Precision Analgesia's clinical validation engine integrates with Epic, Cerner, and Meditech via SMART on FHIR and CDS Hooks — surfacing a specific, actionable, guideline-cited recommendation at the moment of prescribing, which the clinician reviews and can accept or override, with the override logged.
Opioid complications are no longer just clinical errors — they are serious legal and financial risks that demand systemic, workflow-integrated decision support.
Annual Economic Burden
Prescription opioid misuse and overdose cost the U.S. economy $78.5B per year (Florence CS et al., Medical Care, 2016;54(10):901-906 — 2013 national data). A national macro figure, not a single hospital's or event's cost.
Undetected Risk
In the PRODIGY trial, 46% of monitored inpatients on continuous monitoring experienced opioid-induced respiratory depression (OIRD) events (Khanna AK et al., Anesthesia & Analgesia, 2020;131(4):1012-1024 — general-care-floor patients on parenteral opioids). Manual nursing checks miss the vast majority of these events.
Alert Fatigue
An estimated 70-90% of drug safety alerts in EHR systems are overridden by clinicians (van der Sijs et al., JAMIA 2006; Phansalkar et al., JAMIA 2013). Specific, actionable, guideline-cited recommendations at the moment of prescribing — not generic popups — are needed to change behavior.
Opioid-related adverse events increasingly expose hospitals to systemic "failure to monitor" and corporate-negligence liability theories, on top of the $78.5B/year national economic burden of prescription opioid misuse (Florence CS et al., 2016) and the 70-90% EHR alert-override rate documented in the literature. Passive warnings no longer provide safe harbor. The legal standard increasingly favors documented, guideline-cited safeguards at the point of prescribing.
Six validated clinical modules — purpose-built to reduce opioid-related adverse events, close prescribing gaps, and generate auditable compliance documentation.
24-drug database with route-aware, organ-adjusted dosing and cross-tolerance reduction. Validated against CDC 2022 and NCCN 2025 guidelines.
A 10-rule deterministic safety engine plus OIRD risk scoring (PRODIGY), MME threshold logic, CDC naloxone co-prescribing prompts, and pharmacogenomic guidance — covering renal failure, hepatic decompensation, pregnancy, pediatrics, QTc prolongation, and geriatrics. Advisory with documented override: the clinician reviews the recommendation and reasoning, then accepts, adjusts, or overrides it, with every override logged. The sole exception is a non-overridable pediatric gate (blocks codeine/tramadol under age 12, per FDA Black Box warnings).
Non-linear NCCN/APS tiered conversion ratios with QTc monitoring, elderly overrides, and stepwise 3-day transition schedules. Replaces dangerous static conversion tables.
5-phase structured clinical pathway: Screening (DAST-10, ASSIST) → DSM-5 Diagnosis → COWS Assessment → MOUD Induction → Discharge. Generates complete SOAP notes.
14-factor PRODIGY/RIOSORD composite scoring with auto-generated monitoring plans per risk tier. Detects synergistic risks (benzodiazepines + COPD/OSA "Triple Threat").
250+ iOS clinical validation scenarios plus 120+ backend pytest tests. Every recommendation hyperlinked to source guideline — full "Glass Box" transparency for independent clinician review.
Three steps from clinician action to evidence-based recommendation — no additional training, no workflow disruption.
Physician clicks a button in Epic or Cerner. The EMR opens a secure SMART on FHIR session — either embedded in the chart or in a new window.
OAuth 2.0 token exchange authenticates the session. The app queries patient demographics, lab values (eGFR, LFTs, QTc), and current medications via FHIR R4.
App loads instantly with patient context pre-filled. Safety gates auto-execute, OIRD risk is scored, and the clinician receives gated, evidence-based recommendations.
When a clinician selects or signs an opioid order, Epic fires a CDS Hook to our service endpoint. The Precision Analgesia engine evaluates all 10 safety rules in real-time and returns actionable cards — warnings, dose adjustments, and alternative recommendations — that the clinician reviews and can accept, adjust, or override.
For safety gates (renal contraindications, pediatric black box warnings), hospital Epic teams can configure Best Practice Advisories (BPAs) powered by our logic. Every override is logged. The sole non-overridable rule is the pediatric gate, which blocks codeine/tramadol prescribing under age 12 per FDA Black Box warnings.
Age, sex, demographics
Renal, hepatic, pregnancy, COPD, OSA, CHF (ICD-10)
Creatinine/eGFR, LFTs, QTc interval (LOINC)
Active opioids, benzodiazepines, naltrexone (RxNorm)
A unified clinical intelligence platform — not a collection of standalone calculators.
| Capability | Precision Analgesia | General Tools |
|---|---|---|
| Safety Gates | 10-rule engine, auto-applied, advisory with documented override | Manual — clinician must remember |
| Workflow | End-to-end single interface | Fragmented separate apps |
| Risk Scoring | Automatic PRODIGY + monitoring plans | Standalone calculators |
| OUD Pathway | Full 5-phase wizard + SOAP notes | Not available |
| Traceability | "Glass Box" — every rec sourced | Black box outputs |
| Validation | 250+ scenarios + 120+ backend tests | None published |
| HIPAA | Zero data persistence — ephemeral by design | Varies |
From sandbox validation to live clinical deployment — a structured, low-risk rollout designed for enterprise health systems.
Register on Epic's developer portal. Build SMART on FHIR launch flow, implement FHIR R4 queries, validate CDS Hooks service endpoint against synthetic patient data.
Security risk assessment with a prospective partner hospital. A BAA template exists and requires counsel review and execution before any PHI-adjacent pilot. Epic staging environment configuration, clinical workflow review with pharmacy and nurse informaticists. Private SMART app registration — no Connection Hub listing required for pilot.
Planned limited deployment on select medical-surgical floors, targeting real-world clinical validation with physician champions recruited at that time. Data collection and outcome tracking against baseline metrics. No pilot is currently active.
Pilot expansion, Epic Connection Hub listing application, and broader system-wide availability. Continuous outcome tracking for ROI documentation and settlement fund reporting.
Built for Non-Device CDS compliance from the ground up. Self-assessed as Non-Device CDS under the 21st Century Cures Act as revised by FDA's January 6, 2026 CDS guidance, pending confirmatory review by regulatory counsel — designed to minimize device regulatory overhead for your IT department.
No image, waveform, or device-signal processing. All inputs are discretized clinical parameters from structured EHR fields.
Designed exclusively for physicians, NPs, PAs, and clinical pharmacists. Mandatory clinical responsibility acknowledgment on every session.
Full formula, data inputs, and intermediate calculations displayed for every recommendation. Zero black-box outputs — complete derivation shown.
All safety gates are advisory recommendations with documented overrides, by design since June 2026 (the sole exception is the non-overridable pediatric gate). A confirmatory counsel memo is planned before EHR BPA integration and has not yet been obtained.
Self-assessed as Non-Device Clinical Decision Support under the 21st Century Cures Act, pending confirmatory review by regulatory counsel. Our deterministic, fully-traceable engine is designed to meet all four criteria — every safety gate is an advisory with a documented override — with a confirmatory counsel memo planned, but not yet commissioned or obtained, before BPA integration to confirm the classification (and the resulting 510(k) status).
If confirmed, would avoid a SaMD clearance path — not yet a settled or guaranteed outcome
Every recommendation is hyperlinked to its source guideline (CDC 2022, NCCN 2025, AGS Beers Criteria 2023, ASAM 2020). Clinicians can independently verify any recommendation against primary literature in under 30 seconds. The clinician always retains full prescribing autonomy.
One-click to source · All formulas shown inline · Deterministic — not AI/ML
Architectural guarantee: all patient data is ephemeral — processed in-memory only with 30-minute auto-wipe. Zero data persistence to disk. No PHI leaves the EHR environment. The application operates entirely within your institution's security perimeter.
No BAA data warehouse · Zero PHI at rest · No breach surface for your CISO
Generates auditable logs of every recommendation surfaced and every clinical override. Builds a defensible record demonstrating systemic safety infrastructure — directly addressing "failure to monitor" and "corporate negligence" legal theories, against a backdrop of a $78.5B/year national economic burden from prescription opioid misuse (Florence CS et al., 2016) and documented 70-90% EHR alert-override rates (van der Sijs et al., JAMIA 2006; Phansalkar et al., JAMIA 2013).
Every override documented · Every gate logged · Complete audit trail
The founder is an addiction medicine fellow at Yale (fellowship began July 2026) — directly aligned with the platform's core clinical domain: OUD consultation, MOUD induction, COWS scoring, and buprenorphine protocols. This training pathway is intended to provide the clinical depth to advance from shadow-mode evaluation to a quality-improvement pilot expected/anticipated to qualify for IRB-exempt status, subject to Yale's own IRB determination, generating real-world safety metrics intended to support future hospital contract discussions.
Stage 2 — Active
Clinical Review
Stage 3 — Planned
Regulatory Counsel
Stage 4 — Planned
QI Pilot (Pending IRB Review)
Precision Analgesia may qualify as a potentially eligible, discretionary remediation-spend category under a hospital's Exhibit E settlement allocation. Funding is subject to that hospital's own settlement administrator and state-specific allowable-use rules — this is not a designated or guaranteed funding source.
Inquire About FundingWhether you're a CMIO evaluating clinical tools, a CFO exploring settlement-funded technology, or a physician champion seeking safer prescribing workflows — we're ready to discuss integration at your institution.
Direct Contact
dan@lifelinemedtech.org