1. The Service

Regulatory Impact provides regulatory intelligence, data aggregation, search, analytics, summaries, visualizations, product profiles, reports, and related research tools.

The Service may include information from public sources, third-party data sources, user-provided information, automated processing, and generated outputs.

The Service supports research, analysis, and workflow efficiency. It does not replace professional judgment, legal advice, medical advice, regulatory advice, statistical review, or independent verification of source materials.

2. Who May Use the Service

You may use the Service only if you:

1. Are at least 18 years old;
2. Can form a binding contract;
3. Are not prohibited from using the Service under applicable law;
4. Will use the Service in compliance with these Terms and all applicable laws; and
5. If using the Service for an organization, have authority to act on that organization's behalf.

We may refuse access, suspend accounts, or terminate use of the Service if we determine that a user does not meet these requirements or presents legal, security, operational, or reputational risk.

3. Account Responsibilities

You are responsible for all activity under your account. You agree to:

1. Provide accurate account, billing, and organization information;
2. Keep login credentials confidential;
3. Use reasonable security measures to protect your account;
4. Promptly notify us of suspected unauthorized access or security incidents;
5. Ensure that your users comply with these Terms;
6. Maintain appropriate internal controls for how your organization uses Service outputs; and
7. Review all outputs, data, and source references before relying on them.

You may not share accounts, sell access, or permit unauthorized users to access the Service unless expressly allowed by your subscription or written agreement with us.

4. Acceptable Use

You may use the Service for lawful business, research, regulatory, commercial, operational, and analytical purposes.

You may not:

1. Use the Service for unlawful, deceptive, fraudulent, harmful, or abusive purposes;
2. Use the Service to make clinical, medical, legal, investment, regulatory, or commercial decisions without appropriate professional review;
3. Misrepresent Service outputs as official determinations by FDA, CMS, EMA, another regulator, or any third party;
4. Upload, submit, or process information that you do not have the right to use;
5. Upload protected health information, patient-level health data, confidential regulatory submissions, trade secrets, or other sensitive information unless we expressly permit it in writing;
6. Attempt to reverse engineer, copy, scrape, crawl, harvest, or bulk export the Service except through permitted features;
7. Bypass rate limits, access controls, authentication measures, or usage restrictions;
8. Interfere with the operation, security, integrity, or availability of the Service;
9. Use the Service to develop, train, benchmark, or improve a competing product without our written permission;
10. Remove copyright, attribution, source, or proprietary notices;
11. Introduce malware, malicious code, or harmful files;
12. Use automated systems to access the Service in a manner that burdens or disrupts our infrastructure;
13. Use the Service in a manner that violates third-party terms, intellectual property rights, privacy rights, or contractual obligations; or
14. Use the Service to generate or distribute false, misleading, defamatory, infringing, or unlawful content.

We may monitor usage for security, abuse prevention, product improvement, compliance, billing, and operational purposes.

5. Subscriptions, Billing, Cancellation, and Refunds

Some features may require a paid subscription. Subscription terms, pricing, seat limits, feature limits, billing cadence, and usage limits will be presented at sign-up, in an order form, on a pricing page, or in another written agreement.

Unless otherwise stated:

1. Subscriptions renew automatically until cancelled;
2. Fees are billed in advance;
3. You authorize us and our payment processors to charge applicable fees, taxes, and charges to your selected payment method;
4. You are responsible for keeping payment information current;
5. Cancellation takes effect at the end of the then-current billing period;
6. We do not provide refunds or credits for partial billing periods, unused seats, unused features, or unused time, except where required by law or expressly stated in a written agreement;
7. We may change pricing or subscription features on notice, with changes applying at the next renewal or as otherwise disclosed; and
8. If payment is overdue, we may suspend or limit access until amounts are paid.

Free, trial, beta, pilot, early-access, enterprise, pilot, custom, or annual arrangements may be modified, limited, discontinued, or governed by separate written terms.

6. Ownership of the Service

Regulatory Impact owns all rights, title, and interest in the Service, including software, workflows, databases, compilations, interfaces, visual designs, trademarks, models, prompts, templates, documentation, analytics methods, and proprietary content.

These Terms do not transfer ownership of the Service to you. We grant you a limited, non-exclusive, non-transferable, revocable right to access and use the Service during your subscription or permitted access period, subject to these Terms.

7. Your Content and Data

“Your Content” means information, files, text, queries, prompts, uploads, notes, saved projects, feedback, configuration settings, and other materials you submit to the Service.

As between you and Regulatory Impact, you retain ownership of Your Content. You grant us a limited license to host, process, transmit, store, display, analyze, and use Your Content as needed to provide, secure, operate, maintain, support, and improve the Service; generate requested outputs; enforce these Terms; comply with law; and perform obligations under your subscription or agreement.

You are responsible for ensuring that Your Content is accurate, lawful, non-infringing, and appropriate for submission.

8. Generated Outputs

The Service may generate summaries, tables, charts, regulatory analyses, product profiles, search results, draft language, recommendations, or other outputs.

Subject to your compliance with these Terms, you may use outputs generated for you through the Service for your internal business purposes and, where permitted by your subscription, for external work product. However:

1. Outputs may be incomplete, inaccurate, outdated, duplicative, or based on imperfect source data;
2. Outputs may require independent verification against primary sources;
3. Outputs are not official regulatory determinations;
4. Outputs are not legal, medical, scientific, statistical, regulatory, investment, or business advice;
5. You are responsible for reviewing outputs before use, publication, submission, or reliance; and
6. Outputs may be similar or identical to outputs provided to other users where similar inputs, public data, or common analytical methods are used.

Regulatory Impact retains ownership of the Service, underlying technology, workflows, methods, datasets, and proprietary materials used to generate outputs.

9. Third-Party Data, Public Sources, and Integrations

The Service may reference, link to, import, process, summarize, or display information from public agencies, third-party websites, APIs, vendors, and data providers.

We do not control third-party sources and do not guarantee that third-party data is complete, current, accurate, available, or fit for your intended use. Third-party sources may change, become unavailable, impose restrictions, or contain errors.

If you connect third-party integrations, you authorize us to access and process information from those integrations as necessary to provide the Service. Your use of third-party integrations may also be governed by third-party terms.

10. Feedback

If you provide suggestions, comments, corrections, ideas, or other feedback, you grant Regulatory Impact a perpetual, irrevocable, worldwide, royalty-free right to use that feedback without restriction or compensation.

We are not required to treat feedback as confidential unless we have signed a separate written agreement stating otherwise.

11. Confidentiality

If we enter into a separate confidentiality agreement, nondisclosure agreement, data processing agreement, enterprise agreement, or order form with you, that agreement will govern the confidential information covered by it.

Absent a separate written agreement, you should not submit highly sensitive, regulated, confidential, proprietary, patient-level, or controlled information to the Service.

12. Availability and Changes

We aim to provide a reliable Service, but we do not guarantee uninterrupted availability. The Service may be modified, suspended, limited, or discontinued at any time for maintenance, security, operational, legal, vendor, or business reasons.

We may add, remove, modify, or limit features, data sources, integrations, usage limits, or outputs. We are not responsible for loss resulting from downtime, data source changes, integration failures, maintenance, or discontinued features.

13. Disclaimers

The Service is provided “as is” and “as available.”

To the maximum extent permitted by law, Regulatory Impact disclaims all warranties, express or implied, including warranties of accuracy, completeness, merchantability, fitness for a particular purpose, title, non-infringement, availability, and reliability.

We do not warrant that:

1. The Service will be uninterrupted, secure, timely, or error-free;
2. Outputs will be accurate, complete, current, or suitable for any particular use;
3. Third-party data will be available, accurate, or complete;
4. Errors will be corrected;
5. The Service will meet your regulatory, legal, clinical, operational, commercial, or business requirements; or
6. Use of the Service will produce any specific business, regulatory, financial, or operational outcome.

You are responsible for validating all information before relying on it.

14. Limitation of Liability

To the maximum extent permitted by law, Regulatory Impact will not be liable for indirect, incidental, consequential, special, exemplary, enhanced, or punitive damages; loss of profits; loss of revenue; loss of business opportunity; loss of goodwill; loss of data; business interruption; regulatory delay; failed submission; adverse agency action; or costs of substitute services.

To the maximum extent permitted by law, our total liability for all claims will not exceed the greater of:

1. The amount you paid to us for the Service in the 12 months before the event giving rise to the claim; or
2. One hundred U.S. dollars.

These limitations apply regardless of the legal theory, even if we have been advised of the possibility of damages.

15. Indemnification

You agree to defend, indemnify, and hold harmless Regulatory Impact from claims, damages, liabilities, losses, costs, and expenses, including reasonable attorneys' fees, arising from or related to:

1. Your use of the Service;
2. Your Content;
3. Your violation of these Terms;
4. Your violation of law or third-party rights;
5. Your reliance on or use of outputs; or
6. Use of the Service by anyone accessing it through your account.

16. Termination

You may stop using the Service at any time. You may cancel a paid subscription through the account interface or by contacting support@regulatoryimpact.com.

We may suspend or terminate your access immediately if:

1. You violate these Terms;
2. Payment is overdue;
3. Your use creates security, legal, operational, or reputational risk;
4. We are required to do so by law;
5. A third-party provider or data source restricts access; or
6. We discontinue the Service or relevant feature.

After termination, your right to use the Service ends. We may retain or delete account information and Your Content in accordance with our Privacy Policy, legal obligations, backup practices, and legitimate business needs.

17. Governing Law and Dispute Process

These Terms are governed by the laws of the State of Georgia, without regard to conflict-of-law rules.

Before filing a claim, each party agrees to attempt to resolve the dispute informally. The party raising the dispute must send written notice describing the dispute and requested resolution to support@regulatoryimpact.com with the subject line “Legal Dispute Notice.”

The parties will have 30 days to attempt informal resolution. If the dispute is not resolved informally, either party may bring an action in the state or federal courts located in Georgia.

18. Changes to These Terms

We may update these Terms from time to time. The updated version will be posted on this page with a new “Last Updated” date.

If changes are material, we may provide additional notice through the Service, by email, or by another reasonable method. Continued use of the Service after updated Terms become effective means you accept the updated Terms.

19. Contact for Legal Questions

For legal questions about these Terms, contact: