Scrambler Therapy Data Manager (STDM)
CE and FDA Certification
ST-NET and the STDM software has received the CE certification as medical device. The software increases the efficacy and safety of Scrambler Therapy, and is therefore considered as an integrating part for the correct usage of the medical device itself and its best clinical practice. For this reason the software certification is that of a medical device.
FDA still does not foresee any specific certification for this type of software (Not Classified).
This software is very powerful, but has been designed to be extremely user friendly. Thus many software functions are completely automated .
Privacy and data security
Data security is locally guaranteed by archive encryption and the possibility to use a password to access all program functions. Data sent to the ST-NET HUB, apart from being encrypted, eliminates all the patient's personal information, including address, email, and telephone numbers. When the patient's file is opened a unique code is generated to replace his real identity.
Data sent over ST-NET network pertain exclusively to folders managed by STDM. No other data type belonging to the system where the software is installed (including information rendered available by the operating system) is analyzed or sent over the network.
Health Insurance Portability And Accountability Act (HIPPA) and Safe Harbor Compliance
ST-NET is fully compliant to HIPAA and Safe Harbor privacy standards. Implemented multi-level protection requirements are higher than those in most popular commercial software. HIPPA acknowledges the Safe Harbor method as complaint to privacy protection. Currently there is no official body to certify compliance to HIPPA, but HIPPA acknowledges the Safe Harbor method as complaint to privacy protection (http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/De-identification/guidance.html ).
STDM uses simultaneously the two de-identification methods envisaged by HIPAA (Expert Determination method and “Safe Harbor” method).
Data sharing in a private network
If also the STDM-Sync module has been downloaded it is quite easy to create a private network and share the database among the computers that access the same ftp folder specifically set-up. The folder can be created either on a public or private network.
Data confidentiality in research
If data of clinical trials underway are not sent to the international database for a specific timeframe (max. 5 years), suffice to check the “Enrolled in clinical trial” yellow box. Having checked the box will allow you to choose from the month list (0 to 60 ). This data will remain confidential and separate from the common database. By so doing the algorithm that manages the Hub will automatically free all data for the selected time-frame.
By clicking on “Automatic analysis” an algorithm analyzes the treatment data and highlights the main control parameters, indicating the percentage shift from the normal values.Meaningful shifts or serious anomalies are highlighted in red.
When these data are keyed in the file automatically goes from an active to a completed status. The file will then be visible only on the completed list. In this case it is also possible to fill in the Brief Pain Inventory, Pain Detect, DN4 by clicking on the button.
The follow up icon includes 3 follow up files that can be filled in at chosen time-frames, usually 1, 2 and 3 months at end treatment-cycle. Pain Relief values are calculated automatically. It is also possible to fill in a Brief Pain Inventory, Pain Detect, DN4 for each follow up by clicking on the button.
Other useful commands
Exporting the database
This function is very useful for clinical researchers. From the “File” Menu click on “Database Export” to start the export activity. It is possible to select filters to export only files with specific features. The analysis is carried out among all the completed medical records in the archive. The generated file can be either in .csv or .txt, both general standards usually compatible with any off-the-shelf software.
The specific file structure and sync. requirement is easily managed by the Backup/Historical Data /Import functions. File names vary and for this reason not using internal software functions for archive maintenance can generate errors and data loss. By using these functions one avoids file duplication and always storage of most updated versions in the archive.
Backup command exports the entire archive to the desired position (another folder, on a hard disc, UBS flash drive etc.). Backup is progressively numbered.
Historical data command transfers into a separate archive the folders that exceed the chronological limit set on the appropriate window.
Import archive from...
Enables to recover folder content from Backup or Historical Archive. During import activity there is also a check to verify whether a more recent file is not already on the local archive. If this were the case the less recent file will not be imported. If a file is not present or a more recent from the one in the local archive it is copied into the local archive.
This software is designed for a complete digital document management, but in some cases a printed version might be necessary. “Report” on the menu bar allows to print a preview of the essential data from the patient's medical record. Complete information included in each patient medical record are many. In order to print them the record must be exported with commands on the File menu or in the patient medical record choosing most fit format. It will then be possible to select only information necessary, format them and print them with software commands that opened the record from inside.