Artificial Intelligence Addendum to WebChart Customer SLA (Click Thru) - Template (KD Draft 06.12.23)

Artificial Intelligence Addendum

This Artificial Intelligence Addendum (“AI Addendum”) is by and between Medical Informatics Engineering, Inc. (“MIE”) whose principal place of business is 6302 Constitution Drive, Fort Wayne, Indiana 46804, USA, and Customer agreeing to these terms (“Customer”) and is appended to and forms part of the WEBCHART Services License Agreement by and between MIE and Customer executed by the parties (the “Agreement”). Capitalized terms used but not defined herein shall have the meaning given in the Agreement. Except as modified below, the terms of the Agreement shall remain in full force and effect.

This AI Addendum is effective as of the date that Customer agrees to the terms of this AI Addendum by clicking the “I AGREE” button.

In consideration of the mutual obligations set forth herein, the parties hereby agree that the terms and conditions set out below shall be added as an addendum to the Agreement. Except where context requires otherwise, references in this AI Addendum to the Agreement are to the Agreement as amended by, and including, this AI Addendum.

1. USE OF AI FUNCTIONALITY

   1. Representations and Warranties; Customer Responsibilities.

By accessing or using the Services chosen by Customer pursuant to the Agreement, Customer agrees to only use the Services in the manner and for the purposes as set forth in this AI Addendum and the Agreement. The artificial intelligence or machine learning functionality available on the Services (the “AI Functionality”) is intended for use only by Customer. By accessing or using the AI Functionality, Customer agrees that the AI Functionality is: (1) intended for the purpose of supporting or providing recommendations to Customer; (2) intended for the purpose of enabling the Customer to independently review the basis for such recommendations that the AI Functionality presents. The Customer 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, Customer acknowledges and agrees that any examples of potential diagnoses or other output generated using the AI Functionality may be incorrect, harmful, or biased, and Customer will not rely on or substitute such examples or output for Customer’s own professional judgment or the professional judgment of Customer’s medical and healthcare professionals. The Customer 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 Customer’s consideration and is subject to Customer’s verification. It is not to be taken as a warranty or representation by which MIE assumes legal responsibility. Customer expressly acknowledges and agrees that MIE is not responsible for the results or outcomes of any decisions made based on Customer’s use of the AI Functionality and that Customer is solely responsible for all decisions made, advice given, actions taken, and failures to act based on their use of the AI Functionality. Further, Customer shall require its End Users to execute an end user agreement in a form substantially similar to this AI Addendum prior to the use of the AI Functionality.

2. <strong>Practice of Medicine</strong>

Customer 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 AI Addendum shall preclude Customer, in its sole discretion, from permitting a duly licensed and qualified professional, who: (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 1.2, the parties agree that MIE has informed Customer that the outputs generated by the AI Functionality is computer-generated and not human-generated, and may be inaccurate or incomplete.

3. <strong>Billing, Coding, and Claims Restrictions</strong>

Customer 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 AI Addendum shall preclude Customer, in its sole discretion, from permitting a duly trained and qualified individual, who: (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 1.3, the parties agree that MIE has informed Customer that the output generated by the AI Functionality is computer-generated and not human generated, and may be inaccurate or incomplete.

4. <strong>Clinical Research Restrictions</strong>

Customer 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 AI Addendum shall preclude Customer, in its sole discretion, from permitting a duly trained and qualified individual, who: (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 1.4, the parties agree that MIE has informed Customer that the output generated by the AI Functionality is computer-generated and not human generated, and may be inaccurate or incomplete.

5. <strong>Health Care Purposes</strong>

To the extent that Customer permits a duly trained and qualified individual to use the AI Functionality for any health care purposes, including in connection with the functions, activities, and services referenced in Sections 1.2, 1.3, and 1.4, the parties agree that MIE has informed Customer 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.

6. <strong>Further Restrictions</strong>

Customer 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 AI Addendum and the Agreement; or (6) buy, sell, or transfer application programming interface keys from, to, or with a third party.

2. PRIVACY AND SECURITY; COMPLIANCE WITH LAWS

2.1 European Union Data Privacy and Foreign Countries

Customer 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, Customer further acknowledges and agrees that it shall not transmit any data via the AI Functionality that originates outside the United States of America.

2.2 Compliance with Laws.

Customer shall comply with all Laws (as defined herein) as it relates to its, and its employees, agents, contractors, and any other person authorized by Customer to use the AI Functionality pursuant to this AI Addendum (collectively, the “End Users”) possession, access, use, disclosure, transmissions, or release of personally identifiable information (“PII”) and protected health information (“PHI”) submitted via the AI Functionality. Customer 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 Customer or its End Users (collectively, a “Customer Security Incident”) that may arise as a result of Customer’s use of the AI Functionality; and (ii) it shall hold harmless, defend, and indemnify MIE from any Customer Security Incident or Customer’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 2.2 shall survive the expiration or termination of the Agreement.

3. Disclaimers; No Warranties.

THE AI FUNCTIONALITY MADE AVAILABLE THROUGH THE SERVICES 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 CUSTOMER’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 CUSTOMER OR ITS END USERS; AND

(C) THE ACCURACY, COMPLETENESS, OR SUITABILITY OF ANY DATA OR INFORMATION USED IN ANY CLINICAL RESEARCH ACTIVITIES CONDUCTED BY CUSTOMER OR ITS END USERS; AND

(D) ANY INFORMATION ENTERED BY CUSTOMER OR ITS END USERS INTO A PATIENTS MEDICAL RECORD BASED ON OUTPUTS RECEIVED OR INFORMATION GENERATED BY THE AI FUNCTIONALITY.

CUSTOMERS AND ITS END USERS HAVE SOLE CONTROL OVER WHAT INFORMATION IS ENTERED INTO THE MEDICAL RECORD AND MIE IS NOT LIABLE FOR CUSTOMER OR 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 CUSTOMER AND ITS END USERS 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 CUSTOMER OR ITS END USERS TO BE ADDED TO THE MEDICAL RECORD.

4. Indemnification; Hold Harmless.

Customer, by and on behalf of itself and its affiliates, 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) Customer’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; (b) any reliance by Customer’s employees, agents, patients, medical professionals, and health care professionals on the AI Functionality; and, (c) Customer’s or its End Users’ violation of the terms of this AI Addendum. For avoidance of doubt, claims arising under this Section 4 shall apply to both first- and third-party claims. This Section 4 shall survive the termination or expiration of this AI Addendum and the Agreement.

[CLICK THROUGH AGREEMENT FOLLOWING]

Click-Through Agreement to Artificial Intelligence Addendum****:

**The Customer acknowledges and agrees that it has read the Artificial Intelligence Addendum and agrees to all terms contained therein. **

By clicking “I AGREE” the Customer, by its duly authorized representative, agrees to be bound by all terms of the Artificial Intelligence Addendum.