ユーザー向けサイバーセキュリティガイドライン
オプティメⅡ、オプティメ e2024-04-26 Pub. No.: S0069-0

CYBERSECURITY GUIDELINES
Protecting your practice against cybersecurity threats is a shared responsibility between theimaging device manufacturer and you, as the healthcare provider. The imaging device
manufacturer has taken precautions to ensure that your imaging system is protected against suchthreats.
However, the protection of any networked system is always the responsibility of the healthcare
provider. It is highly recommended to have a qualiﬁed IT security professional check and maintainthe office network system for proper protection against viruses, malware, and intrusions. It isrecommended to always have active and up-to-date antivirus and anti-malware software,
together with a correctly conﬁgured ﬁrewall, installed on the workstation where the image viewing
and image acquisition software are used.
Failure to maintain cybersecurity can result in compromised imaging device functionality, loss ofdata (PHI or PII) availability or integrity, or exposure of other connected devices or networks tosecurity threats.
Report any cybersecurity incident related to the use of the device to the manufacturer.

Operating environment
To function, the device requires a workstation with a dental imaging software. The device produces Xray images in the industry standard image formats (e.g. DICOM and JPEG), depending on the dental
imaging software used.
Any software used to capture and view X-ray images with the device (e.g. DTX Studio Clinic or a third
party dental imaging software supporting TWAIN) must conform to the local regulatory standards,
regulations and approval required to place the device on the market.
Any workstation used with the device must conform the workstation minimum requirements presented
in the device documentation as well as the dental imaging software system requirements.

Figure 1. Example of system network infrastructure and security

225640-PTU R1

Instructions for security conﬁgurations
Authentication and authorization
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Take precautions to ensure unauthorized personnel cannot access the patient data or
manipulate the image data on the workstation or the imaging device.
Make sure the office network is protected from unauthorized access and separated from avisitor network, if provided.
Access to all workstations should be protected with strong passwords.
Do not use default passwords in network devices.
Do not share or reuse passwords.
Use individual user accounts for all authorized personnel.

Personal identiﬁable information••

Do not include PII (personally identiﬁable information) in computer host names.
Do not include PII in Windows user account names.

Backup•A suitable backup system is recommended to safeguard user-created data. Backup of usercreated data is solely the responsibility of the healthcare provider.

Network•••

The imaging device must be connected to a private, ﬁrewall hardware and/or software
protected local area network to ensure proper data security and protection against
unauthorized access. All connections from outside of the local area network to the imaging
device must be blocked and unused ports to external hosts closed. Connections between theimaging device and workstation in the local area network must be allowed.
For more detailed information on the ﬁrewall conﬁguration, see DTX STUDIO™ DRIVER &DEXIS™ CONNECT Installation and use instructions.
Connecting the imaging device to an IT-network that includes other equipment or modifying
the IT-network can cause unidentiﬁed safety or security risks to patients or operators. It is theresponsibility of the organization managing the IT-network to identify, analyze, evaluate, andcontrol these possible risks.
Network components used in the IT-network must not use default passwords and wirelessconnections, if used, must be encrypted, and secured with a strong password.

Antivirus••

All workstations should have active and up-to-date anti-virus software installed.
The workstation connected to the imaging device must use an anti-virus software and haveindividual password protected user accounts to prevent unauthorized access to patient data.

Software updates and decommissioning
It is recommended to always update the system to the latest available software and operating
system versions. Failure to do so may lead to unauthorized access. Only authorized service
technicians are allowed to install and service the device and related software. Contact themanufacturer representative for software updates.
Refer to the device and driver software instructions for details on decommissioning of the device andthe driver software at the workstation.