Last updated: 09/05/2025

Intended Use as Clinical Decision Support

HealthLeap Nutrition is clinical decision support software intended to assist registered dietitians in the hospital setting by surfacing adult inpatients (≥18 years) who may be at nutritional risk. The software analyzes EHR information and presents contributing factors and supporting evidence to help clinicians prioritize assessments. It is not a diagnostic tool and does not provide treatment recommendations. It must not be used as the sole basis to determine nutritional risk or the presence or risk of malnutrition, but should be used in conjunction with clinical assessments, physical assessments, laboratory findings, among others, to aid in nutritional risk assessment.

Scope limitations: Not for pediatric, outpatient, or emergency decision-making. Use only by registered dietitians with access to the patient’s medical record.

Important Safety Information

Results reflect the data available in the health record and may be incomplete, delayed, or inaccurate; clinicians should verify underlying data in the EHR before acting.

Signals are advisory and do not replace professional judgment.

Do not use for time-critical/emergent decision-making.

Local clinical policies and guidelines prevail. Follow your institution’s procedures for escalation and documentation.

Data Sources, Transparency & Clinical Review

The product displays contributing factors and supporting evidence to enable clinicians to independently review the basis for any risk signal.

Sites should ensure appropriate data quality, interfaces, and refresh cadences. Configuration and data differences can affect outputs.

Performance & Generalization

Performance statements on this website reflect specific studies, data vintages, configurations, and populations; results will vary across institutions and over time. Your institution should evaluate the tool in your local environment before relying on it for workflows.

Regulatory Status (U.S.)

HealthLeap Nutrition is designed to align with FDA’s Non-Device CDS framework under FD&C Act §520(o)(1)(E), including transparency that enables a clinician to independently review the basis for outputs. Regulatory expectations may evolve; refer to FDA guidance for context.

Reporting & Feedback

To report product issues, potential safety concerns, or suggestions, contact team@healthleap.ai.