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Privacy Policy for PrediClear LLC

Effective Date: May 2, 2026

1. Introduction

PrediClear LLC ("we," "us," or "our") is committed to protecting your privacy. This policy outlines how we collect, use, and safeguard professional and personal data in compliance with the New Jersey Data Protection Act (NJDPA) and relevant federal standards for medical device regulatory intelligence.

2. Data We Collect

Personal Information: Name, professional email, and job title collected via "Early Access" forms.

Sensitive Data (NJDPA): We do not knowingly collect health-related data from consumers. We only process regulatory metadata provided by professional users for the purpose of compliance research.

AI Interaction Data: Transcripts of queries to our AI engine to improve research accuracy.

3. AI & Data Sovereignty (The "Clean Room" Guarantee)

In accordance with our "Zero-Leak" architecture:

  • No Training on Proprietary Data: We do not use your proprietary device descriptions, design controls, or regulatory strategies to train foundational or third-party Large Language Models (LLMs).
  • Data Isolation: Your project data is siloed and accessible only to your authorized users.

4. Consent & Your Rights (NJDPA 2026)

Under New Jersey law, you have the right to:

  • Access & Correct: Request a copy of the data we hold about you.
  • Opt-Out: You may opt-out of "Profiling" or automated decision-making that produces legal effects.
  • Delete: Request the permanent deletion of your professional contact information.

To exercise these rights, contact our Data Privacy Officer at legal@prediclear.com.

5. AI Transparency (NJ SB 3668)

In accordance with 2026 New Jersey AI Transparency regulations, users are hereby notified that the data and summaries provided through this platform are compiled and generated by autonomous artificial intelligence systems. Human support is available upon request.

6. HIPAA & Business Associate Agreements (BAA)

While PrediClear LLC is primarily a regulatory research tool, we are architected to be HIPAA-ready. For enterprise clients requiring the processing of Protected Health Information (PHI), we will execute a formal Business Associate Agreement (BAA) as required by 45 CFR § 164.504(e).

7. Changes to this Policy

We will notify you of any material changes via email or a prominent notice on our website.

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PrediClear LLC provides a decision-support tool for regulatory research. We do not provide legal, clinical, or regulatory advice. All AI-generated outputs require verification by a qualified professional.
© 2026 PrediClear LLC. AI-powered regulatory intelligence for medical devices.