The Security and Privacy facilities within Sono Heart products meet HIPAA requirements as well as 21CFR part 11 FDA regulations for electronic records and electronic signatures. The Security facility within Sono Heart software provides an administrator with the tools necessary to set up passwords and user rights for all system users. With the security feature, each user is required to log on and provide a password in order to launch the program. Once logged on, the user has access to only those features included in the security level assigned to him/her.

Once the physician has completed review of a study, he selects Electronic Signature, enters his electronic signature password, and the report is electronically signed. Distribution rules can be set so that the study is automatically sent through hospital distribution channels once a report is electronically signed.

An associated Audit Trail facility provides user/date/time stamps of all changes to final reports together with a pdf version of the full revised report. The user/date/time stamps together with the changes are stored in an audit database so that query audits can be run as needed.

All user passwords are encrypted and stored in a database. All databases are secured by a password, which is required to open the database.

The security logon feature includes logging all unsuccessful login attempts. After 3 unsuccessful tries, the log on screen is closed and a message is written to the Failed Access file. The user name, date and time are included in this file.