Medical Disclaimer & FDA Status Notice

Under Section 3060 of the 21st Century Cures Act (amending Section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act), Oye Scribe is classified strictly as an administrative, clinical workflow support software tool.

Not a Medical Device:

Oye Scribe is not an FDA-approved or cleared medical device. It does not perform diagnostic functions, analyze clinical data to generate treatment directives, or automate clinical decision-making.

Exemption Status:

Because the software serves solely as a documentation aid and preserves the clinician's ability to independently review and edit the source text, it is entirely exempt from FDA 510(k) regulatory oversight and pre-market review.

Professional Use Only:

Oye Scribe is designed, licensed, and intended exclusively for use by licensed medical practitioners, clinicians, and authorized healthcare facilities. It is not intended for consumer or patient-facing diagnostic use.

No Medical Advice:

Oye Scribe does not practice medicine, provide medical advice, or render clinical opinions. Any automated outputs, including transcripts, structural templates, and clinical summaries, are linguistic interpretations of recorded ambient audio and must never be treated as definitive clinical data.

The practicing healthcare provider retains 100% final clinical and legal responsibility for the review, verification, accuracy, and editing of all medical records, charts, and documentation generated or assisted by Oye Scribe.

The Review Imperative:

Artificial intelligence and speech-to-text models can misinterpret complex terminology, omit critical contextual clinical modifiers, or introduce factual inaccuracies ("hallucinations").

Mandatory Verification:

The user must manually review, verify, and edit every note, medication name, dosage recommendation, and symptom summary before appending it to a patient's Electronic Health Record (EHR). ARCA VISION LABS LLC disclaims all liability for diagnostic errors, omissions, treatment delays, or medical malpractice claims resulting from unedited or unverified notes.

Oye Scribe is built on an offline-first, data-localized architecture designed to isolate and protect patient information.

Local-First Architecture:

Oye Scribe operates using secure on-device encryption (AES-256). Audio recording, speech-to-text transcription, and text processing occur locally on the host iOS device. One optional feature — diagnosis-code assistance, which is off unless you enable it — sends de-identified text (never raw audio or PHI) to a third-party model; see our Privacy Policy at https://oye.is/privacy.

Zero Cloud PHI:

No Protected Health Information (PHI) or raw audio data is transmitted to or stored on ARCA VISION LABS LLC servers. Any metadata or telemetry transmitted to maintain application health is strictly de-identified.

Hardware Liability Waiver:

Data persistence and the security of the local physical environment are managed solely by your device's native hardware security modules. ARCA VISION LABS LLC assumes zero liability or operational responsibility for HIPAA violations, unauthorized data access, or data loss resulting from lost, stolen, unencrypted, or compromised user hardware.

The use of this software does not establish a doctor-patient, fiduciary, or clinical relationship between ARCA VISION LABS LLC and any patient. Clinical outcomes and documentation accuracy remain solely the product of the independent relationship between the licensed healthcare provider and their patient.

Copyright (c) 2026 ARCA VISION LABS LLC. All rights reserved. Oye Scribe is provided "as is" and "as available," without warranty of any kind, express or implied, including but not limited to warranties of merchantability, fitness for a particular purpose, or non-infringement.

In no event shall ARCA VISION LABS LLC be liable for any direct, indirect, incidental, or consequential damages—including clinical errors, malpractice claims, or data loss—arising out of or in connection with the use or performance of this software. Liability for diagnostic errors remains entirely with the provider/user.