Important Notice — Read Before Use
The VITALS Prompt Engine ("the Engine") is a prompt-generation tool. It is not a medical device, not clinical decision support, and not a substitute for clinician judgment. The Engine produces template language intended to assist licensed clinical and administrative staff in drafting documentation. It does not provide medical advice, diagnosis, treatment recommendations, or medication recommendations.
Beta status and scope
- Friends-and-family beta. Not intended for production patient care.
- Not reviewed or cleared by the U.S. Food and Drug Administration. Not a Software-as-a-Medical-Device (SaMD) under FDA classification rules.
- No HIPAA Business Associate Agreement is in place for v1. Do not enter Protected Health Information (PHI).
- Educational and administrative writing assistance only. Scope is intentionally limited to documentation drafting.
Required practice before any output is used
- Human clinical review is required before any output is shared with patients, submitted to payers, filed in medical records, or used in patient care.
- Clinicians retain full professional responsibility for clinical decisions and the accuracy of any final artifact.
- Cross-check medication-adjacent content against DailyMed and Drugs@FDA before use.
- Verify every citation by opening the cited source before relying on it. AI-generated citations can be wrong.
No warranty
The Engine is provided "as is" without warranty of any kind, express or implied. SynthesisArc disclaims all warranties of merchantability, fitness for a particular purpose, accuracy, and non-infringement. Use is at the user's own professional discretion and risk. SynthesisArc assumes no liability for clinical, regulatory, financial, or reputational outcomes arising from use of any Engine output.
Jurisdiction and audit
- Operated from the United States. Use outside the U.S. requires separate evaluation against local regulatory frameworks (EU MDR, UK MHRA, Health Canada, applicable provincial or national regimes). Not pre-validated for non-U.S. use.
- Inputs and outputs are logged with a cryptographic hash, timestamp, and session metadata for audit and quality-review purposes. Logs are retained per SynthesisArc internal policy.
- Do not submit complaints, adverse events, or PHI through the Engine. Use your established SynthesisArc channel for those.
By generating, saving, or sharing any output from the Engine, the user acknowledges and accepts the terms of this notice. Last revised: 2026-05-13. Maintained by SynthesisArc.