Methodology and governance
Last updated June 4, 2026
This page documents how The Gastroenterologist is built, how its content is sourced and kept current, and the basis on which we believe it fits the non-device clinical decision support category. It is written to help an institution's compliance, clinical, and information-security reviewers evaluate the tool. It is not legal or regulatory advice, and the final determination rests with the reviewing institution.
What the tool is
The Gastroenterologist is a software reference for qualified clinicians. It brings society guidelines, validated risk scores, screening and eradication pathways, sourced landmark trials, and a citation-based assistant into one place. Every recommendation, score, and number is tied to a named published source that the clinician can open and read.
Regulatory positioning, non-device clinical decision support
We believe the tool meets the four criteria for software that is not a medical device under section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act, added by the 21st Century Cures Act and interpreted in the FDA guidance on Clinical Decision Support Software.
- It does not acquire, process, or analyze a medical image, a signal from an in-vitro diagnostic device, or a pattern or signal from a signal-acquisition system.
- It displays and analyzes published medical information, namely society guidelines and peer-reviewed studies, together with patient-independent clinical inputs that the clinician enters.
- It supports or provides recommendations to a healthcare professional about prevention, diagnosis, or treatment of a disease or condition.
- It is designed so the healthcare professional can independently review the basis for any recommendation rather than rely primarily on it. Every score, regimen, and statement shows the guideline or trial it comes from, with page-level citations and links to the original, so the clinician can read the source and reach an independent conclusion.
Two design choices support the fourth criterion in particular. First, the tool is intended for professional users, not patients, and not for time-critical or emergency decisions where there would be no opportunity to consult the source. Second, the assistant answers only from indexed guideline text and presents the verbatim supporting quotes and page numbers alongside every answer, so the clinician sees the basis, not a black box.
The most sensitive areas
The calculators and any dosing or regimen content are the most sensitive parts, because they come closest to a specific recommendation. We reduce that risk in four ways.
- The calculators implement only published, validated instruments, used as their authors defined them.
- Each result is labeled with the guideline behind it and, where the source states one, the recommendation strength or evidence quality.
- Every threshold, dose, and interval shows its source.
- A persistent notice reminds the clinician that results are summaries to be verified against current prescribing information and local protocols, and that doses and regimens are the guideline's statements rather than individualized orders for a named patient.
How content is sourced and verified
- Guidelines. Recommendation documents are taken from their issuing bodies (AGA, ACG, ASGE, BSG, the US Multi-Society Task Force on Colorectal Cancer, the US Preventive Services Task Force, and the World Gastroenterology Organisation) and indexed with page numbers so every answer can cite a page.
- The assistant. It retrieves relevant indexed passages and answers only from them, presenting verbatim quotes with the page number. When the indexed text does not cover a question, it says so rather than guessing. A traceability check confirms that quoted text appears in the cited source at the cited page.
- Landmark trials. Each trial in the evidence browser is verified against its PubMed record by title, its DOI is confirmed to resolve, and its ClinicalTrials.gov registration is confirmed where one exists. The primary result, the effect estimate, and the quoted finding are copied from the published abstract.
- Journal summaries. Article metadata comes from PubMed. The structured summaries are condensed from the source abstract and are labeled as summaries to verify against the original.
Guideline basis and content currency
Each tool is tied to a specific society guideline. The table records the guideline basis for each tool. When a society publishes a new version, we update the underlying content and the date on this page.
| Tool | Primary guideline basis |
|---|---|
| Upper GI bleeding risk (Glasgow-Blatchford, AIMS65, pre-endoscopy Rockall) | ACG 2021 upper gastrointestinal and ulcer bleeding, with each score as originally derived |
| Acute pancreatitis severity (BISAP) | ACG and AGA acute pancreatitis guidance, BISAP as originally derived |
| C. difficile severity and regimen | ACG 2021 Clostridioides difficile infection |
| IBD activity (Harvey-Bradshaw, partial Mayo) | AGA and ACG inflammatory bowel disease guidelines, indices as originally derived |
| IBS (Rome IV) | Rome IV criteria and ACG irritable bowel syndrome guidance |
| GERD assessment (GerdQ and alarm features) | ACG 2022 gastroesophageal reflux disease |
| Celiac serology interpreter | ACG celiac disease guidance |
| Colorectal cancer screening | US Multi-Society Task Force and USPSTF 2021, with the USMSTF surveillance intervals |
| H. pylori eradication | ACG 2024 Helicobacter pylori treatment |
| IBD therapy reference | AGA and ACG ulcerative colitis and Crohn's disease guidelines |
| Advanced endoscopy (choledocholithiasis, post-ERCP pancreatitis, peri-endoscopic antithrombotics, resection strategy, bowel preparation) | ASGE guidance and the relevant endoscopic classifications, as published |
Refresh process
- We monitor the issuing societies for new or revised guidance.
- When a society publishes a new version, we replace the indexed source, rebuild the index, and re-run the verification checks.
- We then update the guideline basis and the date recorded here.
- The journals feed refreshes on a schedule, and each landmark trial is verified at the time it is added.
Privacy and security
The calculators run entirely in the browser. The assistant sends only the typed question to a third-party artificial intelligence provider and keeps nothing afterward. There are no accounts, advertising cookies, or behavioral trackers. The site is served over HTTPS with a strict content security policy and standard security headers. Full detail is in the Privacy page and the Terms of use.
Reporting an issue
If you find content that looks wrong or out of date, please tell us through the contact form. Corrections to clinical content are prioritized.