Last updated: 10/28/2025

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. The software uses only existing data from the hospital’s EHR and evidence-based risk factors. It does not acquire or process medical images, waveforms, or signals from medical devices. The software provides information to support, but not direct, clinical decision-making.

Scope limitations: Not for pediatric, outpatient, or emergency decision-making. Use only by registered dietitians with access to the patient’s medical record. HealthLeap Nutrition is not an FDA-cleared or approved medical device and should not be represented as such.

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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. Clinicians remain solely responsible for all clinical decisions and patient care.

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. HealthLeap Nutrition identifies risk signals using structured patient data (e.g., lab results, demographics, diagnoses, and nutrition documentation) and evidence-based risk criteria derived from clinical literature and clinical guidelines. Each signal includes a display of the data elements and rule logic supporting the output, enabling the clinician to independently review and validate the basis for the recommendation. Sites are responsible for maintaining appropriate data security, system configuration, and user access controls to ensure reliable software performance.

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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. Performance metrics are illustrative and context-specific; results should not be interpreted as validated across all populations.

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. HealthLeap Nutrition is designed to meet the exclusion criteria for Non-Device Clinical Decision Support under Section 520(o)1)(E) of the FD&C Act. It uses only existing patient data from the EHR to surface adult inpatients who may be at nutritional risk. It does not acquire or process medical images or signals. The tool supports but does not direct clinical decision making. Each output includes underlying data elements and logic summaries to allow clinicians to independently review the basis for the recommendation. HealthLeap Nutrition is not an FDA-cleared or approved medical device and clinicans remain solely responsible for patient care decisions.

Reporting & Feedback

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