90-MDS2 Form.pdf

Manufacturer Disclosure Statement for Medical Device Security MDS2 Device Category 10551, 18191

Manufacturer Carl Zeiss Meditec AG

Document ID 2012-00391

Document Date 2013-02-08

Device Name and Model CIRRUS photo 600

Software Revision

1.5.2 Build 1377

Software Release Date 2013-02-08

Other N/A

Manufacturer or Representative Contact Information

Name

Title

Department

Company Name

Telephone Number

E-mail

MANAGEMENT OF ELECTRONIC PROTECTED HEALTH INFORMATION (ePHI) As defined by HIPAA Security Rule, 45 CFR Part 164 Yes No N/A Note #

1. Can this device transmit or maintain electronic Protected Health Information (ePHI)? Yes

2. Types of ePHI data elements that can be maintained by the device:

a. Demographic (e.g., name, address, location, unique identification number)? Yes

b. Medical record (e.g., medical record #, account #, test or treatment date, device identification number)? Yes

c. Diagnostic/therapeutic (e.g., photo/radiograph, test results, or physiological data with identifying characteristics)? Yes

d. Open, unstructured text entered by device user/operator? Yes

3. Maintaining ePHI: Can the device

a. Maintain ePHI temporarily in volatile memory (i.e., until cleared on by power-off or reset)? Yes

b. Store ePHI persistently on local media? Yes

c. Import/export ePHI with other systems? Yes

4. Mechanisms used for the transmitting, importing/exporting of ePHI: Can the device

a. Display ePHI (e.g., video display)? Yes

b. Generate hardcopy reports or images containing ePHI? Yes

c. Retrieve ePHI from or record EPHI to removable media (e.g., disk, DVD, CD_ROM, tape, CF/SD card, memory stick)? Yes

d. Transmit/receive or import/export ePHI via dedicated cable connection (e.g., IEEE 1073, serial port, USB, FireWire)? Yes

e. Transmit/receive ePHI via a network connection (e.g., LAN, WAN, VPN, intranet, Internet)? Yes

f. Transmit/receive ePHI via an integrated wireless connection (e.g., WiFi, Bluetooth, infrared)? No

g. Other N/A

ADMINISTRATIVE SAFEGUARDS Yes No N/A Note #

5. Does manufacturer offer operator and technical support training or documentation on device security features? Yes

6. What underlying operating system(s) (including version number) are used by the device? Yes 1

PHYSICAL SAFEGUARDS Yes No N/A Note #

7. Are all device components maintaining ePHI (other than removable media) physically secure (i.e., cannot remove without tools)? Yes

8. Does the device have an integral data backup capability (i.e., backup onto removable media such as tape, disk)? Yes

9. Can the device boot from uncontrolled or removable media (i.e., a source other than an internal drive or memory component)? Yes TECHNICAL SAFEGUARDS Yes No N/A Note #

10. Can software or hardware not authorized by the device manufacturer be installed on the device? Yes

11. Can the device be serviced remotely (i.e., maintenance activities performed by service person via network or remote connection)? Yes

a. Can the device restrict remote access to specific devices or network locations (e.g., specific IP addresses)? No

b. Can the device log provide an audit trail of remote-service activity? No

c. Can security patches or other software be installed remotely? Yes

12. Level of owner/operator service access to device operating system: Can the device owner/operator?

a. Apply device manufacturer-validated security patches? Yes

b. Install or update antivirus software? Yes

c. Update virus definitions on manufacturer-installed antivirus software? Yes

d. Obtain administrative privileges (e.g., access operating system or application via local root or admin account)? Yes

13. Does the device support user/operator specific ID and password? Yes

a. Does your system support strong passwords, such as Minimum length; combination of letters, symbols and numbers; inability to use previous three passwords; some letters in CAPS?

No

b. Does your system enforce password aging, e.g.., you must change password every 90 days? No

14. Are access sessions terminated after a predetermined length of inactivity (e.g., auto logoff)? Yes 2

15. Events recorded in device audit log (e.g., user, date/time, action taken): Can the audit log record

a. Login and logout by users/operators? Yes 3

b. Viewing of ePHI? No 4

c. Creation, modification or deletion of ePHI? No 4

d. Import/export or transmittal/receipt of ePHI? No 4

16. Does the device incorporate an emergency access (“break-glass”) feature that logs each instance of use? No

17. Can the device maintain ePHI (e.g., by internal battery) during power service interruptions? No 5

18. Controls when exchanging ePHI with other devices:

a. Transmitted only via a physically secure connection (e.g., dedicated cable)? Yes

b. Encrypted prior to transmission via a network or removable media? No

c. Restricted to a fixed list of network addresses (i.e., host-based access control list)? No

19. Does the device ensure the integrity of the ePHI data with implicit or explicit error detection/correction technology? Yes 6

20. Other N/A

* Recommend use of ECRI’s Universal Medical Device Nomenclature System (UMDNS).

This form is adapted from HIMSS (Healthcare formation and Management Systems Society) MDS2 v 1.0 (2004-11-01) © 2004, HIMSS. HIMSS form adapted from Information Security for Biomedical Technology: a HIPAA Compliance Guide, ACCE/ECRI, 2004. ACCE—the American College of Clinical Engineering;

ECRI—formerly the Emergency Care Research Institute. <CZMI RA wgg v.2011-07-13> Page 1

Manufacturer Disclosure Statement for Medical Device Security--MDS2

RECOMMENDED SECURITY PRACTICES

• Device should be operated within a secured network only (firewall)

• Customer should enable the “user manager” module of CIRRUS photo to limit access to the device functions to skilled and trustworthy personnel

EXPLANATORY NOTES (from questions 1 – 19) IMPORTANT: Refer to Instructions for the Manufacturers Disclosure Statement for medical Device Security for the proper interpretation of information provided in this form.

1. Microsoft Windows Embedded POSReady 2009

2. The device software module "User manager" must be activated

3. The Windows operating system logs login/logout. The device software module "User manager" provides additional role based access privileges within the device software. This is logged in an additional debug log.

4. Actions are logged in debug log only.

5. The device does not handle power service interruptions. All the data that exists on the hard drive or connected PACS, however, will be available after power has been restored.

6. Only implicit, e.g. JPEG internal error detection, SQL database server internal consistency check.

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This form, with customized responses, adapted from HIMSS (Healthcare formation and Management Systems Society) MDS2 v 1.0 (2004-11-01) © 2004, HIMSS.

All rights reserved. HIMSS form adapted from Information Security for Biomedical Technology: a HIPAA Compliance Guide, ACCE/ECRI, 2004. ACCE—the American College of Clinical Engineering; ECRI—formerly the Emergency Care Research Institute.