Methodology and governance

For institutional compliance review

What Adiposphere is

Adiposphere is an educational clinical decision-support reference for the assessment and management of overweight and obesity. It brings the major society guidelines, validated risk and staging tools, anti-obesity medication and surgery references, the sourced trial record, and a cited assistant into one place. It is intended for licensed health care professionals. It is not intended for patients to self diagnose or self treat, and it is not intended for time-critical or emergency decisions.

Regulatory positioning, non-device clinical decision support

Adiposphere is intended to function as non-device Clinical Decision Support software under section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act, as amended by the 21st Century Cures Act, and consistent with the FDA Clinical Decision Support Software guidance of September 2022. That exclusion applies when all four of the following hold, and Adiposphere is designed so that each one does.

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. Adiposphere processes only typed inputs and published medical information.
It is intended to display, analyze, or print medical information, here the published society guidelines and the trial literature.
It is intended to support or provide recommendations to a health care professional about prevention, diagnosis, or treatment, not to a patient or caregiver.
It is intended to let the health care professional independently review the basis for any recommendation, so they do not rely primarily on the software. Every calculator names the instrument it implements, and every assistant answer shows the verbatim source text and page behind each point, so the clinician can check the basis and reach their own judgment.

Not a medical device. Adiposphere is not a medical device, is not FDA cleared or approved, and is provided for educational decision support. It must not be the sole basis for any clinical decision. This page states the intended positioning and is not legal or regulatory advice. Confirm the classification with your own regulatory and compliance office before deployment.

The sensitive parts, calculators and dosing

The calculators implement published, validated instruments such as the CDC extended BMI method, Mifflin-St Jeor energy estimates, the Edmonton Obesity Staging System, and the ASMBS and IFSO surgery thresholds. Drug references reflect FDA prescribing information and guideline dosing. Each is shown transparently with its source so the clinician can review and confirm it. Outputs are estimates. Always verify dosing, eligibility, and intervals against current prescribing information and local protocols.

Clinical governance and content currency

Each tool names the guideline basis it implements and carries a review note. Content is checked against the cited source guidelines, and when a society issues an update the affected tool is re-reviewed and re-dated. Institutional faculty review and sign-off is recommended before clinical use, and an institution may record its own reviewer and date against each tool. To flag an item that looks out of date or incorrect, use the contact form.

Limitations

Educational decision support, not individualized medical advice for a named patient.
Not for time-critical or emergency use.
The assistant answers only from the indexed guidelines and says so plainly when the evidence is insufficient.
Questions outside obesity medicine, such as luminal gastroenterology or hepatology, are redirected to the relevant sister reference rather than answered here.