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Manufacturer Disclosure Statement for Medical Device Security – MDS2
DEVICE DESCRIPTION
Device Category Manufacturer Document ID Document Release Date
Siemens Healthineers DX014286 Rev 01
Device Model Software Revision Software Release Date
RAPIDPoint 500e System V5.0 25 Jul 2019
Company Name Manufacturer Contact Information
Manufacturer or Siemens Healthineers
Representative
Contact Information Representative Name/Position
Intended use of device in network-connected environment:
Transmission of Results/Status with LIS/DataManager System
Email for Cartridge Credit
MANAGEMENT OF PRIVATE DATA
Yes, No,
Note #
Refer to Section 2.3.2 of this standard for the proper interpretation of information requested in this form. N/A, or
See Note
A Can this device display, transmit, or maintain private data (including electronic Protected Health Information
[ePHI])?
Yes __
B Types of private data elements that can be maintained by the device:
B.1 Demographic (e.g., name, address, location, unique identification number)? Yes __
B.2 Medical record (e.g., medical record #, account #, test or treatment date, device identification number)?
Yes __
B.3 Diagnostic/therapeutic (e.g., photo/radiograph, test results, or physiologic data with identifying
characteristics)?
Yes __
B.4 Open, unstructured text entered by device user/operator? See Note 1
B.5 Biometric data? No __
B.6 Personal financial information? No __
C Maintaining private data - Can the device:
C.1 Maintain private data temporarily in volatile memory (i.e., until cleared by power-off or reset)? Yes __
C.2 Store private data persistently on local media? Yes __
C.3 Import/export private data with other systems? Yes __
C.4 Maintain private data during power service interruptions? Yes __
D Mechanisms used for the transmitting, importing/exporting of private data – Can the device:
D.1 Display private data (e.g., video display, etc.)? Yes __
D.2 Generate hardcopy reports or images containing private data? Yes __
D.3 Retrieve private data from or record private data to removable media (e.g., disk, DVD, CD-ROM, tape,
CF/SD card, memory stick, etc.)? Yes __
D.4 Transmit/receive or import/export private data via dedicated cable connection (e.g., IEEE 1073, serial port,
USB, FireWire, etc.)? Yes __
D.5 Transmit/receive private data via a wired network connection (e.g., LAN, WAN, VPN, intranet, Internet,
etc.)?
Yes __
D.6 Transmit/receive private data via an integrated wireless network connection (e.g., WiFi, Bluetooth,
infrared, etc.)? No __
D.7 Import private data via scanning? Yes __
D.8 Other? N/A __
1. Limited to 15 Char's for Custom Demographics fields
Management of
Private Data notes:
© Copyright 2013 by the National Electrical Manufacturers Association and
the Healthcare Information and Management Systems Society.
HN 1-2013
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Device Category Manufacturer Document ID Document Release Date
0 Siemens Healthineers DX014286 Rev 01 0
Device Model Software Revision Software Release Date
RAPIDPoint 500e System V5.0 25 Jul 2019
SECURITY CAPABILITIES
Yes, No,
Note #
Refer to Section 2.3.2 of this standard for the proper interpretation of information requested in this form. N/A, or
See Note
1 AUTOMATIC LOGOFF (ALOF)
The device's ability to prevent access and misuse by unauthorized users if device is left idle for a period of time.
1-1 Can the device be configured to force reauthorization of logged-in user(s) after a predetermined length of inactivity
(e.g., auto-logoff, session lock, password protected screen saver)?
No __
1-1.1 Is the length of inactivity time before auto-logoff/screen lock user or administrator configurable? (Indicate
time [fixed or configurable range] in notes.) N/A __
1-1.2 Can auto-logoff/screen lock be manually invoked (e.g., via a shortcut key or proximity sensor, etc.) by the
user? N/A __
ALOF
notes:
2 AUDIT CONTROLS (AUDT)
The ability to reliably audit activity on the device.
2-1 Can the medical device create an audit trail?
No __
2-2 Indicate which of the following events are recorded in the audit log:
2-2.1 Login/logout See Note 2
2-2.2 Display/presentation of data No __
2-2.3 Creation/modification/deletion of data No __
2-2.4 Import/export of data from removable media No __
2-2.5 Receipt/transmission of data from/to external (e.g., network) connection No __
2-2.5.1 Remote service activity N/A __
2-2.6 Other events? (describe in the notes section) N/A __
2-3 Indicate what information is used to identify individual events recorded in the audit log:
2-3.1 User ID No __
2-3.2 Date/time Yes __
2. Successful logins are recorded in the audit log.
AUDT
notes:
3 AUTHORIZATION (AUTH)
The ability of the device to determine the authorization of users.
3-1 Can the device prevent access to unauthorized users through user login requirements or other mechanism?
See Note 3
3-2 Can users be assigned different privilege levels within an application based on 'roles' (e.g., guests, regular users,
power users, administrators, etc.)? Yes __
3-3 Can the device owner/operator obtain unrestricted administrative privileges (e.g., access operating system or
application via local root or admin account)? No __
3. When the System is set in "Restricted" mode, it prompts for user login to access the System. When the System is in
AUTH "Limited" mode, it prompts for user login for select screens such as CartReplacement, Calibrations, Setup etc..
notes:
© Copyright 2013 by the National Electrical Manufacturers Association and
the Healthcare Information and Management Systems Society.
HN 1-2013
Page 19
Device Category Manufacturer Document ID Document Release Date
0 Siemens Healthineers DX014286 Rev 01 0
Device Model Software Revision Software Release Date
RAPIDPoint 500e System V5.0 25 Jul 2019
Yes, No,
Note #
Refer to Section 2.3.2 of this standard for the proper interpretation of information requested in this form. N/A, or
See Note
4 CONFIGURATION OF SECURITY FEATURES (CNFS)
The ability to configure/re-configure device security capabilities to meet users’ needs.
4-1 Can the device owner/operator reconfigure product security capabilities? See Note 4
4. User Can reconfigure security features of the application only. User cannot install additional security capabilites.
CNFS
notes:
5 CYBER SECURITY PRODUCT UPGRADES (CSUP)
The ability of on-site service staff, remote service staff, or authorized customer staff to install/upgrade device's security patches.
5-1 Can relevant OS and device security patches be applied to the device as they become available? See Note 5
5-1.1 Can security patches or other software be installed remotely? No __
5. Security patches are included as part of Siemens software release media, but are not installable without software
CSUP release(i.e. no operating system specific patches)
notes:
6 HEALTH DATA DE-IDENTIFICATION (DIDT)
The ability of the device to directly remove information that allows identification of a person.
6-1 Does the device provide an integral capability to de-identify private data? See Note 6
6. Field Service has access to a tool that can remove PHI from the database
DIDT
notes:
7 DATA BACKUP AND DISASTER RECOVERY (DTBK)
The ability to recover after damage or destruction of device data, hardware, or software.
7-1 Does the device have an integral data backup capability (i.e., backup to remote storage or removable media such
as tape, disk)? See Note 7
7. Yes, user can backup data to comma separated value(csv) data files with patient results including ePHI
DTBK No data run-time restore.
notes:
8 EMERGENCY ACCESS (EMRG)
The ability of device users to access private data in case of an emergency situation that requires immediate access to stored
private data.
8-1 Does the device incorporate an emergency access (“break-glass”) feature? Yes 8
8. Password of the day provided by Siemens Support.
EMRG
notes:
9 HEALTH DATA INTEGRITY AND AUTHENTICITY (IGAU)
How the device ensures that data processed by the device has not been altered or destroyed in an unauthorized manner and is from
the originator.
9-1 Does the device ensure the integrity of stored data with implicit or explicit error detection/correction technology?
No __
IGAU
notes:
© Copyright 2013 by the National Electrical Manufacturers Association and
the Healthcare Information and Management Systems Society.
HN 1-2013
Page 20
Device Category Manufacturer Document ID Document Release Date
0 Siemens Healthineers DX014286 Rev 01 0
Device Model Software Revision Software Release Date
RAPIDPoint 500e System V5.0 25 Jul 2019
Yes, No,
Note #
Refer to Section 2.3.2 of this standard for the proper interpretation of information requested in this form. N/A, or
See Note
10 MALWARE DETECTION/PROTECTION (MLDP)
The ability of the device to effectively prevent, detect and remove malicious software (malware).
10-1 Does the device support the use of anti-malware software (or other anti-malware mechanism)? Yes __
10-1.1 Can the user independently re-configure anti-malware settings? Yes __
10-1.2 Does notification of malware detection occur in the device user interface? No __
10-1.3 Can only manufacturer-authorized persons repair systems when malware has been detected?
Yes __
10-2 Can the device owner install or update anti-virus software? No __
10-3 Can the device owner/operator (technically/physically) update virus definitions on manufacturer-installed anti-
virus software? No __
MLDP
notes:
11 NODE AUTHENTICATION (NAUT)
The ability of the device to authenticate communication partners/nodes.
11-1 Does the device provide/support any means of node authentication that assures both the sender and the recipient
of data are known to each other and are authorized to receive transferred information?
Yes 11
11. Firewall Endpoint can be configured to accept only authorized nodes
NAUT
notes:
12 PERSON AUTHENTICATION (PAUT)
Ability of the device to authenticate users
12-1 Does the device support user/operator-specific username(s) and password(s) for at least one user?
Yes
12-1.1 Does the device support unique user/operator-specific IDs and passwords for multiple users?
Yes __
12-2 Can the device be configured to authenticate users through an external authentication service (e.g., MS Active
Directory, NDS, LDAP, etc.)? No __
12-3 Can the device be configured to lock out a user after a certain number of unsuccessful logon attempts?
No __
12-4 Can default passwords be changed at/prior to installation? Yes
12-5 Are any shared user IDs used in this system? No __
12-6 Can the device be configured to enforce creation of user account passwords that meet established complexity
rules? No __
12-7 Can the device be configured so that account passwords expire periodically? Yes
12-7 Yes, passwords expire when used with RAPIDComm. 12-1 The device prompts for Password and recognizes the user
PAUT based on the password entered. It does not prompt for both username and password for one Step Authentication. For two
notes: Step Both Operator and Password are displayed but its not Default Setup.
13 PHYSICAL LOCKS (PLOK)
Physical locks can prevent unauthorized users with physical access to the device from compromising the integrity and confidentiality
of private data stored on the device or on removable media.
13-1 Are all device components maintaining private data (other than removable media) physically secure (i.e., cannot
remove without tools)? Yes __
PLOK
notes:
© Copyright 2013 by the National Electrical Manufacturers Association and
the Healthcare Information and Management Systems Society.
HN 1-2013
Page 21
Device Category Manufacturer Document ID Document Release Date
0 Siemens Healthineers DX014286 Rev 01 0
Device Model Software Revision Software Release Date
RAPIDPoint 500e System V5.0 25 Jul 2019
Yes, No,
Note #
Refer to Section 2.3.2 of this standard for the proper interpretation of information requested in this form. N/A, or
See Note
14 ROADMAP FOR THIRD PARTY COMPONENTS IN DEVICE LIFE CYCLE (RDMP)
Manufacturer’s plans for security support of 3rd party components within device life cycle.
14-1 In the notes section, list the provided or required (separately purchased and/or delivered) operating system(s) -
including version number(s). See Note 14.1
14-2 Is a list of other third party applications provided by the manufacturer available? Yes 14.2
14.1 Windows 10 loT Enterprise , plus subsequent application updates
RDMP 14.2 . Most 3rd party software used are referenced in RAPIDPoint 500e Release Notes in addition we have Raima database
notes: and McAfee
15 SYSTEM AND APPLICATION HARDENING (SAHD)
The device's resistance to cyber attacks and malware.
15-1 Does the device employ any hardening measures? Please indicate in the notes the level of conformance to any
industry-recognized hardening standards. Yes 15.1
15-2 Does the device employ any mechanism (e.g., release-specific hash key, checksums, etc.) to ensure the installed
program/update is the manufacturer-authorized program or software update?
Yes __
15-3 Does the device have external communication capability (e.g., network, modem, etc.)? See Note 15.3
15-4 Does the file system allow the implementation of file-level access controls (e.g., New Technology File System
(NTFS) for MS Windows platforms)? No __
15-5 Are all accounts which are not required for the intended use of the device disabled or deleted, for both users and
applications? Yes __
15-6 Are all shared resources (e.g., file shares) which are not required for the intended use of the device, disabled?
Yes __
15-7 Are all communication ports which are not required for the intended use of the device closed/disabled?
Yes __
15-8 Are all services (e.g., telnet, file transfer protocol [FTP], internet information server [IIS], etc.), which are not
required for the intended use of the device deleted/disabled? Yes __
15-9 Are all applications (COTS applications as well as OS-included applications, e.g., MS Internet Explorer, etc.) which
are not required for the intended use of the device deleted/disabled?
Yes __
15-10 Can the device boot from uncontrolled or removable media (i.e., a source other than an internal drive or memory
component)? No __
15-11 Can software or hardware not authorized by the device manufacturer be installed on the device without the use of
tools? No __
15.1 Uses Embedded version of Operating System with fewer components, prevents autolaunch
15.3 The device can be connected to a LAN (for connection to external data manager) but does not connect to internet.
SAHD notes:
16 SECURITY GUIDANCE (SGUD)
The availability of security guidance for operator and administrator of the system and manufacturer sales and service.
16-1 Are security-related features documented for the device user? Yes __
16-2 Are instructions available for device/media sanitization (i.e., instructions for how to achieve the permanent deletion
of personal or other sensitive data)? Yes 16.2
16.2 Available to Service but not to users.
SGUD notes:
© Copyright 2013 by the National Electrical Manufacturers Association and
the Healthcare Information and Management Systems Society.
HN 1-2013
Page 22
Device Category Manufacturer Document ID Document Release Date
0 Siemens Healthineers DX014286 Rev 01 0
Device Model Software Revision Software Release Date
RAPIDPoint 500e System V5.0 25 Jul 2019
Yes, No,
Note #
Refer to Section 2.3.2 of this standard for the proper interpretation of information requested in this form. N/A, or
See Note
17 HEALTH DATA STORAGE CONFIDENTIALITY (STCF)
The ability of the device to ensure unauthorized access does not compromise the integrity and confidentiality of private data stored
on device or removable media.
17-1 Can the device encrypt data at rest? Yes __
STCF
notes:
18 TRANSMISSION CONFIDENTIALITY (TXCF)
The ability of the device to ensure the confidentiality of transmitted private data.
18-1 Can private data be transmitted only via a point-to-point dedicated cable? No __
18-2 Is private data encrypted prior to transmission via a network or removable media? (If yes, indicate in the notes
which encryption standard is implemented.) Yes 18.1
18-3 Is private data transmission restricted to a fixed list of network destinations? Yes __
18.1 TLS 1.2
TXCF
notes:
19 TRANSMISSION INTEGRITY (TXIG)
The ability of the device to ensure the integrity of transmitted private data.
19-1 Does the device support any mechanism intended to ensure data is not modified during transmission? (If yes,
describe in the notes section how this is achieved.) Yes 19.1
19.1 Uses checksum
TXIG
notes:
20 OTHER SECURITY CONSIDERATIONS (OTHR)
Additional security considerations/notes regarding medical device security.
20-1 Can the device be serviced remotely? No __
20-2 Can the device restrict remote access to/from specified devices or users or network locations (e.g., specific IP
addresses)? No __
20-2.1 Can the device be configured to require the local user to accept or initiate remote access? Yes 20.2
20.2 The Remote Access can be enabled/disabled by local user. Local user can see "Remote Viewer" connection was
established and can force disconnection via Banner button on every screen.
OTHR
notes:
© Copyright 2013 by the National Electrical Manufacturers Association and
the Healthcare Information and Management Systems Society.
