PHI (Personal Health Information)
No, Audiqueen does not send PHI data to the cloud.
All Audiqueen data are stored solely in the Audiqueen database that is owned by the client and located on the local servers of the hospital or medical unit. The access is exclusively controlled by the local authorities (IT dept). Users with administrator rights decide which other users are authorized to view or edit the data. All user access is password restricted. The session logger gives an overview of relevant activities (who has had what kind of access to which patient's file?).
Neither Otoconsult nor any other third party has access to the data in Audiqueen's database if this is not explicitly granted to them by the owner, for instance for specific servicing tasks.
Only a limited number of non-PHI data is automatically shared with Otoconsult's cloud service. These data relate to the use licence activation, the infrastructure used, and some metadata regarding the database for servicing and maintenance purposes.
Regulatory
Following a decision of the Belgian Competent Authority (FAGG), Audiqueen v 3.9 and higher is no medical device. It is a data management package, compliant with GDPR, HIPAA, and the Privacy Rule.