Guideline for
KAKUTEI of image information
v. 2.1

Public Interest Incorporated Association
Japanese Society of RadiologicalTechnology
August 18, 20141

Preface for English version
Japanese Society of Radiological Technology recognizes that more
research papers to introduce or investigate Japanese practices should bealso published in English.
Accordingly, the English version of “Guideline for KAKUTEI of image
information” is created with the following intentions:(a) initiatives driven by radiological technologists in Japan for improving
care delivery are introduced to international societies with adequate
context; and(b) individuals who write research papers in English would be able torefer to this guideline as appropriate.
In the English version, the following two words are respectively kept intheir original Japanese as they represent core theme of this guideline:
KAKUTEI is an act of storing image information for use as grounds fordiagnosis in information systems such as PACS; andKENZO is an operation of optimizing image quality before KAKUTEI.
While readers without experiences in Japanese practice may not befamiliar with these operational concepts, we wish that they may become
clearer throughout the text of this guideline.
For all readers of this English version, it is strongly advised that if inquestion, the original publication of the “Guideline for KAKUTEI of image
information” in Japanese is referred to for clarification.
October 1, 2016
Public Interest Incorporated Association
Japanese Society of Radiological Technology

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1. Introduction ...................................................................................................................3
2. The scope of this guideline and intended image information of this guideline ........................ 5
3. KAKUTEI and creation responsibility of image information ......................................................5
3.1. The provision of authenticity ........................................................................................... 5
3.2. KAKUTEI operations and creation responsibility ...............................................................6
3.2.1. Cases involving image processing ............................................................................. 6
3.2.2. Recording the personnel responsible for creation ..................................................... 7
3.2.3. Cases without explicit KAKUTEI operations ...............................................................7
3.2.4. Time synchronization ...............................................................................................8
3.2.5. Electronic signatures ................................................................................................ 8
4. Handling film copies and image information from external medical institutions ....................... 94.1. Storage obligations ......................................................................................................... 94.2. Handling portable media from external medical institutions .......................................... 10
4.3. Importing image information and creation responsibility ............................................... 10
5. Conditions for film digitization ............................................................................................. 10
5.1. Films as objects of storage
5.2. Electronic information as objects of storage
5.2.1. Image information storage by digitizers at each point of care .................................. 11
5.2.2. Electronic storage of previously accumulated films by digitizers .............................. 12
6. Retention period and compression of image information ...................................................... 12
7. KENZO ............................................................................................................................ 13
7.1 Types of information to be verified ............................................................................. 13
7.2 Cases of KENZO Operations.................................................................................... 14
7.2.1. Case 1: KENZO at modalities ................................................................................... 11
7.2.2. Case 2: Specialized software applications for KENZO .............................................. 12(3) Case 3: KENZO using Image Viewer as a PACS functionality .......................................... 12
8. External storage, backup at external facilities, and sharing within regional medical collaborationof clinical image information .................................................................................................. 15
8.1. External storage ....................................................................................................... 15
8.2. Backups at external facilities ......................................................................................... 16
8.3. Sharing within regional medical collaboration................................................................ 16

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1. Introduction

The digitization of image information has not only improved the usability of medical images

at medical institutions, leading to filmless environments, but has also enabled additional image
processing, which aids diagnosis and the exchange of digital image information between
medical institutions, including teleradiology.

Before the digitization of image information, it was difficult to modify images printed on film;

thus, to ensure the traceability of image information, it sufficed to appropriately store physicalfilms as grounds for diagnosis. However, with the proliferation of information systems, it has
become common practice at medical institutions to create and store digitized image

information whose content differs from that of conventional film-based image information. For
example, it is not difficult to carry out additional image processing with the intention ofincreasing the value of its data or to overwrite an existing digital image entirely. In such cases,

however, concerns about the provenance and authenticity of image information arise, since theoriginal image may have been altered over time. In clinical practices in particular, it is obviously
dangerous to alter the image information used by doctors as their grounds for diagnosis.

In order to deal with this problem and ensure the authenticity of necessary information, it is

crucial to clarify the time at which image information became grounds for diagnosis andproperly document where the responsibility for its creation and the obligation of its storage,
reside. The Ministry of Health, Labor, and Welfare (MHLW) has published “Guideline for the

Security Management of Medical Care Information Systems” (the MHLW security management

guideline v. 4.3, March 2016) as a guideline for handling digitized medical information and theoperation and management of medical information systems.

This guideline was prepared by the guideline creation group of the Japanese Society ofRadiological Technology in FY 2009, declaring that “the KAKUTEI of image information isassumed as a duty of radiological technologists," as set forth in each medical institution’s
policy and procedure manual and in accordance with the aforementioned security

management guideline. Taking into consideration the operations particular to digital images,
such as image processing and the procedure for handling image information at medical

institutions, this guideline was specifically designed to guideline the KAKUTEI and storage ofimage information and to promote appropriate processes for the KAKUTEI and management ofdigital images.

This guideline is intended to demonstrate concepts that will aid medical institutions indetermining how and when timing information is set for KAKUTEI and to clearly define it intheir policy and procedure manual.

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In the process preceding the KAKUTEI and storage of an image, there exist numerous

operational procedures and policies unique to each medical institution, such as image quality
optimization, the confirmation of supplemental information (also called KENZO), andphysicians' methods for specifying information as grounds for diagnosis.

This guideline pays particular attention to the concept of the KAKUTEI of a record, which isnecessary for the provision of authenticity, as required by the MHLW security management
guideline, and requires clear definition in policy and procedure manuals with regard to thethreshold and timing of the KAKUTEI of information of, for example, images obtained in exams.
Here, the "KAKUTEI of record” in imaging and "KENZO operations" in imaging are considered

to be the outcome and the process of quality assurance, respectively. Because they are both

important steps, this guideline treats them as reasonably sequential procedures. However, theintroduction of a KENZO system designed for increased efficacy or operational convenienceand the discussion of timing definitions for the KAKUTEI of a record are two dimensionallydifferent concepts; hence, this guideline does not suggest that any specific KENZO system isrequired for the KAKUTEI of a record. Moreover, the definition of KENZO and appropriate

image handling procedures, which are important responsibilities of medical personnel withclinical roles, are left for another discussion.

This guideline, recognizing the importance of KAKUTEI, establishes requirements for fulfillingthe duties of a radiological technologist, with the expectation that any staff member canbecome responsible for the creation of image information (per an institution’s policy andprocedure manual). In addition, periodic review is planned to avoid the obsolescence of thisguideline; please confirm that this is the latest version and be aware of future updates.
2. The scope of this guideline and intended image information of this guideline

This guideline is designed for persons involved in picture archiving and communication

systems (PACS) or any other information systems dealing with image information, as well as
those involved with those systems’ operation, utilization, service and maintenance, or
disposition.

Persons responsible for handling "radiographs," as indicated in Medical Care Law

Enforcement Regulations Article 20, or “image information legally subject to storage,” among

other image information that requires protection of personal information, as in the "records ofdiagnoses” in Articles 21, 22, and 22.2 of the Medical Care Law (July 30 1948. Act No. 205),
should be familiar with this guideline.

53. KAKUTEI and the creation responsibility of image information

This section clarifies the KAKUTEI and responsibility for the creation of image information as

grounds for diagnosis and conditions regarding these responsibilities.
3.1．The provision of authenticity

The MHLW security management guideline states as a requirement for electronic storage,that "in order to electronically store documents required to be preserved by law, it is requiredthat not only those digitized documents can be used without difficulty but also their accuracy is
at sufficient level such as to being used as evidence of lawsuits."

Here, three criteria for the provision of authenticity, the provision of visual readability, andthe provision of storage property are listed as legal conditions for electronically storing

documents. Of these criteria, authenticity is a measure of whether the lawfully createddocument has been protected from false input, overwriting, erasure, or confusion and that the
responsibility for its creation, as viewed by a third party, is clear.
3.2． KAKUTEI operations and creation responsibility

As institutional requirements regarding creation responsibility, "it is required, forelectromagnetic records, to devise a process that confirms the presence of the fact ofmodification or erasure made within their legally required storage period and its contents andto clarify the responsibility for the creation of those electromagnetic records.” (The ministerial
ordinance regarding the use of telecommunication technologies for the preservation of

documents, as done by private enterprises, is based on the regulations of the Ministry of

Health, Labor and Welfare. Article 4 Clause 4.2, March 25, 2005.) The ministerial ordinanceregarding the use of telecommunication technologies for document preservation by private
enterprises is based on the regulations of the MHLW.

At medical institutions, image information obtained from an imaging device or modality for

use as grounds for diagnosis is stored in information systems such as PACS; the act of storing
this information is effectively the KAKUTEI operation, and the person who carried it out is

responsible for the image information’s creation. For example, if a radiological technologist
carries out imaging examination and stores the image information in PACS as "image

information legally subject to storage," the radiological technologist is responsible for thecreation of the image information as the person who performed its KAKUTEI and storage

operations. Moreover, it is the duty of the person responsible for creation to confirm before

6storing the information that it has been correctly created and entered and that there has been
no rewriting, erasure, or confusion.

To be certain of these operations, carried out before the act of KAKUTEI, it is not necessarily

required to retain a history of these operations. In addition, creation responsibility also occurs
for rewriting and erasure operations after KAKUTEI; however, if the change is only for

temporary display (such as changes in density or magnification) and there is no change in theoriginally stored image data, then incremental KAKUTEI and storage are not required.

In order to clearly present creation responsibility, it is necessary to clarify the person

responsible for creation, and to devise a way to promptly present this informationelectromagnetically or on documents when required.
3.2.1. Cases involving image processing

Image information whose authenticity is to be secured is considered confirmed (or“KAKUTEI-ed”) and the image information preceding the confirmed records is not subject tothe provision of authenticity.

For example, if a radiological technologist processes a 3D image and KAKUTEI-then-storesthe processed image information in PACS, and a physician performs a diagnosis using thisimage information, then the image information used to make the 3D image (i.e., thin-slice
images) are not objects of storage. In this case, the person responsible for creation is theradiological technologist who stored the processed image in PACS (Q & A in the MHLW security
management guideline v. 4.3, Q42).

Moreover, regarding the 3D images, the Q & A of the MHLW security management guidelinev. 4.3 specifies:

Q: "For an x-ray CT, I use the original image and 3D images created from theoriginal images for diagnoses. Is it allowed, with electronic [storage], to delete

the 3D images used for the diagnoses as long as I save the original images? It isdifficult to reproduce the 3D images completely because the parameters are notstored."

A: "There is no need to save processed image information used directly for the
diagnoses and clinical services, provided their reproduction is, in principle,

possible. In this case, however, because it is difficult to reproduce the 3D image
used for the diagnoses completely, the 3D image should not be deleted."

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3.2.2. Recording the personnel responsible for creation

It is necessary to specify, in the policy and procedure manual, where the record of theperson responsible for image information creation is stored. Records of persons responsible

for creation are not always supplemental to the image information; they can be noted in othersystems or on paper documents.

For example, the following stipulation can be considered: "for CT images, one who

performed the examination as recorded in the RIS (Radiology Information System) is the
person who operated KAKUTEI of the examination."
3.2.3. Cases without explicit KAKUTEI operations

To clarify the personnel responsible for creation of a record, certain operational cases

assume that it is KAKUTEI-ed, even without an explicit KAKUTEI operation. In practice, suchcases include those in which image information is automatically sent from the imaging
modality to PACS and saved, at which time the image information is considered to be

KAKUTEI-ed, or in which the image information is considered to be KAKUTEI-ed at a specified

time of day or after a pre-defined amount of time has elapsed. In such cases, it is necessary toestablish a method for specifying the personnel responsible for creation, as well as operational
methods, and it must be clearly documented in the policy and procedure manual.

For example, if the policy and procedure manual states that " image information sent

automatically from the CT to PACS is KAKUTEI-ed at midnight on the same day, and the person
responsible for creation is so-and-so," this person is responsible for the appropriate storage ofsuch image information. If additional notes, overwriting, or erasure become necessary, thiscontent must be created as new information in association with the KAKUTEI-ed image

information and KAKUTEI-stored as such. In this case, the person responsible for creation is theone who carried out the operation.
3.2.4. Time synchronization

It is necessary for records to contain the date and time of creation based upon a reliablereference time. A reliable reference time needs to be periodically synchronized with the standard
time such that the accuracy maintained is adequate for recording clinical services. At medical
institutions, medical and diagnostic imaging devices (hereafter referred to as modalities) and

PACS, at the least, must be time-synchronized. It is not mandatory to deploy a system such as atime server.

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3.2.5. Electronic signatures

Electronic signatures, according to the Law Concerning Electronic Signatures, must verify two

points: that the information has been created by the signer and that the information is notaltered. These two verifications are required for electronically preserving documents that
require signatures (sign and seal) by law.

While it is possible to prove that the author and documents have not been tampered with,the time-stamp policy verifies this with the time of creation. With a time-stamp, it is proven thatthe document actually existed at the time of the stamp, as synchronized with standard time,
independent of the embedded clocks of individual information systems, and that no
manipulation was made afterward.

Verifications from reliable third parties—a certificate authority and time-stamp station—isneeded for electronic signatures and time stamps, respectively. Although these methods areuseful for establishing trust with external parties, applying them to documents that require lessverification may affect daily operations.

For the electronic storage of image information, it is necessary to clarify the personnel

responsible for its creation and to appropriately record the date and time of KAKUTEI. However,
it is not mandatory to perform electronic signatures or time stamps as indicated in the Law

Concerning Electronic Signatures, and it would suffice to record them with image information
systems, medical information systems, or with their application software.

4. Handling film copies and image information from external institutions

At medical institutions, image information obtained from examinations and thereafter

KAKUTEI-stored must be properly managed, including the recording of the personnel

responsible for creation. Lately, collaboration among medical institutions for the provision of
medical care to patients has become common practice, and there are many cases in which
image information is supplied from external medical institutions. As such, storage andmanagement obligations related to this image information must be clarified.
4.1．Storage obligations

Clearly, the results of imaging examinations performed at an external institution must be

properly retained by the external institution itself. If the external image information is used formaking diagnoses or therapy plans, and in cases in which such decisions are noted in the

medical record, it may become necessary to record this image information as the basis of thesedecisions. In addition, in the case of clinical information sharing for the provision of care topatients, the institution that initiates the sharing of image information will have purposes such9

as seeking out a diagnosis that warrants greater expertise or requesting consultation regarding
treatment Guideline. Therefore, it might be necessary to store the image information as
grounds for accountability for the receiving institution.

In these cases, the image information used as grounds for diagnosis must be stored.

Image information can be brought into a medical institution through various means, such as

by network or portable media. For the "form of image information provision," the Health

Information and Communication Standards (HELICS) Board has published a standardization

guideline, "HS009 IHE Integrated Profile: Portable Data for Imaging Integration Profile and Its
Application Guideline."

4.2. Handling portable media from external institutions

Portable media brought into a medical institution belongs to the patient and does notnecessarily need to be retained by the referred medical institution. When discarding portable

media, MHLW security management guideline 6.7, "Discarding information" must be followed.
4.3. Importing image information and creation responsibility

It is necessary to clearly document the assignment of responsibility pertaining to image

information imported from external medical institutions in the policy and procedure manual. In

general, the person who imported the image information to PACS is responsible for its creation.
In addition, when supplemental information is modified, this action needs to be recorded but
not necessarily electronically recorded.
5. Conditions for film digitization

If medical records such as films are received, stored, or handled, followed by their digitization,

the MHLW security management guideline, Chapter 9, "Electronic storage of paper-based
clinical records with an image scanner,” must be followed.
5.1． Films as objects of storage

Most frequently, film digitization is carried out for handling convenience and the films are

retained in their original state. In this case, the digitized information is reference informationand not subject to storage obligation. For the purposes of authenticity and proper storage, it isquite effective to preserve the original films. However, the protection of personal informationmust be treated in the same way as for content whose storage is required. In addition, it isimportant to ensure that digitization precision is sufficient for clinical services. The Japan

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Radiological Society (JRS) has provided, "The guideline for handling digital images v. 2.0," which
defines the precision required for scanning.

Digitized images should be stored in DICOM format to avoid incompatibility with visualization

software. The policy and procedure manual must establish guideline for proper digitizing
methods.

5.2． Electronic information as objects of storage

Examples of digitized information as objects of storage are presented in the following two

scenarios.
When clinical services are mostly carried out with electronic documents throughutilization of tools such as electronic medical records, the case in which papers or films
from external medical institutions are shared for care provision. These cases arediscussed in Section 5.2.1.

Upon introduction of systems such as electronic medical records, prior records remainin hard copy and consistent information handling cannot be performed. Alternatively,

there is not enough space to store the paper documents. These cases are discussed in
Section 5.2.2.

In either case, electronic storage should only be carried out if the co-existence of electronic
information and films causes major information handling problems.

5.2.1. Image information storage by digitizers at each point of care

In addition to the conditions stated in Section 5.1, the following operational conditions must

be met: (i) the equivalence of information between digitized images and films is verified and amanager for information creation and operations is put in place to ensure that handling iscarried out appropriately; (ii) the person responsible for record creation (executor or manager)
must establish electronic signatures and time stamps as per the law and in a timely manner,clarifying responsibility for the records. For electronic signatures, the MHLW security

management guideline 6.12, "About making electronic signatures for signs and stamps requiredby law," must be followed; and (iii) film digitization is completed within a set period of timeupon receiving the film. This period of time should be one to two days, as set forth in the policy
and procedure manual, and should not hinder clinical services.

5.2.2. Electronic storage of previously accumulated films by digitizers

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We do not recommend this situation in this guideline. In addition to the methods indicated in

Section 5.1, most purposes should be met by externally storing films. If an explicit decision ismade to carry out this operation, a number of actions are required in order to ensureaccountability. That is, upon meeting all of the conditions indicated in Section 5.2.1., it isnecessary to obtain patient consent in advance and conduct a rigorous audit. The MHLW

security management guideline 9.3 requires the following steps: (i) provide notice to and gain

prior consent from patients, (ii) develop an action plan and evaluate its validity by a committee

consisting of both internal and external knowledgeable persons, and (iii) an audit by an external
agent with adequate capabilities.

6. Retention period and compression of image information

Image information legally belongs to "other records of clinical services." The Medical Care Law

Enforcement Regulations Article 20 requires two years of retention, and Article 9 of theregulations for medical institutions and medical training institutions requires three years ofretention from the day of the conclusion of the clinical service. Moreover, for medical records,

Medical Practitioners’ Act Article 24, Dental Practitioners Law Article 23, and the regulations for
medical institutions and medical training institutions Article 9 require five years of retention.
Image information must be stored in the same condition as viewed for interpretation. If adiagnostic reading is made with a lossless compression image, it must be stored in this way andnot with lossy compression. While the aforementioned requirement may not apply for image

information whose age has passed legally required retention period, handling must be otherwise
be documented in the policy and procedure manual.

For example, image information is stored with lossy compression five years after theconclusion of the clinical service. Nonetheless, this is not applicable if such handling would cause
any disadvantage to the patient.
7. KENZOKENZO refers to actions carried out by radiological technologists to assist physicians ininterpreting images and making diagnoses, such as verification of appropriate images,

correction of images as necessary, or deletion of unnecessary images, before confirmation (orKAKUTEI) of those images. The points to be verified before KAKUTEI include whether theacquired image information is in accordance with the exam order and whether supplementary
information was correctly entered. Additionally, modifications in supplementary image

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information, image density, image direction, and the sequence of images should be corrected
as necessary.

KENZO does not require special devices, equipment, or application software; it can becomprehensively carried out by striking a balance between the technical and operational needs.
Each medical institution should, upon judging their scale, department systems, andcharacteristics, consider the most effective actions.
7.1 Types of information to be verified

A sample of information requiring verification while conducting KENZO is summarized inTable 1.

Patient information

Patient ID
Patient nameAge

Exam order information

Sex

Ordering Department
Ordering Physician

Content of examination

Purpose of examination
Image information

Date and time of examination
Modalities

Number of images
Number of series

Sequence of images

Body part to be examined
Extent of examination
Direction of images
Image density
Contrast

Image quality
Marking

Other handling13

※Direction of images: top, bottom, right, left, anterior, posterior※Image quality: image blurring, sharpness, etc.
※Other handling: filter, MIP, MPR, 3D, etc.
7.2

Cases of KENZO Operations

We list a few cases of KENZO below, but each institution may deploy a combination of these

operation types or various others for different imaging modalities. In addition, KENZO

operations do not have to be performed by technological means alone and can be carried out
operationally. For example, a cross-check of patient information can be performed either byautomatically collating it between one copy transmitted from Radiology Information System(RIS) to KENZO application software and another contained in the image information, or bymanually cross-checking it between a copy viewed on an RIS display or hard copy and anotherdisplayed on an image viewer.

7.2.1. Case 1: KENZO operated at imaging modalities

In this case, KENZO is performed at an imaging modality through which exam images are taken.

With or without KENZO application software, KENZO operations are performed at the modality.
KENZO-completed images are then sent to a storage device for electronic storage.
7.2.2. Case 2: Specialized software applications for KENZOThis case involves sending images from the imaging device to a KENZO-dedicated system andcarrying out KENZO operations with specific KENZO application software. KENZO-completed
images are then sent to a storage device for electronic storage.

7.2.3. Case 3: KENZO using Image Viewer as a PACS functionality

Images from an imaging device that are stored in PACS are retrieved to Image Viewer, inwhich KENZO is performed, and then sent to a storage device for electronic storage. With orwithout KENZO application software, KENZO operations are performed in Image Viewer. If thestorage device contains images before and after KENZO, it is necessary to distinguish between
the two images and ensure that the post-KENZO image is not deleted by mistake.

8．External storage, backup at external facilities, and sharing within regional medical
collaboration of clinical image information

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There has been confusion regarding the external storage of image information, backups at

external facilities, and sharing within regional medical collaboration. This section explainsrequirements that relate to each of the aforementioned cases respectively.
8.1 External storage

In this guideline, external storage means to store and operate clinical records legally subject tostorage outside of the medical institution, while meeting the three principles of electronicstorage in the MHLW security management guideline. If a loss in readability occurs because of
external storage, it is necessary to store those records within the institution under conditions
meeting the three principles of electronic storage.

In addition, for securing the readability of externally stored records through networks, the

MHLW security management guideline indicates that it is necessary to store medical records

and information anticipated to be needed urgently within the institution or maintain copies of
equivalent information internally while they are stored externally. The MHLW security

management guideline also indicates that it is necessary for medical institutions to prepare for

network trouble or failures at the external storage institutions to which information is entrusted,even if it may not be urgently needed.
8.2. Backups at external facilities

There are following two types of external data backups: (i) medical record backups, made inpreparation for loss of medical records and (ii) disaster recovery backups designed forcontinuity of clinical services in times of disaster. Because the two types differ in purpose, theynaturally differ in data volume and structures, the timing of backup data acquisition, and legal
requirements.

For medical record backups, although the provision of authenticity, the provision of visualreadability, and the provision of storage property are not required for backup data themselves,
it is obvious that criteria equivalent to those of medical records are required at the time ofrestoration. In addition, when restoring, it is important to prove that a document is restored.
When contracting with service providers, it is necessary to add this proof in the agreement.
Conversely, for disaster recovery backups, there are no such legal requirements. Eachcommunity or institution should determine the data items necessary for disaster backup
according to their purpose.

8.3. Sharing within regional medical collaboration

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In this section, data refer to those accumulated for external storage or backups. Therefore,

when making secondary use of those data for regional medical collaboration or medical
research, it is necessary to take adequately intricate steps.

The sharing of information by multiple medical institutions requires a patient's consent, andwhile external storage or backups may be needed for medical institutions to fulfill their own

responsibilities, it is a misunderstanding to presume that those externally stored or backed-up
data can be shared without taking appropriate measures.

When using data for regional medical collaboration, it is necessary to establish operational

mechanisms, such as the acquisition of patient consent, policy agreements between

participating institutions, clearly defined shared information and access rights management,

understanding of each institution's scope of responsibility, and provisions for interoperability(refer to the appendix of the MHLW security management guideline).

In addition, for image information, there are conceptual differences between KAKUTEI at a

medical institution that provides such image information in the context of regional medical
collaboration, and the “retention of data as grounds for diagnosis” at another medical

institution where diagnosis is made based on the provided image information (refer to Section
4.1 for storage obligations in such cases).

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