Legal & Disclaimers
Last updated: August 18, 2026
1. No HIPAA / PHI Handling
DDF Flow is not a HIPAA-covered service and is not designed to receive, store, or transmit Protected Health Information (PHI) as defined under the Health Insurance Portability and Accountability Act (HIPAA). You must not enter any patient-identifiable data, medical records, or other regulated health information into the platform. You are solely responsible for ensuring that your use of DDF Flow complies with HIPAA and any other applicable health-privacy laws.
2. Not a Validated QMS
DDF Flow is not a fully validated Quality Management System (QMS) and has not been validated in accordance with 21 CFR Part 820, ISO 13485, or any other QMS standard. The software is provided as a productivity and drafting aid only. It does not replace your organization's validated QMS, document-control procedures, or regulatory review process. All generated documents must be independently reviewed, approved, and released under your own controlled procedures before submission or use.
3. No Liability for Data Breach, Loss, or Use
To the maximum extent permitted by law, DDF Flow and its operators accept no liability for any data breach, unauthorized access, loss of data, corruption of data, or any damages arising from the use of—or inability to use—the platform. You acknowledge that you use the service at your own risk and that you are responsible for maintaining your own backups, security controls, and risk-management practices.
4. AI-Generated Content & No Liability for Wording
DDF Flow is fully AI-based. All document text, classifications, recommendations, and analyses are generated by artificial-intelligence models and may contain errors, omissions, or inaccurate wording. DDF Flow holds no liability for any incorrect, misleading, or non-compliant wording produced by the system. Every output must be reviewed and verified by a qualified human reviewer before reliance or submission. You are solely responsible for the accuracy and regulatory sufficiency of any document you produce using the platform.
5. No Regulatory or Legal Advice
Nothing provided by DDF Flow constitutes regulatory, legal, engineering, or professional advice. Outputs are general informational drafts and do not create any professional relationship between you and DDF Flow. You should consult qualified regulatory, legal, and technical professionals regarding your specific device and submission.
6. Use at Your Own Risk
The platform is provided "as is" and "as available" without warranties of any kind, express or implied, including merchantability or fitness for a particular purpose. Your use of any generated content in a regulatory submission, product file, or commercial activity is at your sole risk and discretion.
7. User Responsibility
You are responsible for all content you create, upload, or submit through DDF Flow, and for ensuring it meets applicable regulatory requirements including FDA 21 CFR Part 820, ISO 13485, IEC 62304, ISO 14971, and any other standards relevant to your device and jurisdiction.
8. Intellectual Property & Copyright
© 2026 DDF Flow. All rights reserved. The DDF Flow name, logo, software, design, and content are the property of DDF Flow and are protected by copyright and other intellectual-property laws. Unauthorized reproduction, distribution, or use of the platform or its materials is prohibited. Content you generate using the platform remains yours; the underlying software and templates remain the property of DDF Flow.
9. Third-Party Data
DDF Flow references third-party data (including FDA databases) for convenience. We do not control and are not responsible for the accuracy, availability, or completeness of such third-party data, and we make no warranty regarding it.
10. Limitation of Liability
In no event shall DDF Flow, its operators, or affiliates be liable for any indirect, incidental, special, consequential, or punitive damages, or any loss of profits or data, arising out of or related to your use of the platform, even if advised of the possibility of such damages. Your sole remedy is to discontinue use of the service.
11. Indemnification
You agree to indemnify and hold harmless DDF Flow and its operators from any claims, damages, or expenses arising out of your use of the platform, your content, or your breach of these terms.
12. Changes to This Notice
We may update this legal notice at any time. Continued use of the platform after changes constitutes acceptance of the updated terms.
13. Governing Law
These terms are governed by the laws of the jurisdiction in which DDF Flow operates, without regard to conflict-of-law principles.
Questions about this notice? Contact contact@illobra.com.