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9th Industrial Structure Council Commercial Distribution
Information Subcommittee Bio Subcommittee
Reference material 1
Personal Genetic Information Protection WG
November 30, 2016

In the business field using personal genetic information in the economic and industrial field
Personal information protection guidelines

December 17, 2004
(Partially revised on December 1, 2008)
(Partially revised on November 25, 2014)

Ministry of Economy, Trade and Industry

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table of contents

preamble
I. Purpose and scope
II. Legal Interpretation Guidelines / Examples
1. 1. Definition (related to Article 2 of the Act)
1-1. Terms related to the nature of information
(1) "Personal information" (related to Article 2, Paragraph 1 of the Law)
(2) "Genetic information"
(3) "Personal genetic information"
(4) "Samples, etc."
(5) "Medical information"
(6) "Anonymization"
(7) "Personal information database, etc." (related to Article 2, Paragraph 2 of the Law)
(8) "Personal data" (related to Article 2, Paragraph 4 of the Law)
(9) "Retained personal data" (related to Article 2, Paragraph 5 of the Law)
1-2. Terms related to the person and the business
(10) "Person" (related to Article 2, Paragraph 6 of the Law)
(11) "Business operator handling personal information" (related to Article 2, Paragraph 3 of the Law)
(12) "Business operator handling personal genetic information"
(13) "Businesses handling genetic information"
1-3. Terms related to the handling of "personal genetic information"
(14) "Informed consent"
(15) "Anonymization administrator"
(16) "Personal Genetic Information Handling Review Committee"
(17) "Genetic counseling"
1-4. Terms related to dealing with the person
(18) "Notify the person"
(19) "Publication"
(20) "Clarify the purpose of use to the person"
(21) "Personal consent"
(22) "A state that the person can easily know"
(23) "A state that the person can know (including the case of responding without delay at the request of the person)"
(24) "Offer"
2. 2. Obligations of businesses handling personal genetic information, etc.
(1) Purpose of use of personal genetic information (related to Articles 15 to 16 of the Act)
(1-2) Sensitive information

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(2) Acquisition of personal genetic information (related to Articles 17-18 of the Act)
(3) Management of personal genetic information (related to Articles 19 to 22 of the Act)
1) Ensuring the accuracy of personal genetic information (related to Article 19 of the Act)
2) Safety management measures (related to Article 20 of the Act)
3) Employee supervision (related to Article 21 of the Act)
4) Supervision of contractors (related to Article 22 of the Act)
(4) Provision to a third party (related to Article 23 of the Act)
(5) Publication of matters related to personal genetic information, disclosure / correction / suspension of use of personal genetic information
Etc. (related to Articles 24 to 30 of the Act)
1) Publication of matters related to personal genetic information (related to Article 24 of the Act)
2) Disclosure of personal genetic information (related to Article 25 of the Act)
2-2) Genetic counseling
2-3) Precautions for DNA testing and paternity testing
3) Correction of personal genetic information, etc.
4) Suspension of use of personal genetic information, etc.
5) Explanation of the reason (related to Article 28 of the Act)
6) Procedures for responding to requests for disclosure, etc. (related to Article 29 of the Act)
7) Fees (related to Article 30 of the Act)
(6) Grievance (related to Article 31 of the Act)
(7) Transitional measures (related to Articles 2 to 5 of the Supplementary Provisions of the Law)
(8) Personal Genetic Information Handling Review Committee
(9) Business plan of a business operator handling personal genetic information
3. 3. Handling of personal information at research institutes attached to private organizations
III. Thinking about "recommendations", "orders" and "emergency orders"
Ⅳ. Review of guidelines
V. It is a reference for businesses handling personal genetic information to properly and effectively fulfill their obligations.
Matters / standards

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preamble
The progress of human genome / gene analysis research has made full use of information technology using personal genetic information.
Improving people's health and welfare through a wide range of medical and health services, as well as new medical and health services
It is trying to play an important role in fostering the service industry.
On the other hand, personal genetic information analysis reveals the genetic predisposition of the person and his / her relatives, and also
Ethical, legal or social depending on the treatment, such as being able to identify the person
Respect for human rights, with the understanding and cooperation of society, personal genetic information as it can lead to problems
It is essential to carry out the project properly under the strict control of the information.
Based on such a request, this guideline is to protect personal genetic information safely.
It clarifies the measures that the business operator should comply with.
I. Purpose and scope
This guideline is the Law Concerning the Protection of Personal Information (Law No. 57 of 2003; hereinafter
It is called "law". ) "Personal information" decided by the Cabinet on April 2, 2004 based on Article 7, Paragraph 1.
Based on the "Basic Policy on the Protection of Information", "The Law Concerning the Protection of Personal Information"
Guidelines for the industrial sector ”(2004 Ministry of Health, Labor and Welfare / Ministry of Economy, Trade and Industry Notification No. 4”
issue. Hereinafter referred to as "Economic and Industrial Sector Guidelines". ), And Article 6 of the Act
And based on Article 8, business fields that use personal genetic information among the fields under the jurisdiction of the Ministry of Economy, Trade and Industry
Take necessary measures to take special measures to protect personal information in
Activities related to taking measures and ensuring the proper handling of personal information by businesses in the relevant field
It is defined as a concrete guideline to support the movement.
In addition, considering the ethical and social aspects of personal genetic information, ethical instructions in the research field
"Ethical Guidelines for Human Genome / Gene Analysis Research" (Ministry of Education, Culture, Sports, Science and Technology, 2001)
It was stipulated based on the Ministry of Health, Labor and Welfare / Ministry of Economy, Trade and Industry Notification No. 1).
In this guideline, "personal genetic information handling business operator" gives "personal genetic information" and "remains".
Established measures to be taken when "businesses handling genetic information" handle "genetic information"
The parts that are not specified in this guideline are the economic and industrial fields.
The guidelines apply.
In addition, this guideline applies to the personal information of employees of the target business operator.
Absent.
Regarding the provisions described as "must do" in this guideline
If you do not comply with it, the Minister of Economy, Trade and Industry may determine that you are in breach of the provisions of the law.
On the other hand, if you do not comply with the provisions that say "to do"
Although it is not judged to be a violation of the provisions of the law, the provisions stating that "it shall be"
Also, personal information should be handled carefully under the principle of respect for the individual's personality.
The basic idea of ​the law that proper handling should be achieved in consideration of the fact (Article 3 of the law)
Based on the above, and from the viewpoint of ensuring the strict implementation of proper handling of personal genetic information, the company
We must strive to work as much as possible as a social responsibility. However,
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The purpose of the law (law) to consider the usefulness of personal information when protecting personal information
In light of the purpose of Article 1), it also limits activities necessary for the public interest and legitimate business activities.
is not it.
Authorized personal information protection organizations in this field, businesses handling personal genetic information, genetic information
In the handling business, based on this guideline etc., personal information according to the actual situation of each business etc.
Establish further measures as voluntary rules to ensure the proper handling of information
And.
"Business using personal genetic information" means inspection, analysis, appraisal, etc. related to personal genetic information.
It is a business to be carried out, such as base sequence / single nucleotide polymorphism, genetic test such as constitution test, DNA test.
There are services such as paternity testing and paternity testing, and gene contract analysis. Self at the request of an individual
When acquiring genetic information from medical institutions, and by contracting from medical institutions and other businesses, testing and analysis,
In some cases, only appraisal is performed. Of these businesses, there are other guidelines and guidelines
In this case, the scope of application of this guideline is as follows.
When obtaining a sample directly from an individual, a constitutional test, DNA test, paternity test, etc. are performed.
To Of these, when a medical institution, etc. conducts a test using genetic information, "medical care / assistance"
It is the subject of "Guidelines for the proper handling of personal information by protection-related businesses".
In addition, the personal genetic information analysis carried out in the research is "Human Genome / Gene Analysis Research".
It is the subject of the "Ethical Guidelines for". In addition, the quality, effectiveness and safety of pharmaceuticals and medical devices
Pharmaceuticals and medicines implemented based on the Act on Ensuring Sexuality (Act No. 145 of 1960)
Clinical trials of medical equipment, etc., as well as post-marketing surveys and tests, have already been conducted based on this law.
"Ministerial Ordinance on Standards for Conducting Clinical Trials of Pharmaceuticals (Ministry of Health and Welfare Ordinance No. 28, 1997)", "Medical
Ministerial Ordinance on Standards for Post-Manufacturing and Sales Surveys and Testing of Chemicals (Ministry of Health, Labor and Welfare 2004)
It is regulated by Ordinance No. 10). Inspections, analyzes, appraisals, etc. that do not correspond to these
As a general rule, it is subject to this guideline.
If you want to obtain a sample from a medical institution and perform inspection, analysis, appraisal, etc.
Be subject to guidelines. In addition, inspection companies and analysis companies are conducting joint research with research institutes, etc.
If it plays a part, it will be subject to the "Ethical Guidelines for Human Genome / Gene Analysis Research".
In addition, the work performed by the Sanitary Inspection Center is under the jurisdiction of the Ministry of Health, Labor and Welfare, and this guideline
Not subject to.
In addition to following this guideline when conducting a "physical examination", its significance is objective.
It needs to be clearly shown as specific data.
Businesses based on forensic background such as DNA testing and paternity testing are subject to this guideline.
However, in view of its peculiarity, it also follows the original guidelines set by related academic societies.
I will do it.
The number of personal genetic information and genetic information excluded from the application of the law exceeds 5,000.
Even for businesses that do not have it, in light of the peculiarities of personal genetic information, we will comply with this guideline.
I will make an effort.
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II. Legal Interpretation Guidelines / Examples
1. 1. Definition (related to Article 2 of the Act)
1-1. Terms related to the nature of information
(1) "Personal information" (related to Article 2, Paragraph 1 of the Law)
Other than the following items, the example of the Ministry of Economy, Trade and Industry Guidelines is used.
(6) As described in "Anonymization", the information that can be linked and anonymized is a code.
Or, if it is in the corporation that holds the correspondence table of the number and personal information, the actual analysis etc.
By linking the anonymization information owned by the owner and the correspondence table, the entire corporation can be anonymized.
The information that has been provided is also organized as personally identifiable information and falls under "personal information".
To do.
(2) "Genetic information"
Generally, through the process of business using personal genetic information, which is carried out using samples, etc.
Information obtained or already attached to a sample, etc., based on human genetic characteristics and it
Information that indicates the constitution. However, in this guideline, it is possible to identify an individual.
Although it is impossible, only the information showing the genetic characteristics and the constitution based on it is defined as "genetic information".
Information that can be used to identify an individual and that indicates a genetic characteristic or a constitution based on it is
It is defined as "personal genetic information" specified in (3).
(3) "Personal genetic information"
Of the "personal information" specified in (1), the genetic characteristics of the individual and the constitution based on it are shown.
Information that can be used to identify an individual.
(4) "Samples, etc."
Blood, tissues, cells, body fluids, excrement, etc. to be used for businesses using personal genetic information
It refers to a part of the human body such as human DNA extracted from these and medical information of the person.
(5) "Medical information"
Information such as disease names, medication names, and test results obtained through diagnosis and treatment.
(6) "Anonymization"
Do not leak a person's personal information to the outside in violation of laws, this guideline or business plan
As such, remove all or part of the personally identifiable information from that personal information and replace it.
It means to attach a code or number that has nothing to do with the person. Information associated with samples, etc.
Of these, even if certain information is not enough to identify a specific person, various lists, etc.
If the person can be identified by combining it with other available information,
Remove all or part of the information required for the combination so that the person cannot be identified.
To say that.
There are two methods for anonymization as follows. Linkable Anonymized information is coded
Or, if it is in the corporation that holds the correspondence table of the number and personal information, the actual analysis etc.
By linking the anonymization information owned by the owner and the correspondence table, the entire corporation can be anonymized.
The information that has been provided is also organized as personally identifiable information and corresponds to personal information.
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It is considered to be. On the other hand, in the case of a corporation that does not have a correspondence table, it is applicable to personal information.
It's irresistible.
a Linkable anonymization
A new code or number assigned to the individual so that the individual can be identified if necessary.
Anonymization by leaving a correspondence table of
b Unlinkable anonymization
Anonymous by a method that does not leave a correspondence table like a above so that individuals cannot be identified
To
(7) "Personal information database, etc." (related to Article 2, Paragraph 2 of the Law)
The law defines specific personal information as systematically constructed, but it is systematically structured.
In this guideline, we will comply with this guideline even if there is no information.
This term is not used.
(8) "Personal data" (related to Article 2, Paragraph 4 of the Law)
The law defines it as personal information that constitutes a "personal information database, etc.", but systematically
This guideline is to comply with this guideline even if the information is not configured.
In, it is treated as "personal genetic information".
(9) "Retained personal data" (related to Article 2, Paragraph 5 of the Law)
Although it is positioned as a part of "personal data" in the law, it is not systematically constructed.
Information is also subject to this guideline, so in this guideline, "individuals"
Treat as "human genetic information".
1-2. Terms related to the person and the business
(10) "Person" (related to Article 2, Paragraph 6 of the Law)
(11) "Business operator handling personal information" (related to Article 2, Paragraph 3 of the Law)
According to the example of the Ministry of Economy, Trade and Industry guidelines. However, this guideline is "individual inheritance"
About measures to be taken when "information handling business operator" handles "personal genetic information"
It is a fixed one.
(12) "Business operator handling personal genetic information"
"Personal genetic information handling business operator" means "personal genetic information handling business operator" among "personal information handling business operators".
Businesses that carry out business using "reports" (including businesses that do this as part of their business)
U. This is the case for businesses that obtain samples directly from the person. For that business
Persons whose number of personal genetic information provided does not exceed 5,000 on any day of the past June
Even so, we will comply with this guideline.
(13) "Businesses handling genetic information"
A "genetic information handling business operator" is a business that uses only genetic information that cannot be identified by an individual.
Anonymized information that refers to the business operator (including the business operator that does this as part of the business)
This is the case for businesses that are entrusted with only the data and perform analysis. Although not subject to the law, this guide
We will comply with the line. The number of genetic information used for the business has been 6 in the past.
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Comply with these guidelines, even if there are no more than 5,000 people on any day of the month
I will protect it.
1-3. Terms related to the handling of "personal genetic information"
(14) "Informed consent"
Regarding the business that the person uses personal genetic information in advance from the business operator handling personal genetic information
After receiving sufficient explanation, the significance, purpose, method, expected result, disadvantage and precision of the business
Understand the degree, and based on free will, the same in writing regarding the acquisition and handling of samples, etc.
It means giving intention.
(15) "Anonymization administrator"
In a business operator handling personal genetic information, personal information of the person is leaked to the outside of the business operator.
The person in charge of managing personal information and anonymizing it so that it does not occur.
(16) "Personal Genetic Information Handling Review Committee"
Ethical, legal, and company regarding the suitability and other matters of business content using personal genetic information
A collegial system established as an advisory body to the representatives of business operators in order to investigate and deliberate from a social perspective.
Institution.
(17) "Genetic counseling"
A doctor or medical servant who is proficient in sufficient medical genetic knowledge / experience and counseling
Psychology of the person or family with sufficient expertise and experience in clinical genetics
The genetic test and all businesses including it by a person who can provide social and social support
To answer general questions and anxieties or worries about hereditary constitution, etc.
Therefore, we will support you so that you can make your own choices and actions for your future life, or
To help.
1-4. Terms related to dealing with the person
(18) "Notify the person"
In this guideline, the "notice" stipulated by law shall be explained and agreed in writing.
Informed consent including. However, Article 24, Paragraph 2 of the Law
The items stipulated in paragraphs 3 and 3 are based on the examples of the guidelines for the economic and industrial fields.
(19) "Publication"
Regardless of the example of the guidelines in the field of economy and industry, it shall be as follows.
In this guideline, all "publication" stipulated by law is a written explanation.
It shall be based on "informed consent" including consent.
(20) "Clarify the purpose of use to the person"
Regardless of the example of the guidelines in the field of economy and industry, it shall be as follows.
"Informed consent" that clearly states the purpose of use, including written explanation and consent
It shall be due to.
(21) "Personal consent"
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Regardless of the example of the guidelines in the field of economy and industry, it shall be as follows.
In this guideline, all "personal consent" stipulated by law is in writing.
It shall be based on "informed consent" including explanation and consent.
(22) "A state that the person can easily know"
According to the example of the Ministry of Economy, Trade and Industry guidelines.
(23) "A state that the person can know (including the case of responding without delay at the request of the person)"
According to the example of the Ministry of Economy, Trade and Industry guidelines.
(24) "Offer"
According to the example of the Ministry of Economy, Trade and Industry guidelines.
2. 2. Obligations of businesses handling personal genetic information, etc.
(1) Purpose of use of personal genetic information (related to Articles 15 to 16 of the Act)
(1) Identification of purpose of use (related to Article 15, Paragraph 1 of the Law)
Other than the following items, the example of the Ministry of Economy, Trade and Industry Guidelines is used.
Businesses handling personal genetic information should provide info when handling personal genetic information.
As part of a mood outlet, the purpose of its use must be identified.
Specifically, it is not subject to inspection more strictly than the example of the guidelines in the field of economy and industry.
The purpose must be specified to the extent that the gene is clarified.
In addition, the business operator handling genetic information also uses it when handling genetic information.
The purpose will be specified by the example of the guidelines in the field of economy and industry.
(2) Change of purpose of use (related to Article 15, Paragraph 2 of the Law and Article 18, Paragraph 3 of the Law)
According to the example of the Ministry of Economy, Trade and Industry guidelines.
③ Restrictions on purpose of use (related to Article 16, Paragraph 1 of the Law)
Other than the following items, the example of the Ministry of Economy, Trade and Industry Guidelines is used.
Businesses handling personal genetic information exceed the scope necessary to achieve the purpose of use.
As a general rule, we will not handle information (related to Article 16, Paragraph 1 of the Act). However,
Inform about appropriate and clear purpose and sample handling method as follows
This is not the case if you get a mood outlet.
[Case]
I: Research aimed at improving testing technology using samples taken for DNA testing and paternity testing
When storing and using for the purpose, an appropriate and clear purpose ("improvement of appraisal technology", etc.),
When providing to a third party, the other party, storage method, safety management measures to be taken, research end
Obtain informed consent regarding how to dispose of the sample after completion.
④ Business succession (related to Article 16, Paragraph 2 of the Law)
According to the example of the Ministry of Economy, Trade and Industry guidelines.
⑤ Exemption (related to Article 16, Paragraph 3 of the Law)
According to the example of the Ministry of Economy, Trade and Industry guidelines.

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(1-2) Sensitive information
Businesses handling personal genetic information, except for personal genetic information used for business, have political views and confidence.
Religion (religion, thought and beliefs), trade union membership, race and ethnicity, family origin and books
Information on the place of residence, health care and sexual life, and criminal history is based on laws and regulations.
Unless it is necessary, it will not be acquired or used.
(2) Acquisition of personal genetic information (related to Articles 17-18 of the Act)
① Implementation of informed consent
The business operator handling personal genetic information should give a sufficient theory in advance to the person regarding the following items.
Make a statement and carry out a business using personal genetic information with the written consent of the person.
I will do it.
In addition, when the test results have a legal effect, such as DNA test and paternity test.
In the document, after giving an appropriate and sufficient explanation about its legal effect.
We will obtain face-to-face consent.
Withdrawal of informed consent shall be stipulated in the contract. Ta
However, in view of the peculiarity of personal genetic information, we will respond if the person requests withdrawal.
In that case, unless the person wishes to take measures other than disposal.
Samples, etc. and test results related to the person concerned shall be anonymized and discarded. In that case
The contract also stipulates that the person should be required to pay the necessary costs.
[Contents to be included in informed consent documents]
・ Significance, purpose and method of business (target genetic factors, analysis method, accuracy, etc.) in the future
If any additions or changes are expected, that is the case. Especially when performing a constitutional examination,
The significance of is clearly shown as objective data. ), Business period, business
How to handle samples after completion, expected results and disadvantages (social life such as social discrimination)
Including the above disadvantages. )etc
・ How to withdraw informed consent, requirements for withdrawal, and withdrawal
(Including disposal method, etc.), cost burden, etc.
・ Business name, address, telephone number, representative name and job title
・ Anonymization and safety regarding the handling of information at each stage from acquisition of samples to disposal
Specific method of management measures
・ When outsourcing analysis, etc. to another company, or when sharing it, the outsourcer, jointly
Name and consignment of user, anonymization of personal genetic information for shared use, safety management
Specific method of measures
・ The Personal Genetic Information Handling Examination Committee examines the suitability of project implementation fairly and neutrally.
is being done
・ Matters concerning disclosure of personal genetic information (reception desk, acceptance method, disclosure
If a fee is incurred, include that fact. )
・ Information related to the use of genetic counseling
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・ Regarding inquiries (correction of personal information, withdrawal of consent, etc.), contact information for complaints, etc.
Information to do
② Appropriate acquisition (related to Article 17 of the Act)
According to the example of the Ministry of Economy, Trade and Industry guidelines.
③ Notification or publication of purpose of use (related to Article 18, Paragraph 1 of the Law)
Regardless of the example of the guidelines in the field of economy and industry, it shall be as follows.
Instead of notifying and disclosing the purpose of use after acquiring personal genetic information,
After clarifying the purpose of use in advance in writing with a foamed outlet
It will be obtained with the consent of.
④ Obtained directly in writing (related to Article 18, Paragraph 2 of the Law)
Other than the following items, the example of the Ministry of Economy, Trade and Industry Guidelines is used.
The purpose of use shall be clearly stated by informed consent.
⑤ Change of purpose of use (related to Article 18, Paragraph 3 of the Law)
According to the example of the Ministry of Economy, Trade and Industry guidelines.
⑥ Exemption (related to Article 18, Paragraph 4 of the Law)
According to the example of the Ministry of Economy, Trade and Industry guidelines.
(3) Management of personal genetic information (related to Articles 19 to 22 of the Act)
1) Ensuring the accuracy of personal genetic information (related to Article 19 of the Act)
Other than the following items, the example of the Ministry of Economy, Trade and Industry Guidelines is used.
The business operator handling genetic information provides genetic information to the extent necessary to achieve the purpose of use.
We will endeavor to keep it accurate and up-to-date.
2) Safety management measures (related to Article 20 of the Act)
Other than the following items, the example of the Ministry of Economy, Trade and Industry Guidelines is used.
Regarding the handling of personal genetic information, prevention of information leakage, loss or damage, etc.
Do not take organizational, human, physical and technical security management measures for the security management of information
Must be. At that time, after anonymizing as specified below, the Ministry of Economy, Trade and Industry Guide
Take appropriate measures by referring to the [Matters to be taken] on the line.
Strive. Also, regarding genetic information, for safety management, systematic, human, physical,
Technical safety management measures shall be taken. At that time, the person's information was leaked and lost.
Considering the magnitude of infringement of rights and interests that the person incurs in the event of a loss, information such as anonymization
Take necessary and appropriate measures according to the risks caused by the handling status of information, etc.
To do.
[Anonymization]
Businesses handling personal genetic information set up anonymization managers and, in principle, obtain samples, etc.
Be sure to anonymize the samples, etc. promptly afterwards, and before consignment or provision to a third party.
I will do it.
The anonymization administrator should perform the anonymization work and give informed consent.
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On the other hand, the correspondence table created for the anonymization work is properly managed and disposed of, and personal remains.
We will strictly manage the information so that it will not be leaked.
A business operator handling genetic information has acquired samples, etc. that have not been anonymized by the consignor.
In that case, it will be treated as personal genetic information after being anonymized.
3) Employee supervision (related to Article 21 of the Act)
According to the example of the Ministry of Economy, Trade and Industry guidelines.
4) Supervision of contractors (related to Article 22 of the Act)
According to the example of the Ministry of Economy, Trade and Industry guidelines.

(4) Provision to a third party (related to Article 23 of the Act)
① Principle (related to Article 23, Paragraph 1 of the Law)
Other than the following items, the example of the Ministry of Economy, Trade and Industry Guidelines is used.
As a general rule, we will not provide it to a third party (Article 23, Paragraph 1 of the Act). However
However, as shown below, informed consent regarding the clear purpose and how to handle the sample, etc.
If you get an outlet, this is not the case.
[Case]
I: Research aimed at improving testing technology using samples taken for DNA testing and paternity testing
When storing and using for the purpose, an appropriate and clear purpose ("improvement of appraisal technology", etc.),
Regarding the other party, storage method, safety management measures to be taken, sample disposal method after the research is completed, etc.
And get informed consent.
② Opt-out (related to Article 23, Paragraph 2 of the Law)
Businesses handling personal genetic information will not opt ​out.
* Opt-out (quoting METI guidelines)
Opt-out is an exceptional measure that can be selected with respect to the principle (1) in this section.
Matters specified in i to iv below in advance when providing personal data to a third party
Notify the person, or keep it in a state that the person can easily know, and the book
With the consent of the person, provided that the provision to a third party is stopped at the request of the person.
It means that personal data can be provided to a third party. In Article 23, Paragraph 2 of the Law
In the case of doing this, the business operator handling personal information does not have the consent of the person.
It is said that personal data can be provided to a third party.
I. The purpose of use is to provide it to a third party.
Ii Items of personal data provided to third parties
Ⅲ Means or method of provision to a third party
Ⅳ Provision of personal data that identifies the person at the request of the person to a third party
To stop.
③ Those that do not correspond to a third party (related to Article 23, Paragraph 4 of the Law)
Other than the following items, the example of the Ministry of Economy, Trade and Industry Guidelines is used.
As an example of entrustment, "when requesting genetic counseling from doctors, medical professionals, etc."
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There is.
④ Personal data related to employment management
According to the example of the Ministry of Economy, Trade and Industry guidelines.
(5) Publication of matters related to personal genetic information, disclosure / correction / suspension of use of personal genetic information, etc. (Act)
Articles 24 to 30 related)
1) Publication of matters related to personal genetic information (related to Article 24 of the Act)
(1) Notification of matters related to personal genetic information to the person (related to Article 24, Paragraph 1 of the Act)
According to the example of the Ministry of Economy, Trade and Industry guidelines.
(2) Notification of purpose of use of personal genetic information (related to Article 24, Paragraphs 2 and 3 of the Law)
According to the example of the Ministry of Economy, Trade and Industry guidelines.
2) Disclosure of personal genetic information (related to Article 25 of the Act)
Other than the following items, the example of the Ministry of Economy, Trade and Industry Guidelines is used.
When a business operator handling personal genetic information discloses genetic information to the individual, the following 2-2)
Adhere to the genetic counseling method described in.
2-2) Genetic counseling
When a business operator handling personal genetic information intends to disclose genetic information, it may be medical or
Considers the psychological impact, etc., and implements it in-house or in an appropriate facility as necessary.
Establish a system that allows the person to receive genetic counseling through referrals, etc.
And.
Genetic counseling is learned from sufficient medical genetic knowledge / experience and counseling.
Experienced doctors or healthcare professionals, or sufficient clinical genetics expertise / experience
Conducted by persons who have and can provide psychological and social support such as the person and family
Need to be. If someone other than a doctor or healthcare professional provides this counseling
Is carried out in cooperation with doctors, medical professionals, etc. who are proficient in genetic counseling.
And.
Genetic counseling includes questions about the genetic test and the business in general, including it.
By responding to the anxiety or worries of the person over hereditary constitution, etc., future life
Supporting or assisting people to make their own choices and actions toward their activities
The purpose.
Genetic counseling will provide you with the most accurate and up-to-date relevant information possible.
I will try to do so. Also, using simple words that the person can understand, the person is fully reasonable.
Always make sure that you understand what you are doing, and if you wish, continue to do so.
And.
2-3) Precautions for DNA testing and paternity testing
Regarding the legal effect of the test results in DNA test and paternity test,
Persons with sufficient legal knowledge and experience will cooperate to provide information and provide advice.
In paternity testing, it is important to respect the welfare of individuals and families, and the following
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Consider the points.
I. Pay the utmost attention to the welfare of minors, especially infants who often have a small voice.
To pay.
Ii Those who have a direct effect of the appraisal, that is, the appraised parents and children, sample providers, etc.
Note that there is no objection to the implementation of the appraisal in the meantime.
3) Correction of personal genetic information, etc.
According to the example of the Ministry of Economy, Trade and Industry guidelines.
4) Suspension of use of personal genetic information, etc.
According to the example of the Ministry of Economy, Trade and Industry guidelines.
5) Explanation of the reason (related to Article 28 of the Act)
According to the example of the Ministry of Economy, Trade and Industry guidelines.
6) Procedures for responding to requests for disclosure, etc. (related to Article 29 of the Act)
Other than the following items, the example of the Ministry of Economy, Trade and Industry Guidelines is used.
In the case of a business operator handling personal genetic information, the person requesting disclosure, etc. must be the person or his / her agent.
When deciding the method of confirmation, make sure that the confirmation procedure is sufficient and appropriate.
Must.
In addition, Article 8 of the Law Enforcement Ordinance on the Protection of Personal Information (Cabinet Order No. 507 of 2003)
In response to the request for disclosure, etc. by the agent in paragraph 2, the business operator handling personal genetic information asks the person himself / herself.
Only direct disclosure, etc. is not hindered.
7) Fees (related to Article 30 of the Act)
According to the example of the Ministry of Economy, Trade and Industry guidelines.
(6) Grievance (related to Article 31 of the Act)
According to the example of the Ministry of Economy, Trade and Industry guidelines.
(7) Transitional measures (related to Articles 2 to 5 of the Supplementary Provisions of the Law)
According to the example of the Ministry of Economy, Trade and Industry guidelines.
(8) Personal Genetic Information Handling Review Committee
Businesses handling personal genetic information examine the suitability of business implementation using personal genetic information.
Therefore, we will establish a personal genetic information handling review committee. However, personal genetic information
If it is difficult to set up a handling review committee, joint ventures, general incorporated associations, general goods
It has a personal genetic information handling review committee established by an incorporated association, an academic society, or an industry group.
Can be replaced with this. In addition, a similar committee already set up in the business operator
The name does not matter as long as it is reorganized into a review committee that conforms to this guideline.
Based on this guideline, the Personal Genetic Information Handling Review Committee will determine the suitability of project implementation, etc.
We will examine it from scientific, ethical, legal, social and technical viewpoints and collect personal genetic information.
Can express opinions in writing to the handling business operator.
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The Personal Genetic Information Handling Review Committee is in the process of implementing personal genetic information handling businesses.
Regarding the business, it is recognized that it is necessary for changing or canceling the business plan or for proper business implementation.
Can give an opinion.
The Personal Genetic Information Handling Review Committee stands in an independent position and has various perspectives.
Appropriately structured and luck so that fair and neutral examinations can be conducted by committee members from various positions.
I will run it.
The content of the proceedings of the Personal Genetic Information Handling Review Committee should be clarified concretely.
Although it will be disclosed to the public, human rights of providers, originality of research, protection of intellectual property rights, competition
The part that may hinder the preservation of the position in the dispute is the Personal Genetic Information Handling Review Committee.
It can be kept private by the decision of. In this case, the Personal Genetic Information Handling Review Committee
Will disclose the reason for keeping it private.
Members of the Personal Genetic Information Handling Review Committee leak information that they have learned in the course of their duties without a justifiable reason.
It should not be done. The same is true even after resigning from that position.
(9) Business plan of a business operator handling personal genetic information
A business operator handling personal genetic information is trying to implement a business plan.
Considering the peculiarities of personal genetic information, various effects expected on the person, etc. due to the business, etc.
Based on the above, the necessity of the business, the business method to prevent the disadvantage of the person, etc. are fully considered.
We will prepare a business plan.
For businesses handling personal genetic information, the storage period of samples, etc. has exceeded the period specified in the business plan.
In that case, the consent of the person or his / her agent shall be observed and the item shall be discarded.
A business operator handling personal genetic information formulates or changes a business plan that uses personal genetic information.
Further decisions will be made with respect for the opinions of the Personal Genetic Information Handling Review Committee.
[Matters to be stated in the business plan]
・ Procedures and methods of informed consent
・ How to protect personal information
・ Results predicted by the business and the concept of disclosure
・ How to store and use samples, etc.
・ Concept of genetic counseling and counseling in DNA test and paternity test
Gu's way of thinking
3. 3. Handling of personal information at research institutes attached to private organizations
Other than the following items, the example of the Ministry of Economy, Trade and Industry Guidelines is used.
This guideline is for the protection of personal information in "business fields" using personal genetic information.
The "research field" is defined as "human genome / gene analysis research".
The ethical guidelines to be applied.
III. Thinking about "recommendations", "orders" and "emergency orders"
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According to the example of the Ministry of Economy, Trade and Industry guidelines.
Ⅳ. Review of guidelines
According to the example of the Ministry of Economy, Trade and Industry guidelines.
V. It is a reference for businesses handling personal genetic information to properly and effectively fulfill their obligations.
Matters / standards
Other than the following items, the example of the Ministry of Economy, Trade and Industry Guidelines is used.
Businesses handling personal genetic information are listed below according to the content of their business.
We will endeavor to comply with the inn, etc.
・ "Guidelines for Genetic Testing" (August 2003, Medical Genetics Society, Japan
This Genetic Counseling Society, Japan Society for Genetic Medicine, Japan Society of Obstetrics and Gynecology, Japan Small
Child Genetics Society, Japanese Genetics Society, Japanese Teratology Society, Japanese Teratology Society, Japan
This Mass Screening Society, Japanese Society of Clinical Laboratory Medicine, Familial Tumor Study Group)
・ "Guidelines for DNA testing" (December 1997, Japan DNA Polymorphism Society DNA testing
Review Committee)
・ "Guidelines for paternity testing" (June 1999, Japan Forensic Society for paternity testing
walking group)
・ "Ethical Guidelines for Contracted Human Genetic Testing" (April 2001, Japan Hygiene Inspection)
Institute of Genetic Testing Ethics Review Committee)

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