ECG Buddy Terms and Conditions (T&C)
1. Introduction
1.
These Terms and Conditions ("T&C") cover the use, features, and access to the service (as defined below).
2.
The T&C constitute a binding contract between ARPI Inc., a limited liability company organized and existing under the laws of the Republic of Korea, and the Customer (as defined below). The company's registered address is ARPI Inc., Room 12 Startup Incubation Center, 172, Dolma-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea.
3.
The Customer agrees to accept the T&C before using the service and agrees to comply with the conditions stated in the T&C at all times.
4.
The T&C constitute the entire agreement between the Customer and ARPI Inc.
2. Definitions
1.
Terms capitalized in these T&C have the meanings given below.
2.
"Application" refers to the mobile and desktop application named ECG Buddy, which is a South Korea MFDS Class 2 medical device. It utilizes deep learning algorithms to analyze ECG images or waveform data to assist in the diagnosis of arrhythmias and provide risk scores for emergency situations and cardiac dysfunctions, thereby supporting physiciansโ diagnostic decisions as a standalone software medical device.
3.
"ARPI Inc." refers to the manufacturer of the Application, ARPI INC., and includes all entities affiliated with ARPI Inc. through common control, management, or ownership for which ARPI Inc. acts as an agent.
4.
"User" refers to the medical professional using the Application, with the definition provided in Article 5.4.
5.
"Service" means the ECG Buddy mobile and desktop application provided by ARPI Inc. to the Customer.
6.
"Billing Policy" includes all policies regarding the payments Users must make for using the Application, determined by ARPI Inc.'s internal policies. This billing policy includes cost determination based on the number of ECG analysis requests and a subscription model where limited credits are provided for monthly use during a specified period.
7.
"Customer" refers to the entity or individual who has ordered the Service.
8.
"ECG" refers to an electrocardiogram, which measures the electrical activity of the heart. This Application uses only 12-Lead ECGs, and thus any mention of ECG in this document refers exclusively to 12-Lead ECGs.
9.
"Effective Date" means the date the Customer accepts these T&C as per Article 3.3.
10.
"License" has the meaning given in Article 8 of these T&C.
11.
"Regulation" includes all laws and guidelines proposed by regulatory authorities related to medical devices in all countries where the product is legally available. In certain countries, this Application can be serviced without separate approval procedures. Therefore, this Regulation encompasses detailed laws related to medical devices as well as connected digital healthcare laws.
12.
"Privacy Policy" refers to the notice provided to Customers and related data subjects regarding the processing of personal data in connection with the Application and their associated rights. The Privacy Policy is based on Article 30 of the Personal Information Protection Act of the Republic of Korea, and detailed information regarding the processing of personal data can be reviewed during the membership registration process for the use of this Application.
13.
"Report" means the classification of heart rhythms and the digital biomarker scores ranging from 0 to 100 generated by the Application, which assist in a physician's diagnosis and are the result of analyzing the User-inputted ECG.
14.
"Trial Period" has the meaning given in Article 6.12 of these T&C.
15.
"Research Use Only" refers to products intended by the manufacturer solely for research purposes, not for diagnostic, therapeutic, or clinical applications. These products are used in laboratory research, preclinical testing, and investigational studies to explore scientific principles, validate new technologies, and develop future diagnostic tools. However, due to varying legal definitions of Research Use Only (R.U.O) products across different countries, certain functionalities of the application may be restricted according to the regulatory requirements of the relevant country. For more details, please refer to Article 5.12.
3. Contract
1.
ARPI Inc. agrees to provide the services defined in these T&C, and the Customer agrees to use the services in compliance with the T&C and to pay the agreed price for the services.
2.
The following items constitute ARPI Inc.'s offer:
a.
The mobile application accessible through the Apple App Store or Google Play Store;
b.
The desktop application accessible through the ARPI Inc. website;
c.
Specific offers from ARPI Inc.
3.
The T&C are concluded by the Customer's acceptance of the offer through the following means:
a.
Ordering the mobile application through the Apple App Store or Google Play Store;
b.
Ordering the desktop application through the ARPI Inc. website;
c.
Accepting a specific written offer, such as invoice from ARPI Inc.
4. Payments and Subscription Plan
1.
The Customer agrees to pay the fees specified in the relevant subscription plan.
2.
For the mobile application, the fees are paid on the date the subscription is ordered through the Apple App Store or Google Play Store, and subsequently on the first day of each automatic renewal subscription period. Unless the Customer cancels the personal plan before the end of the current subscription period, the personal plan will be automatically renewed at the end of the subscription period.
3.
For the desktop application, fees will be paid as specified in the invoice issued by ARPI Inc. and, in any case, must be paid within 30 days from the invoice date.
4.
ARPI Inc. reserves the right to unilaterally change the fees. ARPI Inc. will notify the Customer of such changes at least two months prior to their effective date. If the changed fees are not acceptable to the Customer, the Customer may choose not to renew the subscription plan after the billing period ends.
5.
The Customer may cancel or change the subscription plan at any time. Such changes will take effect in the next billing period. The obligation to pay for reports already generated prior to cancellation remains unaffected.
5. Use of the Application
1.
To use the application, each user must create an account. Users are required to provide the following details to successfully create an account: country of use, affiliated institution, type of institution, department, occupation, and email address.
2.
To use the application, the Customer must have a compatible mobile phone or portable mobile device, or a Windows laptop or desktop PC as defined in the applicable user manual.
3.
The version of the application software may be periodically upgraded to add new features and services, improve user experience, and remove bugs or certain functions.
4.
Users must have basic knowledge of ECG interpretation and must be licensed medical professionals authorized to provide medical services in the country where the Application is used, complying with all regulatory requirements imposed on medical professionals in that country.
5.
Individuals who are not medical professionals cannot use the application.
6.
Users must keep their login credentials confidential and must not disclose them to third parties, taking appropriate protective measures to prevent unauthorized access.
7.
Registration is completed when the user logs in for the first time after initial signup.
8.
Users must not log in using another user's registration information, nor obtain or collect another user's registration information.
9.
Users must not use the application in life-supporting or life-maintaining systems, or ECG monitoring and/or alert devices.
10.
Users must use the application according to the user manual provided within the application. The user manual is also uploaded on our website (www.arpi.ai).
11.
Each report is available for 6 hours after generation, after which it can no longer be accessed by the user. This is part of our security protocol to enhance cybersecurity. ARPI Inc. does not store any patient information or ECG data.
12.
If the Application or any part of the Subscription Services is labeled as "Research Use Only" or similar in the user interface or associated documentation, you acknowledge that this part of the Subscription Services is intended solely for research purposes. It must not be used for clinical diagnosis, patient management, or any investigation not exempt under 21 CFR Part 812 or other applicable laws and regulations, such as Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices. The definition of "Research Use Only" product refers to Article 2.15.
6. Customer Obligations
1.
The Customer acknowledges and agrees that the Service must be used exclusively in accordance with the T&C, the Privacy Policy, and the laws of the Republic of Korea, New Zealand, and the UAE. If the Customer's use of the Service is subject to other laws, the Customer must comply with those laws and regulations. This Article 6.1 does not affect Article 13 of the T&C.
2.
The Customer shall not interfere with or disrupt the operation of the Service (or attempt to do so), infringe on the rights of third parties, or engage in any unethical, illegal, or bad faith activities.
3.
The Customer shall not make fully automated decisions based on the information provided by ARPI Inc. while using the Service, and shall always ensure appropriate human intervention, review, and verification by the User before using such information for any purpose.
4.
The Customer and Users specifically acknowledge and agree that the Application, as a software medical device, may contain errors. Users, as medical professionals, are fully responsible for patient care. When providing care to patients, Users must not rely solely on the Application and must act cautiously, evaluating the patient's overall clinical condition, including elements not included in the Application (e.g., the patient's visual examination status or other test results).
5.
The Customer is fully responsible for using the Service and all results of such use.
6.
The Application can be used on compatible mobile phones or portable mobile devices running the operating system specified in the Application, or on Windows laptops or desktop PCs. The Customer acknowledges that because the Application is provided via the internet and mobile networks, its quality and availability may be affected by factors beyond ARPI Inc.'s reasonable control.
7.
The Customer acknowledges that the Application may only be used in countries where it meets the regulatory requirements for marketing as a medical device. ARPI Inc. commits to making reasonable efforts to notify the Customer if the Application is being used outside of such countries.
8.
The Customer shall not (i) create or distribute copies of the Application; (ii) attempt to copy, reproduce, alter, modify, reverse engineering, disassemble, decompile, transmit, exchange, or translate the Application; or (iii) create any derivative works of the Application, nor allow third parties to perform any of the activities listed in 6.8.
9.
The Customer acknowledges that ARPI Inc. is based in the Republic of Korea and is responsible for complying with obligations related to transferring data outside of the Republic of Korea when using the Service from their own country.
10.
The Customer agrees to indemnify ARPI Inc. for any damages resulting from the Customer's violation of the T&C.
11.
The Customer must fully comply with these T&C and, in particular, with the obligations applicable to the Customer.
12.
For initial testing purposes of the Service, ARPI Inc. may grant each Customer the following rights for a limited period ("Trial Period"):
a.
For the mobile application: The Trial Period begins on the Effective Date; during the Trial Period, the Service is provided free of charge to the Customer; the Customer can receive up to 10 reports per day during the Trial Period.
b.
ARPI Inc. may extend the Trial Period based on the Customer's request or the result of internal meetings.
13.
The Customer acknowledges that ARPI Inc. can review each user's registration to confirm that the user complies with the conditions specified in Article 5.4 and 5.5.
14.
The Customer agrees that all communications from ARPI Inc. or notifications expected under the T&C will be sent to the Customer via the email address provided in the Customer's account.
15.
The Customer shall send any comments, feedback, unexpected adverse event cases, or questions arising during the use of the Service to ARPI Inc. using the following email address, in accordance with the T&C: [email protected]
7. Responsibility of ARPI Inc.
1.
ARPI Inc. reserves the right to change the scope of the Service. In such cases, the Customer has no right to claim damages or other compensation unless otherwise specified in Article 12 of the T&C. The Customer has the right to terminate the T&C according to Article 11.2 of the T&C.
2.
The Customer is fully responsible for using the Service, and ARPI Inc. is not liable in any way for such use or its results, except for the relevant legal responsibility related to defective devices.
3.
ARPI Inc. provides no warranties related to the Service other than those provided in these T&C.
4.
Specifically, and without limitation, ARPI Inc. does not guarantee that (i) the Service will be free from unexpected software errors, (ii) the Service will meet all Customer expectations, (iii) the Service will be free from any malfunctions, (iv) the Service will provide accurate or reliable results, or (v) the Service will operate without interruption.
5.
ARPI Inc. is not liable for any lack of availability of the Service or for any other communication system errors that make the Service unavailable.
6.
If ARPI Inc. determines that the Customer is using the Service in violation of the T&C or applicable laws, it may, at its discretion, cancel the registration of specific Customers or Users, temporarily or permanently block their access to the Service, or terminate the T&C.
7.
ARPI Inc. may discontinue the provision of the Service in certain countries due to regulatory restrictions without the Customer's consent.
8.
ARPI Inc. may suspend access to the Service for necessary updates, maintenance, and changes without the Customer's consent. ARPI Inc. commits to making the Application available within the scope required by MFDS (KR), Medsafe (NZ), and MOHAP (UAE) to ensure performance, safety, and reliability consistent with intended use.
8. Intellectual Property and License
1.
All services provided to the Customer, including the mobile and desktop applications and the reporting functionality provided by the Application, are subject to ARPI Inc.'s strong intellectual property rights, including copyrights and trademarks.
2.
By entering into the T&C, ARPI Inc. grants the Customer a non-exclusive, non-transferable, non-sublicensable, revocable license ("License") to use the mobile and desktop applications for the purposes specified in these T&C. The License is granted for the duration of the T&C.
3.
The Customer shall not modify the mobile or desktop applications or their source code in any way, nor may the Customer update the mobile or desktop applications or their source code in any way.
4.
In connection with the use of the content service provided by the Customer, the Customer may provide feedback, recommendations, contribute to service improvements, or participate in various surveys, thereby providing ARPI Inc. with information or materials (including written documents, photos, video or audio recordings, software, statistical data, databases) that may be protected by intellectual property rights.
9. Data Protection
1.
Both parties acknowledge and agree that the services provided by ARPI Inc. may include the processing of personal data on behalf of the Customer. In relation to such personal data, ARPI Inc. acts as a processor, and the Customer acts as a controller. This processing is subject to these T&C, the Privacy Policy, and the Personal Information Protection Act of the Republic of Korea.
2.
Obligations of ARPI for Data Processing
a.
ARPI Inc. processes (i) ECG images provided by the Customer and (ii) identification, email addresses, institution names, occupations (job titles), profile information, and other related data of the Customer using the Application for the operation and management of the Application.
b.
ARPI Inc. will not disclose personal data to third parties except when necessary to (i)perform the activities and services specified in the T&C; (ii) comply with the documented instructions of the Customer; (iii) comply with a third partyโs merger, acquisition, or other investment involving ARPI Inc.; or (iv) comply with data protection laws or other applicable laws to which ARPI Inc. is subject. In such cases, ARPI Inc. will inform the Customer of the legal requirements prior to processing the personal data (to the extent permitted by law).
3.
Obligations of the Customer for Data Processing
a.
The Customer commits to fully comply with all applicable data protection laws and regulations, and in particular, to provide appropriate notices, and have a lawful basis for processing personal data as specified in these T&C. The Customer must also conduct any necessary assessments required under the relevant data protection laws.
b.
The Customer is fully responsible for their processing, systems, IT infrastructure, and the mobile or other devices used (e.g., the mobile devices on which the Customer installs the Application) and must comply with applicable laws and maintain appropriate technical and organizational measures.
c.
The Customer must ensure that (i) only individuals who need access to the Service and personal data within the Service have such access, (ii) individuals using the Service comply with confidentiality obligations, and (iii) all individuals using the Service use the Application following the Customer's instructions as the controller and comply with the T&C. The Customer must ensure that appropriate access controls and suitable technical and organizational measures are in place to guarantee these requirements.
4.
Both parties acknowledge and agree that the services provided by ARPI Inc. may involve (i) processing of the Customer's personal data, (ii) processing of anonymized or pseudonymized forms of data collected by the Customer, or (iii) processing for regulatory requirements or legal claims. ARPI Inc. acts as a controller concerning such processing.
10. Confidentiality
1.
The following information is considered confidential ("Confidential Information"): all trade secrets, know-how, processes, ideas, proposals, proprietary techniques and methods, and all related information provided or disclosed orally, in writing, electronically, visually, or through audio recordings or other means;
2.
Technical, economic, and commercial information, information about prices and their calculation methods, products and/or related documents and manuals, including their content, research and development information, including research and development plans, business development plans, business and product marketing plans, past and present economic results, forecasts and estimates of economic results, budgets, and other economic data, details about ARPI Inc.'s internal structure and employees, and information about future strategies provided or disclosed orally, in writing, electronically, visually, or through audio recordings or other means;
3.
The existence and content of all discussions related to the subject matter of the T&C; all information designated as confidential by ARPI Inc. unless otherwise agreed; and all notes, records, or copies related to the information described in 10.1 to 10.2 prepared by either party or their employees.
4.
ARPI Inc. may provide the Customer with access to Confidential Information. The provided Confidential Information must be used for the purposes for which it was provided and may not be used for other purposes.
5.
The disclosed Confidential Information must be kept confidential by the Customer and must not be disclosed to third parties or individuals unless otherwise agreed by ARPI Inc. and the Customer or specified in these T&C.
6.
The Customer agrees to protect and safeguard Confidential Information from unauthorized access and to notify ARPI Inc. without delay if a violation of this Article 10 is suspected. The Customer also agrees to return all provided Confidential Information upon request by ARPI Inc. at any time.
7.
If Confidential Information is in physical document form, the Customer must return it physically. If the Confidential Information is stored electronically, the Customer must securely delete all electronically stored Confidential Information and destroy the media containing such Confidential Information. The Customer is obligated to provide ARPI Inc. with written certification of the deletion and destruction.
8.
All Confidential Information belonging to each party remains the sole property of that party, and the recipient does not acquire any rights to the Confidential Information unless otherwise specified in the T&C.
11. Termination and Modification
1.
These T&C are entered into on the effective date and remain in effect indefinitely unless terminated separately. The T&C remain valid as long as the Customer uses or has access to the Service, and the Customer is bound by these T&C.
2.
The Customer may terminate the T&C and cancel the personal plan at any time. Termination becomes effective at the end of the then-current monthly subscription plan;
3.
For annual subscription plans, termination becomes effective one month after the termination date of the T&C. The Customer is not entitled to a refund for any unused portion of the subscription period.
4.
The Customer acknowledges that they will lose access to the Service once the termination of the T&C becomes effective.
5.
ARPI Inc. reserves the right to terminate the T&C at any time without reason, with effect from the next billing period, by giving non-face-to-face notice (in writing, by phone, etc.).
6.
If ARPI Inc. terminates the T&C or ceases to provide the Service to the Customer for any reason, the Customer is entitled to a refund for the purchased Service.
7.
ARPI Inc. reserves the right to amend and supplement parts of the T&C at any time. This provision does not affect rights and obligations that have already arisen during the validity period of the previous version of the T&C.
8.
In the event of any amendments or updates to the T&C, ARPI Inc. will notify the Customer by email to the email address provided in the Customer's account within a reasonable period before the amendment takes effect.
9.
Except for amendments reflecting changes in applicable law, in the event of any amendment to these T&C, the Customer has the right to reject the planned amendment and terminate the T&C without providing a reason, in accordance with Article 11.2 of these T&C. Such termination will take effect at the end of the current billing period.
10.
However, if the Customer is in a "Trial Period" where no payment is made for the Service, we may immediately implement amendments or updates to the T&C. We will notify the Customer of these T&C again in a reasonable manner when billing starts.
12. Limitation of Liability
1.
In no event shall ARPI Inc.โs total aggregate liability under these T&C, whether arising from tort (including negligence) or otherwise, exceed the actual fees paid by the Customer to ARPI Inc. for the Service during the one year preceding the event giving rise to the liability, and in no case shall it exceed $500,000.
2.
The parties agree that the limited liability for damages arising from a breach of the T&C is appropriate given the subject matter of the T&C and the context of the business relationship.
3.
The limitation of liability for damages represents a foreseeable and reasonable compensation ratio that the parties could anticipate in connection with the facts and objectives related to the potential outcomes of a breach of obligations under these T&C on the date of entering into these T&C.
4.
Nothing in the T&C shall limit or exclude ARPI Inc.'s liability for gross negligence or any liability that cannot be excluded by law, particularly liability for death or personal injury caused by ARPI Inc.'s negligence.
5.
ARPI Inc. is not liable to the Customer for any damage or alteration to portable devices, mobile phones, Windows laptops, or Windows desktop PCs, including any damage or alteration resulting from the installation or use of the Application or the Customer's use of the Service in violation of these T&C.
13. Governing Law and Dispute Resolution
1.
These T&C and any disputes or claims arising out of or in connection with them shall be governed by and construed in accordance with the laws of the Republic of Korea. The parties jointly agree that the relevant laws of the Republic of Korea shall govern these T&C.
2.
In the event of a dispute arising in relation to the T&C or the provision of the services described herein, the parties shall endeavor to resolve the dispute amicably without resorting to legal action.
3.
Any disputes or claims arising out of or in connection with the T&C, including disputes relating to their validity, breach, termination, or nullity, shall be finally resolved through arbitration by a dispute resolution committee located in a third country. The place of arbitration may be determined through mutual agreement between the parties and the Customer, and the language of the proceedings shall be English.
4.
This clause shall be governed by and construed in accordance with the laws of the Republic of Korea.
5.
Notwithstanding the above, ARPI Inc. reserves the right to bring any monetary claims arising from the Customer's payment obligations to the courts of the Republic of Korea.
14. Final Provisions
1.
The Customer declares that the rights and obligations specified in the T&C are fair and understandable and fully agrees to them.
2.
The T&C, and, where applicable, specific offers from ARPI Inc., constitute the entire agreement between the parties and supersede all prior agreements, promises, warranties, representations, and understandings related to the subject matter, whether written or oral.
3.
The Customer does not have the right to assign or transfer any rights or claims arising under or in connection with the T&C, in whole or in part, to any third party without prior consent.