Diabetes
CGM streams, insulin adherence, and longitudinal glucose variability tracking.
We build RPM platforms that connect wearables, medical devices, and sensors to clinical workflows — device integration, FHIR write-back, hybrid alerting, and CPT 99453–99458 documentation, with the SaMD regulatory path scoped from day one.
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Remote patient monitoring lets providers observe vitals and behavior between visits using wearables, medical devices, and patient-reported inputs — extending clinical oversight into chronic, post-acute, and elderly care. Done well, it turns raw device streams into prioritized clinical action and CPT-eligible revenue.
Off-the-shelf RPM tools tend to flood clinicians with undifferentiated alerts, lock you to one device vendor, and leave billing and EHR write-back as an exercise for the buyer. We build the full stack — device integration, FHIR write-back, hybrid alerting, and CPT 99453–99458 documentation — with the SaMD regulatory path scoped up front.
What it is
Remote patient monitoring lets providers observe patient vitals and behaviour between in-person visits using wearables, medical devices, and patient-reported inputs. Done well, it extends clinical eyes into chronic care, post-acute care, and elderly care.
Done poorly, it floods clinicians with noise. We focus on signal: intelligent alerting, FHIR-native EHR write-back, and clinical documentation that actually supports CPT billing codes 99453–99458.
A layered RPM architecture that separates device ingestion, the alerting and analytics engine, and the FHIR write-back and billing layer — so each scales independently as your device mix and patient volume grow.

Every capability pairs a clinical outcome with the device standard, code, or control that makes it real in production.
BLE, cellular, and API integrations across consumer wearables (Apple Watch, Fitbit, Dexcom) and FDA-cleared medical devices, normalized into a single FHIR-native ingestion layer instead of one-off per-vendor adapters.
FHIR R4 Observations, DeviceUseStatements, and DiagnosticReports written back to the EHR of record, so RPM data lands in the clinician's existing chart rather than a separate portal.
Documentation and time-tracking built for CPT 99453 (device setup), 99454 (device supply), 99457 (first 20 minutes of clinical time), and 99458 (each additional 20 minutes) — the billing workflow lives inside the clinician console.
Hybrid alert logic — hard clinical thresholds plus ML anomaly detection tuned to each patient's baseline — with clinician-tunable sensitivity and alert triage to prevent fatigue.
Multi-patient clinician view with risk scoring and drill-down, plus patient-facing apps for vitals logging, medication adherence, and contextual reminders.
For analytics that drive clinical decisions, we classify the software early against the IMDRF / FDA Software as a Medical Device (SaMD) framework and engineer to the correct regulatory path from the start.
Clinical categories
CGM streams, insulin adherence, and longitudinal glucose variability tracking.
BP, arrhythmia detection, and post-MI monitoring with cardiology integration.
SpO₂, spirometry, and exacerbation risk modelling.
Fall detection, activity levels, and medication adherence for at-home seniors.
Post-discharge vitals tracking to prevent readmission in the 30-day window.
Prenatal and postpartum monitoring with blood pressure, weight, and symptom tracking.
Device coverage
We work across consumer wearables and FDA-cleared medical devices — picking per build based on clinical category, reimbursement posture, and patient population.
Turning raw device data into prioritised clinical action is the entire job. Our RPM stack is tuned for signal over noise.
Health Insurance Portability and Accountability Act
Protect PHI with privacy-first architecture, encrypted storage and transmission, strict access controls, and traceable audit logs.
General Data Protection Regulation
Implement lawful consent flows, data minimization, retention controls, and secure processing for sensitive health data.
Fast Healthcare Interoperability Resources
Enable standardized health data exchange across apps, care teams, and systems through robust FHIR-ready APIs.
Health Level Seven International
Support enterprise-grade interoperability with HL7-based integrations for records, events, and clinical messaging workflows.
Health Information Trust Alliance
Align security programs to healthcare-specific control and risk management practices trusted by providers and ecosystem partners.
Health Information Technology for Economic and Clinical Health Act
Design with breach notification readiness, digital record safeguards, and operational controls that support regulated care programs.
FDA Software as a Medical Device
Plan software quality, traceability, and documentation pathways for products that may require SaMD review and submission.
Medical Device Regulation (European Union)
Prepare EU market-ready processes for risk classification, evidence tracking, and lifecycle governance under MDR expectations.
Substance Abuse and Mental Health Services Administration
Apply confidentiality controls and consent-aware sharing models for behavioral and mental health data experiences.
Standards we build against
A phased delivery that runs device integration, clinical workflow, and CPT billing as parallel tracks — so the platform reaches production on a predictable timeline.
We map who reviews alerts and when, choose the device mix per population (reimbursement and adherence drive the choice), and design the ingestion and access model before any code is written.
Hybrid rules-plus-ML alerting tuned with clinical leadership, the multi-patient dashboard, and the patient-facing logging app — built on a HIPAA-ready core with audit logging.
FHIR R4 Observation and DeviceUseStatement write-back and the CPT 99453–99458 documentation flow, validated against synthetic and partner-assisted test data.
Phased rollout with alert calibration over the first 4–6 weeks, monitoring, and support as your device families and patient cohort grow.
Alert logic decision
Choosing the right alert logic is critical — too strict and clinicians miss real events, too loose and they get alert fatigue.
| Dimension | Rules-based thresholds | ML anomaly detection |
|---|---|---|
| How it works | Fires when a vital crosses a predefined threshold | Learns each patient's baseline and fires on deviation |
| Setup time | Fast — clinician-configured thresholds | Requires training window per patient (1–2 weeks) |
| Explainability | Fully explainable to clinician | Requires attribution and confidence surfacing |
| Noise profile | High noise for heterogeneous populations | Lower noise when properly calibrated |
| Best for | Acute thresholds, hard clinical limits | Chronic management, longitudinal baselines |
| Our default | Hybrid — hard thresholds PLUS ML anomaly as a second signal | Not either/or; they work together |
Most production RPM platforms should use hybrid alert logic — hard thresholds for acute safety, ML anomaly for longitudinal drift.
Related proof of compliant delivery: for Lera Health we built a privacy-first data layer and testing-to-insights workflow end to end. It is not an RPM product, but it demonstrates how we structure device and biomarker data, PHI, and consent the same way a compliant monitoring build demands.

From chronic-care clinics to at-home and post-acute programs — we bring the device fluency and billing discipline to make RPM clinically useful and financially sustainable.
HIPAA controls, SaMD classification, and CPT-ready documentation designed into the architecture from sprint one — never bolted on before launch.
We integrate across cardiac, CGM, respiratory, and adherence devices, so your team won't spend the engagement teaching us how each data stream behaves.
Milestone-driven delivery — a working device-to-dashboard flow in weeks, with billing and EHR write-back following on a predictable schedule.
Design, engineering, QA, and compliance under one point of accountability — a team fluent in FHIR, device integration, and RPM reimbursement.
Device-to-clinic RPM, delivered to production
Tell us your clinical category, device strategy, and EHR of record. We'll return a scoped delivery plan with alert logic options.
contact@agnotic.com
Partnerships
contact@agnotic.com