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  The Next Generation Medical Infrastructure Law has been enforced
to promote medical research using big data.
Learn how our medical information is used in this booklet.

Supervised by Medical Information System Development Center (MEDIS)CONTENTS

1 Information technology supporting advanced medical care .... 4Content of Medical Information and Purposes of Use
Medical Care is Based on a Great Deal of Research
Data-based healthcare service

10

8

6

2 System to protect the privacy of patients ..................................... 12
Medical Care and Privacy: The Importance of the Rights of Patients
Privacy and Protection of Personal Information
Personal Information Protection Act

18

Next Generation Medical Infrastructure Law

16

14

20

3 Prevention of the Leakage of Medical Information ................... 24
Anonymization to Protect the Identity of Individuals 26
Encryption to Ensure Security 28
Data Exchange with Appropriate Measures 30
Protection through Strict Security Surveillance 32
4 For our Future Medical Care ............................................................. 34
Pursuing both availability and security 36

For Our Future Medical Care…
Medical progress never ceases to amaze us. We often see cases where it becomes

possible to cure a disease that was incurable a mere decade ago. This progress is theresult of the strenuous efforts of many healthcare professionals, medical researchers, andinvestigators at pharmaceutical companies around the world. Have you ever wondered
how they conduct healthcare and medical research and development? Sometimes theyfind new chemicals, and other times they culture cells in test tubes to discover something
new. However, analysis of patient medical data plays one of the most important roles. In
other words, the good will of many of those fighting against disease supports progressin healthcare. The advancement of what we know as modern medicine would not havebeen achieved if it had not been for the good will of many patients from ten, fifty, andeven a hundred years ago.

This booklet explains in a clear and simple manner how the good intentions ofpatients are used for future medical care without prejudicing their rights.

3

1 Information Technology Supporting Advanced
Medical Care

Q

What types of medical data are there and for what purpose arethey used?

A Medical data includes the medical history of patientsthat is gained by physicians by asking patients questions
regarding their medical conditions, various tests (blood

test, X-ray exam, etc.) results, diagnosis, treatment(prescription, injection, procedure, surgery, rehabilitation,etc.), and results of treatment. Doctors examine individual
patient data and use it for medical treatment. At the sametime, data are collected from many patients to createcomprehensive statistical data, which can be used for
improvement of medical care in general.

4Q

What is clinical research?

A Clinical research evaluates the efficacy and safety of medicalcare by aggregating and analyzing the test and treatment resultsof many patients. Conducting a large number of clinical studies
will promote evidence-based medicine and improve medical careprovided to individual patients.

D r. H i d e o Ya s u n a g aProfessor of the Graduate Schoolof Medicine, the University ofTokyo; physician and doctor of
medical science; graduated fromthe Department of Medicine at theFaculty of Medicine of the Universityof Tokyo; specialized in medical big
data research. His recent works
include All Medical Practice Is
Uncertain (NHK Publishing) and
Health Economics (Chuo Keizai-sha).

Q

What kind of information is receipt information?

A The histories of medical care provided to patientsare recorded on medical fee bills (receipts). In recent
years, anonymized receipt information of many patientshas been collected and analyzed for the improvementsof healthcare delivery systems and the quality of medical
practice.

5

Content of Medical Information and Purposes of Use
Health is the most important thing in our life. We all want and pursue physicaland mental well-being. Any of us can get necessary medical attention at any time
when we are ill or injured. The role of medical institutions is to provide us with longterm and extensive health support ranging from routine medical examinations andprovision of advice on healthcare to specialized treatment of particular diseases.
Doctors and nurses collect a variety of information to ensure that patients receive
appropriate treatment. They listen carefully to patients and include the detailsof diagnosis and treatment (e.g., prescription, injection, procedure, surgery,rehabilitation, etc.) in their medical records. All of those records are stored as
medical information (i.e., data). In addition to numerical values, data contains
documents and images.
Medical information has two main purposes of use. The first is to be used for6treatment of patients, and the second is to help improve medical care. Both are
aimed at restoring patients’ health.

Two purposes of use of medical data***************************************************************

1 Treatment

2 Improvement of medical care

Doctors make medical judgment andprovide treatment
based on the personal
medical information ofeach patient.

Data is collected from many patients tocreate statistical datafor improvement of
medical care andprevention of diseases.

These are also the purposes of

medical care!

The data is used to treat disease and to maintain and improve health in both cases.

7Medical Care is Based on a Great Deal of Research
The medical care we receive in hospitals and clinics is based on the study of
medicine. Medical research includes basic research and clinical research.
Basic research reveals the mechanisms and functions of human cells, tissues,and genes, and elucidates the origin of diseases. This type of research is mainly
conducted in laboratories.Clinical studies are conducted on people in medical
practice. In clinical research, data are collected from many patients to performstatistical analysis and to obtain new evidence.
Even the patients suffering from the same disease have different conditions anddegrees of progression. A certain type of treatment may work for some patients, but
it may not be effective for others. Medicine is fraught with uncertainty. Therefore,
it is important to conduct clinical research to determine what tests and treatments
are most appropriate for each type of patients. Evaluation of the effectiveness and8safety of medical treatment contributes to the progress of medicine to more reliable
practice.
In recent years, medicine has become complex and diversified. We have an
increasing opportunity to listen to and understand the explanations about diseases
provided by doctors and to decide on our own what treatment to receive. The
improvement of the quality of life (QOL) of patients largely depends on clinicalresearch. A number of clinical studies are conducted for the utilization of medical
information and to provide the best medical treatment possible for each patient.

Medical data is utilized by hospitals andresearch institutes to provide patientswith optimal medical care.

9Data-based Healthcare Service
Japan applies a universal healthcare system, which signifies that almost all thenation’s citizens have joined public health insurance. Medical services covered bypublic health insurance are called insured healthcare services. Most of the medical
institutions in Japan offer insured healthcare services, but not all medical services
are covered by public health insurance. Certain evidence (scientific basis) supporting
effectiveness and safety of the medical services is required for services to be coveredby public health insurance.
Patients pay a part of their medical expenses to receive insured healthcare
services. The history of insured healthcare services is recorded as data on medical
fee bills (receipts). Medical institutions submit those receipts to examination andpayment agencies to bill them for medical expenses. Examination and payment
agencies pay the medical expenses when the submitted bills are deemed appropriate.
10

Recently, a large volume of anonymized receipt data have been collected and havebeen used for numerous and discrete purposes. National and local governments
utilize such data to understand the actual state of medical care in each region toestablish an appropriate healthcare delivery system. Receipt data are also used inclinical research.

How receipt data is used

Utilization of medical big

data***************************************************************

・・・・・・・・・・・・・・・・・・・・・・・・・・・・

Receipt data are business data generated daily in medical institutions.
In addition to their use for medical expense claims, the utilizationof a large volume of anonymized receipt data contributes to theimprovements of the insured healthcare service delivery system andthe quality of medical care.
“Anonymization” is to make an individual unidentifiable by processing
name, date of birth, health insurance number, etc.

11

2 System to protect the privacy of patientsQ

I do not want anyone to know about my medical condition.
How is the privacy of medical information protected?

A Medical care is based on the results of medical research

conducted using data on actual cases of disease andtreatment. However, since physical and medical conditions
are the most sensitive and important personal information,
doctors and healthcare professionals have been handlingsuch information carefully for a long time.
Nowadays, however, we have access to many medical
data. Genetic testing kits for home use are available online
and anyone can self-administer a simple cancer test.
So far, medical information used to be handled only byhealthcare professionals, but now any business entity or

12individual has easy access to such information. In fact,some companies misuse such data to make money.
The Personal Information Protection Act wasamended to prevent this situation. It prohibits misuse

and the use of medical information of other individuals
without their express permission. However, medical
research and the development of medicine would bevery difficult without access to medical information.
The Next Generation Medical Infrastructure Law
was enforced to permit the use of a part of the datanecessary for research and development for future
medical care after removing personally identifiable
information. This law protects the privacy of patients.
Those who feel uncomfortable allowing their medical
data to be used can request the suspension of use.
Please do not worry, the information will never be usedwithout the permission of individual patients, and it will
not affect the treatment provided.

D r. R y u i c h i Ya m a m o t oDirector of the Medical Information
System Development Center/Visiting
Professor of Jichi Medical University;
graduated from Osaka Medical College;
physician and doctor of medical science;
specialized in safety managementof medical information and privacy
protection in medical care. His publishedresearch includes Protection of Personal
Medical Information and Security (coauthored) (Yuhikaku Publishing), All
About the Social Security and Tax
Number System (Nikkei BP), andUtilization of Medical Information andProtection of Personal Information(EDITEX).

13

Medical Care and Privacy: The Importance of the Rights of Patients
Medical care is based on the study of medicine, and the advancement of medicine
requires access to human data. At the same time, personal information such as medical
history and physical condition is concerned with the privacy of individuals. These data
are important for medical treatment, but they can disadvantage certain individuals incertain cases. For example, someone who has been operated for cancer may be refused
an important role at work due to the risk of the recurrence of the disease. Some people
are also concerned that hereditary diseases may disadvantage them in marriage
and employment. Such discrimination caused by judgment based on prejudices andpreconceptions is a serious problem and should not be tolerated.
Since extremely sensitive personal data is handled in medical practice, doctors andpharmacists are required to comply with the nation’s criminal laws and serious penalties
are imposed for violations in the protection of confidentiality. Nurses and public health14

professionals are also required to maintain confidentiality, as stipulated in the laws
related to their medical qualifications. At the same time, the Personal Information
Protection Act contains provisions to protect individual information in general. This law
also stipulates that medical data should be handled with particular care.
Although law requires confidentiality of information, only a few doctors haveever been accused of violations. Since the confidentiality of information is consideredan ethical obligation of professionals engaged in medical practice rather than a legal
obligation, it is very well protected in Japan. The World Medical Association announced
the Helsinki Declaration and the Lisbon Declaration for doctors from most parts of theworld. These declarations emphasize the importance of using patient data with great
caution. These documents represent sets of non-legally binding ethical principles thatdefine the rights and obligations of patients to receive medical services, including theright to information on their disease and the entitlement of protecting it from others.
These principles are also observed in Japanese medical practice.
15

The protection of privacy and personal information
We all have information about ourselves that we want to keep private. The rightto privacy is the right to protect such secret information and it is recognized as ahuman right guaranteed by the constitution. It is considered an individual’s privilege
to control personal information to prevent private and secret information pertaining
to a particular person from being disclosed or used for purposes other than thosefor which it was initially intended without the permission of the concerned person.
Let us use the following example of online shopping to explain this rather complex
concept of protection of privacy and personal information.
You want to buy hot sauce online and need to provide the seller with some ofyour personal information such as your name and address. You will assume that yourname and address will be used to send you the ordered item. Since you agree with the
purpose of use of your personal information, your privacy will not be violated if the16

seller collects, stores, and uses your name and address.
However, what if the hot sauce seller gives your name and address to anothercompany and that company sends you an e-mail advertising red chili paste? Since
you like spicy food, you may be tempted to buy the product, but you will not likethe fact that some company you do not even know has your personal information.
This instance represents a case of the violation of your privacy as your personal
information was used for purposes other than those for which you had agreed.
In the event that a business operator handling personal information uses suchinformation for improper purposes or discloses it to a third
party without the consent of the information provider,
the business operator will be obligated to suspend its
operations or delete the information. This obligation
is prescribed by the Personal Information Protection
Act, which is explained in the section that follows.
17Personal Information Protection Act
In Japan, the Personal Information Protection Act came into force in 2005. The
Act was significantly revised in 2017. The Personal Information Protection Act is closely
related to privacy, but it is a law designed to prescribe the duties of companies that
handle personal information rather than to protect the right of the information provider.
Since privacy is a right, the interest of every individual should be considered
supreme. However, the degree of importance of personal information varies
according to the type and the holder of the information. For example, while
storeowners will have no problem sharing their store address with anyone,celebrities will try to prevent the public from knowing where they live. It is difficult
to regulate individual circumstances by law; hence, the duties prescribed for business
operators who handle personal information serve as the framework of the Personal
Information Protection Act. The Act requires holders of personal information to18

protect the privacy of those who provide their personal information.
However, the reinforcement of the protection of privacy makes it harder to use
personal information even for appropriate purposes. Conversely, an overemphasison convenience and a neglect of security can lead to problems such as information
leakage. Companies should develop and follow policies to maintain a balance
between convenience and security.

Points of the revised Personal Information Protection Act***************************************************************
The following two points are pivotal factors for thefield of medicine:◆ Information related to the medical historyof patients is now categorized as information
requiring special handling☞ Personal information requiring special handlingmust be handled with extraordinary care and cannot
be used unless the information provider gives firm
approval.

◆ The stipulation of anonymized information
has been added☞ Anonymized information is personal informationfrom which data such as name, address, date ofbirth, and gender have been removed to preventthe identification of a particular individual. Suchinformation can be used without the information
provider’s consent.

19

Next Generation Medical Infrastructure Law
We hope that the explanations provided above have established the association
between the accumulation of patient data and medical research, and that theimportance of patient data to the advancement and development of medical
technology is now clear. In addition to the privacy of individuals, the concept of
public interest is important in the collection of medical data.
The public interest is “the welfare of the general public.” However, medical data
do not bring immediate or direct benefits to all humanity. To be precise, the use of
medical data is concerned with “the future well-being of the general public.”
Between the seventeenth and nineteenth centuries, many people lost their lives
because of diseases such as cholera, dysentery, and tuberculosis. At that time,
there were no effective means to combat infections or diseases caused by bacteria.
However, patients and healthcare professionals kept detailed records of their fights
20

against such diseases as well as the treatment and nursing care that was provided.
The recorded data were examined later and were used for medical research, leading
to the development of antibiotics that were effective against bacteria. The discovery of
how people become infected has made it possible for us to develop resistance and toprevent certain diseases. Nowadays, few people die of cholera and dysentery. Somepeople may still suffer from tuberculosis, but the disease is curable with medication.
Patient data from more than a century ago contributes to present public interestas they serve our needs today. Although those data did not help the patients at thetime they were recorded, diseases that are curable these days might have still beenfeared as intractable diseases if those data had not been used for scholarly research.
This above is an example of how medical data are used. The Personal
Information Protection Act sometimes makes the use of data for public interest
difficult. The Act is aimed at preventing the violation of privacy (e.g., identificationand leakage of personal information) and thus emphasizes the importance of the21

public interest. However, if it interferes with medical research, the development of
new medical technologies, or the use of personal information to prevent a disease
from spreading, the Act will ultimately render a disservice to the public.
Therefore, the Act Regarding Anonymized Medical Data to Contribute to Researchand Development in the Medical Field, commonly referred as the Next Generation
Medical Infrastructure Law, has been established to promote more efficient and safer
use of medical data through prior confirmation of the purpose of use for public interestand for the establishment of a system to prevent the violation of privacy.
Companies require the authorization of the government to be able to obtaindata from medical institutions. These entities are strictly examined and they aremandated to demonstrate that they are capable of protecting the privacy of thepatients and that the obtained information will be used exclusively for public interest
purposes. Medical researchers receive data from authorized companies to conduct
their investigations.
22Provision of information
on medical examinationand treatment



Incorporation of research results
such as new highly eﬀective
treatments in medical practiceMedical institutions
Citizens / patients
データ
ベース

Authorized companies



Researchers
Provision of the information necessary
for research and development

Personally identifying information such as name and address will not be provided.

23

3 Prevention of leakage of medical information

Q

How is my medical information provided
to companies?

A When your medical information is collected frommedical institutions under the Next Generation Medical
Infrastructure Law, the information is encrypted so thatit can be read only if decrypted before being passed
to authorized companies. A special key, which is understrict control, is required to decrypt the encrypted
medical information. It is impossible for a third party todecrypt medical information once it is encrypted.

24

D r. K a t s u y a T a n a k a
Lecturer at the Graduate School of
Medicine and Faculty of Medicine,the University of Tokyo; completed
the doctoral program in Industrial
Machinery Engineering without adoctoral degree at the School ofEngineering, the University of Tokyo;
doctor of medicine; specialized
in cryptography for big data andnetwork security management inmedical institutions.

Q

Is it impossible to identify individuals based on informationsuch as the name of the disease and age provided to researchers?

A

The collected medical data are anonymized
before being employed for research by
converting dates of birth and consultation
duration into ages and numbers of days or byc l a s s i f y i n g d i s e a s e s i n t o g ro u p s t o ma k e i t

impossible for people to know to which patient
the original medical information belongs.
Researchers receive the data altered in such amanner that will not affect their investigations.
Authorized companies ensure that theanonymized medical data do not personallyidentify individuals before they are passed toresearchers.

25Anonymization to Protect the Identity of Individuals
The most important aspect of protecting privacy is to make it impossible forsomeone to know to whom a particular set of data belongs. However, it is not easy tochange medical and health data into non-personally identifying information.
For example, it is almost impossible to identify an individual based on theinformation that he or she visited a university hospital in Tokyo on January 25, 2019.
However, with the information that the person visited a medical institution in Tokyoon January 25, February 19, March 13, April 18, April 24, and May 15, 2019, his or hercolleagues or friends may be able to identify that person based on other informationsuch as that he or she took leaves of absence on those days. In such an instance,
the first day of visit is not specified and the dates from the second visit onward are
replaced with the expressions such as 28 days, 34 days, and 56 days after the first
visit to make it difficult to identify the individual.
26

Since actual medical data contain more information, sometimes a data subject
can be identified when analyzed in detail. Nevertheless, it is possible to make theidentification of individuals almost impossible by altering different types of data. This
process is called data anonymization. The Personal Information Protection Commission, aJapanese government commission charged with the protection of personal information,
has made guidelines on the methods of data anonymization available to the public.
The personal data handled in medicine are highly sensitive compared with
the information handled in other fields. For this reason, the Next Generation
Medical Infrastructure Law sets forth stricter standards than the guidelines on data
anonymization published by the Personal Information Protection Commission. It also
requires the developed processing technologies to be considered in the use of data afteranonymization. The use of data created based on such standards prevents problems suchas the identification of individuals based on personal information and stops the misuse of
data.
27

Encryption to Ensure Security
The medical data handled under the Next Generation Medical Infrastructure Law
include all information about the medical condition of each individual patient. If third
parties other than medical institutions or authorized companies gain access to thistype of health data, there is a risk that the personal information and health conditionsof patients may be leaked to third parties. This Law prescribes the encryption of
medical data before it is passed to authorized companies. Encryption is the process of
encoding information in such a manner that only companies authorized to receive themedical data can access it. Keys are used to encrypt medical information before it iscollected and to decrypt it after it is passed to authorized companies. These keys aremuch longer than passwords we normally use. These keys are strictly controlled andthey incorporate a system preventing encrypted medical data from being decrypted bythird parties other than authorized companies and involved medical institutions.
28

Little Review

Review points. "Secure Utilization of Medical Data"
The utilization of medical data is crucial for the development of medical science.

● The utilization of patient medical (medical care) data is essential for the advancement of medical care,such as the development of innovative therapeutic drugs that can cure cancer, and the research of nextgeneration medical care such as IPS cells.

Medical information is transferred under encryption so that the contents can not beeasily disclosed to any third party.

● Incidents of leaks of confidential information including Internet crime and loss of USB memory have occurred
frequently. It is considered important to protect the privacy of information handled by medical treatment.

● Medical data is encrypted using strictly managed proprietary information (electronic keys).
● Communication between healthcare providers and certified company is as secure against leaks andtampering as with online banking where money is exchanged over the Internet.

Medical data is utilized after anonymization processing so that individuals can not
be identified.

● Anonymization is a process of processing information partially to make personal identification impossible(such as generalizing and replacing with another character).

● Anyone can identify a person by anonymized information (cannot re-identify).
● Anonymization of medical information is performed on a more strict basis than general uses such as
handling purchasing history (such as point cards) and transportation usage history (such as IC card tickets).

29

Data Exchange with Appropriate Measures
Encrypted medical data are sent to authorized companies either through a
network line or through the use of a hard disk. The same method as online banking
is employed for data to be sent through a network, and medical data cannot be
deciphered while it is being collected. It is possible to track the delivery status whendata are sent using a hard disk as a record of the delivery needs to be kept.
Medical data sent through a communication line are temporarily stored on
a computer accessible from the Internet. However, once an authorized company
receives them, they are transferred to a storage area strictly controlled by thecompany and deleted from the computer to which the data have been sent. Thismethod helps to prevent the diffusion of important information to unauthorizedthird parties.

30Medical institutions that are
subject to the Next Generation
Medical Infrastructure Law

Authorized company’ sdata center

Storage

Sent usinga safe method

Encryption key

Decryption key

Decryption
Encryption

Medical information

Encrypted
medical information

Unauthorized third parties
cannot decrypt data31

Protection through Strict Security Surveillance
Medical data collected by authorized companies are anonymized and evaluatedafter being decrypted on computers managed by those companies. All computers
are kept up-to-date and are required to have antivirus software installed on theirsystems. Computers storing collected medical data over a prolonged duration areprogrammed not to allow any external communication to prevent the unintended
diffusion of medical data due to infection by computer viruses.
Computers managing medical data are located in a strictly controlledenvironment to prevent the unauthorized access to and external use of the data.
At the same time, all operations on computers handling medical data have to berecorded by law.

32

Authorized company

Emergency monitoring

Authorized company’ sdata center

Constant monitoring

One-way
communication

OS latest antivirus
Intrusion control

Medical information storage area

Personal
information

Internal use only33

4 For future medical care of our citizens

Q

I understand that our medical data are important for future medicalcare. Do they serve other purposes than the advancement of medical
technology?

A Japan is one of the few countries in the world that mandate a universal healthcare

system. All citizens have health insurance and access to low-cost advanced medicalcare. In recent years, medicine has made remarkable progress in Japan. The country’s
mature medical system has facilitated the collection of patient data and has promoted theadvancement of medical research. In doing so, it has contributed to the establishment of
the current healthcare services.
You may not normally think too much about the universal healthcare system.
However, medical care is closely related to our lives in terms of the social security system
as well as the technology used to cure diseases.

34

Since the promotion of the use of medical data indirectly affects

healthcare system reforms and the medical policies, medical expenses
and insurance premiums are expected to decrease because of thestreamlining of medical and nursing care services. It may take sometime, but providing more reliable and better quality medical and nursing
care offers immense benefits to our society.

Tw o i m p o r t a n t m a t t e r s m u s t b e e n s u r e d t o m a i n t a i n t h euniversal healthcare system. First, medical data should not be kept
locked in storage; instead, some aspects that are useful for researchand development must be deployed for future medical purposes.
Second, the privacy of the medical data of individual citizens should
be protected by all means. A person has the right to inspect personal
information at any time and is entitled to refuse to provide personal
data for research if there are any concerns. The data will continue to be
used for the individual’s treatment.
Japan has suffered significant damage caused by a number ofnatural disasters in the recent past. However, volunteers have helped
and empowered many victims. Your understanding and cooperation asa volunteer providing medical information will contribute to the future
medical care of our citizens.

D r. M a y u m i Yo s h i d a
Senior Researcher at the
Medical Information System
Development Center;completed a master ’s
degree at the Institute ofInformation Security; Master’sin information science;
specialized in the protectionof personal information ofpatients in medical institutions,in the use of data, in theprotection of privacy, and in
the appropriate methods ofobtaining consent.

35

Pursuing both availability and security
We hope that by now you appreciate the importance of the analysis of patient
data for the improvement of medical care and for the sustenance of the universal
healthcare system. At the same time, patient data are sensitive personal informationand their privacy should never be violated. Moreover, we have explained that thedevelopment of the Personal Information Protection Act has made it somewhat
difficult for bona fide medical researchers to use patient data for the purposes of the
progress of future healthcare.
We are sure that some of you would like to help those in need, volunteer to help
victims of catastrophes such as earthquakes and floods, or make donations.
However, you should not invite trouble for volunteering or making donations.
Likewise, using the data provided by patients should never violate their privacy.
A proverb states: “if you run after two hares, you will catch neither.” This36

maxim implies that one cannot simultaneously do two things successfully andteaches the importance of focusing on one thing at a time. However, this axiom is
not appropriate for patient data. According to the proverb, if we pursue both theeffective use of patient data and the protection of privacy, we will achieve neither
outcome. In fact, there are ways to use data even as individual privacy is protected.
One such way is the application of the Next Generation Medical Infrastructure Law.
In team sports, we often hear the expression “one for all, all for one.” This same istrue of the future of our medical care. We must run after two hares.
Caring for the interest of every individual is the most important element of theprotection of privacy. Although the Next Generation Medical Infrastructure Law
stipulates all possible measures to be taken to protect privacy, patients can refuse
to extend their medical data at any time. This action will not affect the medical
treatment provided to those who do not want their medical information to be used
for research or other legitimate purposes.
37

When you go to a hospital or a clinic in the future, you may receive a manual on
the Next Generation Medical Infrastructure Law. We usually only go to a hospital ora clinic for health reasons and at such times, we often do not feel capable of thinking
about other extraneous concerns. However, your data will not be used for at least amonth after you are provided a full explanation about the Next Generation Medical
Infrastructure Law. You can also deny the provision of your data at any time in the
future. We recommend that you will remember the contents of this book and thatyou will make a reasoned decision whenever you are ready.
“Medical care is a part of our lives, and it is an essential thing. To make the mind
and body a healthy and comfortable society, each one is interested in their own
health and thinking about tomorrow's medical care it is important to go.

38

o knowI want t
more…
a little

Let mehelp you

Legal system and related ministries related to"Mechanism of providing medical information"
Act Regarding Anonymized Medical Data to Contribute to Research and Developmentin the Medical Field (Act No. 28 of 2017)

Since the legislation has a rather lengthy and complex name, it is commonly referred to as the Next
Generation Medical Infrastructure Law. The basic policy was approved in a cabinet meeting on April
27, 2018, and the law was enforced on May 11 of the same year. For more information, please visit thewebsite mentioned below:“Enforcement of the Next Generation Medical Infrastructure Law” by the Cabinet Secretariat Healthand Medical Strategy Office

http://www.kantei.go.jp/jp/singi/kenkouiryou/jisedai_kiban/houritsu.html(Confirmed in March 2019)

Act on the Protection of Personal Information (Act No. 57 of May 30, 2003)

The often-heard term “Personal Information Protection Act” refers to this piece of legislation. It was
the first privacy law to be enacted in 2003 and was revised in 2015, and the so-called revised Personal
Information Protection Act was enforced at the end of May 2017. This Act establishes the basic policies,
cabinet orders, rules, and guidelines, which are classified according to the founder and the businesscategory. Please visit the website below for more information:“Personal Information Protection Commission: Personal Information Protection Act” by Personal
Information Protection Commission

https://www.ppc.go.jp/personalinfo/(Confirmed in March 2019)39

Medical Information System
Development Center (MEDIS)----------------------------------------------MEDIS was instituted in 1974. The center
assists in the promotion of security,
standardization, and introduction of new
systems for the popularization of a medical
information system that is focused onelectronic health records. It intends tocontribute to the formation of a national
healthcare system that is adapted forthe advancement of medicine, to theimprovement of national welfare, and to thedevelopment of the information society.

We have produced a comic
version brochure “How to provide
medical information? — A systemof medical information utilization
for tomorrow medical care”, inwhich we gently explain how toutilize your medical information.
You can download it from thefollowing website. Please read it!
Fair and safe use of Anonymized STandardized Health
Data of Japan : FAST-HDJhttps://www.fast-hdj.org/※ An organization established by MEDIS-DC. We are promoting
the utilization of anonymized medical information collected, thatis useful for the progress of medical care and medical science.

Date of issue:
March 31, 2019
Supervising editor: Dr. Hideo Yasunaga(Professor of the Graduate School of Medicine,the University of Tokyo; physician and doctor of medical science)
Medical Information System Development Center
Editor:EDITEX
Publisher:
Medical Information System Development Center
Sanko Building 2F, 1-1 Kagurazaka, Shinjuku-ku, Tokyo 162-0825
TEL: 03-3267-1923 FAX: 03-3267-1931 URL: https://www.medis.or.jp/
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