Regulatory Assessment
Our Transparent Position on FDA and FTC Regulations
Last Updated: October 30, 2025
Preliminary Analysis - Not Legal Opinion
This document represents our preliminary, non-binding assessment of potentially applicable regulations. This is NOT a legal opinion.
- We are NOT attorneys and do not provide legal advice
- This assessment is subject to change as our product evolves and regulations develop
- Regulatory authorities may interpret these matters differently
- This should not be relied upon as definitive legal guidance
We welcome corrections and feedback from legal experts and regulatory authorities at legal@dlyog.com
Why This Page Exists
Transparency is important to us. The regulatory landscape for software applications is complex and evolving. The FTC emphasizes transparency, and we want to be completely open about our assessment of whether FDA and FTC regulations apply to AI4Echolalia™.
This page documents our analysis using the official FTC Mobile Health App Interactive Tool and FDA guidance. We welcome feedback and are committed to correcting any misunderstandings. If you have questions or concerns, please contact us at legal@dlyog.com.
Document Preparation & Review Status
Prepared by: This assessment has been prepared internally by DLYog Lab Research Services LLC (we are NOT attorneys).
We continue to monitor FDA and FTC guidance as our product evolves and as the regulatory landscape develops. This document will be updated to reflect any changes in our understanding or guidance from regulatory authorities.
Last Updated: October 2025 | Next Scheduled Review: January 2026
Our Position
AI4Echolalia™ is an educational training application for parents, NOT a health application or medical device.
✓ Educational Purpose: We provide parent training and education on echolalia patterns
✓ No Medical Function: We do NOT diagnose, treat, prevent, or cure any medical condition
✓ Minimal Data Collection: We collect only email for login (no PII, no PHI)
✓ Anonymous Processing: Voice transcription is anonymized; users can use any name
✓ Parent-Directed: Parents control all inputs and receive educational feedback
FDA Medical Device Assessment
FDA Question 7: Is your app intended for:
- Use in the diagnosis of disease or other conditions?
- Use in the cure, mitigation, treatment, or prevention of disease?
- To affect the structure or any function of the body?
Our Answer: NO
Reasoning:
- AI4Echolalia does NOT diagnose echolalia or any medical condition
- AI4Echolalia does NOT treat, cure, prevent, or mitigate echolalia
- AI4Echolalia does NOT affect any bodily structure or function
- We provide educational pattern detection to help parents recognize repetition patterns
- Parents receive coaching prompts to support home-based speech practice
- We explicitly state: "Not a medical device" and "Not a substitute for speech-language therapy"
FDA Assessment
Based on our interpretation of FDA guidelines, we believe AI4Echolalia does not meet the definition of a medical device and may not be subject to FDA regulation.
FDA Guidance Reference: Apps that are "solely intended for maintaining or encouraging a healthy lifestyle and unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease" are excluded from the device definition under Section 520(o)(1)(B) of the FD&C Act.
Our application provides educational training for parents to support speech practice at home, and we do not believe it diagnoses, treats, or affects any medical condition. However, the FDA may interpret this differently.
FTC Mobile Health App Assessment
We have carefully reviewed the FTC Mobile Health App Interactive Tool and answered each question honestly based on our application's actual functionality and data practices.
Question 1: Does/will your app collect, share, use, or maintain health information?
Our Answer: NO - We position this as educational training data, not health information
Detailed Reasoning:
- What we collect:
- Email address (for login only)
- Anonymized voice transcripts (for educational pattern detection)
- Session summaries (echolalia frequency counts, no identifiable information)
- What we do NOT collect:
- No real names required (users can use any name)
- No medical history
- No diagnosis information
- No treatment records
- No PHI (Protected Health Information)
- No audio recordings (deleted after transcription)
- Educational Context: Voice data is used solely for educational pattern detection training - to help parents learn to recognize echolalia patterns, similar to how a language learning app uses speech data to teach pronunciation
- No Personal Identifiers: Voice transcripts are anonymized and cannot be linked back to any individual
Assessment: We believe AI4Echolalia collects educational training data rather than "health information" as typically defined by FTC health app guidance.
Interpretive Uncertainty: The distinction between "educational speech training data" and "health information" is not clearly defined in FTC guidance. Reasonable minds could differ on this classification. We interpret our data collection as educational because:
- No medical diagnosis or treatment occurs
- Data is anonymized and used only for pattern detection training
- Parents receive educational coaching, not medical advice
However, the FTC could interpret speech pattern data from children with autism as "health-related" regardless of our intended educational purpose. We continue this assessment out of an abundance of caution and transparency.
Question 11: Is your app for use by consumers?
Our Answer: YES
Reasoning:
- AI4Echolalia is a web-based application available to parents/consumers
- Currently in invite-only pilot with approved users
- DLYog Lab is a for-profit LLC, not a nonprofit (FTC Act applies)
FTC Act Applicability: The FTC Act Section 5 applies to us as a consumer-facing application. We must:
- ✓ Not make deceptive or misleading claims
- ✓ Have reasonable privacy and security practices
- ✓ Honor our privacy promises to users
- ✓ Ensure our health benefit claims are substantiated
Our Compliance: We comply with FTC Act Section 5 requirements regardless of health app classification. We maintain transparent privacy policies, reasonable security practices, and do not make unsupported health benefit claims.
Question 12: Does your app collect, receive, or maintain identifiable health information?
Does your app access health information in personal health records, send information to personal health records, or provide services to entities that maintain health records?
Our Answer: NO
Reasoning:
- No Identifiable Health Information: We do not collect information that can identify individuals and relate to their health conditions
- No PHR Access: We do NOT access, send, or receive data from Personal Health Records (EHRs/EMRs)
- No Integration with Health Systems: We do NOT connect to hospitals, clinics, health plans, or medical record systems
- No Health Care Provider Services: We are NOT providing services to covered entities (hospitals, doctors, etc.)
- Anonymous Educational Data Only: Voice transcripts are anonymized and used solely for educational pattern detection, not health record keeping
FTC Health Breach Notification Rule Assessment: Based on our current understanding, we believe the FTC Health Breach Notification Rule does not apply to AI4Echolalia because we do not collect, receive, or maintain identifiable health information or operate as a vendor of personal health records. However, regulatory authorities may interpret our data practices differently.
Question 13: Is your app intended for children under 13?
Our Answer: NO
Reasoning:
- Target Audience: AI4Echolalia is designed for parents and adult caregivers, not children
- Parent-Controlled: Parents create the account, login, and control all interactions
- No Child Accounts: We do NOT allow children to create accounts or login
- No Child Data Collection: We do NOT knowingly collect personal information from children:
- Account/email belongs to parent
- Names are optional and can be pseudonyms
- Voice transcripts are anonymized (no child identification)
- Child-Directed Content: The app does NOT contain child-oriented activities, games, or incentives
COPPA Assessment: Based on our interpretation, we believe COPPA does not apply to AI4Echolalia because:
- We believe the app is not directed to children under 13
- We do not have actual knowledge that we are collecting personal information from children
- The app is designed as a parent-directed educational training tool
- Parents control all inputs, accounts, and data
However, the FTC may interpret child-directedness differently based on various factors.
Question 16: Does your app offer substance use disorder treatment services or products?
Our Answer: NO
Reasoning:
- AI4Echolalia provides echolalia detection training for parents
- We do NOT provide substance use disorder treatment services
- We do NOT provide substance use disorder treatment products
OARFPA Assessment: We believe the Opioid Addiction Recovery Fraud Prevention Act does not apply to AI4Echolalia as we do not provide substance use disorder treatment services or products.
Overall Regulatory Assessment
Our Preliminary Assessment Summary
FDA: We Believe Not Applicable
Based on our interpretation, we believe AI4Echolalia does not meet the definition of a medical device. We do not intend to diagnose, treat, cure, prevent, or mitigate any disease or condition. We position ourselves as an educational training application for parents. However, the FDA may interpret our intended use differently.
FTC Health Breach Notification Rule: We Believe Not Applicable
Based on our current data practices, we believe we do not collect identifiable health information, do not access personal health records, and do not operate as a PHR vendor or PHR-related entity. However, the FTC may interpret "health information" more broadly than we currently understand.
COPPA: We Believe Not Applicable
We designed AI4Echolalia as a parent-directed educational tool, not a child-directed service. Parents control all accounts and data. However, the FTC applies multiple factors when determining child-directedness, and they may reach a different conclusion.
FTC Act Section 5: Applicable
As a consumer-facing application, we believe FTC Act Section 5 applies to our operations. We are committed to truthful representations, reasonable privacy and security practices, and honoring our privacy promises to users.
Important Caveat
This assessment represents our good-faith interpretation of applicable regulations based on our application's current functionality and data practices. The regulatory landscape for software applications is complex and evolving.
We acknowledge that regulatory authorities may have different interpretations, and we remain committed to:
- Ongoing monitoring of regulatory guidance
- Adjusting our practices as needed to ensure compliance
- Maintaining transparent communication with users
- Seeking legal guidance when necessary
Our Data & Privacy Practices
What We Collect
- Email address (login only)
- Anonymized voice transcripts (educational pattern detection)
- Session summaries (echolalia frequency, no identifiers)
What We DON'T Collect
- No audio storage (deleted after transcription)
- No real names required
- No medical/diagnosis information
- No PHI or PII
How We Protect Data
- Encrypted transmission (HTTPS)
- Secure database storage
- No third-party data sharing
- Parent-controlled data deletion
Parent Control
- Parents create and control accounts
- Export data anytime
- Delete data anytime
- Choose any names (pseudonyms OK)
Our Commitment to Regular Updates
We commit to reviewing and updating this regulatory assessment quarterly (every 3 months) or sooner if:
- Our product features or data practices change significantly
- New FDA or FTC guidance is issued
- We receive feedback indicating our interpretation may be incorrect
- Regulatory authorities provide specific guidance on our application
Update Schedule:
- Last Updated: October 30, 2025
- Next Scheduled Review: January 30, 2026
- Review Frequency: Quarterly (Q1, Q2, Q3, Q4)
Update Log: All substantive changes to this assessment will be documented in an update log available upon request at legal@dlyog.com
We WELCOME Corrections & Feedback!
Found an Error? Tell Us!
We tried our best, but mistakes can happen.
If you believe our regulatory interpretation is incorrect, incomplete, or misleading:
- We WANT to hear from you
- We are OPEN to correction and discussion
- We will REVIEW your feedback promptly
- We will UPDATE this page if needed
Who should contact us: Regulatory experts, legal professionals, consumer advocates, industry peers, or anyone with relevant regulatory knowledge
We are committed to getting this right. Your feedback helps us improve.