Based upon "Section 3060(b) of the 21st Century Cures Act" a company determines their Software product is exempt from FDA Regulation based on "(D) for transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results, findings by a health care professional with respect to such data and results, general information about such findings, and general background information about such laboratory test or other device, unless such function is intended to interpret or analyze clinical laboratory test or other device data, results, and findings;"
A healthcare professional is accessing this product from the EU for a USA citizens health record. Is that acceptable for global regulations?
A US based patient is accessing this product from the EU for their personal health information. Is that acceptable for global regulations?
A healthcare professional is accessing this product from the EU for an EU citizen's health records. Is that acceptable for global regulations?
An EU based patient is accessing this product from the EU for their personal health information. Is that acceptable for global regulations?
A healthcare professional is accessing this product from the EU for a USA citizens health record. Is that acceptable for global regulations?
A US based patient is accessing this product from the EU for their personal health information. Is that acceptable for global regulations?
A healthcare professional is accessing this product from the EU for an EU citizen's health records. Is that acceptable for global regulations?
An EU based patient is accessing this product from the EU for their personal health information. Is that acceptable for global regulations?
