Basic Product Information
1. What is the exact name and model of the neurotechnology device?
2. Can you provide a high-level overview of how the device functions?
3. What specific purposes / functions does the device aim to provide?
4. In which countries or regions is the device currently deployed or planned to be deployed?
5. How does brain/neural data figure in your business model?
Part 1: Data governance and regulatory landscape
1. What have been key challenges related to data in the development (and if applicable, release) of your neurotechnology device?
2. How much does regulation or ethics figure in your product development? Do you have an ethicist or regulatory affairs officer?
3. Is current regulation fit for purpose for your device? How or how not? What changes would you like to see in the regulatory environment for your product?
4. Have you or do you plan to interact with government institutions or regulators? If yes, which ones? Why?
Part 2: Data Flow Mapping
Data Collection
1. What types of data are collected directly from patients/consumers? (e.g., name, contact information, date of birth, medical history, purchasing history)
2. What types of data are collected during device usage? (e.g., neural signals, movement patterns, physical responses)
3. Are any special categories of data collected, such as genetic data or biometric identifiers?
4. How is the data initially captured by the device? (e.g., sensors, electrodes, cameras)
5. At what frequency is data collected? (continuous, episodic, event-triggered)
6. Is audio or video recording involved in any part of the treatment process?
Data Processing and Storage
1. Where is the collected data initially stored? (on the device, local servers, cloud)
2. Is any processing done on the device itself before transmission?
3. What data transformations or analytics are performed on the raw data?
4. How long is data retained? Are there different retention periods for different types of data?
5. Is data anonymized or pseudonymized / de-identified at any point? If so, how?
Data Transfers
1. Is data transferred from the device to other systems? If yes, please describe the transmission methods.
2. Is data transferred outside the organization? To whom and for what purpose?
AI and Automated Processing
1. Does the device or associated systems use AI or machine learning to process patient/consumer data?
2. If yes, please provide further information on the AI/machine learning algorithms and their data processing
3. How are the quality and accuracy of algorithmic outputs monitored and verified?
Future Plans
1. Are there planned changes to data collection or processing in future versions of the device?
2. Will it be possible in planned upgrades to collect new types of data?
3. Are there plans to integrate this device data with other systems or devices?