Version 2025-01 · Effective upon acceptance
⚠ IMPORTANT — PLEASE READ CAREFULLY. YOUR USE OF THIS SERVICE IS ENTIRELY AT YOUR OWN RISK AND DISCRETION. THIS DOCUMENT CONTAINS LIMITATIONS OF LIABILITY, WAIVERS, HOLD HARMLESS PROVISIONS, AND INDEMNIFICATION OBLIGATIONS THAT SIGNIFICANTLY AFFECT YOUR LEGAL RIGHTS.
By accessing, registering for, or using the Adverse Events Reporting System ("Service," "System," "Platform"), operated by Dr Sean Hall ("Operator," "we," "us," "our"), you ("User," "you," "your") acknowledge that you have read, fully understood, and unconditionally agree to be bound by these Terms of Service and Conditions of Use ("Terms"). Your electronic acceptance — by clicking "I Agree," checking an acceptance checkbox, or by continuing to use the Service — constitutes a legally binding contract equivalent in force and effect to a written, signed agreement.
If you do not agree to every provision of these Terms, you must immediately cease all access and use of the Service. The Operator reserves the right to deny access to any user who does not accept these Terms.
These Terms apply to all users worldwide, regardless of country of residence, domicile, or the jurisdiction in which the Service is accessed. Where local law confers rights that cannot be excluded by contract, only those mandatory rights are preserved; all other rights and remedies are waived to the fullest extent permitted by applicable law.
YOUR USE OF THIS SERVICE IS SOLELY AT YOUR OWN RISK AND DISCRETION. THE OPERATOR MAKES NO REPRESENTATION THAT THE SERVICE IS APPROPRIATE, LAWFUL, OR AVAILABLE FOR USE IN ANY PARTICULAR JURISDICTION. YOU ARE SOLELY RESPONSIBLE FOR DETERMINING WHETHER YOUR USE COMPLIES WITH ALL LAWS AND REGULATIONS APPLICABLE TO YOU.
You expressly acknowledge and agree that:
The Adverse Events Reporting System is a digital platform that facilitates the collection and submission of adverse event reports relating to medical products, medications, vaccines, and other healthcare interventions. The Service may assist in forwarding reports to regulatory authorities; however, the Operator does not guarantee that any report will be received, reviewed, acted upon, or accepted by any regulatory body.
The Service is not a medical device, does not provide medical advice, and does not constitute a regulatory compliance solution. It is a reporting facilitation tool only.
TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, THE SERVICE IS PROVIDED ON AN "AS IS," "AS AVAILABLE," AND "WITH ALL FAULTS" BASIS. THE OPERATOR AND ITS OFFICERS, DIRECTORS, EMPLOYEES, AGENTS, CONTRACTORS, SUCCESSORS, AND ASSIGNS (COLLECTIVELY, "OPERATOR PARTIES") EXPRESSLY DISCLAIM ALL WARRANTIES, WHETHER EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, OR NON-INFRINGEMENT, AND ANY WARRANTY THAT THE SERVICE WILL BE UNINTERRUPTED, TIMELY, SECURE, ACCURATE, COMPLETE, OR ERROR-FREE.
No oral or written information or advice given by the Operator or any of its agents creates any warranty not expressly stated in these Terms.
THE OPERATOR EXPRESSLY DISCLAIMS ALL RESPONSIBILITY AND LIABILITY FOR ANY LOSS, HARM, OR CONSEQUENCE ARISING FROM SYSTEM ERRORS, TECHNICAL FAILURES, DATA LOSS, SERVICE INTERRUPTIONS, OR DOWNTIME — WHETHER PLANNED OR UNPLANNED, AND REGARDLESS OF CAUSE.
The Operator specifically disclaims liability for:
It is your sole responsibility to maintain alternative methods of adverse event reporting and regulatory compliance independent of this Service. You must not rely solely on this Service to meet any legally mandated reporting obligation.
TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT SHALL THE OPERATOR PARTIES BE LIABLE TO YOU OR ANY THIRD PARTY FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, PUNITIVE, OR EXEMPLARY DAMAGES, INCLUDING LOSS OF PROFITS, REVENUE, DATA, GOODWILL, PERSONAL INJURY, PROPERTY DAMAGE, OR LOSS OF LIFE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
IN ALL CASES, THE TOTAL CUMULATIVE LIABILITY OF THE OPERATOR PARTIES FOR ANY CAUSE OF ACTION SHALL NOT EXCEED THE GREATER OF: (A) THE TOTAL AMOUNT PAID BY YOU TO THE OPERATOR IN THE TWELVE (12) MONTHS PRECEDING THE CLAIM, OR (B) ONE HUNDRED UNITED STATES DOLLARS (USD $100.00).
SOME JURISDICTIONS DO NOT ALLOW EXCLUSION OR LIMITATION OF CERTAIN DAMAGES. IN SUCH JURISDICTIONS, LIABILITY IS LIMITED TO THE FULLEST EXTENT PERMITTED BY LAW. THESE LIMITATIONS DO NOT APPLY TO LIABILITY FOR FRAUD OR WILLFUL MISCONDUCT.
BY USING THE SERVICE, YOU HEREBY RELEASE, WAIVE, AND FOREVER DISCHARGE THE OPERATOR PARTIES FROM ANY AND ALL CLAIMS, DEMANDS, ACTIONS, LIABILITIES, LOSSES, DAMAGES, COSTS, AND EXPENSES OF ANY NATURE, WHETHER KNOWN OR UNKNOWN, FIXED OR CONTINGENT, ARISING OUT OF OR RELATING TO YOUR USE OF, OR INABILITY TO USE, THE SERVICE — INCLUDING WITHOUT LIMITATION CLAIMS ARISING FROM SYSTEM ERRORS, DATA LOSS, FAILED REPORT TRANSMISSION, OR REGULATORY NON-COMPLIANCE.
IF YOU ARE A CALIFORNIA RESIDENT (OR A RESIDENT OF A JURISDICTION WITH ANALOGOUS PROVISIONS), YOU EXPRESSLY WAIVE THE PROVISIONS OF CALIFORNIA CIVIL CODE SECTION 1542 AND ANY ANALOGOUS LAW OF ANY OTHER JURISDICTION.
You agree to defend, indemnify, and hold harmless the Operator Parties from and against any and all claims, liabilities, damages, judgments, awards, losses, costs, expenses, and fees (including reasonable attorneys' fees) arising out of or relating to:
THIS SERVICE IS NOT A MEDICAL DEVICE AND DOES NOT CONSTITUTE MEDICAL ADVICE, DIAGNOSIS, OR TREATMENT. NOTHING IN THIS SERVICE SHOULD BE CONSTRUED AS A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE OR INDEPENDENT CLINICAL JUDGMENT.
The Service does not establish any healthcare professional-patient relationship. Healthcare professionals must exercise independent professional judgment in all clinical matters. Submission of a report through this Service does not guarantee compliance with any reporting obligation imposed by any regulatory authority, professional body, employer, or applicable law. Users are solely responsible for ensuring their reporting obligations are met through appropriate and legally compliant channels.
You are solely responsible for the accuracy, completeness, and timeliness of all information you submit; ensuring your reports comply with all applicable legal and regulatory requirements; maintaining account security; maintaining backup records of all reports independently of this Service; and verifying receipt and acceptance of reports by any regulatory authority.
You warrant that all information you provide is truthful, accurate, and not misleading. Submission of false or fraudulent adverse event reports may constitute a criminal offence under applicable law.
Healthcare professionals acknowledge that use of this Service does not relieve them of any independent professional, legal, or ethical reporting obligation; that they remain solely responsible for the content and quality of any clinical notes they add; and that the reminder system provided is a convenience tool only and does not constitute a compliance management system or substitute for professional judgment.
You agree not to submit false or fabricated reports; violate applicable law; attempt unauthorized access to any part of the Service or its infrastructure; transmit malware or harmful code; harvest or scrape data without authorization; reverse-engineer the Service; impersonate any person or entity; or use the Service in any manner that impairs its proper operation.
By using the Service you consent to the collection, processing, and storage of personal and medical information. While the Operator implements reasonable security measures, no system is completely secure. The Operator does not guarantee the security of information transmitted and is not liable for unauthorized access, disclosure, or loss of data.
You are responsible for ensuring your submission of personal or health information complies with all applicable data protection laws in your jurisdiction, including without limitation HIPAA, GDPR, the Australian Privacy Act, and any other applicable national, state, or local legislation.
The Service relies on third-party infrastructure and services the Operator does not control. The Operator is not responsible for the availability, performance, security, or terms of any third-party service. Your use may be subject to additional third-party terms and conditions.
These Terms shall be governed by and construed in accordance with the laws of the United States of America and the State of Delaware, without regard to conflict of law principles. All disputes shall be resolved exclusively in state or federal courts located in Delaware, USA, and you irrevocably submit to the personal jurisdiction of such courts.
Users accessing the Service from outside the United States acknowledge and agree that their use is subject to United States law and that they are responsible for compliance with their local laws. The United Nations Convention on Contracts for the International Sale of Goods does not apply. Any dispute must be brought in your individual capacity only — not as a class action or representative proceeding.
The Operator reserves the right to modify these Terms at any time in its sole discretion. When changes are made the version number will be updated and users will be required to re-accept. Continued use of the Service after modification constitutes acceptance of the modified Terms.
The Operator may suspend or terminate your access at any time without notice or liability. Provisions that by their nature survive termination will continue to apply. If any provision is found unenforceable it will be modified to the minimum extent necessary. These Terms constitute the entire agreement between you and the Operator regarding the Service and supersede all prior agreements.
Terms of Service Version 2025-01 · Adverse Events Reporting · Dr Sean Hall
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