V-STATS™ 4.10 Installation Manual
Main new features introduced by V-STATS™ 4.10
A) Modifications related to patient data in V-STATS and V-CareNeT
· Implementation of General Data Protection Regulation (GDPR) requirements
What is GDPR and what does this mean for V-STATS/V-CareNeT?
GDPR (https://www.eugdpr.org/) is a European Union (EU) directive, replacing the Data Protection Directive 95/46/EC. The transitional period ends on May 25, 2018. From this date on, only the GDPR shall apply. The objective is to harmonize European data protection laws while focusing on strengthening EU citizens’ rights protecting their personal data. All companies and organizations, which process EU citizens’ data, are affected, regardless of where these companies or organizations are based and where the data are being processed.
Particularly in the healthcare sector, this implies that every person dealing with personal (patient) data must adhere to the GDPR. In addition to hospitals, medical practices, pharmacies, laboratories and health insurances (to name but a few), manufacturers of medical technology products are equally affected.
SenTec therefore revised V-STATS including V-CareNeT in order for the user to adhere to GDPR. Each individual organization (hospital, medical practice) may determine whether they save patient data and which data should be saved. The organization is responsible for complying with applicable regulations. With this new release, SenTec offers measures which allow GDPR-conform handling of patient data. The following points provide an overview of the GDPR requirements, indicate where V-STATS/V-CareNeT are affected and how these requirements are met in particular.
1. Preventing unauthorized access of patient data, protection of unauthorized use of the infrastructure needed for patient data processing.
V-STATS now has a login function. A login window appears upon starting the program where the user must enter a password in order to be identified as a legitimate user. Thus, unauthorized persons may not access V-STATS. Authorized users may only view data which they are permitted to view.
Note: Using V-CareNeT (licensed version) does not require a separate login. For changing V-CareNeT settings see Instruction Manual chapter 12.2.
Note: Apart from the login password, there is also an admin password. The admin password serves the same purpose as already known from the password protecting previous V-STATS versions (e.g. protection of SDM configuration and profiles, special functions relating to the SDM).
The password for protecting V-STATS Settings, SDM Profiles & Configuration and Special Functions is referred to as Admin password in order to differentiate it from the Login password.
- Unauthorized access of data must be prevented. If necessary, supervisory authorities and the data owner (patient) must be informed. The encryption of patient data is a measure for preventing unauthorized access. This encryption is a sufficient measure for preventing infringement of protection. Therefore, it is not necessary to inform the supervisory authorities or the data owner.
For this reason, SenTec decided to encrypt patient data. Therefore, a key needs to be created upon installation. This happens at a push of a button as V-STATS has a dedicated function for doing so. Subsequently, V-STATS will use this key automatically; a copy must be stored safely and may be exported if necessary (e.g. to hand over patient data to another authorized person).
3. Upon installation, existing data are being encrypted with the new key.
Note: Only files in the default directory are automatically encrypted. Files in other directories are not encrypted. This may be done at a later stage via the file manager.
- It is still possible to enter patient data. However, before entering data the user must tick the box “Release personal data” and confirm the subsequent data protection warning. This applies to both, V-STATS and V-CareNeT.
- When downloading data (from an SDM), these data are automatically encrypted. Measurement values and patient data are saved separately, whereby the patient data are encrypted.
Note: Should you require support from SenTec, never send any patient data to SenTec or your local SenTec representative.
- Patients have the right to receive their data in a common, machine-readable format. The already present data export within V-STATS fulfils this requirement, for example converting and exporting in the EDF+ format.
B) Modifications related to system requirements for installing V-STATS 4.10
· Compatibility with Windows 10 (32 and 64 bits)
· V‑STATS 4.10 is compatible with the following software versions of the SenTec Digital Monitor: SMB-SW V08.00.x., V08.01.x and V08.02.x
· Update to V‑STATS 4.10 is only supported if the installed V‑STATS license is registered and has version 4.00 or newer.
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V-STATS™ 4.10 updater if you already have installed and registered V-STATS™ license