Clinical Imaging Portal Requirements
Purpose
Develop a controlled imaging portal for AI-driven facial analysis in medspa clinical environments. The system captures standardized client facial photographs and calibrated 3D/depth data to support practitioner-reviewed assessment of skin tone, texture, congestion, pigmentation, and longitudinal facial volume/depth change against 2026 global cosmetic-clinic workflows.
Intended Use and Regulatory Positioning
- Intended use: acquire repeatable facial imaging data in a controlled clinic environment and generate practitioner-reviewed decision-support outputs for aesthetic assessment and longitudinal monitoring.
- The system must not present autonomous diagnosis, treatment selection, or therapeutic claims unless separately validated and cleared in the deployment jurisdiction.
- For TGA-oriented review, claims, labeling, risk management, clinical evaluation, cybersecurity, software lifecycle, and post-market monitoring must be maintained as controlled records.
- AI outputs must be labeled as clinical decision support with practitioner sign-off, confidence/quality flags, limitations, contraindications, and version identifiers.
- Any volume/depth measurement claim must be supported by a locked calibration workflow, verification data, defined accuracy limits, and clinical validation across representative users and skin tones.
Form Factor
- Fixed-position tabletop or wall-mounted facial imaging portal.
- Repeatable client face position using chin/forehead guide or equivalent rigid patient-positioning fixture.
- High-resolution camera system centered on the face with controlled working distance and focus.
- Calibrated stereo/depth imaging geometry with fixed camera baseline, rigid mount, known intrinsics/extrinsics, and field-serviceable calibration checks.
- Multi-zone illumination ring around the camera with diffuse white illumination and optional polarized capture workflow.
- Secure operator interface through embedded compute UI or locked-down clinical workstation.
Hardware Requirements
- Embedded compute module with camera input, local storage, networking, and secure boot capability.
- Primary high-resolution MIPI CSI camera module via FFC connector; target module: Sony IMX477/IMX519-class camera for production.
- Second synchronized MIPI CSI camera connector for calibrated stereo depth capture, wired to the CM4 CAM0 interface.
- Controlled illumination driver with per-zone PWM/current control.
- White LEDs selected for stable color temperature and high CRI; production design must use calibrated LEDs and optical diffuser.
- Secure element for device identity, key storage, signed updates, and encrypted session workflows.
- USB-C service/power input and network connectivity for clinic IT integration.
- Production enclosure must mechanically lock camera baseline, client distance, illumination geometry, and color reference target position.
Controlled Repeat Imaging Protocol
- Verify client consent, operator authentication, device identity, calibration status, and software/model version before capture.
- Enforce fixed geometry: patient positioning fixture engaged, camera-to-face distance in tolerance, face alignment in tolerance, and stereo camera baseline mechanically verified.
- Run illumination calibration before clinical capture: exposure target, LED PWM/current setting, color temperature/CCT, white balance, and diffuser/LED health check.
- Include a color/reference target or calibrated reference region in the capture field when feasible; record whether it passed validation.
- Capture standardized frontal image plus calibrated stereo/depth pair; optional left/right/oblique views may be added in future revisions.
- Perform image-quality checks: focus, exposure, face alignment, motion blur, illumination uniformity, color reference validation, stereo correspondence quality, and depth-map completeness.
- Store raw/original images and raw/depth data separately from AI-derived outputs with audit metadata.
- Session metadata must include operator ID, client ID/pseudonym, date/time, device serial, camera serials, firmware version, model version, working distance, exposure, gain, white balance, CCT/illumination settings, calibration target result, temperature if available, and quality flags.
Facial Volume and Depth Measurement Requirements
- Clinical-grade volume/depth assessment requires dedicated 3D sensing; 2D RGB-only images are insufficient for defensible facial volume-loss measurement.
- Selected method for this prototype: calibrated passive stereo using two matched MIPI CSI camera modules connected to J1 and J3, with fixed baseline and software synchronization/quality gating.
- The depth pipeline must include camera intrinsic calibration, stereo extrinsic calibration, rectification, depth reconstruction, facial landmark registration, longitudinal alignment, and regional volume-change computation.
- Calibration workflow must use a traceable calibration target and store calibration date, operator, target ID, residual reprojection error, baseline, lens configuration, and pass/fail result.
- Accuracy targets must be established in clinical validation before making quantitative volume claims; production requirements should define minimum detectable volume change by facial region and acceptable repeatability limits.
- Depth outputs must be quality-gated and must disclose when texture, hair, occlusion, facial expression, makeup, specular reflection, or poor alignment limits measurement reliability.
AI Clinical Output Categories
- Skin tone: Fitzpatrick-aware tone estimate and uniformity notes.
- Texture: pores, roughness, fine lines, wrinkle/texture gradients.
- Volume loss: calibrated 3D regional contour/volume indicators with practitioner review and confidence bounds.
- Congestion: comedone/blocked-pore and inflammatory congestion indicators.
- Pigmentation: hyperpigmentation, melasma-like patterning, dyschromia, redness/brown spot segmentation.
Clinical/Legal Workflow
- Practitioner review and sign-off are mandatory before treatment recommendations.
- Reports must disclose algorithm version, capture conditions, calibration status, confidence/quality flags, and limitations.
- Validation must include diverse skin tones, ages, facial anatomies, lighting conditions, and cosmetic-clinic populations; benchmark against practitioner-labeled datasets current to 2026 global cosmetic-clinic standards.
- Clinical validation must separately assess RGB appearance categories and 3D/depth volume outputs.
- The system must support traceability from a report back to raw images, depth data, calibration data, software versions, and device configuration used at capture time.
Privacy, Security, and Audit Controls
- Encrypt images, depth data, calibration records, and analysis records at rest and in transit.
- Use secure boot, signed updates, hardware key storage, role-based access, audit logs, retention controls, and clinic-specific access policy.
- Audit logs must record operator authentication, consent capture, acquisition attempts, rejected/accepted captures, calibration events, report generation, export, deletion, and configuration/software changes.
- Support consent capture, data minimization, client access/export/deletion workflows, and clinic-specific retention policy.
- Cybersecurity controls must include unique device identity, vulnerability/update process, credential handling, network hardening, and documented incident response.
Open Validation Items
- Final production camera modules, lenses, lighting parts, and calibration target are not yet locked.
- Stereo measurement accuracy and repeatability targets must be validated before clinical quantitative volume-loss claims.
- DRC/ERC and manufacturing export remain blocked until routing and review convergence are completed.