Provider Guide › Clinical Boundaries

Clinical Boundaries

PancreaTrack is a patient-reported outcomes platform, not a medical device. Understanding what the system can and cannot do is essential for safe clinical use.

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PancreaTrack is not an FDA-cleared medical device

Data on this platform should be used to supplement — never replace — clinical assessment, physical examination, laboratory testing, and imaging. All clinical decisions remain the sole responsibility of the treating provider.

What PancreaTrack Is

  • A structured patient-reported outcomes (PRO) collection platform
  • A tool for visualizing longitudinal trends in self-reported symptoms
  • A communication bridge between patients and their care team
  • A supplement to — not a replacement for — the clinical encounter

What PancreaTrack Is Not

  • A diagnostic tool
  • A treatment recommendation engine
  • An EHR or medical record system
  • A real-time clinical monitoring system
  • A HIPAA Business Associate (currently — see HIPAA Roadmap)
  • An emergency alert system

AI Content Limitations

The AI-generated summaries and insights in PancreaTrack are produced by Claude (Anthropic's AI model) using the patient's logged data as context. These summaries:

  • Reflect only what the patient has chosen to log — incomplete logging produces incomplete summaries
  • Do not incorporate EHR data, imaging, pathology, or physician notes from other systems
  • Are generated by a general-purpose language model, not a specialized medical AI
  • May contain errors, omissions, or plausible-sounding but incorrect clinical statements
  • Should be read as a structured recap, not a clinical opinion
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Verify abnormal flags independently

If the AI brief or lab tab flags an abnormal value or pattern, confirm it against the patient's raw logged data and your own clinical assessment. Do not act on an AI-generated flag alone.

Data Accuracy

All data on the platform is patient self-reported. Patients may:

  • Estimate food portions or fat content inaccurately
  • Log pain scores retrospectively (less reliable than real-time)
  • Misidentify Bristol stool types
  • Transcribe lab values incorrectly from paper reports

Treat logged data as a directional signal, not a precise clinical measurement.

Liability

PancreaTrack provides tools for clinical communication. Clinical decisions, diagnoses, and treatment plans are the responsibility of the licensed provider. PancreaTrack, LLC assumes no liability for clinical outcomes based on data interpreted from this platform.