i-SENS Continuous Glucose Monitoring Service System Terms of Use
Contract starting date: September 11th, 2023
Contract execution date: September 11th, 2023
i-SENS Continuous Glucose Monitoring System Service Terms of Use
This terms of use follows the order of (i) 'common conditions' that apply to the usage of all Continuous Glucose Monitoring System (hereinafter referred to as CGM System) services, (ii) conditions that apply to individual CGM System services (CareSens Air, Sens365). Please refer to the contract according to the corresponding service and user and agree before using the services.
The i-SENS CGM System products and services include subjects of regulation by medical device relatedauthorities (e.g., Korean Ministry of Food and Drug Safety (MFDS), etc.). Authorization and verification of i-SENS products and services by related authorities can be found in the product guide and description. Users must recognize that the use of i-SENS CGM System products and services in countriesother than countries where it is authorized as a medical device by the responsible authorities is prohibited, and agreeing to this contract indicates that the user is aware of this. i-SENS is exempt fromany responsibility for damages or disadvantages that occur to all users or third-party users due to a violation of this point, and i-SENS has the right to be compensated for any damages to i-SENS.
Table of contents
■ Common conditions
Article 1 (Purpose and effectiveness of the contract); Article 2 (Terminology); Article 3 (Contract notifications and changes); Article 4 (Notifications to users); Article 5 (Protection of the personal information and sensitive information of users); Article 6 (Exemptions); Article 7 (Purpose of the services); Article 8 (Use of the services); Article 9 (Termination of services and notification of termination); Article 10 (Obligations of i-SENS); Article 11 (Obligations of the user); Article 12 (Rights to ownership); Article13 (Compensation for damages); Article 14 (Regulations outside of the contract); Article 15 (Governing laws and solutions to conflict)
■ CareSens Air service
Article 16 (Use of the CareSens Air service); Article 17 (Connection and termination of the CareSens Air service for i-SENS account members); Article 18 (CareSens Air service content); Article 19 (Third-party partner apps); Article 20 (Data restoration and deletion); Article 21 (Ownership of transmitted data)
■ Sens365 services
Article 22 (Sens365 service usage and details); Article 23 (Start and end of the Sens365 service for CareSens Air usage members); Article 24 (Start and end of the Sens365 service for care providers); Article 25 (Confidentiality obligation of care providers); Article 26 (Restoration and deletion of data);Article 27 (Ownership of transmitted data)
■ Additional Clauses
■ Common conditions
Article 1 (Purpose and effectiveness of the contract)
This terms and conditions contract (hereinafter referred to as the "contract") aims to set the basic conditions of use for the Continuous Glucose Monitoring System (hereinafter referred to as "CGM System") product and related wired and wireless services provided by i-SENS Co., Ltd. (hereinafter referred to as "i-SENS") between i-SENS and the user in relation to rights, obligations, andresponsibilities. By clicking the 'Agree' button of this contract posted by i-SENS, the user expresses his or her agreement to the contract before using i-SENS services. Therefore, please read the terms andconditions of the contract and the related operation policies carefully. The content of this contract can be checked from the start screen of each service while using the service. The efforts of i-SENS tohandle the personal information of users safely and other issues related to personal information protection can be checked in Article 5 of this contract (Protection of the personal information and sensitive information of users) and the i-SENS CGM System services Privacy Policy.
Article 2 (Terminology)
1. The terms of this contract are as follows.
2. Any terminology used in this contract that is not defined in Item 1 shall follow the definitions in related laws and individual service descriptions. Other terminology shall follow general customs and business customs.
Article 3 (Contract notifications and changes)
1. Some of the services provided by i-SENS or affiliated services provided by a third party (hereinafter referred to comprehensively as "individual services") will have seperate regulations or a seperate terms of agreement for each service. The terms of agreement for the individual services can be checked through other methods of notification such as the start screen of each service. If the content of the individual services contract is in conflict with the content of this contract, the contentof the individual services contract applies first.
2. The user will be notified of the terms and conditions of this i-SENS contract and the address, company name, CEO's name, and name of the person in charge of personal information protection management when he/she first uses the i-SENS services, and this information will also be shownso that it can easily be viewed within each service during use to protect the right of the user to access this information.
3. i-SENS may make changes to the contract if necessary within a range that does not break any related laws. If changes are made to the contract, the changes will be announced on the i-SENS start screen or notification board seven days before the changes come into effect. However, if thechanges made are disadvantageous to the user, a notification is made 30 days beforehand, and members are notified individually.
4. The user has a duty to check notifications of the company related to contract changes. The company shall not be held responsible for damages to the user that arise due to changes to a contract the user has agreed to, or due to the user not checking the changes to the contract.
5. If i-SENS gives a notification in accordance with the item above and no rejection is expressed from the date of notification to the date of change, and it is clearly indicated that this shall be considered an agreement to the changes, in the case that the user does not make a remark of rejection, it will be regarded that the user has agreed to the changes.
6. If the user does not agree to the changes to the contract, the user may not be able to continue using the services to which the contract applies.
Article 4 (Notifications to users)
1. i-SENS may give notifications to users using e-mail or SMS/MMS, push notification services(hereinafter PNS) of app alarm systems, and other appropriate communication methods to inform the user.
2. When random users need to be notified and notification in accordance with the previous item is not possible, i-SENS may post the notification on the service notification board for 30 days instead. However, if the content significantly affects the user or is disadvantageous to the user, the changesshall be notified, and members shall be individually notified.
Article 5 (Protection of the personal information and sensitive information of users)
1. i-SENS places great importance on protecting the personal information of users, and makes efforts to protect the personal information of users in accordance with the Personal Information Protection Act of Korea and other related laws.
2. The personal information of users is collected and used to the minimum extent necessary withinthe purpose and range agreed to by the user for the smooth provision of services. Notificationsrelated to services and marketing information may be sent to the user's contact information withinthe purpose and range agreed to by the user. Information related to personal informationprotection and handling and other related areas can be accessed through the service menu andthe Privacy Policy posted for users to see (http://caresensair.com).
Article 6 (Exemptions)
1. If damages arise for the user during the usage of the services, i-SENS takes responsibility only when i-SENS is directly responsible for the damages that occurred. i-SENS shall not be held responsible for damages that occur without intentionality or fault, as with the following Items.
2. There is a possibility of errors in services and legality due to reasons that are not the responsibility of i-SENS (including but not limited to safety, reliability, accuracy, completion, validity, corresponding to a certain purpose, security errors, errors and bugs, violation of rights, etc.). i-SENS shall not be held responsible for service error if there is no intentionality or fault on the part of i-SENS.
3. The information provided to the user through the i-SENS services is for reference, and cannot substitute for medical diagnosis or treatment. How the application of the information is subjectwholly to the judgment of the user and i-SENS does not take any responsibility as long as there is no intentionality or severe fault on the part of i-SENS.
4. The services provided to the user by i-SENS can include products and services provided through a third party collaborating with i-SENS, and the third party provider shall be responsible for these products and services.
5. Even in the case defined in Item 4 of this Article, if a user suffers damages due to unfulfilled liabilities or illegal actions due to the fault of i-SENS (excluding cases of severe fault), i-SENS shall not be held responsible for damages that are not direct damages but are due to a special circumstances, are indirect damages, or are other damages, etc. (including cases where i-SENS or the user predicted or could have predicted the occurrence of damages).
Article 7 (Purpose of the services)
The i-SENS CGM System products and services include subjects of regulation by medical device related authorities (e.g., Korean Ministry of Food and Drug Safety (MFDS), etc.). Authorization and verificationof i-SENS products and services by related authorities can also be found in the product guide and description.
Article 8 (Use of the services)
1. i-SENS services are provided 24 hours a day except when this is not possible due to business or technical reasons. However, i-SENS can conduct service maintenance or check-ups when necessary, and services can be limited during this time. Free i-SENS services may be edited, changed, or terminated partially or wholly in order to provide a more effective product. In this case, unless there is a special related law, there shall be no compensation for users.
2. If services are upgraded, changed, added, or deleted, i-SENS will make an effort to notify users ofthe changes through the service start screen or other methods. Users are recommended to use the latest version for a smooth experience with the services. Any limitations to all or some services due to the failure to abide by the guidelines will not be compensated unless there is a special related law.
3. i-Sens will make an effort to notify users of important announcements needed for use of the services. i-SENS will give notifications to users individually through e-mail or service alarms or other electronic methods, or to all members using the start screen or notifications of the i-SENS CGM System product and services domain website or app.
4. Users must abide by the regulations of this contract and the notifications and guidelines of the services, and must not do any of the following.
Article 9 (Termination of services and notification of termination)
1. If personal information stored by i-SENS is deleted or damaged due to a national emergency, a defect with service equipment that is beyond the control of i-SENS, or other uncontrollable circumstances, i-SENS shall not be held responsible.
2. In the case of an emergency system check-up, expansion, or change, natural disasters, nationalemergencies, or other circumstances where normal services cannot be provided, services may be limited or stopped temporarily. Members will be notified of the reason and period prior to the limitation to minimize disadvantages to members. However, if services are stopped due to reasons i-SENS cannot control (intentionality of the system manager, disk errors, system down, etc.), or dueto the intent or fault of another party (PC communication company, period communication company, system maintenance company, etc.) prior notification may not be possible and post notifications will be posted.
3. If some or all of the services need to be stopped permanently due to a change to a new service or a business judgment of i-SENS, users shall be notified individually 30 days in advance.
4. If usage of the services is permanently terminated due to a clear violation of the law by the user or other reason, all services and benefits through the services will be terminated and not compensated for. Please take note of this. The user may appeal in this case, and if the appeal is found to be fair, protective measures such as restoration shall be taken.
5. i-SENS may divide the range of services and set different periods of usage for different ranges. Notifications are provided in this case.
Article 10 (Obligations of i-SENS)
1. i-SENS does not leak or distribute the personal information or sensitive information of users gained through the services to a third party without the consent of the user. However, if a request is made by an organization related to a legal investigation or through a government office, informationmay be shared through the proper legal procedure.
2. To provide users with continuous, stable services, i-SENS continuously fixes and restores related equipment and software in the case of errors unless there is an unavoidable situation where this is not possible. However, in the case of a natural disaster, emergency situation, or other unavoidable situation, services may be stopped temporarily or terminated. Refer to the terms and conditions ornotifications provided by partners for information on changes or the termination of services provided by service partners such as third party partner apps, or inquire with those parties directly.
3. i-SENS responds quickly to user complaints related to the services, and if quick handling is not possible, the reason and expected schedule are communicated to the user.
4. i-SENS abides by laws related to service operation and maintenance, including the Personal Information Protection Act of Korea, the Protection of Communication Secrets Act, and theTelecommunications Business Act.
Article 11 (Obligations of the user)
1. In the case of one or more of the followings, i-SENS can delete posts or set a period of usage suspension for the services. The user shall be held fully responsible for this unless there is intentionality or fault on the part of i-SENS, and the user must compensate i-SENS for any damagescaused through his/her actions.
2. When limiting usage such as by deleting posts or stopping services in accordance with the previous Item, i-SENS notifies users of the reason for limitation, the type of limitation and period, and how to object beforehand. Users may appeal through the process set by i-SENS. If i-SENS judges thereason to be fair, i-SENS shall quickly restore the posts or re-open usage of services.
3. Users may not illegally distribute or use the commercial software through methods that are not permitted, such as hacking, decompiling, or reverse engineering. i-SENS shall not be held responsible for damages, punishment from related organizations, or legal action due to the violation of these rules, and users have the obligation to compensate i-SENS for any damages dueto their actions.
4. Data sharing and download functions within the services are only possible through user selection, and the user is responsible for his/her actions.
Article 12 (Rights to ownership)
1. The copyrights and intellectual rights of the services belong to i-SENS.
2. The copyright and other intellectual properties of work provided by a third party that has a contract with i-SENS belong to the company that provides the work unless stated otherwise in the contract with the party.
3. i-SENS possess the rights to all services of i-SENS and all information and material provided through the services. These are all assets of i-SENS or the usage rights belong to i-SENS, and thus i-SENS is protected by related laws. A written contract must be entered into with i-SENS to use the information and services in this item for any goal other than the provision of services, for quotes, or even for non-profit purposes, and they can only be used with the source clearly shown. Using the information or material without consent, including copying, modifying, reproducing, distributing,publishing, exhibiting, transferring, or selling, or using the materials to produce tangible or intangible products or services is prohibited.
4. According to Item 3 of this article, even if a user uses the information and material of i-SENS based on a written contract with i-SENS, opening and providing the information to a third party other than the party of the contract is not allowed, and if there is a violation, the user will be heldresponsible for compensation for damages.
5. If the user agrees to this contract and abides by it, i-SENS grants the user the right (hereinafter referred to as "service license") to use limited services (including service software) that are non-exclusive and can be canceled. The user can only use this service license for the purpose ofproviding services and cannot transfer to another party or reuse the content. The user is permitted to use the services only during the period for which the service license is granted, and the user recognizes and agrees that any other rights, such as service property rights and intellectual property rights, are not transferred to the user. This service license does not apply to the i-SENS servicename, brand, or logo, and all copyrights, trademark rights, patent rights, and other related rights belong to i-SENS and are protected by related laws.
Article 13 (Compensation for damages)
If the user uses the services provided for any usage other than that stated in the contract, such as the prohibited copying of some or all content, sharing content, providing content, or sharing in the form of publications or electronic storage devices, this is a violation of the user's obligations, and i-SENS may file for compensation of all damages that arise from these actions.
Article 14 (Regulations outside of the contract)
Any circumstances not stipulated in this contract and the interpretation of this contract shall be based on individual service contracts or related laws, and when a law is not applicable, general customs shall be followed.
Article 15 (Governing laws and solutions to conflict)
1. The original copy of this contract shall be in Korean.
2. The relationship between the user and i-SENS in relation to this contract and the i-SENS services shall follow Korean law.
3. Disputes between the user and i-SENS that arise in relation to the usage of the services or this contract shall be resolved through negotiations between the two parties, but if a resolution cannot be reached, a court jurisdiction shall be decided in accordance with civil suit law.
■ CareSens Air service
※ CareSens Air is a medical device. Use it together with the CareSens Air app service to manage individual glucose levels.
※ The CareSens Air product and related app service cannot be used for the purpose of disease diagnosis, treatment, mitigation, prevention, etc. None of the information provided through this service constitutes a professional medical act, such as diagnosis or prescription, as defined by Korean medical law or pharmaceutical law. Please consult a medical professional for more professional and accurate information.
Article 16 (Use of the CareSens Air service)
1. The 'CareSens Air app service' or 'CareSens Air service' connects a continuous glucose monitoring sensor with the sensor user's mobile device to measure and collect glucose level data for monitoring. It is a mobile app provided by i-SENS that shares data with the i-SENS server to manage users' glucose data, and furthermore helps manage diabetes effectively together with the care provider,who is an additional Sens365 service user provided by i-SENS.
2. Users can download and install the app or program from a device within the range defined by i-SENS and use the services. However, the app or program structure and function can differ according to the type of device and OS.
3. If the user uses the CareSens Air app without creating an i-SENS service account, the basic blood glucose monitoring fuction of the app can be used, but the user's blood glucose level and other information is not backed up or saved in the i-SENS server. Thus, some functions may have limitations, such as in confirming past data or sharing user information with the care provider orother family members through the Sens365 service.
Article 17 (Connection and termination of the CareSens Air service for i-SENS account members)
1. Members of the i-SENS service account can connect their account within the CareSens Air app, and those who have completed connection can use all the functions provided through the services.
2. When a user who has completed connection with the service account does not want to use the CareSens Air service anymore, the CareSens Air app may be deleted. In this case, the member's i-SENS account is maintained, so in order to delete data connected to the i-SENS account, the user must close his/her i-SENS account (https://accounts.i-sens.com) and then delete the app.
Article 18 (CareSens Air service content)
The 'CareSens Air service' provided by i-SENS includes the following details..
- Service name: CareSens Air Continuous Glucose Monitoring Service
제1Article 19 (Third-party partner apps)
1. CareSens Air is connected to various third party partner services and apps to provide more diverse and improved services. Data is connected with partner apps with the agreement of users.
2. The third party service provider has the responsibility for the content and information accuracy of content provided independently by the third party partner app, and i-SENS shall not be held responsible for such unless there is intentionality or fault on the part of i-SENS.
3. Please read the terms and conditions contract of the partner app before agreeing to use third party services, and be aware of the notes of caution of each app before use.
4. The user can control data connection with partner apps under Settings.
Article 20 (Data restoration and deletion)
1. Members can back up various data created through the CareSens Air service or a third party partner service to the server to store it safely and easily restore it if necessary. i-SENS shall keepusers' data saved on the server for one year. After one year, data can be backed up in the form of a zip file.
2. If the CareSens Air service app is deleted from a device, the data is deleted from the device as well, but it may be saved on the server.
3. Data saved on the server will be stored for the period required by law upon termination of membership, and deleted after the period. Please refer to thee i-SENS CGM System service PrivacyPolicyfor more information on the data deletion process and method.
4. When deleting a third party partner app, the deletion is handled in accordance with the data policy of the partner. Be sure to check the details. The partner is wholly responsible for the deletion process, and i-SENS shall not be held responsible unless there is intentionality or severe fault onthe part of i-SENS.
5. The data shown through a smart device may differ according to the device or service version used by the user.
Article 21 (Ownership of transmitted data)
1. Data sent and saved by members on the i-SENS server belong to the members
2. By saving members' data on the i-SENS server and providing i-SENS with data, members grant i-SENS a license to use, distribute, copy, modify, post, and change data in a non-exclusive way with no royalties for the purpose of providing members with services.
3. If the user agrees, i-SENS can collect data created from the CareSens Air services and turn the data into pseudonymous data (including pseudonymous data required by law) for research purposes, and produce, access, and possess data or open it to a third-party researcher for product development, performance testing, service upgrade verification, or the evaluation of effects onmedical professionals.
■ Sens365 services
※ CareSens Air product users can receive blood glucose data uploaded on the CareSens Air app and use it with the Sens365 services for blood glucose management. Uploaded data can be shared with a care provider and monitored remotely by the health maanger. However, this service cannot be usedfor the purpose of disease diagnosis, treatment, mitigation, prevention, etc. None of the information provided through this service constitutes a professional medical act, such as diagnosis or prescription, as defined by Korean medical law or pharmaceutical law. Please consult a medical professional for more professional and accurate information.
Article 22 (Sens365 service usage and details)
1. The Sens365 services are divided into members' web services for users of CareSens Air, which measures continuous glucose levels, who have signed up for i-SENS services, and a web page and app service for care providers who share and manage the users' data.
2. The 'Sens365 service for CareSens Air members' is part of the Sens365 services for care providers to manage the blood glucose levels and the data needed for the health management of i-SENS CGM System users. It is a service for users who have saved i-SENS data on the cloud provied by i-SENS, and is a web service with the purpose of comprehensively reviewing the health data of users and setting up a method to share data with a care provider.
3. The 'Sens365 service for CareSens Air members' provided by i-SENS includes the following details.
- Service name: Sens365 service for CareSens Air members
4. The 'Sens365 service for care providers' is a web page/mobile app that displays comprehensive data to provide a service where care providers such as family members, caretakers, and medical professionals can manage the health data of i-SENS CGM System CareSens Air users. In particular, if the care provider is a medical professional, the shared data can be a reference to decidetreatment methods.
5. The 'Sens365 service for care providers' provided by i-SENS includes the following details.
- Service name: Sens365 service for care providers
6. The Sens365 app can be used from any device where the app can be downloaded and installed, as permitted by i-SENS. However, the app or program structure and function can differ according to the type of device and OS.
Article 23 (Start and end of the Sens365 service for CareSens Air usage members)
1. The 'Sens365 service for CareSens Air members' is a service where existing members of the CareSens Air app can share data through the cloud and manage blood glucose with a care provider. Personal information including health information and health data collected from the reader, the CareSens Air app, and other connected devices authorized by i-SENS is saved on the Sens365 server, and can be viewed by members or care providers authorized by members.
2. Members of the i-SENS account service can connect their account to the CareSens Air app and log in to the 'Sens365 service for CareSens Air members' to use the service right away.
3. Non-members who use the CareSens Air app without creating an i-SENS service account cannot use the 'Sens365 service for CareSens Air members.'
Article 24 (Start and end of the Sens365 service for care providers)
1. A care provider can use the Sens365 services by creating an i-SENS service account for access to member services.
2. For a care provider to receive and manage a CareSens Air member's CGM System data, the CareSens Air member needs to enter the unique group number created by the care provider, or the care provider can enter the sharing code created by the CareSens Air user.
3. If a care provider uses the Sens365 mobile app without joining the i-SENS services as a member, some services can be limited, such as data back-up.
Article 25 (Confidentiality obligation of care providers)
Care providers cannot use the health information or personal information of CareSens Air members that they receive for any purpose other than remote monitoring, health data analysis, or other provision of information, and this information cannot be leaked or shared with a third party without the consent of the user. The care provider is held responsible for any damages due to violations of the confidentiality obligation.
Article 26 (Restoration and deletion of data)
1. The various data created through registration with the Sens365 service is backed up on the server and thus safely stored and can easily be restored. However, i-SENS saves member data on the server for one year, and after one year data can be backed up in the form of a compressed file.
2. Data saved on the server will be stored for the period required by law upon termination of membership, and deleted after the period. Please refer to the i-SENS CGM System services PrivacyPolicyfor more information on the data deletion process and method.
Article 27 (Ownership of transmitted data)
1. Data sent and saved by members on the i-SENS server belong to the members.
2. By saving their data on the i-SENS server and providing i-SENS with data, members grant i-SENS a license to use, distribute, copy, modify, post, and change data in a non-exclusive way with no royalties (referred to as 'license') for the purpose of providing members with services.
3. If the user agrees, i-SENS can collect data created from the Sens365 services and turn the data into pseudonymous data (including pseudonymous data required by law) for research purposes, and produce, access, and possess data or open it to a third party researcher for product development, performance testing, service upgrade verification, or the evaluation of effects onmedical professionals.
■ Supplementary Provisions
Article 1 (Date of execution) This contract shall be executed from September 11th, 2023.
If you have any queries about the i-SENS System services, please contact the Customer Center (080-910-0900).