Terms & Conditions
& Privacy Policy
Terms of Use & Privacy Policy
(User Contract)
Effective Date: 2024-05-01, Version 2.0
Read this agreement very carefully
TERMS OF USE DETAILS
Introduction:
1.1 Risktech Domains Inc, a Delaware corporation ("Riskbased.ai," "Risktech Domains,", "MAUDE 2.0", "TPLC 2.0", "Recalls.fyi," "Us," or "We"), operates Riskbased.ai, along with websites accessible through external hyperlinks within Recalls.fyi, Riskbased.ai, certain mobile versions and apps, and associated social media outlets (collectively, the "Site"). The Site provides access to publicly available information from governmental agencies, analyses, data analytics conducted by Us and our partners, and user discussion/chat rooms containing user-provided Content (defined below) as well as content We provide (collectively, the "Services").
1.2 All information provided is from the public domain, fda sources, and FOIA. The term “public domain” encompasses those materials that are not protected by intellectual property laws such as copyright, trademark, or patent laws in America (USA). No individual owns these works; rather, they are owned by the public. Anyone can use a public domain work without obtaining permission and without citing the original author, but no one can ever own it.
Each year, the FDA receives several hundred thousand MDRs of suspected device-associated deaths, serious injuries, and malfunctions submitted by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as healthcare professionals, patients, and consumers. The FDA uses MDRs to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments.
Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use. Because of this, MDRs comprise only one of the FDA’s several important postmarket surveillance data sources.
MDRs can be used effectively to:
• Establish a qualitative snapshot of adverse events for a specific device or device type; and
• Detect actual or potential device problems used in a “real world” setting/environment, including:
o Rare, serious, or unexpected adverse events;
o Adverse events that occur during long-term device use;
o Adverse events associated with vulnerable populations;
o Off-label use; and
o Use error.
As previously stated, although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use. Because of this, MDRs comprise only one of the FDA’s several important postmarket surveillance data sources. Important limitations of MDRs include:
• The data alone cannot be used to establish rates of events, evaluate a change in event rates over time, or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.
•Confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report. Establishing a cause-and-effect relationship is especially difficult if circumstances surrounding the event have not been verified or if the device in question has not been directly evaluated.
•MDRs are subject to reporting bias, attributable to potential causes such as reporting practice, increased media attention, and/or other agency regulatory actions.
•MDRs do not represent all known safety information for a reported medical device and should be interpreted in the context of other available information when making device-related or treatment decisions.
1.3 By using the Services, whether as an individual or a representative of a company or business entity using a company or business entity email for contact information ("You"), you agree to the terms and conditions set forth in this legally binding agreement, including our Privacy Policy (governing personal information collection, use, sharing, tracking, and storage) (collectively, the "Terms"). If you purchase Services from us, you also agree to any terms or conditions outlined in an order form specifying the Services you've acquired, which becomes part of this agreement (an "Order Form"). In case of conflicts between these terms and conditions, our Privacy Policy, or an Order Form, the following order of precedence applies: (1) Order Form, (2) Privacy Policy, (3) these terms and conditions. If you do not agree to these Terms, refrain from accessing, purchasing, or using the Services. This agreement is between You and Us, with no third-party beneficiaries.
The Services:
2.1 Authorized Use: You may use the Services during the term of this agreement solely for Your internal business purposes supported by the relevant Content or material. If you are an employee of an academic institution, You may also use the Services for academic research purposes.
2.2 Usage Restrictions: You agree to comply with the following restrictions and obligations in Your use of the Services:(i) You possess the legal authority to enter into this agreement and, if using the Services on behalf of a business entity, you are authorized to contractually bind such entity to this agreement.(ii) You will adhere to all applicable laws, including privacy laws, intellectual property laws, anti-spam laws, export control laws, tax laws, and regulatory requirements.(iii) When posting Content, ensure that i) all Content is relevant to the discussion or topic, ii) all Content is accurate and not misleading, and iii) you possess the necessary intellectual property rights to provide the Content and grant the described license in Section 4.(iv) Maintain the security and confidentiality of your login information, prohibiting sharing these with others.(v) Do not use the Services to compete with us or for purposes not allowed under Section 2.1, including building a library of provided documents.(vi) Do not excessively download material or Content through the Services, as determined by our discretion, and do not develop, support, or use software, devices, scripts, robots, or any other means to scrape or copy data from the Services.(vii) Do not attempt to reverse engineer, decompile, disassemble, decipher, or derive the source code for the Services or related technology.(viii) Do not post or upload Content that is harassing, defamatory, abusive, threatening, obscene, harmful, tortuous, libelous, or invasive of another's privacy, and do not include unauthorized advertising, promotional materials, chain letters, spam, junk mail, or mass email to recipients who have not consented to such mailings.(ix) Do not upload or post Content containing digital worms, viruses, or other harmful, disruptive files, code, or programs.
2.3 Changes to the Platform: We may change, suspend, or terminate the Platform or any part of it, or modify prices prospectively at our discretion, with notice posted on the Platform. Such changes take effect upon your use of the Platform following our notice.
2.4 No Legal Advice or Opinion: You understand and agree that (a) no part of the Services shall be construed as the provision of legal advice or legal opinion by us to you, (b) that you have the opportunity at any time during use of the Services to review all potential courses of action with your internal counsel or other employees or agents.
Term, Termination, and Suspension:
3.1 Term: This agreement remains in effect for i) as long as you use the Services or ii) for the duration specified in an active Order Form. Order Forms renew automatically for 1-month, 3-month, or 12-month periods unless either party provides 30 days' advance written notice of non-renewal.
3.2 Termination: You can terminate this agreement by ceasing all use of the Services or, if you have an Order Form, by notifying us in writing. Termination of an Order Form before its expiration does not result in a refund for the unused service period. We may terminate this agreement if i) we cease to provide the Services, refunding the prorated unused payment if applicable, or ii) You breach this agreement and fail to remedy the breach within 5 days of notice sent to your provided contact information. Sections 4, 6, 7, 8, and 9 survive the agreement's termination.
3.3 Suspension: We may suspend Your use of the Platform at our discretion if we believe you have violated this agreement or if your user credentials are compromised.
Intellectual Property:
4.1 Content: "Content" refers to all content, including text, images, photos, audio, video, and other data or communication posted or provided to Us via the Platform, excluding personally identifiable information. All Content you share remains your property, and you are solely responsible for it.
4.2 License to Content: By providing Content, you grant Us a perpetual, irrevocable, non-exclusive, transferable, royalty-free, sublicensable, fully paid-up, worldwide license to use, modify, reproduce, publish, distribute, adapt, translate, create derivative works, archive, store, share, post, sublicense, or make available Your Content for any purpose, with or without attribution.
4.3 Our Intellectual Property: We retain all intellectual property rights in the Platform and the content made available through it. Trademarks and logos used with the Platform are the property of their respective owners. Risktech Domains, Recalls.fyi, Riskbased.ai, and other Risktech trademarks and service marks are our trademarks or registered trademarks. You may not use these without our prior written consent.
Payment:
5.1 Fees and Payment: As payment for the Services, You will pay any fees specified in an Order Form no later than 30 days after receiving our invoice. Past due balances will accrue interest monthly at 1.5% or at the maximum statutory rate, whichever is lower. You are responsible for any taxes, tariffs, customs duties, surcharges, or fees imposed by law in connection with the Services.
Limitation of Liability:
6.1 Disclaimer: Except as prohibited by law, we are not liable for indirect, incidental, special, consequential, or punitive damages, or any inaccurate data, information, or Content, loss of data, content, information, profits, or revenues related to the Platform, regardless of prior notice of such liability. 6.2 Limitation: Our liability, for all claims in aggregate, does not exceed the lesser of (A) the fees paid for the most recent 12-month period for the Services, if any, or (B) USD $1,000. 6.3 Materiality and Survival: This limitation is a material inducement for us to enter this agreement and is intended to survive any finding by a court or arbiter that the exclusive remedies under this agreement fail of their essential purpose.
Warranty Disclaimer:
7.1 No Warranty: Except for warranties that cannot be excluded by law, the Services (including Content and information) are provided on an "as is" and "as available" basis, and we do not guarantee uninterrupted or error-free Services. We disclaim all express, implied, or statutory warranties and representations, including those related to merchantability, fitness for a particular purpose, data accuracy, and non-infringement.
Indemnification:
8.1 Indemnification: You agree to defend, indemnify, and hold Us, our affiliates, directors, officers, employees, and agents harmless from any demands, loss, liability, claims, damages, or expenses, including reasonable attorneys' fees, related to (i) Your use of the Platform, (ii) any Content You use or distribute outside the Platform, or post, upload, or transmit within the Platform, and (iii) Your breach of this agreement.
Admin/General Provisions:
9.1 Change: We may make changes to this agreement at our discretion by posting updated terms on the Platform with an effective date. Your continued use of the Services constitutes acceptance of any changes. 9.2 Assignment: You may not assign this agreement without our written consent, while we may assign it to any affiliate or purchaser without your consent. 9.3 Severability: If any provision is found by a court to be contrary to law, the provision will be modified to best fulfill its objectives, and the remaining provisions will remain in effect. 9.4 Governing Law and Jurisdiction: This agreement is governed by Delaware law, with legal actions brought exclusively in a federal or state court in Delaware. Both parties waive the right to a jury trial. 9.5 Waiver: Neither party waives its rights under this agreement by failing to enforce or having waived a previous breach. 9.6 Subcontractors: We can use subcontractors without notice or consent to fulfill our obligations under this agreement.9.7 Attorney’s Fees: In any action to enforce this agreement, the prevailing party is entitled to attorneys' fees and costs.
Notice: We will provide notices using the Platform or your provided contact information. Keep your contact information updated. Legal notices to us can be sent to jess@riskbased.ai. or jess@recalls.fyi
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PRIVACY POLICY
Effective Date: 2024-04-01, Version 2.0
Read this agreement very carefully
Introduction:
1. Introduction
Welcome to Recalls.fyi ("Website," "Site," or "We"). We respect your privacy and are committed to protecting your personal information, in compliance with the California Consumer Privacy Act (CCPA). This Privacy Policy outlines how we collect, use, disclose, and safeguard your personal data when you visit and interact with our Website.
2. Information We Collect
2.1. Categories of Personal Information: We may collect the following categories of personal information, depending on your interactions with our Website: Personal identifiers (e.g., name, email address, phone number), Online identifiers (e.g., IP address, cookies, device identifiers), Commercial information (e.g., purchase history), Internet or other electronic network activity information (e.g., browsing history), Geolocation data, Inferences drawn from any of the above.
2.2. Sources of Information: We may collect personal information from various sources, including information you provide, automatically collected information, and information from third parties.
2.3. Purpose of Collection: We collect personal information for various purposes, including providing services, improving user experiences, and complying with legal obligations.
3. How We Use Your Information
We use the information we collect for the following purposes:
3.1. Service Delivery: We use your information to provide and maintain the services offered on our Website.
3.2. Personalization: We use your information to personalize your experience, analyze usage patterns, and improve our services.
3.3. Communication: We may use your contact information to send you updates, newsletters, promotional materials, and other communications related to our services.
3.4. Legal Compliance: We collect and use your information to comply with legal obligations and respond to legal requests.
4. Sharing Your Information
We may share your information with:
4.1. Service Providers: We may share your information with third-party service providers who assist us in providing our services and maintaining our Website.
4.2. Legal Requirements: We may disclose your information to comply with legal obligations, respond to legal requests, and protect our rights, privacy, safety, and property.
4.3 Customer Testimonies & Marketing Material: We may declare on our public facing website that your company or entity is currently, has previously, utilized ur services or website as marketing material.
4.3 Confidential & Proprietary Information: All data is derived from Public Domain and, therefore, would not be confidential or proprietary because nobody can ever own Public Domain product. That said, we will not publish confidential communications or text exchanges between Company and Customers.
5. Your Rights Under CCPA
Under the CCPA, California residents have the following rights:
5.1. Right to Know: You have the right to know what personal information we have collected about you over the past 12 months, including the categories of personal information and sources.
5.2. Right to Delete: You have the right to request the deletion of your personal information, subject to legal requirements.
5.3. Right to Opt-Out: You have the right to opt-out of the sale of your personal information, if applicable.
5.4. Non-Discrimination: We will not discriminate against you for exercising your rights under the CCPA.
6. Data Security
We take reasonable measures to protect your personal information from unauthorized access, disclosure, alteration, or destruction. However, no online data transmission or storage is 100% secure.
7. Changes to this Privacy Policy
We may update this Privacy Policy to reflect changes in our practices or for other operational, legal, or regulatory reasons. We encourage you to review this Privacy Policy periodically.
8. Contact Us
If you have questions or concerns about this Privacy Policy or our data practices, please contact us at jess@recalls.fyi.
9. Consent
By using our Website, you consent to the terms of use and terms of this Privacy Policy.
10. Customer Stories: we reserve the right to publish who are customers are as part of the terms of use, but will request prior consent or prior notification as appropriate.