MIE - OpenAI End User Agreement (draft 06.01.2023)

END USER AGREEMENT AND TERMS OF USE
This End User Agreement (“EUA”) is a legal agreement between you (the “End User”) and Medical Informatics Engineering, Inc. (“MIE”), and contains the terms and conditions governing the use and access of the AI Functionality made available as part of the MIE Software identified in the [WEBCHART Services License Agreement/Master Services Agreement] (the “Agreement”) by and between MIE and the other party listed therein ([“Customer/Client”]).

Before you, as the End User, click on the “I AGREE” button at the end of this EUA, carefully read the terms and conditions of this EUA. By clicking on the “I AGREE” button, you are consenting to be bound by and are becoming a party to this EUA. This EUA is effective as of the date you click “I AGREE.”

1. GENERAL

   1. Grant of Access. As part of the [WebChart/Enterprise Health Solution] (the “MIE Software”), MIE has made available certain artificial intelligence or machine learning functionalities (the “AI Functionality”) designed to assist and optimize End User’s use of the MIE Software. MIE hereby permits End User to use the AI Functionality made available as part of the MIE Software. At all times, End User agrees to use the AI Functionality in accordance with the provisions of this EUA.

   2. Relationship of the Parties. This EUA does not create a partnership, joint venture or agency relationship between End User and MIE or any of MIE’s affiliates. MIE and End User are independent contractors and neither party will have the power to bind the other or to incur obligations on the other’s behalf.

2. TERM AND TERMINATION

   3. Termination; Suspension. This EUA takes effect as of the date that End User agrees to the terms of this EUA by clicking the “I AGREE” button and remains in effect until terminated. MIE may terminate this EUA at any time, and for any reason, by providing you at least fifteen (15) days’ advance notice. MIE may terminate this EUA immediately if (a) the Agreement between MIE and [Customer/Client] is terminated for any reason; (b) the End User breaches any terms of this EUA; (c) there are any changes in relationships with third-party technology vendors; or, (d) such termination is needed to comply with Laws.

   4. Effect on Termination. Upon termination, End User agrees to immediately stop using the AI Functionality and return any materials related to the use thereof, which may include printed and on-line materials, user guides, product specifications, training manuals, and other similar information that assist End User with the use of the AI Functionality, which may be updated from time to time.

3. USE OF AI FUNCTIONALITY

   5. Representations and Warranties; End User Responsibilities. By accessing or using the AI Functionality, End User agrees to only use the AI Functionality in the manner and for the purposes as set forth in this EUA and the Agreement. The AI Functionality available on the MIE Software is intended for use only by End User. By accessing or using the AI Functionality, End User agrees that the AI Functionality is: (1) intended for the purpose of supporting or providing recommendations to End User; and (2) intended for the purpose of enabling the End User to independently review the basis for such recommendations that the AI Functionality presents. The End User shall not rely primarily on any of such recommendations from the AI Functionality to make a clinical diagnosis or treatment decision regarding an individual patient. Without limiting the foregoing, End User acknowledges and agrees that any examples of potential diagnoses or other output generated using the AI Functionality may be incorrect, harmful, or biased, and End User will not rely on or substitute such examples or output for End User’s own professional judgment. The End User shall not use the AI Functionality without the judgment of a qualified health care provider with the ability to take into account individual circumstances of each patient’s or employee’s case. The information contained in or provided by the AI Functionality is offered solely for End User’s consideration and is subject to End User’s verification. It is not to be taken as a warranty or representation by which MIE assumes legal responsibility. End User expressly acknowledges and agrees that MIE is not responsible for the results or outcomes of any decisions made based on End User’s use of the AI Functionality and that End User is solely responsible for all decisions made, advice given, actions taken, and failures to act based on their use of the AI Functionality.

   6. Practice of Medicine. End User shall not use the AI Functionality or the outputs generated from the AI Functionality for the practice of medicine, including for the purposes of preventing, diagnosing, or treating a disease or condition; provided, however, that nothing in this EUA shall preclude End User, in its sole discretion, who is a duly licensed and qualified professional, and: (a) is authorized to practice medicine in the relevant jurisdiction; and (b) has been trained and is otherwise qualified in such professional’s applicable scope of practice; to (c) use the AI Functionality in connection with the prevention, diagnostic, or treatment services as such professional sees fit, within the scope of such professional’s qualifications and job duties, subject to such professional’s sole discretion and judgment, and pursuant to such professional’s review and verification of all data, outputs, and information relied upon in providing such services. For purposes of this Section 3.2, the parties agree that MIE has informed End User that the outputs generated by the AI Functionality is computer-generated and not human-generated, and may be inaccurate or incomplete.

   7. Billing, Coding, and Claims Restrictions. End User shall not use the AI Functionality or the outputs generated from the AI Functionality for the purposes of coding medical claims or otherwise supporting medical billing, coding or claims generation; provided, however, that nothing in this EUA shall preclude End User, in its sole discretion, who is a duly licensed and qualified professional, and: (a) maintains such certifications as are available and required for individuals performing such activities; and (b) has been trained and is otherwise qualified in the provision of coding, claims, and billing activities; to (c) use the AI Functionality in connection with coding, claims, and billing activities or functions, subject to such individual’s professional discretion and judgment, within the scope of such professional’s qualifications and job duties, and pursuant to such individual’s review and verification of all data, outputs, and information relied upon in performing such activities. For purposes of this Section 3.3, the parties agree that MIE has informed End User that the output generated by the AI Functionality is computer-generated and not human generated, and may be inaccurate or incomplete.

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   8. Clinical Research Restrictions. End User shall not use the AI Functionality or the outputs generated from the AI Functionality, for purposes relating to clinical research that is subject to 45 C.F.R. part 46 or 21 C.F.R. part 50 or is otherwise regulated by state or federal laws or regulations; provided, however, that nothing in this EUA shall preclude End User, in its sole discretion, who is a duly trained and qualified individual, and: (a) has submitted a written study or plan to an institutional review board (“IRB”), as defined in 21 C.F.R. § 56.102, that describes the AI Functionality and its outputs, and explains how the AI Functionality and its outputs will be used and shared for research-related purposes; (b) has obtained written IRB approval stating that the AI Functionality and its outputs may be used and shared for such research purposes; (c) has obtained all approvals required by applicable laws or institutional policies and procedures to use the AI Functionality and its outputs for research activities, including obtaining any required authorizations and consents from patients or individuals; (d) has been trained and is otherwise qualified in the performance of clinical research; and (e) has agreed in writing to perform such research activities in compliance with all applicable state and federal regulations, including regulations codified at 45 C.F.R. parts 160 and 164, 45 C.F.R. part 46, 21 C.F.R. part 50, and 21 C.F.R. part 11, and any guidance issued by the U.S. Department of Health and Human Services, Office of Human Research Protections, and the U.S. Food and Drug Administration; to (f) use the AI Functionality in connection with research activities, or functions, subject to such trained and qualified individual’s discretion and judgment, within the scope of such individual’s qualifications and duties, and pursuant to such individual’s review and verification of all data and information relied upon in performing such activities. For purposes of this Section 3.4, the parties agree that MIE has informed End User that the output generated by the AI Functionality is computer-generated and not human generated, and may be inaccurate or incomplete.

   9. Health Care Purposes. To the extent that End User, who is a duly trained and qualified individual, uses the AI Functionality for any health care purposes, including in connection with the functions, activities, and services referenced in Sections 3.2, 3.3, and 3.4, the parties agree that MIE has informed End User about the limitations associated with the data, outputs, and information generated by the AI Functionality, which shall include without limitation, notification that the outputs generated may be inaccurate or incomplete.

   10. Further Restrictions. End User is not permitted to: (1) use the AI Functionality in a manner that violates any Laws, safety and usage guidelines provided at https://beta.openai.com/docs/usage-policies , and any other service terms provided at https://openai.com/api/policies/service-terms/ and https://openai.com/policies/terms-of-use ; (2) use the AI Functionality in a manner that infringes, misappropriates, or otherwise violates MIE’s or a third-party technology vendor’s intellectual property rights; (3) modify or create derivative works of the AI Functionality; (4) reverse assemble, reverse compile, decompile, translate, engage in model extraction or stealing attacks, or otherwise attempt to discover the source code or underlying components of models, algorithms, and systems of the AI Functionality; (5) use the AI Functionality to extract data other than as permitted by this EUA and the Agreement; or (6) buy, sell, or transfer application programming interface keys from, to, or with a third party.

4. PRIVACY AND SECURITY; COMPLIANCE WITH LAWS

5. European Union Data Privacy and Foreign Countries. End User acknowledges and agrees that it is prohibited from transmitting data via the AI Functionality that is protected under the European Union General Data Protection Regulation or any applicable data privacy and security laws of a foreign country. For avoidance of doubt, End User further acknowledges and agrees that it shall not transmit any data via the AI Functionality that originates outside the United States of America.

6. Compliance with Laws. End User shall comply with all Laws (as defined herein) as it relates to its (and its employees and agents) possession, access, use, disclosure, transmission, or release of personally identifiable information (“PII”) and protected health information (“PHI”) submitted via the AI Functionality. End User acknowledges and agrees that (i) it shall be responsible for any and all costs, fines, penalties, fees or expenses, including attorneys’ fees, related to any security incident, data breach, unauthorized access, unauthorized disclosures, or use of PHI caused by End User or its employees, agents, or contractors (collectively, a “End User Security Incident”) that may arise as a result of End User’s use of the AI Functionality; and (ii) it shall hold harmless, defend, and indemnify MIE from any End User Security Incident or End User’s violation of any Laws. “Laws” is defined as all applicable international, federal and state laws, rules and regulations, including, but not limited to, any laws or regulations governing (a) the privacy and security of PHI or PII, including the Health Insurance Portability and Accountability Act of 1996, as amended; (b) the delivery of billing of health care services, including, but not limited to, telehealth or telemedicine services; and (c) the retention of health or other related records. This Section 4.2 shall survive the termination or expiration of this EUA.

7. DISCLAIMERS; NO WARRANTIES

THE AI FUNCTIONALITY MADE AVAILABLE THROUGH THE MIE SOFTWARE IS PROVIDED “AS IS” AND WITHOUT WARRANTIES OF ANY KIND EXPRESS OR IMPLIED. TO THE FULLEST EXTENT PERMISSIBLE PURSUANT TO APPLICABLE LAW, MIE DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT OF PROPRIETARY RIGHTS. MIE DOES NOT WARRANT THAT THE FEATURES AND FUNCTIONALITY OF THE AI FUNCTIONALITY WILL BE UNINTERRUPTED OR ERROR-FREE, THAT DEFECTS WILL BE CORRECTED, OR THAT THE AI FUNCTIONALITY IS FREE OF VIRUSES OR OTHER HARMFUL COMPONENTS. MIE DOES NOT REVIEW, MONITOR, EVALUATE, OR ANALYZE ANY INFORMATION GENERATED FROM THE AI FUNCTIONALITY FOR ANY MEDICAL PURPOSE. MIE DOES NOT ENGAGE IN THE PRACTICE OF MEDICINE OR PROVIDE ANY MEDICAL ADVICE. IT IS END USER’S RESPONSIBILITY TO PROVIDE MEDICAL ADVICE OR MAKE CLINICAL DECISIONS BASED ON OUTPUTS GENERATED BY THE AI FUNCTIONALITY. MIE IS NOT RESPONSIBLE OR LIABLE FOR: (A) ANY ADVICE, COURSE OF TREATMENT, DIAGNOSIS, OR ANY OTHER INFORMATION OR SERVICES THAT ANY PATIENT MAY OBTAIN OR RECEIVE; (B) ANY BILLING, CODING, OR CLAIMS ACTIVITIES CONDUCTED BY END USER; (C) THE ACCURACY, COMPLETENESS, OR SUITABILITY OF ANY DATA OR INFORMATION USED IN ANY CLINICAL RESEARCH ACTIVITIES CONDUCTED BY END USER; AND (D) ANY INFORMATION ENTERED BY END USER INTO A PATIENTS MEDICAL RECORD BASED ON OUTPUTS RECEIVED OR INFORMATION GENERATED BY THE AI FUNCTIONALITY. THE END USER HAS THE SOLE CONTROL OVER WHAT INFORMATION IS ENTERED INTO THE MEDICAL RECORD AND MIE IS NOT LIABLE FOR END USERS’ DECISION TO PURGE, COPY, ADD, OR DELETE ANY INFORMATION GENERATED BY THE AI FUNCTIONALITY THAT MAY BE MADE PART OF A PATIENT’S MEDICAL RECORD. MIE RESERVES THE RIGHT TO RECORD CONVERSATIONS BETWEEN END USER AND THE AI FUNCTIONALITY AND TO STORE SUCH CONVERSATIONS FOR A PERIOD OF THIRTY DAYS AT WHICH TIME SUCH CONVERSATIONS AND OUTPUTS GENERATED BY THE AI FUNCTIONALITY WILL BE AUTOMATICALLY DELETED, UNLESS OTHERWISE ELECTED BY END USER TO BE ADDED TO THE MEDICAL RECORD.

18. INDEMNIFICATION; HOLD HARMLESS

End User agrees to indemnify, defend, and hold harmless MIE and its affiliates and their respective officers, directors, employees, agents, successors, representatives, attorneys, and assigns, from any and all losses and threatened losses arising from, in connection with, or related to: (a) End User’s use of the AI Functionality, including without limitation any use of output generated from the AI Functionality or inputs entered into the AI Functionality by End User; (b) any reliance by End User’s employees, agents, patients, medical professionals, and health care professionals on the AI Functionality; and, (c) End User’s violation of the terms of this EUA. For avoidance of doubt, claims arising under this Section 6 shall apply to both first- and third-party claims. This Section 6 shall survive the termination or expiration of this EUA.

19. MISCELLANEOUS

If any provision of this EUA is determined to be unenforceable, the rest of this EUA will remain in full force. The delay or failure to assert a right herein or to insist upon compliance with any term of condition of this EUA shall not constitute a waiver of that right or excuse a subsequent failure to perform any term or condition. End User may not assign any of the rights herein without prior written approval from MIE. This EUA will be binding on the parties’ permitted successors and assigns. This EUA will be governed by the laws of the State of Indiana without regard to choice-of-law principles. The parties hereby submit and consent to the exclusive jurisdiction of any federal court located within the Northern District of the State of Indiana, assuming such court agrees to federal jurisdiction (otherwise, the state court located within Allen County of the State of Indiana) and irrevocably agree that all actions or proceedings relating to this EUA shall be litigated in such courts, and each of the parties waives any objection which it may have based on improper venue or forum non conveniens to the conduct of any such proceeding in such court. This EUA is the entire agreement between MIE and the End User as to the subject matter. End User has full power and authority to agree to all terms of this EUA on behalf of itself. The agreement to this EUA by the End User constitutes a legal, valid, and binding obligation of the End User.
End User Agreement:
**The End User acknowledges and agrees that it has read this End User Agreement and agrees to all terms and conditions contained therein. **
By clicking “I AGREE,” the End User agrees to be bound by all terms of this End User Agreement.