Clinical Services Layer (The Clinic)

This document defines the Clinical Services Layer, which enables optional physician involvement in the Regain Health. When enabled, the app can function as a medical provider, diagnostic authority, and medication management tool—with a licensed physician in the loop.

Detailed Physician Integration Architecture: See 10-Clinical-Expanded-Mode.md for the "Collaborative Intelligence" model.

1) Purpose

The Clinical Services Layer extends the core system to support telemedicine, clinical decision support, and prescription management. It transforms the app from a wellness-only product into a hybrid platform where licensed physicians can deliver care using the full context of the user's Health State.

Key references:

Operating modes: 01-Vision-and-First-Principles.md § 3
Core architecture: 02-Core-Product-System.md
Compliance: 05-Compliance-Safety-Privacy.md

2) Architecture Overview

The core system has four layers:

The Spine (Health State)
The Brain (Assessment Engine)
The Muscle (Protocol Engine)
The Shield (Safety/Escalation)

The Clinical Services Layer adds a fifth: The Clinic.

3) Operating Modes

3.1 Standalone Mode (Default)

No physician involvement
Wellness product positioning
Lifestyle recommendations only
Not a medical provider, diagnostic authority, or medication manager
Escalates to external healthcare when red flags appear

3.2 Expanded Mode (Opt-in)

Licensed physician in the loop
Can function as medical provider
Can render diagnoses (physician validates using CDS)
Can manage medications (physician prescribes; app tracks)
Regulatory and liability posture shifts to clinical entity

Users can transition between modes based on their needs and subscription tier.

4) Provider Network #providers

4.1 Partner Network

On-demand access via telemedicine API partners (e.g., Wheel, Truepill, Akido).

4.2 BYOD Network (Bring Your Own Doctor)

User invites their existing physician to join the platform.

4.3 Provider Licensing Requirements

Partner Network: Partner API is responsible for ensuring physicians are licensed in the patient's state.
BYOD Network: System verifies the physician holds an active license in the state where the patient is located at time of service.

5) Clinical Decision Support (CDS) #cds

The CDS surfaces existing system intelligence to physicians, enabling informed decision-making.

5.1 CDS Components

5.2 CDS Principle

CDS is decision support, not decision making. The physician always makes the final clinical decision. This framing is critical for FDA regulatory posture (avoiding Software as a Medical Device classification for autonomous decision-making).

5.3 CDS Integration Points

Async visits: Health State summary + Assessment auto-attached to messages
Sync visits: Live CDS panel displayed alongside video call
Post-visit: CDS informs prescription decisions and follow-up recommendations

6) Visit Management #visits

6.1 Async Visits

6.2 Sync Visits

6.3 Visit Documentation

All visits generate structured documentation:

Chief complaint and HPI
Relevant Health State data reviewed
Assessment and plan
Prescriptions issued (if any)
Follow-up recommendations

Documentation is stored as part of the user's Health State and accessible for future visits.

7) Prescription Management #prescriptions

7.1 Jurisdiction-Aware Routing

The system maintains a database of state/country regulations and routes prescriptions accordingly:

7.2 Routing Logic

Before routing a prescription, the Jurisdiction Router checks:

Prescriber license status and state
Patient location at time of service
Drug schedule (controlled vs non-controlled)
Telehealth prescribing rules for the jurisdiction
Ryan Haight Act compliance (in-person exam requirements)

7.3 Prescription Tracking

Once prescribed, medications become part of the Health State:

Adherence tracking: User logs doses; correlate with outcomes
Refill management: Surface refill needs and expiration
Outcome correlation: Feed prescription data back into CDS for future visits

8) Regulatory Considerations #compliance

8.1 HIPAA

When Expanded mode is active, the platform operates as a covered entity or business associate depending on structure:

All partners must sign Business Associate Agreements (BAAs)
PHI handling follows HIPAA Security Rule requirements
Audit logging for all access to clinical data

8.2 State Medical Licensing

Partner Network: Partner API handles multi-state licensing
BYOD Network: System verifies physician license in patient's state
Visit cannot proceed if licensing requirements are not met

8.3 FDA Software as a Medical Device (SaMD)

The CDS is framed as decision support:

Presents information for physician review
Does not make autonomous clinical decisions
Physician always renders final judgment

This positions the system outside FDA's enforcement focus for clinical decision support (per FDA guidance on CDS).

8.4 DEA and Controlled Substances

For controlled substance prescriptions:

Route through partner with DEA registration
EPCS (Electronic Prescribing for Controlled Substances) compliance
Identity proofing requirements for prescribers

8.5 Ryan Haight Act

For controlled substances prescribed via telemedicine:

Ensure in-person exam requirements are met (either via partner protocol or initial visit requirement)
Document compliance in visit record

9) Safety Integration

The Clinical Services Layer integrates with the existing safety system (The Shield):

9.1 Red Flag Escalation

If the system detects red-flag symptoms during a clinical visit:

Immediately surface to the physician
If no physician available, escalate to 911 guidance
Never gate safety-critical information behind paywall or appointment availability

9.2 Medication Safety

Drug interaction checking against current medications in Health State
Allergy/contraindication alerts surfaced to prescriber
Dosing guidance (non-binding) from evidence sources

9.3 Audit Trail

All clinical interactions are logged:

Who accessed what data, when
Clinical decisions made and rationale
Prescriptions issued and routing
User available for compliance review and quality assurance

10) North Star

When a physician joins the loop, they should feel like they have a world-class support team: the Health State gives them complete context, the Assessment Engine gives them hypotheses to validate or refute, and the Protocol Engine shows what's already been tried. They make better decisions faster, and the user gets elite-clinic care without the elite-clinic price.