randomized Controlled Trial | Journal of Clinical Oncology
https://ascopubs.org/doi/10.1200/JCO.2015.63.0830

・

Celia Alvarez (2019), Mobile Apps for Increasing Treatment Adherence: Systematic Review
J Med Internet Res. 2019 Jun; 21(6)https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6604503/
The Japan Research Institute Working Group for Healthcare Digital Reform, Pursuit oflinking and utilization of medical/healthcare data for sustainable healthcare system
https://www.jri.co.jp/page.jsp?id=104452

・

Medical Experience Japan Electronic medical record subcommittee Proposal for reform ofelectronic medical record system as a tool for pursuit of reasonable healthcare for people(September 30, 2021) https://medicalexcellencejapan.org/jp/yojigen/・Regulatory reform promotion council, 10th Working Group for healthcare and nursing(March 28, 2019) https://www8.cao.go.jp/kiseikaikaku/suishin/meeting/wg/iryou/20190328/agenda.html
https://www8.cao.go.jp/kiseikaikaku/suishin/meeting/wg/iryou/20190328/gijiroku0328.pdf

・MHLW, DX (Digital Transformation) Action Strategies in Healthcare for SaMD (DASH for
SaMD

November 24, 2020 https://www.mhlw.go.jp/content/11124500/000761867.pdf

・Cabinet Office・

Office of Prime Minister Headquarters for promotion of global health strategy

Society5.0

https://www8.cao.go.jp/cstp/society5_0/

https://www.kantei.go.jp/jp/singi/kenkouiryou/index.html

・

Health and Labor Sciences Research Grant in FY 2021 Research Summary Report(representative: Shohei Nakano Study on understanding of status of data utilization andidentification of challenges in development and research of medical devices utilizing AI )Link

・Basic guidance on private PHR vendors handling of information on health checkups.
https://www.meti.go.jp/policy/mono_info_service/healthcare/00phrshishin_20220401.pdf

Section 3 Whole issue of digital health technology assessment and its perspectives
This section focuses on evaluating digital health technology (i.e., healthcare DX) for inclusion in thehealth insurance system.
First, the main issues related to digital health technology assessment/value assessment aresummarized, covering the assessment method for digital health technology and various
perspectives. Issues related to assessment are then discussed, including the reduction of burdens
on healthcare professionals, technology equalization and optimization, assessments in line with
rapid product development and improvement, and problems specific to digital health technology(such as programmed medical devices) that are difficult to assess properly in the current medical
fee system. This is followed by a presentation of foreign cases, and a proposal for expansion of thescope for additional fee for a first-time patient without a referral and a system use for medical
expenses combined with treatment outside insurance coverage.
This section focuses on the digital health technology specified in the PMD Act (i.e., that used for the
diagnosis, treatment, and prophylaxis of human diseases in medical care). The term digital healthtechnology may include any IT-related technology used in healthcare. However, this section
excludes discussion of technologies used to share information in medical institutions or conduct
optimization (such as electronic medical health records).

3.1 Digital health technology assessment/main challenges related to value assessment
3.1.1 Digital health technology assessment contributing to reduction of burden on healthcare
professionals, etc.
While many digital health technologies offer high efficacy and safety for patients, some digital
health technologies can reduce the burden on healthcare professionals and help equalize
technology.
For example, a program for supporting diagnostic endoscopy equipped with AI can help equalize
medical technology by increasing the accuracy of non-specialists and reduce the burden on
healthcare professionals through the support provided by imaging interpretation.
Under the current medical fee system, assessments of medical techniques and equipment are
performed for techniques that are found to have efficacy and safety levels higher than those of theexisting techniques. However, it is unclear how best to evaluate reductions in the burden on
healthcare professionals and technology equalization. As will be mentioned later, the Central Social
Insurance Medical Council has discussed only the current framework for the FY 2022 revision of
medical fees.
3.1.2 Assessment in line with speed of product development and improvement
Medical devices have shorter development and improvement cycles than pharmaceuticals have.
However, digital health technologies have even shorter cycles. Changes in line programs may leadto widely different performance levels.
It takes at least four to five months to re-evaluate existing medical technology/equipment todetermine medical fees (points) by functional classification or technical fee for both special
treatment materials and technical-fee included ones. In this situation, it is difficult to provide thebenefits of new technologies to patients rapidly, and suppliers have few incentives for rapid
development and provision.

3.1.3 Assessment of technology contributing to optimization of medical institutions andsystems
Digital health technology often contributes to the optimization of medical institutions operations
and systems (e.g., reduction in medical costs), which reduces the burden on healthcare
professionals.
As has been mentioned, for example, supporting imaging interpretation can help reduce the burden
on physicians and advance optimization in medical institutions through the supporting function toprepare reports of the interpretation results. In addition, a software program for supporting thedesign of a surgery plan, which is expected to have high precision, can save time in surgery
simulation. This technology can also contribute to data collection and management, as well as
telemedicine.
The evaluation of medical institution and system optimization within the framework of the medical
fee system includes the evaluation of many materials purchased by medical institutions (e.g.,
personal computers). It is thus natural for a certain framework to be considered necessary for theevaluations conducted in the medical fee system. According to a discussion in the Central Social

Insurance Medical Council for the FY 2022 revision of medical fees, materials that are not approvedor certified as medical devices are not included in the medical fee system.
However, in the Japanese healthcare system, where there is strong demand for the optimization of
medical costs, efforts should be made to introduce digital health technology that enables
healthcare optimization. Therefore, an assessment framework for this type of technology in the
medical fee system is necessary.

3.1.4 Assessment in Japanese health insurance system focused on fee-for-service
The government is promoting a form of new technical fee and premium mainly in the fee-forservice system in line with what it considers appropriate for medical institutions.
The rate of digital health technology adoption will not increase in medical institutions without avisible incentive, even if the government promotes it. According to a member of healthcare
institution, new technology is typically introduced following a discussion with reference to the
medical fee in the administrative office of the hospital, according to a person affiliated with a
medical institution.
It is understandable that the difficulties to assess reductions in the burden on healthcare
professionals and the optimization of medical institutions and systems in the current medical fee
system. However, action must be taken given the relationship between medical fees and theinitiatives of medical institutions, as well as the significant need to optimize medical costs in Japan.
3.2 Overall aspects of evaluation of digital health technology and its perspectives
The main aspects concerning the evaluation of digital health technology and its perspectives are
summarized in Table 1.

Table 1: Overall aspects of evaluation of digital health technology andits perspectives
The main perspectives and elements concerning digital health technology evaluation are shown inthe columns of Table 1. The items to be evaluated are shown in the rows, and the items for which
evaluation method requires consideration are circled in the column.
For example, digital health technology that may contribute to improve patient outcomes may beevaluated in terms of a potential increase in the technical fee (e.g., surgery fee), the premium, or the
management fee for medical devices or special treatment materials.
Among these aspects, the evaluation perspectives that should be considered deeper are discussed
below, along with the relevant evaluation methods.

3.2.1 Reduction of the burden on healthcare professionals
If the reduction in the burden on healthcare professionals is assessed in terms of the technical costin a conventional manner, the technical fee may be negative (rather than positive) from theviewpoint of the amount of money relative to the time consumed by healthcare professionals. In
this situation, medical institutions make no effort to introduce such technology, and development
incentives for companies are significantly reduced.
A discussion of the Central Social Insurance Medical Council for the FY 2022 revision of medical fees
concluded that a program supporting the design of treatment plans cannot be evaluated only interms of a reduced plan preparation time (see below).

Figure 12: An example of practical use of programmed medical devices (fromMHLW s materials)
Three effective methods of evaluating burden reduction for healthcare professionals are described
below.

3.2.1.1 Evaluation as special treatment material
Digital health technology can be evaluated as a special treatment material to ensure that burden
reduction for healthcare professionals is not linked with a reduction in technical fees. It is necessary
to demonstrate that digital health technology, as a special treatment material, has certain clinicalbenefits. Even if the technical fee decreases, the total technical fee and price of the special
treatment material may be positive.
In cases where digital health technology is evaluated as a special treatment material, a rule should
be formulated to clarify the definition of the functional classification of special treatment materials
and their costing methods. For example, while the functional classification of special treatment
materials is defined as a group of special treatment materials that resemble each other in terms of
the structure, intended use, and clinical indications, and others, what structure means forprogrammed medical devices is not clear.

3.2.1.2 Preliminary evaluation
A preliminary evaluation, as defined in this section, is a medical-fee-based evaluation of technology
with a high likelihood of efficacy for which insufficient evidence has been accumulated, and it isperformed in advance of the evidence collection period. In Europe and the United States, this isreferred to as Coverage with Evidence Development and is a widely used process. In Europe,
where evidence of efficacy was not required for the certification of medical devices for a long time,
this kind of system was developed in a context where approved medical devices were not available
for patients because they were not covered by health insurance (efficacy data are now required forall medical devices in Europe from the outset).
Table 2 presents a list of cases wherein the New Technology Add-on Payment (NTAP), a
preliminary evaluation system under Medicare and public health insurance for the elderly in the
United States, was applied to medical devices equipped with AI. For example, the NTAP was applied
to technology that diagnoses diabetic retinopathy using AI.

Table 2: Cases where the US NTAP is applied to medical devices equipped withAI (from NTAP materials)

As mentioned in the opening, digital health technology is developing rapidly and has a shortproduct cycle. Therefore, it may be preferable to evaluate the efficacy this type of technology inclinical settings based on real-world evidence (safety is essential). It is thus reasonable to use apreliminary evaluation system for digital health technology.
Digital health technology that is expected to reduce the burden on healthcare professionals has its
own value. This reduction is expected to reduce accidents. This aspect should be evaluated basedon real-world evidence rather than a framework such as a clinical study.
Advanced healthcare system includes the concept of preliminary evaluation. In advanced
healthcare, evidence is accumulated in clinical settings for materials for which evidence of efficacy
is insufficient for a determination of whether the materials are to be covered by health insurance.
While the cost of the technology of advanced healthcare is paid by patients, the costs of othermedical procedures are paid as medical expenses combined with treatment outside the scope of
public health insurance coverage.
In addition, according to the interim report for regulatory reform promotion prepared by theregulatory reform promotion council in December 2022, a two-phase approval system will be
introduced for Software as a Medical Device (SaMD). In this system, for software approved at thefirst phase based on evidence from nonclinical studies and other sources, based on safety andefficacy, the cost is set to a price somewhat lower than the prices of existing products with a similarfunction covered by health insurance, or a flat price determined based on a newly added functionalclassification (functions similar to existing ones). This is based on the concept used in the
preliminary evaluation process.
Note that careful consideration is necessary regarding a price somewhat lower. If the cost isdetermined to be a price somewhat lower , the reimbursement price set for the second stage
approval by the challenge application and others should be determined without consideration of
the price determined at the first phase. A system is required for this process.

3.2.1.3 DPC functional coefficients
The evaluation of digital health technology introduced to reduce the burden on healthcare
professionals may be reflected in the diagnosis procedure combination (DPC) functional coefficientII, which includes six types of coefficients: data submission coefficient, efficiency coefficient,complexity coefficient, cover ratio coefficient, emergency healthcare coefficient, and regional

healthcare coefficient. Otherwise, a premium related to a reduced burden for healthcare
professionals may be introduced in the system for the addition of basic hospitalization fees for theevaluation based on the functional assessment coefficient I.

3.2.2 Equalization and levelling of healthcare technology
Several techniques (such as a program for endoscopic diagnosis equipped with AI, which
provides higher diagnostic accuracy than non-specialists can provide) can advance the equalizationand levelling of healthcare technology.
In a discussion of the Central Social Insurance Medical Council for the FY 2022 revision of medical
fees, it was pointed out that this type of technique can lead to a mitigation of the standards of
medical institutions, which require the presence of a specialist. This evaluation is clearly related to
medical fees. However, many medical institutions do not have a standard that requires specialists.
Therefore, this concept alone is insufficient.
Assessment methods that can further the equalization of medical technology are described below.

3.2.2.1 Outcome assessment/reward success typeThe equalization of technology is expected to have a positive effect on outcomes in medical
institutions that provide the technology required. Where a certain outcome level is achieved in a
medical institution, an additional technical fee can be introduced via a kind of outcome
assessment/reward success evaluation (i.e., pay-for-performance ).
Although outcome assessment is being increasingly adopted in other countries, there is a risk ofcherry-picking (i.e., the selection of patients who are more likely to achieve a higher outcome in a
medical institution). Therefore, the system design is not simple. In Japan, this type of assessment isincluded in a system for the management fee in a recovery rehabilitation ward and for preventive
instructions for diabetic dialysis patients.
For example, in the evaluation of a program to support colonic endoscopic diagnosis, additional
criteria can be set based on the rate of polyp removal, malignant polyps removed, and other factors
in medical institutions subject to the evaluation. A premium should be introduced in medical
institutions to achieve good outcomes without this AI support program. Nonetheless, when an AI

support program is regarded as useful, medical institutions actively seek to introduce it.

3.2.2.2 DPC functional coefficient
Similar to the system mentioned in the section on reducing the burden on healthcare professionals,
certain benefits can be provided by the DPC system for medical institutions where digital healthtechnology is introduced, contributing to the equalization of medical technology.

3.2.2.3 Selected treatment
The selected treatment system that requires copayment can be used for patients for whom
digital health technology (which ensures a certain level of technique with high accuracy) is used.
This measure was implemented to address the needs of patients who value a sense of security.

3.2.3 Optimization (of medical costs or in medical institutions)
As mentioned, it is difficult to evaluate optimization based on medical fees. However, given theimportance of optimizing Japanese healthcare, a certain form of assessment method should beconsidered.

3.2.3.1 DPC functional coefficient
As with the system described in the section on reducing the burden on healthcare professionals andequalizing medical technology, DPC functional coefficients can be used to evaluate the introductionof a certain digital health technology, contributing to the optimization of healthcare.

3.2.3.2 Assessment of premium for medical devices/management fee
It is difficult to evaluate optimization in medical institutions. However, a certain benefit may beprovided if medical costs are expected to decrease.
For example, a remote monitoring premium (150 points/month) was provided from 2018 for theremote monitoring of CPAP. However, evidence provided by the Central Social Insurance Medical
Council at the time of introduction indicates that no increase in patient efficacy or safety wasobserved.
As shown in Figure 13 below, a premium was given for remote monitoring based on the fact that therate of CPAP use is comparable between patients who visit a hospital every month and patients
who undergo remote monitoring and visit a hospital every three months. In this case, the medical
cost payment frequency decreases from every month to every three months, and remotemonitoring contributes to save the associated medical costs, and the savings are used for remotemonitoring.

Figure 13: Change in the rate of CPAP use for at least 4 hours and comparison of
the rate of CPAP use for at least 4 hours between [visit every 3 months +remote] group and [visit every month] group after RCT completion

If medical cost savings can be clearly shown, the amount of savings can be used to evaluate digital
health technology.

3.2.4 Evaluation in line with speed of product development and improvement
Product improvement and development are much faster with digital health technology than with

conventional medical devices. Therefore, it is difficult to perform assessments based on the healthinsurance system. Therefore, the methods described below should be considered.

3.2.4.1 Preliminary evaluation
The preliminary evaluation mentioned above used to reduce the burden on healthcare
professionals can also be used as part of an early authorization system.
Specifically, the conditional early approval system (such as a system used for regenerative
products) may be employed for programmed medical devices so that early approval/insurance
coverage can be achieved, with a re-evaluation performed based on additional data (e.g., RWD)
collected during a certain period (utilizing a framework for the challenge application).
In this case, flexible operation is necessary so that re-evaluation for a challenging application canbe performed multiple times.

3.2.4.2 Advanced medical care
In the absence of evidence warranting insurance coverage, patient access can be ensured with the
System for Advanced Medical Care A, to which application can be made by a company before
insurance coverage based on RWD after introduction to the clinical setting. At the time of
implementation, the introduction process should be faster than that of the current advanced
medical care system.

3.2.5 Other issues
In addition, the issues described below should be discussed.

3.2.5.1 Primary and secondary prophylaxis
The selected treatment system can be used with digital health technology for primary andsecondary prophylaxis. Although it is necessary to differentiate this from what is irrelevant tocovered medical treatment, medical devices used for prophylaxis for which regulatory approvalhas been provided should be clearly positioned as the selected treatment, as it may be regarded asa mixed medical treatment. Note that the possibility of insurance coverage is limited to secondary
prophylaxis, which is regarded as irrelevant to benefits for medical treatment or selected
treatment, regardless of what evidence may be accumulated in the future.
Otherwise, an introduction may be considered for the health of residents under local governments
and for insured people (to provide countermeasures against lifestyle diseases and metabolic
syndrome, as well as to encourage exercise).

3.2.5.2 Continued development after product launch
If general-purpose devices such as the iPhone are used for program provision, there will be a costfor continued development via device updates. The convenient use of such general-purpose
devices for patients is associated with high values. From this perspective, program provision using
general-purpose devices should be evaluated.

References

Ravi B. Parikh and Lorens A. Helmchen. Paying for artificial intelligence in medicine.
Digital Medicine (2022) 5:63 https://doi.org/10.1038/s41746-022-00609-6

Makoto Tamura, Takuma Sugahara Material pricing system in foreign countriescharacteristics of systems in advanced countries and suggestion to Japan, which
includes Medical device industry-challenges and prospects for leadingindustrialization edited by Takuma Sugahara, Nippon Hyoron Sha Co., Ltd. 2022.



MHLW Homepage. Expert Committee on Special Treatment Materials, Central Social
Insurance Medical Council https://www.mhlw.go.jp/stf/shingi/shingi-chuo_128158.html

Regulatory Reform Promotion Council. Interim report on regulatory reform promotion
December 22, 2022 https://www8.cao.go.jp/kiseikaikaku/kisei/publication/opinion/221222.pdf

Study Group on AI/digital health. Proposal from the study group on insurance
reimbursement of medical technology with consideration for progress in digital healthAugust 2020
https://kyodonewsprwire.jp/prwfile/release/M106249/202009104203/_prw_PA1fl_RP3M
x4RI.pdf
Federici C, Reckers-Droog V, Ciani O, Dams F, Grigore B, Kaló Z, Kovács S, Shatrov K,
Brouwer W, and Drummond M. (2021) Coverage with evidence development schemes
for medical devices in Europe: characteristics and challenges, European Journal of
Health Economics, Jun 12

Section 4 Arrangement of environment for digital health to ensure safety and security of users
and efficient utilization
This section makes a proposal based on four principles (open and inclusive, pursuit of state-of-theart and international compatibility, minimization of human load, and arrangement of environment
with safety and security) and three issues (architecture, laws and regulations, and implementation)that stakeholders should understand in order to promote healthcare DX from the perspective of astable supply of medical devices and IVD as well as the introduction of innovative technology, amid
drastic environmental changes and technological advances.
4.1

Four principles for arrangement of environment for digital healthIn its digital reform policy, the Digital Agency specifies 10 basic principles for the formation of adigital society and three principles for the implementation of online-based administrative services
defined in the Digital Procedure Act. In addition, the Cabinet established a headquarters for thepromotion of healthcare DX in December 2022. The three principles of healthcare DX are as follows:
Digital first (i.e., individual procedures and services are digitally completed in a consistent manner),Once only (i.e., the re-submission of information is unnecessary), and Connected one-stop (i.e.,
multiple procedures and services are performed on a one-stop basis). With reference to theseprinciples, the AMDD proposes four principles for the creation of a digital health environment thatwill foster healthcare safety, security, and effectiveness.
4.1.1 Principle of open inclusion
The current system, which is closed and exclusive, has sought to ensure safety (e.g., security) by
reducing the human load. By contrast, the open-inclusive principle seeks to foster

networkexternality (i.e., increased value via the linking of data owned by medical institutions in Japan withthose owned by local governments), as well as to reduce the human load and ensure security.
4.1.2 Principle of pursuit of state-of-the-art and international compatibility
Providing service at the highest global level requires fostering the utilization and linking of data. Thisshould not be based on uniform and rigid pre-specified regulations but should be done using riskbased evaluation at the introduction stage, to ensure rapid review, flexible, and continuous
improvement utilizing data. In addition, international compatibility should be ensured by examining
the situation in foreign countries, so that their data can be utilized. In this manner, an effort should
be made to establish a system that can take advantage of the global network externality.

4.1.3 Principle of minimization of human load
A system that places a heavy load for operation in the clinical setting is not acceptable. Therefore, itis necessary to establish a system that does not place the burden on healthcare professionals. “Onceonly processes and automation should be introduced for operations for which documentation,
visual inspection, be resident, or onsite participation are required to reduce the human load andhuman error, with tasks being completed by digital processing only.
4.1.4 Principle of arrangement of environment with safety and security
The environment should comply with international standards to ensure security and privacy. In
particular, data storage in on-premises/standalone environments can increase security risks.
Therefore, an open system that uses a public cloud should be considered, as it may paradoxicallyincrease safety.

4.2 Three steps for arrangement of digital health environment (arrangement of digital healtharchitecture/arrangement of laws and regulations/implementation) and medical devicesspecific challenges
Healthcare DX should be implemented based on four principles, and three steps arrangement ofdigital health architecture, arrangement of laws and regulations, and implementation and medical
device-specific challenges should be shared.
4.2.1 Digital health architecture
Proceeding with healthcare DX and the social acceptance of digital health requires the arrangementof an architecture (an overall plan for linking digital health data with the associated systems andtechnology) and by fostering awareness of it, to ultimately achieve safe and effective utilization.
This digital health architecture is a basic concept reflecting the direction of a system for therealization of goals via digital health in Japan. It defines components constituting digital health,including stakeholders, system, and technology, the relationship among components, and therelationship between digital health and the external environment, which serve as a basis for
specific policies.
The government established a headquarters for healthcare DX via Cabinet in 2022 and listed thesocial goals to be realized via healthcare DX. In addition, the MHLW specified policy goals and aschedule in 2021 in the form of a table titled Data Health Reform Schedule. However, theArchitecture cross-section among stakeholders in healthcare DX has not yet been specified andshared. The Proposal on the Promotion of Medical Data Utilization published by the Japan
Research Institute on February 12, 2023, points out that, Although the objectives and directions of
medical data utilization are currently specified, the overall design and comprehensive system
structure has not been made public, with a common understanding among stakeholders being
particularly insufficient, and an effort should be made so that stakeholders can share an awarenessfor the objectives of medical data utilization, and the government policy should specify the sharingof use cases from various stakeholder perspectives.
In this report, noteworthy challenges and proposals are discussed from the perspective of the
medical device and IVD industry for the realization of a standardized platform that would ensureinternational interoperability.
4.2.1.1

Necessity of arrangement of master data related to medical device logistics

The distribution of several tens of thousands of highly controlled medical devices is complex becauseof the necessity for the strict management of medical safety as well as the unique business practices
and industrial structures involved. Difficulties in locating necessary treatment materials or obtaining
the proper quantities can worsen in an emergency, such as a pandemic or earthquake. The AMDD isconcerned about the potential for various future problems, such as a shortage of human resources,
to impact the stable supply of medical materials.
The AMDD collaborates with NEC/Nippon Express in the Smart logistic services project of the Crossministerial Strategic Innovation Program (SIP) to devise a solution of these challenges. It performed
a pilot test of a medical device information platform (PF) in FY 2021, followed by social
implementation in FY 2022. The purpose of the medical information PF is to ensure a stable supply of
medical devices by improving distribution efficiency, and enable the immediate availability of
precise information on the location and amount of necessary medical devices in case of a pandemicor earthquake. Medical device companies are also pursuing the optimization of operations using
RFID/barcodes, the visualization of inventory for distribution/lending, improvements in precision,and the development of new business models (such as cooperative logistics) by sharing information
between players involved in medical device logistics for possible optimization (see Figure 13).

Figure 14: SIP Smart Logistics Program schema (from Cabinet Office materials)

The program highlighted the need for master data at the unified location of medical device
distribution. In particular, the following two types of master data should be collected under theleadership of the government so that national unification and maintenance can be achieved
intensively:
Medical institution code: This code is currently managed and operated by the Regional
Bureau of Health and Welfare. Therefore, modifications such as integration and transfer
across regions cannot be made. This should be updated to the published medical institution
code and turned into master data that can be used at the national level.
Medical device distributor code: Neither the medical device distributor code nor masterdata that can cover branches, business offices, and warehouses at the national level areavailable.
4.2.1.2

Promotion of administrator function for safety management of medical information

system in medical institutions
The FY 2022 medical fee revision specified that the requirements for a review for an additional fee
for a medical record management system should include the assignment of dedicated personnel incharge of medical information system safety management in covered medical institutions with atleast 400 beds and information security training for staff (at least once a year).
A higher level of medical digitalization may lead to the wide use of digital health products in online
systems that cannot be connected to the in-hospital system. Medical institutions increasingly requirean arrangement of basic infrastructure (such as the maintenance of power supply and internet lines)
and an understanding of the trends in state-of-the-art technology. However, medical institutions
often engage in excessive or technically incorrect discussions that stress security reinforcement.
It is necessary to assign administrators in charge of the safety management of medical information
systems who have sufficient knowledge and expertise in medical institutions, as well as to centralize
safety management administrator functions in the regional medical collaboration promotion
corporation (for small- to medium-sized hospitals) in order to facilitate partnerships with companies
for the introduction of new technology and the arrangement of a safety environment. In addition, thegovernment should specify policies and incorporate supportive measures into the digital healtharchitecture.

4.3

Arrangement of laws and regulations

The establishment of a digital health architecture requires a change in the relationship between
stakeholders and the legal system and the governance among the stakeholders. Laws andregulations must define the nature of governance and rules in the new era, and key legal definitions
should be disseminated to stakeholders (including individuals, medical institutions, and companies):
Medical institutions have an obligation to submit medical institution data and standardize
procedures based on guidelines defined by the government on the premise that the data are
owned by patients.
Companies have an obligation to ensure safety in data utilization
Individuals operate under the opt-out principle of healthcare data submission (whereby
data are principally controlled at the time of utilization), and the data are owned andmanaged by them

4.3.1

Introduction of cases demonstrating the necessity of legal arrangement to ensure cybersecurity of medical devices

This section describes issues involving the cyber security and handling of personal information indigital health products unconnected to an in-hospital system and offers proposals for legal
arrangements that would address such cases.

Medical institutions are often required to explain the security of online systems that use digital healthproducts that are not connected to the in-hospital system (in compliance with ISO14971 and
IEC62304) and handle personal information based on their own judgment. Specifically, the following
requirements are observed:
Response on the compliance with the Guidance On Thoroughly Ensuring Cyber Security Of
Medical Devices
Read the main text and supplementary volume of the Guidelines on Safety Management ofMedical Information System Version 5.2 before submitting materials prepared in line with anattached checklist and the Appendix ( Contents To Be Determined for Sharing Medical Information
and Others with an External Agency ).
Given that a detailed response from each medical institution should be made in line with thenotification issued by the MHLW and the content of the guidelines, the burden on companies issignificant.
It is proposed that the implementation of a system based on the once-only principle (such as thearranged specification of standard medical information or system authorization) and its
dissemination should be conducted under the leadership of the government.

4.4

Implementation

The presentation of a digital health architecture and the necessity of legal arrangements are
discussed for the realization of a healthcare DX. First, an environment where patients can obtain thenecessary information and conduct comprehensive discussions with stakeholders is necessary sothat the stakeholders can participate aggressively and effectively in the implementation phase.
4.4.1

Arrangement of environment where options are provided for patients and their families

in an appropriate manner
The achievement of VBHC requires an environment in which patients can select personallyoptimized medical techniques based on appropriate information, which reduces the burden by
preventing duplicate examinations, prescriptions, and needless hospital visits. Specifically, reliablewebsites explaining diseases for patients and certification systems should be established incollaboration with the government and industry.

4.4.2

Investigation of challenges related to implementation of online medical care and its

effectivenessTo promote patient access to medical care, the challenges and effectiveness of the implementationof online medical care should be investigated in a cross-sectional manner by stakeholders such as
medical institutions and patients. Discussions should be conducted about whether it is appropriate
to set the medical fees at the same level when the same outcomes are obtained, or what kind ofsystem is necessary to arrange the appropriate environment for medical institutions and patients.

4.4.3

Digital health conference between government and industry

Collaboration among stakeholders (particularly the government and industry) is necessary to
promote healthcare DX. The Basic Policies for Economic and Fiscal Management and Reform in FY
2022 specifies that an effort itself for the solution of social challenges, as a source of the additional
value creation is positioned as a growth strategy, with medium- or long-term investment and reform
being performed in a well-planned and emphasized manner with government industry
collaboration to achieve solutions to challenges and economic growth.

For healthcare DX,

knowledge-sharing about technology and systems between the government and industry,
continuous updating are necessary to pursue the principles open-inclusive, pursuit of state-of-theart, and international compatibility as specified in Section 4.1.1, and to establish the use cases
describing preferable options and a digital health architecture, which is the basis of the overall planfor healthcare DX promotion.
The MHLW minister, executive members of METI, and industry representatives have discussed thestatus of innovation progress presented by pharmaceutical and medical device industry (the publicprivate dialogue for the creation of innovative pharmaceuticals and medical devices). We propose
the establishment of a Digital Health Conference to serve as a new platform for open and inclusive
discussions on healthcare DX between the government and industry. The specific draft issummarized below.
[Objectives]
Industry side: Sharing advanced cases, challenges, and proposals
Government side: Collection of information on advanced cases and trends in foreign countries aswell as verification of hypotheses specified in a policy agenda

[Composition]
Given that cross-sectional challenges among government agencies are addressed as part of DX
promotion in society as a whole, participation is expected from the Digital Agency, MHLW, METI,MIC, and Headquarters for Healthcare Policy in the Cabinet Office, on the government side.
Cross-sectional participation from the medical device, pharmaceutical, IT infrastructure, cybersecurity services, and insurance industries is expected on the private side (with the industry
associations serving as a contact point).
As needed, healthcare professionals, academic personnel, payers, patient representatives, local
government personnel, and staff members of private companies may be invited.
The office will be operated by subcontracting on a private enterprise basis, ensuring neutral andefficient operation.
[Form]
Digital Health Conference: Closed and mutual discussion and information sharing among
members who are in a position to lead operations in both the government and industry.
Digital Health Private Public Dialogue: Representatives/executive members of member
organizations are expected to participate in this dialogue. The discussion and presented outcomes
are to be confirmed at the digital health conference, with an agreement on the direction of efforts.
This discussion is expected to occur in closed sessions.
For digital health conferences, a collaboration platform is expected to be utilized to enable timely
and flexible online discussions, theme tracking, and information sharing.
[Frequency]
Digital Health Conferences are held approximately four to six times a year
Digital Health Private-Public Dialogue is to be held once every six months[Expected output]
Proposal for government policy such as the basic policy
Proposal and joint statement for the establishment of the digital health architecture
Provision of use cases (including advanced cases in the area of healthcare DX inside or outside
Japan)

References•

Digital Agency Priority program for realization of digital society
https://www.digital.go.jp/policies/priority-policy-program/•

Ad-hoc commission on digital administration, Plan for blanket review of regulations withconsideration for digital principles (June 3, 2022)
https://www.digital.go.jp/assets/contents/node/basic_page/field_ref_resources/cb5865d28031-4595-89308761fb6bbe10/e3650360/20220603_meeting_administrative_research_outline_07.pdf•

Edward W. Marx, et al. Healthcare Digital Transformation: How Consumerism, Technology
and Pandemic are Accelerating the Future (HIMSS Book)•

Medical Excellence Japan, Subcommittee on electronic medical records, Proposals:
MHLW, METI WG on future innovation Interim summary report (March 19, 2019)https://www.meti.go.jp/shingikai/mono_info_service/mirai_innovation/pdf/ct_zentai_2019
03.pdf•11th Committee on utilization of information on health, medical care, and nursing, Working
group on utilization of medical information, etc. Thorough measures for cyber security inmedical institutions (May 27, 2022)•

HIMSS Digital Health A Framework for Healthcare Transformation•

LDP Policy Research Council Headquarters for promotion of digital society, Digital Nippon
2022 (April 26, 2022)https://www.jimin.jp/news/policy/203427.html•

IMD World Digital Competitiveness Ranking 2022 https://www.imd.org/centers/worldcompetitiveness-center/rankings/world-digital-competitiveness/•

Subcommittee on Financial System, Fiscal System Council (April 8, 2022) MOF materials
https://www.mof.go.jp/about_mof/councils/fiscal_system_council/subof_fiscal_system/proceedings/material/zaiseia20220408.html•

Cabinet Secretariat Establishment of headquarters for promotion of healthcare DX
https://www.cas.go.jp/jp/seisaku/iryou_dx_suishin/pdf/siryou1.pdf

•

LDP

•

First Healthcare DX Reiwa Vision 2030 (LDP: 17 May 2022) MHLW Promotion Team (August 8,

Healthcare DX Reiwa Vision 2030 https://www.jimin.jp/news/policy/203565.html2022) Materials https://www.mhlw.go.jp/content/10808000/000992373.pdf•

Akira Morita Legal system for utilization of medical information: What European Health Data

Space (EHDS) Plan suggests (Next Generation Fundamental Policy Research Institute, June8) https://www.nfi-japan.org/recommendation•

Japan Research Institute Proposal on promotion of utilization of medical data (February 9,2023)
https://www.jri.co.jp/column/opinion/detail/13976/

Information-technology Promotion Agency Digital Architecture Design Center (DADC)
https://www.ipa.go.jp/dadc/join/what.html

[Members of Project for Data Utilization, AMDD Digital Health Committee]
PJ1 Infrastructure Team, in charge of Section 4: Arrangement of environment for digital health toensure safety and security of users and efficient utilization.
:Leader, Japanese alphabetical order
Anne Smith

Stryker Japan K.K.

Shin-ichi Ike

Johnson & Johnson K. K.

Go Ikeda

Medtronic Japan Co., Ltd

Makoto Kawai

Zimmer Biomet G.K.

Satoshi Yamazaki

American Medical Devices and Diagnostics Manufacturers Association (AMDD)

ObserverShingo Kasahara

American Medical Devices and Diagnostics Manufacturers' Association AMDD

PJ2 Value Assessment Team, in charge of section 3: Whole issue of digital health technology
assessment and its perspectives:Leader, Japanese alphabetical order
Anne Smith

Stryker Japan K.K.

Go Ikeda

Medtronic Japan Co., Ltd

Tomoyuki Tanigawa

CureApp, Inc.

Makoto Tamura

Medical Technology Policy Institute (MTPI)Ken Fujita

Medtronic Japan Co., Ltd

ObserverShingo Kasahara
AMDD

American Medical Devices and Diagnostics Manufacturers' Association

PJ3 Data Usage Team, in charge of Section 2: Necessity of policies for putting data ownership into
the hands of individuals and secondary use of data by companies.
: Leader, Japanese alphabetical order
Anne Smith

Stryker Japan K.K.

Go Ikeda

Medtronic Japan Co., Ltd

Hideki Inoue

Abbott Japan LLC

Masanori Otake

GE Healthcare Japan Corporation

Aya Saeki

Edwards Lifesciences Corporation

Taro Nihei

Johnson & Johnson K. K.

Kazuhiro Momose

Thermo Fisher Scientific, Inc.

ObserverShingo Kasahara

American Medical Devices and Diagnostics Manufacturers' Association AMDD