Manufacturer Disclosure Statement for Medical Device Security MDS²
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1 V g. Other? VLC Feb//20 Vitrea Software Revision Software Release Date Feb// Opus Parkway Suite #00, Minnetonka, MN MANAGEMENT OF ELECTRONIC PROTECTED HEALTH INFORMATION (ephi) 1. Can this device transmit or maintain electronic Protected Health Information (ephi)? Types of ephi data elements that can be maintained by the device:... a. Demographic (e.g., name, address, location, unique identification number)?... b. Medical record (e.g., medical record #, account #, test or treatment date, device identification number)?... c. Diagnostic/therapeutic (e.g., photo/radiograph, test results, or physiologic data with identifying characteristics)?... d. Open, unstructured text entered by device user/operator?.... Maintaining ephi - Can the device a. Maintain ephi temporarily in volatile memory (i.e., until cleared on by power-off or reset)?... b. Store ephi persistently on local media?... c. Import/export ephi with other systems? Mechanisms used for the transmitting, importing/exporting of ephi Can the device a. Display ephi (e.g., video display)?... b. Generate hardcopy reports or images containing ephi?... c. Retrieve ephi from or record ephi to removable media (e.g., disk, DVD, CD-ROM, tape, CF/SD card, memory stick)?... d. Transmit/receive or import/export ephi via dedicated cable connection (e.g., IEEE 107, serial port, USB, FireWire)?... e. Transmit/receive ephi via a network connection (e.g., LAN, WAN, VPN, intranet, Internet)?... f. Transmit/receive ephi via an integrated wireless connection (e.g. WiFi, Bluetooth, infrared)?... N/A ADMINISTRATIVE SAFEGUARDS 5. Does manufacturer offer operator and technical support training or documentation on device security features? What underlying operating system(s) (including version number) are used by the device?... Microsoft Windows Server 2008 R2 SP1 Standard x64 Edition (servers only) Microsoft Windows Server 2012 R2 Standard x64 Edition (servers only) Microsoft Windows 7 Professional 2-bit Edition with SP1 (clients only) Microsoft Windows 7 Professional 64-bit Edition with SP1 (clients and workstations) Microsoft Windows 8.1 Professional 64-bit Edition (clients and workstations) PHYSICAL SAFEGUARDS 7. Are all device components maintaining ephi (other than removable media) physically secure (i.e. cannot remove without tools)? 8. Does the device have an integral data backup capability (i.e., backup onto removable media like tape, disk)? Can the device boot from uncontrolled or removable media (i.e., a source other than an internal drive or memory component)? _ TECHNICAL SAFEGUARDS 10. Can software or hardware not authorized by the device manufacturer be installed on the device without the use of tools? 11. Can the device be serviced remotely (i.e., maintenance activities performed by service person via network or remote connection)? a. Can the device restrict remote access to specific devices or network locations (e.g., specific IP addresses)?... b. Can the device provide an audit trail of remote-service activity?... c. Can security patches or other software be installed remotely? Level of owner/operator service access to device operating system: Can the device owner/operator a. Apply device manufacturer-validated security patches?... b. Install or update antivirus software?... c. Update virus definitions on manufacturer-installed antivirus software?... d. Obtain administrative privileges (e.g. access operating system or application via local root or admin account)? Does the device support user/operator specific username and password? Does the system force reauthorization after a predetermined length of inactivity (e.g., auto logoff, session lock)?... the Healthcare Information and Management Systems Society. Page 1 of 6
2 V VLC Feb//20 Vitrea Software Revision Software Release Date Feb// Opus Parkway Suite #00, Minnetonka, MN Events recorded in device audit trail (e.g., user, date/time, action taken): Can the audit trail record... a. Login and logout by users/operators?... b. Viewing of ephi?... c. Creation, modification or deletion of ephi?... d. Import/export or transmittal/receipt of ephi? Does the device incorporate an emergency access ( break-glass ) feature that is logged? Can the device maintain ephi during power service interruptions? Controls when exchanging ephi with other devices:... a. Transmitted only via a point-to-point dedicated cable?... N/A b. Encrypted prior to transmission via a network or removable media?... c. Restricted to a fixed list of network destinations Does the device ensure the integrity of the ephi data with implicit or explicit error detection/correction technology?... additional security concerns identified. Other Security Considerations the Healthcare Information and Management Systems Society. Page 2 of 6
3 V VLC Feb//20 Vitrea Software Revision Software Release Date Feb// Opus Parkway Suite #00, Minnetonka, MN SECTION 2 EXPLANATORY NOTES (from questions 1-19) IMPORTANT: Refer to Section of this standard for the proper interpretation of information requested in this form 1. The term device herein refers to the VitreaAdvanced software and /or license. Vital Images does not manufacture hardware system software and /or components. 2. The VitreaAdvanced software can create audit logs that list user actions to ephi data. ephi information available to users is in t DICOM data and Reports. Any time a user loads a dataset, creates snapshots or batches, exports, reports on, prints, burns to media from VitreaAdvanced, action is logged in an audit log file. does not manufacture hardware or operating system software and /or components which may extend these fu 4. Technical Support can use WebEx or VPN for remote application (Vitrea ) support 5. does not provide customers with Anti-Virus Definition Files, Operating System Security or Service Packs. Custom responsible for managing hardware security and software update policies. the Healthcare Information and Management Systems Society. Page of 6
4 VLC Rev. A VLC Feb//2016 Vitrea Software Revision Software Release Date Feb// Opus Parkway Suite #00, Minnetonka, MN MANAGEMENT OF ELECTRONIC PROTECTED HEALTH INFORMATION (ephi) 1. Can this device transmit or maintain electronic Protected Health Information (ephi)? Types of ephi data elements that can be maintained by the device: a. Demographic (e.g., name, address, location, unique identification number)?... b. Medical record (e.g., medical record #, account #, test or treatment date, device identification number)?... c. Diagnostic/therapeutic (e.g., photo/radiograph, test results, or physiologic data with identifying characteristics)?... d. Open, unstructured text entered by device user/operator?.... Maintaining ephi - Can the device a. Maintain ephi temporarily in volatile memory (i.e., until cleared on by power-off or reset)?... b. Store ephi persistently on local media?... c. Import/export ephi with other systems? Mechanisms used for the transmitting, importing/exporting of ephi Can the device a. Display ephi (e.g., video display)?... b. Generate hardcopy reports or images containing ephi?... c. Retrieve ephi from or record ephi to removable media (e.g., disk, DVD, CD-ROM, tape, CF/SD card, memory stick)?... d. Transmit/receive or import/export ephi via dedicated cable connection (e.g., IEEE 107, serial port, USB, FireWire)?... e. Transmit/receive ephi via a network connection (e.g., LAN, WAN, VPN, intranet, Internet)?... f. Transmit/receive ephi via an integrated wireless connection (e.g. WiFi, Bluetooth, infrared)?... g. Other?... N/A te # 2 ADMINISTRATIVE SAFEGUARDS te # 5. Does manufacturer offer operator and technical support training or documentation on device security features? What underlying operating system(s) (including version number) are used by the device?... _ Microsoft Windows Server 2008 R2 SP1 Standard x64 Edition (servers only) Microsoft Windows Server 2012 R2 Standard x64 Edition (servers only) Microsoft Windows 7 Professional 2-bit Edition with SP1 (clients only) Microsoft Windows 7 Professional 64-bit Edition with SP1 (clients and workstations) Microsoft Windows 8.1 Professional 64-bit Edition (clients and workstations) PHYSICAL SAFEGUARDS te # Are all device components maintaining ephi (other than removable media) physically secure (i.e. cannot remove without tools)? Does the device have an integral data backup capability (i.e., backup onto removable media like tape, disk)?... Can the device boot from uncontrolled or removable media (i.e., a source other than an internal drive or memory component)? TECHNICAL SAFEGUARDS 10. Can software or hardware not authorized by the device manufacturer be installed on the device without the use of tools? te # 11. Can the device be serviced remotely (i.e., maintenance activities performed by service person via network or remote connection)? a. Can the device restrict remote access to specific devices or network locations (e.g., specific IP addresses)?... b. Can the device provide an audit trail of remote-service activity?... 4 c. Can security patches or other software be installed remotely? Level of owner/operator service access to device operating system: Can the device owner/operator a. Apply device manufacturer-validated security patches?... 5 b. Install or update antivirus software?... c. Update virus definitions on manufacturer-installed antivirus software?... d. Obtain administrative privileges (e.g. access operating system or application via local root or admin account)? Does the device support user/operator specific username and password? Does the system force reauthorization after a predetermined length of inactivity (e.g., auto logoff, session lock)?... the Healthcare Information and Management Systems Society. Page 4 of 6
5 VLC Rev. A VLC Feb//2016 Vitrea Software Revision Software Release Date Feb// Opus Parkway Suite #00, Minnetonka, MN Events recorded in device audit trail (e.g., user, date/time, action taken): Can the audit trail record... a. Login and logout by users/operators?... b. Viewing of ephi?... c. Creation, modification or deletion of ephi?... d. Import/export or transmittal/receipt of ephi? Does the device incorporate an emergency access ( break-glass ) feature that is logged? Can the device maintain ephi during power service interruptions? Controls when exchanging ephi with other devices:... a. Transmitted only via a point-to-point dedicated cable?... N/A b. Encrypted prior to transmission via a network or removable media?... c. Restricted to a fixed list of network destinations Does the device ensure the integrity of the ephi data with implicit or explicit error detection/correction technology?... additional security concerns identified. Other Security Considerations the Healthcare Information and Management Systems Society. Page 5 of 6
6 VLC Rev. A VLC Feb//2016 Vitrea Software Revision Software Release Date Feb//2016 SECTION Opus Parkway Suite #00, Minnetonka, MN EXPLANATORY NOTES (from questions 1-19) IMPORTANT: Refer to Section of this standard for the proper interpretation of information requested in this form 1. The term device herein refers to the VitreaAdvanced software and /or license. Vital Images does not manufacture hardware or operating system software and /or components. 2. The VitreaAdvanced software can create audit logs that list user actions to ephi data. ephi information available to users is in the form of DICOM data and Reports. Any time a user loads a dataset, creates snapshots or batches, exports, reports on, prints, burns to media or deletes it from VitreaAdvanced, action is logged in an audit log file. does not manufacture hardware or operating system software and /or components which may extend these functions. 4. Technical Support can use WebEx or VPN for remote application (Vitrea ) support 5. does not provide customers with Anti-Virus Definition Files, Operating System Security or Service Packs. Customer is responsible for managing hardware security and software update policies. the Healthcare Information and Management Systems Society. Page 6 of 6
Manufacturer Disclosure Statement for Medical Device Security MDS 2 DEVICE DESCRIPTION
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Disclosure Statement for Medical Device Security MDS 2 DEVICE DESCRIPTION Device Model Company Name Software Revision or Representative Contact Information Hologic, Inc Representative Name/Position Chris
Manufacturer Disclosure Statement for Medical Device Security MDS 2 DEVICE DESCRIPTION MANAGEMENT OF PRIVATE DATA
A B C D HN 1-2013 Page 17,, See te Can this device display, transmit, or maintain private data (including electronic Protected Health Information [ephi])? Types of private data elements that can be maintained
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Page 17 Disclosure Statement for Medical Device Security MDS 2 DEVICE DESCRIPTION Device Model Software Revision Software Release Date Brevera 1.0.1.2 7/31/2017 Company Name Contact Information or David.Gilstrap@Hologic.com
Manufacturer Contact Information 5850 Opus Parkway, Suite 300, Minnetonka, MN 55343, USA (952)
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Manufacturer Disclosure Statement for Medical Device Security MDS 2 DEVICE DESCRIPTION MANAGEMENT OF PRIVATE DATA
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