Open Altio Data Licence

The terms on which you may use, share and adapt the FAERS data in Open Altio.

This licence is between you and Altio AI Platform LLC ("Altio"), the licensor. It sets the terms on which you may use the data in Open Altio. It follows the Creative Commons Attribution 4.0 International License (CC BY 4.0) closely, with three added conditions in sections 4, 5 and 6.

You accept this licence for yourself when you apply for access. Nobody accepts it for you, and you cannot accept it for anyone else. Your access is yours alone: do not let anyone else sign in as you.

1. What this licence covers

The "Data" means the FAERS data Altio prepares and serves through Open Altio: the releases, downloads, filtered exports, query results and the documentation that describes them. The underlying FAERS reports are published by the US Food and Drug Administration (FDA). This licence covers Altio's preparation of them, including deduplication and every field we derive (derived names end in _T). It does not cover the software that builds the Data.

You do not need a MedDRA or WHODrug licence to use Open Altio. The Data names reactions by MedDRA's preferred terms, as the FDA publishes them in FAERS.

MedDRA's codes, its hierarchy above the preferred term and its SMQs are MedDRA's own and are not part of the Data. Open Altio shows them to you only while your organisation's MedDRA subscription is current, as MSSO confirms when we check it, and you may use them only as that subscription allows. This licence does not cover them, so sections 2 and 3 do not let you share them. What WHODrug's licence controls, such as WHO's drug classes, is not part of the Data and is not shown to you, and this licence does not cover it either.

2. What you may do

Provided you follow the conditions below, you may, for any purpose, including commercial use:

• copy and redistribute the Data in any medium or format;
• adapt, transform and build upon the Data, and share what you make.

3. Attribution

When you share the Data, or anything made from it, you must:

• credit "Open Altio" and name the release you used (the FDA quarter, for example 2026Q2);
• link to or name this licence, with its version number;
• say whether you changed the Data, and what you changed;
• say so when what you share is a filtered or partial extract, and never present it as the complete Data.

You must not suggest that Altio or the FDA endorses you or your use. A suitable credit is: "Source: Open Altio, release 2026Q2, licensed under the Open Altio Data Licence, version 4."

4. FAERS reports do not establish causality

FAERS data have limits that you must respect and pass on. There is no certainty that a reported event (an adverse event or a medication error) was actually caused by the product. The FDA does not require proof of a causal relationship between a product and an event before a report is accepted, and reports do not always contain enough detail to evaluate an event properly. The FDA does not receive a report for every adverse event or medication error that occurs with a product; many factors influence whether an event is reported, such as how long the product has been marketed and publicity about the event. FAERS data therefore cannot be used to calculate how often an adverse event or medication error happens in the population.

Altio's deduplication and derived fields are our own work. The FDA has not reviewed or endorsed Open Altio. When you publish results based on the Data, you must include this disclaimer or a statement with the same meaning. The Data is not a basis for decisions about the care of an individual patient.

5. No re-identification

You must not identify, or try to identify, any patient, reporter, healthcare professional or other person described in or behind a report, whether from the Data alone or by linking it with other information. You must not try to contact any such person. If you come across someone's identity by accident, do not record, use or share it, and tell us at contact@altioai.com.

6. Usage is logged

Your use of the Data is recorded. We log each sign-in, each filtered export together with the filters used, each full release download, and the text of every SQL query you run, with the time. We keep these records for 12 months. The privacy notice explains what we keep and why, and how you can delete your account.

7. No warranty

The Data is provided "as is" and "as available", without warranties of any kind, including accuracy, completeness and fitness for a particular purpose. To the fullest extent permitted by law, Altio is not liable for any loss or damage arising from use of the Data.

8. When your rights end

Your rights under this licence end automatically if you break its conditions. They are restored if you put the breach right within 30 days of discovering it, unless we tell you otherwise. We may end your access while a breach is investigated, and we email you the reason. Sections 4, 5 and 7 continue to apply to Data you already hold.

9. Versions of this licence

Each version of this licence has a number and a date. We record which version you accepted and when. If we publish a new version, Data you obtained under an earlier version stays under that version, and Data you obtain after accepting the new version falls under the new one.

10. Governing law

This licence is governed by the law of the State of New Jersey, USA.

11. Contact

Questions about this licence go to Altio at contact@altioai.com.