General Electric MUSE ADVANCED SECURITY GUIDE_SM_2020285-023_C MUSE CV Information System Software Version 005E Advanced Security Guide 2020285-023 Revision C

GE Healthcare

MUSE CV

™

Information System

Software Version 005E

Advanced Security Guide

2020285-023 Revision C

NOTE: The information in this manual only applies to MUSE™ cardiology information system software version 005E.
It

does not apply to earlier software versions. Due to continuing product innovation, specifications in this manual are

subject

to change without notice.

© 2008 General Electric Company. All rights reserved.
MUSE® and MUSE CV® are trademarks owned by General Electric Company. All other marks are owned by their respective

owners.

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Contents

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Revision History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

Notes for Windows 2000 and Windows XP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

Checklist for MUSE Security Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

MUSE Features Which Require Policies/Procedures . . . . . . . . . . . . . . . . . . . . . . . 1-5

Access Control Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

Mid Level Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-6

High Level Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-6

Changing MUSE Service Accounts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-7

Changing the MUSE Accounts Passwords . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-7

Re-Installing the MUSE Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-8

Changing the MACCRA Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-8

User Authentication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

NT Authentication vs. MUSE Authentication . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-9

Force NT Authentication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-9

Unattended Workstation Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10

Logout Screen Saver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-11

Lockout Screen Saver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-16

Accounting/Logging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18

Transmit Log & Status Viewer (Outbound Events) . . . . . . . . . . . . . . . . . . . . . . .1-18

Change Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-20

Logging of System Security Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-21

Archived Log Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-22

Disabling Remote Query & Temporary Devices . . . . . . . . . . . . . . . . . . . . . . . . . . 1-23

MUSE Web . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24

Configure IIS to Log Web Site Activity on MUSE Web . . . . . . . . . . . . . . . . . . . .1-24

Setting Up Client Browser for 128-bit Encryption . . . . . . . . . . . . . . . . . . . . . . . . .1-25

Anti-Virus Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-26

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Appendices Appendix A – HIPAA Overview . . . . . . . . . . . . . . . . . . . . .A-1

HIPAA Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

HIPAA Law Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4

Privacy and Confidentiality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7

Electronic Health Transactions and Code Sets Standards . . . . . . . . . . . . . . . . . . A-8

HIPAA Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-10

Policy and Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-10

Achieving HIPAA Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-11

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-12

How HIPAA-Compliant Can Any Technology Be? . . . . . . . . . . . . . . . . . . . . . . . . A-13

Transactions Rule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-13

Privacy Rule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-13

Security Rule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-14

Overall... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-14

Appendix B – Summary of MUSE Security . . . . . . . . . . . .B-1

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3

Background Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4

Network Presence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4

Transactions, Code Sets, and Identifiers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-5

Identify all of the identifiers this product supports . . . . . . . . . . . . . . . . . . . . . . . . B-5

User Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-5

User Account Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-6

Authorizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-7

Auto-Logoff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-8

Device to Device Authentication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-8

Log All Security Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-8

Log All Patient Data Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-9

Log All Patient Data Modifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-10

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Log All Changes to the Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-10

Audit Log Viewing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-11

Audit Log Mining . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-11

Configuration Lockdown & Security Fixes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-12

AntiVirus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-13

Integrity Controls on Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-13

Backup and Recovery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-14

Encryption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-14

De-Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-14

Digital Signatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-14

Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-14

Appendix C – 21 CFR Part 11 Option . . . . . . . . . . . . . . . .C-1

Biometric Authentication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3

Other 21 CFR Part 11 Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-6

Disable Automatic Updates to Report Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-6

Logging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-6

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For your notes

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Introduction

Advanced Security Guide: Introduction

The MUSE system has several security features which, when properly used and
configured, can support USA facilities in complying with the Health Insurance
Portability and Accountability Act (HIPAA) Security and Electronic Signature
Standards. These new security standards were designed to protect patient’s health
information from improper access, alteration, and loss when it is maintained or
transmitted electronically.

For more information on the HIPAA Security and Electronic Signature Standards
link to:

http://ge.com/hipaa

Compliance with the HIPAA Security and Electronic Signature Standards cannot be
attained solely through the use of the security features on the MUSE system. Sites
which use the MUSE system to maintain and transmit patient health information
must use the security features in conjunction with a security plan which provides for
the user training and secure physical access to patient health information.

This document is provided to describe how to properly set up and use the security
features on the MUSE system. The responsibility of developing the security plan for
user training and secure physical access to patient health lies with the end user.

If you have any questions or need assistance with any of these security setups, call
the Jupiter On-Line Center at 1-800-558-7044.

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Revision History

Advanced Security Guide: Revision History

Each page of the document has the document part number followed by a revision
letter at the bottom of the page. This letter identifies the document’s update level.
The revision history of this document is summarized in the table be low.

Table 1. Revision History, PN 2020285-023

Revision Date Comment

A 15 April 2004 Initial release of manual.
B 21 July 2004 Document edited per feedback from 5E pilot installations.

Document edited for software version v5E.14 release.

C 7 February 2008

Removed “Low Level Security” from “Access Control
Security” section (SRS_2139).

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Advanced Security Guide: Notes for Windows 2000 and Windows XP

Notes for Windows 2000 and Windows XP

The MUSE software uses the WIN.INI file to store miscellaneous run-time
information . If the current user does not have write permissions to the WIN.INI file,
the MUSE software will not run as expected.

By default, Windows 2000 and Windows XP do not provide write permissions to the
WIN.INI file for the “Everyone” group.

The following is suggested as a workaround on systems running Windows 2000 or
Windows XP:

The system administrator must give the “Everyone” or “[DomainName]\MUSE
Users” group change permissions to the WIN.INI file. This can be
accomplished through the file Properties dialog in Windows Explorer.

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Advanced Security Guide: Checklist for MUSE Security Features

Checklist for MUSE Security Features

When setting up security on the MUSE system, use the following checklist as a reminder of security features available on the system
which address both HIPAA and FDA 21 CFR Part 11 requirements. Shaded features are not required for 21 CFR Part 11 compliance but
are considered good security practices.

FDA

Requirement

Authentication

&

Authorization

MUSE Feature Configuration Recommended Solution

MUSEAdmin, MUSEBkgnd, and MUSE Users’
passwords should adhere to facility’s best practice or
policy.

Users should be familiar with how to enable and disable
the MUSERss user.

Configure pcAnywhere Callers list to MUSERss only
pcAnywhere is set to use 128-bit key “Symmetric”

encryption level. (Upgrades only)
pcAnywhere’s “Event Logging” is set to log activities.

(Upgrades only)
NT Users should be mapped to MUSE Users.

“Allow Only NT Authentication” option is installed

All workstations are configured to use “Logout Screen
Saver” or “Lockout Screen Saver.”

*
















Access
Control Security

User
Authentication

Unattended
Workstation
Security

MUSE Users’
Password

MUSERss User

pcAnywhere
Encryption

pcAnywhere
Audit Trails

NT Authentication

Logout or Lockout
Screen Savers

NT Event Log Audit Policy

Accounting

&

Tracking

Web Encryption

&

Logging

Data Integrity Anti Virus

* Enabling of this feature requires the assistance of the Jupiter On-Line Support Center. Please dial 1-800-558-7044 to request

assistance with activating this feature.

Audit Trails Editor Security Enable the Change Log

Secure
Configuration

MUSE Web

Remote Query ‘Remote Query’ feature is disabled.

Temporary Device ‘Temporary Device’ feature is disabled.

SSL Encryption

SSL Logging

Browser

Anti Virus
Software
Configuration

The NT utility “Audit Policy” is set on MUSE Sever and
all workstations to log certain events.

MUSE file server is set to use SSL to force 128-bit
encryption. (See 2003934-001)

MUSE file server is set to use IIS to log MUSE Web
activities.

All browsers that access MUSE Web are updated to use
“High Encryption Pack” (128-bit encryption.)

Anti-virus software is installed and properly configured
on MUSE file server and all workstations.















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Advanced Security Guide: MUSE Features Which Require Policies/Procedures

MUSE Features Which Require Policies/Procedures

The table below contains MUSE features that will require policies and procedures
development to achieve security compliance.

Policies and Procedures Required for HIPAA & FDA Security Compliance

MUSE Feature Policy/Procedure

HL7 Device

COMPUTER Device

MUSE API

Buffer Server

SDLC

Policies and Procedures Required for FDA Security Compliance

Feature Policy/Procedure

Require Technicians to enter ID Number at
cart when taking the ECG









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Advanced Security Guide: Access Control Security

Access Control Security

The MUSE system has two default users, MUSEAdmin and MUSEBkgnd. This
section describes how to change the passwords of these default users to increase the
level of access control security on your system.

You can configure your MUSE system to one of two levels of security. Decide what
level of security you want for your MUSE system after reading and understanding
the information in this section. Determine how the security features available on the
MUSE system will work best in combination with your policies and procedures to
help you achieve HIPAA compilance.

Mid Level Security

The following table describes how to set up your MUSE system for mid level
system access control security.

User Name Password

MUSEAdmin

Change password as described in “Changing the MUSE

Accounts Passwords” on page 7 and tell GE Healthcare Tech

Support the new password. (Call 1-800-558-7044)

High Level Security

Change password as described in “Changing the MUSE

MUSEBkgnd

NOTE: GE Tech Support uses the MUSEAdmin user name and password to log into

MUSE systems remotely.

The following table describes how to set up your MUSE system for high level
system security.

Name Password

MUSEAdmin

MUSEBkgnd

NOTE: Not sharing these passwords with GE Healthcare Tech Support may result in

delays if remote service support is needed.

Accounts Passwords” on page 7 and tell GE Healthcare Tech

Support the new password. (Call 1-800-558-7044)

Change password as described in “Changing the MUSE Accounts

Passwords” on page 7 and DO NOT SHARE THE PASSWORD

with GE Healthcare Tech Support.
Change password as described in “Changing the MUSE Accounts

Passwords” on page 7 and DO NOT SHARE THE PASSWORD

with GE Healthcare Tech Support.

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Advanced Security Guide: Access Control Security

Changing MUSE Service Accounts

The MUSE service accounts are integral to the correct operation of the MUSE
system. The following table identifies the default accounts:

Default Account Description

MUSEAdmin MUSE administrator account. Used by the MUSE application

to perform functions critical to the system operation. Also used
by MUSE Tech Support to help troubleshoot and maintain the
system.

MUSEBkgnd MUSE background account. Used to run the MUSE services.

Changing the MUSE Accounts Passwords

1. Login to the Windows server as the user that you want to change the password
for.

2. Press Ctrl + Alt + Delete.

3. Choose Change Password... from the Windows Security dialog.

4. Enter the current password into the Old Password field.

5. Enter the new password into the New Password field.

6. Enter the new password again into the Confirm New Password field.

7. Click OK.

8. When the message Your password has been changed appears, click OK.

NOTE

If the MUSE server, HIS Interface, and MUSE clients are all using the

Windows domain MUSEBkgnd account to start services, the

same
previous steps need to only be performed once. If using local Windows
accounts (not recommended), the password will have to be changed on
each computer where the account exists.

What you do afterwards depends on which passwords you changed:

 If you changed the password for the MUSE administrative account, you are

done.

 If you changed the password for the MUSE background account, you need to

re-install the MUSE services. Continue to
on page 8.

“Re-Installing the MUSE Services”

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Advanced Security Guide: Access Control Security

Re-Installing the MUSE Services

Windows stores the Windows account name and password of the MUSE
background account with any service registration associated with that account.
Therefore, if you change the Windows account name or password, you also need to
re-install the MUSE services so they can be re-registered with the new Windows
account and password.

1. Open a Command Prompt window on the MUSE file server.

2. Type the following command and press Enter.

cvsinst domain\account password d:\vol000\system\sysinf\services.asc

3. When you receive a message stating that the services have been re-installed,
close the Command Prompt window and restart the CV_SCM service.

4. If there is a HIS Interface, repeat steps 1-3 on the HIS Interface.

5. If there are any MUSE clients with modems defined on them, the modem
services will have to be reinstalled on them. Refer to 2002783-012 for
instructions on installing modem services.

6. Determine whether the MACCRA service is installed and running and
do

one of the following.

 If the MACCRA service is not installed, you are done changing the

MUSE

 If the MACCRA service is installed, continue to “Changing the MACCRA

Service” on page 8.

Changing the MACCRA Service

The MACCRA service is used by several MUSE options, such as MUSE Web and
CV Web. If you change the MUSE background account name or password, use the
following procedure to modify the MACCRA service.

1. In the services list, locate the MACCRA service and open its Properties.

2. On the MACCRA Properties window, select the Log On tab.

3. Make sure the This account option is selected.

4. Enter the Windows domain and account name of the MUSE background
account in the This account field.

5. Enter the account’s password in both the Password and Confirm Password
fields.

6. Click OK.

7. Restart the service for the changes to take effect.

account password.

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Advanced Security Guide: User Authentication

User Authentication

NT Authentication vs. MUSE Authentication

The MUSE system has supported NT Authentication since it’s first release on the
Microsoft Windows NT platform with Version 005A. Using NT Authentication on
a MUSE workstation not only eliminates a second logon using MUSE
Authentication, but also supports a higher level of security as is recommended to
meet HIPAA compliance standards.

Since many facilities have yet to configure their MUSE system users as NT users,
the MUSE 005E system will continue to support MUSE Authentication* logon. In

MUSE 005E, as in previous Version 005 releases, NT workstation nodes can be
configured to use either NT Authentication or MUSE Authentication. Some
facilities still use MUSE Authorization on all MUSE nodes, but some have
switched to using NT Authentication on at least some nodes, if not all. The
transition to NT Authentication on all nodes (i.e. pure NT Authentication mode)
requires that all MUSE users are assigned NT user names and passwords, and that
their NT user names are mapped to their respective MUSE user names. See “MUSE
Information System Operator’s Manual” for details. The scope of the NT users
setup is tied to the number of MUSE users, and for some larger facilities, the
transition from MUSE to NT Authentication may occur over a period of time. When
all NT users setup is complete, the MUSE system can be configured to force NT
Authentication.

Force NT Authentication

The MUSE system supports a new feature which forces NT Authentication.

NOTE TO SERVICE:

This feature is disabled by default and should only be enabled when your MUSE
system is ready for pure NT Authentication mode as described above. (The

“Checklist for MUSE Security Features” on page 4 also documents the prerequisites

for turning on this feature.) This new feature forces all MUSE workstations to use
NT Authentication, regardless of their original authentication setting. Once this
feature is enabled, MUSE Authentication is disabled across the entire MUSE
system.

To enable this new feature on the MUSE system, contact the Jupiter On-Line
Support Center at 1-800-558-7044. There is no additional charge for enabling this
feature.

The Options Installer refers to this feature as “Allow Only NT Authentication.”

* “MUSE Authentication” refers to logon via the MUSE Authorization window.

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Advanced Security Guide: Unattended Workstation Security

Unattended Workstation Security

There are two options available to you for setting up logout/lockout security on
workstations which are left unattended for a specified amount of time. The two
options are:

1. Logout. When workstation is inactive (no mouse or keyboard input) for the
specified amount of time, the current user is logged off Windows NT and the
MUSE session is ended.

2. Lockout. When workstation is inactive for the specified amount of time, the
screen saver selected in the Control Panel is activated.

The table below summarizes these two options for unattended workstation security.
Be sure you understand how each option impacts the user before choosing one of
these options. Inform all system users about how the unattended workstation
security option affects their use of the system.

Table 2. Differences Between the Two Options for Unattended Workstation Security

Item

Logout Screen Saver

WINEXIT

Lockout Screen Saver

Logon with Password Protected

Access will be terminated after predetermined time of inactivity Yes Yes
Require authentication to log back into system Yes Yes
Workstation is locked No Yes

Users can unlock workstation N/A

MUSE application exit Yes

 Last user
 Administrator

 No, if Last user unlocks the workstation
 Yes, if Administrator unlocks the

workstation

 No, if Last user unlocks the workstation

Lose unsaved changes Yes

 Yes, if Administrator unlocks the

workstation

*

Possibility of locking record that was being edited when
screen saver took control.

Yes

 No, if Last user unlocks the workstation
 Yes, if Administrator unlocks the

workstation

* If a record is locked, a message will be displayed indicating the record is being used by another workstation. The message will

display the Node ID of the workstation that has locked the record. To unlock the record, any user can logon the workstation which
has locked the record and start MUSE application.

Once you have selected an unattended workstation security option, proceed with the
setup.

 To set up the Logout Screen Saver (winexit), go to “Logout Screen Saver” on

pages 11 through 15.

 To set up the Lockout Screen Saver (Logon with Password Protected). go to

“Lockout Screen Saver” on page 16.

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Advanced Security Guide: Unattended Workstation Security

Logout Screen Saver

The MUSE system includes the winexit.scr application which, when properly
configured, will logout the current user after the specified amount of time of
inactivity, displaying the Windows logon for the next user. This feature can be used
to provide additional security for unattended workstations on the MUSE system.

Giving Non-Administrators Permission to Use WINEXIT Screen Saver

In order for non-administrators to be able to use the WINEXIT screen saver, the
administrator must add Set Value and Create Subkey permissions for the group
Everyone on the following registry key:

HKEY_Local_Machine\Software\Microsoft\Windows
NT\CurrentVersion\IniFileMappings\Control.ini

Windows 2000 Workstations

Repeat the following steps at each workstation running Windows 2000.

1. Log onto the workstation as administrator.

2. Click Start → Run... .

3. Type REGEDT32.EXE and click OK.

4. Open the following key:

HKEY_Local_Machine\Software\Microsoft\Windows
NT\CurrentVersion\IniFileMappings\Control.ini

5. Click Security → Permissions... .

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6. Click Advanced.

7. Under Name, select Users and click View/Edit.

8. Click to select the Set Value and Create Subkey checkboxes.

9. Click OK twice to save your changes.

10. Select Registry → Exit to exit the Registry Editor.

11. Restart the workstation.

Windows XP Workstations

Repeat the following steps at each workstation running Windows XP.

1. Log onto the workstation as administrator.

2. Click Start → Run... .

3. Type REGEDT32.EXE and click OK.

4. Right-click the following key:

HKEY_Local_Machine\Software\Microsoft\Windows
NT\CurrentVersion\IniFileMappings\Control.ini

5. Click Permissions... from the pop up menu.

6. Click Advanced.

7. Highlight Users under the Name column in the Permissions Entries frame.

8. Click the Edit button.

9. Check the Allow boxes for Set Value and for Create Subkey.

10. Click OK.

11. Click OK.

12. Click OK.

13. Close the Registry.

14. Restart the workstation.

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Advanced Security Guide: Unattended Workstation Security

Existing Windows Users

Any users who are already setup as Windows Users, must log onto each workstation
and select the Logoff Screen Saver in the Control Panel.

1. Log into Windows using your Windows username and password.

2. Select Start → Programs → Command Prompt.

3. Type the following in the Command Prompt window to copy the winexit.scr
file the the system32 directory:

 For W indows 2000 and Windows XP workstations:

copy [Space] c:\mei\w2kexit.scr [Space]
%SystemRoot%\system32\winexit.scr and press Enter

4. Select Start → Settings → Control Panel → Display → Screen Saver.

5. Select Logoff Screen Saver in the Screen Saver list.

9A

6. Select the desired time in the Wait list.

7. Click the Settings... button.
a. Select Force application termination.
b. Set 60 seconds for countdown to application termination.
c. Type MUSE is Shutting down on this Workstation in th e Logoff Message

field.

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Advanced Security Guide: Unattended Workstation Security

a

b

8. Click OK to save your settings in the Wi nExit Setup Dialog window.

9. Click Apply in the Display Properties window.

10A

c

New Windows Users

10. Click OK in the Display Properties window.

11. Press Ctrl + Alt + Delete and click Logoff... button.

12. Click OK when the prompted that This will end your Windows Session.

13. Each user must repeat steps 1 through 10 on each on each workstation.

The following procedure, will ensure that all new users added to the Windows User
list in the future will automatically be set up with the logoff screen saver. These
steps must be repeated at each workstation.

1. Log on as an Administrator.

2. Select Start → Programs → Command Prompt.

3. Type the following in the Command Prompt window to copy the winexit.scr
file the the system32 directory:

 For W indows 2000 and Windows XP workstations:

copy [Space] c:\mei\w2kexit.scr [Space]
%SystemRoot%\system32\winexit.scr and press Enter

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Advanced Security Guide: Unattended Workstation Security

4. With the Command Prompt window still open, make a backup copy of the
Ntuser.dat file by typing the following:

 Windows 2000 or Windows XP Workstations:

echo [Space] F [Space] | [Space] xcopy [Space] /h [Space]
“C:\documents and settings\default [Space] user\ntuser.dat” [Space]
“C:\documents and settings\default [Space] user\ntuserbak.dat” and

press Enter

5. Close the Command Prompt window.

6. Click Start → Run... .

7. Type regedt32.exe and click OK.

8. Click the HKEY_USERS on Local Machine window.

9. Click the HKEY_USERS registry key, and then click Registry.

10. Then Load Hive... from the menu.

11. Click the Ntuser.dat file that is located in the following path:

 Windows 2000 or Windows XP Workst ations:

Documents and Settings\Default User\Ntuser.dat

12. Enter temp_defaultuser in the Key Name dialog box that is displayed and click
OK.

13. Double-click and expand temp_defaultuser.

14. Double-click and expand Control Panel.

15. Add a key:

 Select Edit → Add Key (Windows 2000)
 Select Edit → New → Key (Windows XP)

16. Enter Screen Saver.Logoff in the Key Name field and click OK (if applicable).
A class value is not required.

17. Click Desktop (under temp_defaultuser /Control Panel).

18. In the right window, change the value in ScreenSaveActive to 1.

19. Change the value in ScreenSaverIsSecure to zero (0).

NOTE

By default, this value is already zero (0).

20. Change the value in ScreenSaveTimeOut to desired time. (This value is in
seconds.)

21. Change the value in Scrnsave.exe to %SystemRoot%\system32\winexit.scr

22. Click the temp_defaultuser hive

23. Unload the hive:

 Click Registry → Unload Hive and click Yes to the warning (Windows

2000)

 Click File → Unload Hive and click Yes to the warning (Windows XP)

The changes will be saved in:

Documents and Settings\Default User\ntuser.dat

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Advanced Security Guide: Unattended Workstation Security

Lockout Screen Saver

Existing Windows Users

An alternative way of setting up system security is to set up individual users’ screen
savers with the “Password Protected” option enabled.

The steps below apply only to setting up password protection for existing NT users’
screen savers.

1. Log on with the name and password of the user you are setting up.

2. Select Start → Settings → Control Panel.

3. Double-click Display.

4. Click the Screen Saver tab.

5. Select Password protected checkbox.

6. Click Apply.

7. Click OK.

New Windows Users

8. Close the Control Panel.

The following procedure, will ensure that all new users added to the Windows User
list in the future will automatically be set up with the lock out Password Pro t ect
screen saver. These steps must be repeated by the Administrator at each workstation.

1. Log on as an Administrator.

2. Select Start → Programs → Command Prompt.

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3. Make a backup copy of the Ntuser.dat file by typing the following:

 For Windows NT workstations:

copy [Space] “c:\winnt\profiles\default [Space] user\ntuser.dat”
[Space] “c:\winnt\profiles\default

[Space] user\ntuserbak.dat” and

press Enter

 For W indows 2000 or Windows XP workstations:

echo [Space] F [Space] | [Space] xcopy [Space] /h [Space]
“c:\documents [Space] and [Space] settings\default [Space]
user\ntuserbak.dat” and press Enter

4. Close the Command Prompt window.

5. Click Start → Run... .

6. Type regedt32.exe and click OK.

7. Click the HKEY_USERS on Local Machine window.

8. Click the HKEY_USERS registry key, and then click Registry.

9. Then Load Hive... from the menu.

10. Click the Ntuser.dat file that is located in the following path:

 Winnt\Profiles\Default User\Ntuser.dat (Windows NT)
 Documents and Settings\Default User\Ntuser.dat (Windows

2000 & XP)

11. Enter temp_defaultuser in the Key Name dialog box that is displayed and click
OK.

12. Double-click and expand temp_defaultuser.

13. Double-click and expand Control Panel.

14. Select Edit → Add Key.

15. Enter Screen Saver.Logoff Key Name field and click OK. (A class
value is not required.)

16. Click Desktop (under temp_defaultuser /Control Panel).

17. In the right window, change the value in ScreenSaveActive to 1.

18. Change the value in ScreenSaverIsSecure to 1.

NOTE

By default, this value is zero (0).

19. Change the value in ScreenSaveTimeOut to desired time. (This value is in
seconds.)

20. Change the value in Scrnsave.exe to c:\winnt\system32\logon.scr

21. Click the temp_defaultuser hive

22. Click Registry → Unload Hive.
The changes will be saved in:

Winnt\Profiles\Default User\ntuser.dat (Windows NT)

documents and settings\Default User\ntuser.dat

(Windows 2000 or Windows XP)

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Advanced Security Guide: Accounting/Logging

Accounting/Logging

Transmit Log & Status Viewer (Outbound Events)

The MUSE system logs the following outbound events:

Network Printing to Postscript and PCL printers
Fax
CSI
email messaging
MEI Thermal
MUSE Word Report
Floppy Disk Acquisition

These outbound events can be viewed in System Status → Transmit Log.

MD1350-131A

Each record in the Transmit Log will contain the following fields.

Patient ID
Patient Name
Acquisition Date/Time
Order Number
Task
Station
Spool File Name
Output File

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Advanced Security Guide: Accounting/Logging

Destination Field (Device)
Logged User ID
Logged User Name
Date/time of transmission

NOTE

The MUSE system does not log HL7 and computer events. Policies and
procedures must be established to track the HL7 and computer device events.

The outbound events can also be viewed with the MUSE Status Viewer. At the file
server from the Windows NT desktop, select Start → Programs → MUSE CV
Information → Status Viewer.

MD1350-132A

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Change Log

Setting Up a Change Log

Advanced Security Guide: Accounting/Logging

NOTE

Prior to version 005D software this selection logged changes to confirmed
reports only. With version 005D software, changes to both confirmed as well as
unconfirmed reports are logged.

The MUSE system can be configured to log any changes made to a patient report.
The feature bit must be turned on as follows:

1. Select System → System Setup → Options → Report Type Options.

2. Click on a data type in the Options list and select Log Changes in the Choices
list.

3. Repeat step 2 for each data type.

Viewing and Printing a Change Log

1. The Change Log can be viewed from within a patient report by selecting Test
Data → Change Log.

2. To print the Change Log, click Print in the Change Log window.

11A

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Advanced Security Guide: Accounting/Logging

Logging of System Security Events

The MUSE system can be configured to log system security events to the NT Event
Log. At each file server and workstation, repeat the following steps to set up this

audit.

1. Click Start → Programs → Administrative Tools → User Manager

2. Select Policies → Audit.

3. Select the Audit These Events option button.

4. Select the checkboxes indicated in the table below.

Event Success Failure

Logon and Logoff
File and Object Access
Use of User Rights
User and Group Management
Security Policy Changes
Restart, Shutdown, and System
Process Tracking

5. Click OK to save your changes.

99

9
9

9
99
99

9

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Archived Log Files

Advanced Security Guide: Accounting/Logging

Once a week, the MUSE system automatically archives the following log files.

Log File Path

Archived Transmission Log vol000\system\ArchLog\Transmit\Xmityyww.btr
Archived Edit Change Log vol000\system\ArchLog\EditChg\Echgyyww.btr
Archived Discard Log vol000\system\ArchLog\Discard\Dscryyww.btr
Archived Error Log vol000\system\ArchLog\Error\Erryyww.btr
Archived Event Log vol000\system\ArchLog\Event\Evtyyww.btr
Archived Acquisition Log vol000\system\ArchLog\Acq\Acqyyww.btr

Where: yy = year

ww = Julian week (Day of year / 7)

These files can be viewed using Status Viewer as follows:

1. From the desktop, click Start → Programs → MUSE CV Information System →
Status Viewer.

12A

NOTE

These files are viewable in Status Viewer only when they are located in the
paths shown above. If you archive these files to another location, they must be
copied back to their original locations in order to be viewed with Status Viewer.

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Advanced Security Guide: Disabling Remote Query & Temporary Devices

Disabling Remote Query & Temporary Devices

The MUSE system does not log printing of reports to devices via remote query or to
temporary devices. With version 005D software, however, you can disable the
sending of patient reports to remote query or to temporary devices to enhance the
security of patient reports.

To prevent remote query via CSI modem and/or printing to a temporary device, log
into the system as a System Owner or Site Manager and follow the steps below.

1. Select System → System Setup → Select List → Sites.

Check to
disable CSI
Remote Query

Check to
disable printing
to Temporary
Devices

2. To disable remote query, select the Turn Off CSI Remote Query checkbox.

3. To disable printing to temporary devices, select the Turn Off Temporary Device
checkbox.

4. Click OK.

5. Repeat for each site on the system.

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Advanced Security Guide: MUSE Web

MUSE Web

IIS 4.0 Option Pack is installed on the MUSE Web server. In order to access the
MUSE Web, the user must have their browser configured for 128-bit encryption.

For detailed procedures, see “MUSE CV Web Server Instruction Guide to Enabling
SSL” (PN 2003934-001).

Configure IIS to Log Web Site Activity on MUSE Web

MUSE file server should be configured to enable logging web site activity as
follows:

1. Right-click My Computer and select Manage.

2. Expand Services & Application in the list found in the Tree list (left panel).

3. Highlight Internet Information Services.

4. Right-click on MUSE CV Web Site and select Properties.

5. Ensure that Enable Logging is checked in the Web Site tab.

6. For Active log format, make sure it is W3C Extended Log File Format.

7. Select Properties... .

 Select the General Properties tab.
 Select Weekly for New Log Time Period
 Make sure Log file directory is %WinDir%\System32\LogFiles
 Select Extended Properties tab
 Add/delete/verify checkmarks to obtain the following Extended Logging

Options.

Date

9

Time

9

Client IP Address

9

User Name

9

P Service Name

Server Name

9

Server IP

9

Server Port
Method

9

9

URI Query
Http Status

Win32 Status
Bytes Sent
Bytes Received
Time Taken
Protocol Version
User Agent
Cookie
Referrer

 Click OK in this window and in the next.

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Advanced Security Guide: MUSE Web

Setting Up Client Browser for 128-bit Encryption

MUSE Web server will allow only 128-bit encryption accesses. Users will need to
update their Internet Explorer (IE) 5.0 or 6.0 to have “High Encryption Pack”
installed.

NOTE

The High Encryption Pack can be downloaded from the Microsoft web site.

The steps below describe how to determine the IE encryption level.

1. Start Internet Explorer.

2. Select Help → About Internet Explorer.

3. If Cipher Strength is less than 128-bit, you will need to install High Encryption
Pack.

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Advanced Security Guide: Anti-Virus Software

Anti-Virus Software

Anti-virus software is a requirement for HIPAA compliance. GE has tested the
system with Norton Anti-Virus Corporate Edition and McAfee NetSheild. Either of
these two virus protections software application s can be installed on the MUSE
system without affecting function or performance.

This anti-virus software is not provided with the MUSE system and it remains the
customer’s responsibility to acquire and install anti-virus software on th eir system
per the recommendations of the manufacturer of the anti-virus software.

See the MUSE Pre-Installation Manual (PN 2020285-025) for GE’s recommended
anti-virus software configuration settings. When properly used, anti-virus software
can protect the MUSE system from virus infection and the subsequent data
corruption which can result from a virus infection. However, if improperly
configured, anti-virus software can cause system degradation.

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Advanced Security Guide: Anti-Virus Software

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A Appendix A –

HIPAA Overview

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Appendix A – HIPAA Overview: HIPAA Introduction

HIPAA Introduction

The future of health care in the United States changed on August 2, 1996 when the
Health Insurance Portability and Accountability Act (HIPAA) became law. The
complex and far-reaching federal legislation significantly affects every person and
organization involved in health care. HIPAA rules spell out standards and
requirements for protecting the confidentiality, security, and integrity of all health
information.

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Appendix A – HIPAA Overview: HIPAA Law Overview

HIPAA Law Overview

The primary goals of HIPAA are quantification of consumer health care rights along
with improved privacy and security of medical records. The two main components
of HIPAA are Health Care Portability and Administrative Simplification. The
Health Care Portability legislation became effective in 1996. The Portability part of
HIPAA is well understood and was successfully implemented by the US
government and the medical industry in 1996 and 1997. The Portability legislati on
guarantees the following rights to health care consumers:

 Improved availability and accessibility of health insurance
 Guaranteed right of portability and continuity of health insurance coverage for

individuals and groups

 Prohibits discrimination based on heal th status

HIPAA’s Administrative Simplification provision is composed of four parts and
involves these health care issues:

 Standardization of electronic transfers of patient health, administrative and

financial data

 Privacy and security standards protecting the confidentiality and integrity of

health information

 Unique health identifiers for individuals, employers, health plans and health

care providers

Each part will eventually produce a variety of rules and standards. Many of the rules
and standards are under development. As the rules and standards are finalized and
become law they will have different compliance deadlines. The four parts of
Administrative Simplification are:

1. Electronic Health Transactions Standards

2. Unique Identifiers

3. Security & Electronic Signature Standards

4. Privacy & Confidentiality Standards

HIPAA’s complexity confuses customers. Even the HIPAA name causes confusion.
Recently the meaning of the moniker HIPAA changed. Initially HIPAA referred to
all parts of the legislation. Current usage narrows HIPAA’s meaning to the rules
generated from the Administrative Simplification subsection. GE Medical Systems
Information Technologies follows common usage and unless otherwi s e no ted
HIPAA refers to the rules developed from the Administrative Simplification
subsection.

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Appendix A – HIPAA Overview: HIPAA Law Overview

The main components of HIPAA and their relationships are presented in Figure 1
below.

HIPAA Act of 1996

Health Care Portability

- Availability & Accessibility
Of Health Insurance

- Continuity of Health
Insurance Coverage

- Prohibits Discrimination
Based on Health Status

Administrative Simplification

(Now called HIPAA)

- Privacy & Security of Health Records

- Standardization of Electronic Transfers

- Unique National Identifiers

Transaction Standard

Privacy Standard

Identifiers Standard

Security Standard

Figure 1. HIPAA Components

The HIPAA component with the greatest impact on GEMS-IT customers is the
Privacy Standard. The Privacy Standard is defined in the Administrative
Simplification subsection. The Final Version of the Privacy Standard, (Standards for
Privacy of Individually Identifiable Health Information, 45 CFR Parts 160 and 164),
was published in the Federal Register on December 20, 2000.

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Appendix A – HIPAA Overview: HIPAA Law Overview

The HIPAA implementation and enforcement schedule spans several years. The
Privacy Standard becomes enforceable on April 14, 2003. Table 1 summarizes the
HHS release status and timetable for the HIPAA rules.

Table 1. HIPAA Rules and Rulemaking Timetable

Standard Publication Date Final Ruling

Required

Compliance

1. Insurance Portability Aug 02, 1996 Aug 02, 1996 Jul 01, 1997

2. Electronic Transactions & Code Sets

*

May 07, 1998 Aug 17,2000 Oct 16, 2003

3. Privacy & Confidentiality Nov 03, 1999 Dec 28, 2000 Apr 14, 2003

4. National Provider Identifier May 7, 1998 Expected 2002 –

5. National Employer Identifier Jun 16, 1998 Expected 2002 –

6. Security Aug 12, 1998 Expected 2002 –

7. National Health Plan Identifier In Development – –

8. Claims Enforcement Procedures In Development – –

9. National Individual Identifier

**

Withdrawn – –

* In January, 2002 the Bush Administration extended the deadline for the ‘Electronic Transactions & Code Sets’ from Oct 2002

until October 2003.

** Although the HIPAA law called for a unique health identifier for individuals, HHS and Congress indefinitely postponed any effort

to develop such a standard. (HHS Fact Sheet, Administrative Simplification, 2001)

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Appendix A – HIPAA Overview: Privacy and Confidentiality

Privacy and Confidentiality

The Final Rule for Privacy was published December 28, 2000. Compliance will be
required on April 14, 2003 for most covered entities. In general, privacy is about
who has the right to access personally identifiable health information. The rule
covers all individually identifiable health information in the hands of covered
entities, regardless of whether the information is or has been in electronic form. The
Privacy standards limit the non-consensual use and release of private health
information; give patients new rights to access their medical records and the right to
know who else accessed them; restrict most disclosure of health information to the
minimum needed for the intended purpose; establish new criminal and civil
sanctions for improper use or disclosure; establish new requirements for access to
records by researchers and others.

The Privacy and Confidentiality regulations incorporate five basic patient rights
related to health care information:

 Consumer Control: The regulation provides consumers with critical new rights

to control the release of their medical information

 Boundaries: With few exceptions, an individual’s health care information

should be used for health purposes only, including treatment and payment.

 Accountability: Under HIPAA, for the first time, there will be specific federal

penalties if a patient’s right to privacy is violated.

 Public Responsibility: The new standards reflect the need to balance privacy

protections with the public responsibility to support such national priorities as
protecting public health, conducting medical research, improving the quality of
care, and fighting health care fraud and abuse.

 Security: It is the responsibility of organizations that are entruste d with health

information to protect it against deliberate or inadvertent misuse or disclosure.

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Appendix A – HIPAA Overview: Electronic Health Transactions and Code Sets Standards

Electronic Health Transactions and Code Sets Standards

Health care organizations routinely store and transmit medical information in
electronic format. Electronic medical information is manipulated through a wide
variety of encoding schemes and formats. Standard electronic data interchange
improves the efficiency of health care delivery. National standards make it easier for
health plans, doctors, hospitals and other health care providers to process claims and
other transactions. (HHS Fact Sheet, Administrative Simplification, 2001) The
government and the medical industry perceive standardized representations of
routine medical data as beneficial for all parties involved. The Transactions
Standards mandates use of standardized electronic formats developed by ANSI, the
American National Standards Institute. The Code Set Standards require use of the
most commonly used medical terminology code sets. Final standards for electronic
transactions and code sets were released in Aug 2000. The original compliance
deadline of October 2002 was extended to October 2003.

The Transactions Standards specify the format and content of the following medical
transactions:

 Health claims or equivalent encounter information transfer
 Health claims attachments
 Enrollment and disenrollment actions in a health plan
 Eligibility status in a health plan
 Health care payment and remittance advice
 Health plan premium payments
 First report of injury
 Health claim status
 Referral certification and authorization

The Health organizations must adopt standard code sets for all health transactions.
Code sets are alphanumeric identifiers representing medical data. Medical coding
systems describe diseases, injuries, and other health problems, as well as causes,
symptoms and actions taken. All parties exchanging medical transactions must
generate and accept the same coding. Consistent coding reduces mistakes,
duplication of effort and costs. HIPAA specifies the following commonly used code
sets:

1. International Classification of Diseases, 9th Edition, Clinical Modification,
(ICD-9-CM), Vols 1, 2, 3

2. National Drug Codes (NDC)

3. Code on Dental Procedures and Nomenclature,

4. Health Care Financing Administration Common Procedure Coding System
(HCPCS)

5. Current Procedural Terminology, Fourth Edition (CPT-4),

The Transactions Standards regulate information related to health insurance status
and remittance. GEMS-IT cardiology information system products are clinical
systems and rarely (if ever) process the health insurance and remittance information
affected by the Transactions Standards. The GE Medical Systems Information

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Appendix A – HIPAA Overview: Electronic Health Transactions and Code Sets Standards

Technologies cardiology information system products are not affected by the
Transactions Standards.

The Code Set Standards regulate use of clinical medical information. The Code Set
Standards may affect GE Medical Systems Information Technologies cardiology
equipment. The cardiology equipment may need to support input of code set values
when test information is acquired.

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Appendix A – HIPAA Overview: HIPAA Compliance

HIPAA Compliance

HIPAA compliance is achieved through a combinatio n of changes to ‘policy and
procedure’ and the purchase of HIPAA enhanced hardware, software, and other
technologies. No product can independently confer HIPAA compliance rather the
product must fit into a customer specific HIPAA compliance scheme. Technology
updates and ‘policy and procedure’ changes are pieced together by customers into a
unique and site specific HIPAA compliance solution. The precise mechanisms for
achieving HIPAA compliance are left to the covered entities. HIPAA does not
mandate specific vendor equipment or mechanisms for achieving compliance. The
HIPAA implementers are free to create the systems that enable compliance as they
see fit. The HIPAA implementers must decide how much of the compliance will
come from new and upgraded technology versus the amount achieved via changing
‘policy and procedure’. HIPAA expects a majority of the compliance can be
achieved through ‘policy and procedure’ changes and the remaining compliance
achieved via deployment of new and updated technology. The authors of the HIPAA
provided guidance concerning policy and procedure in the Federal Register (Dec 28,

2000):

Policy and Procedures

The rule requires that covered entities develop and document policies and
procedures with respect to protected health information to establish and maintain
compliance with the regulation. Through the standards, requirements, and
implementation specifications, we are proposing a framework for developing and
documenting privacy policies and procedures rather than adopting a rigid,
prescriptive approach to accommodate entities of different sizes, type of activities,
and business practices. Small providers will be able to develop more limited policies
and procedures under the rule, than will large providers and health plans, based on
the volume of protected health information. We also expect that provider and health
plan associations will develop model policies and procedures for their members,
which will reduce the burden on small businesses.

The myriad of HIPAA compliance solutions presents a difficult challenge to
customers. Customers want to stay focused on their primary job of providing quality
health care. Customers expect vendors to provide detailed HIPAA guidance tailored
to the customer’s unique security needs and health care environment.

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Appendix A – HIPAA Overview: HIPAA Compliance

Achieving HIPAA Compliance

Achieving HIPAA compliance is a top-down process of learning, planning and
implementing. Health care institutions must become intimately familiar with
HIPAA rules. The HIPAA implementer must conduct a self-analysis to determine
how HIPAA fits into their unique situation. The HIPAA rules must be broken down
into understandable categories and tasks. Many internal stakeholders must be
consulted in order to ensure full compliance. Once a plan is in place then the
HIPAA-enabling technology is purchased and the ‘policy and procedure’ documents
created. The last stage is integration and deployment of all the HIPAA mechanisms
followed by an audit, ensuring compliance. The HIPAA compliance effort requires
strong commitment and detailed planning. The American Health Information
Management Association (AHIMA) created the HIPAA Privacy Checklist (2001) to
guide to HIPAA implementers:

 Get management commitment
 Appoint HIPAA team
 Perform GAP analysis
 Understand current security policy and IT practices
 Perform risk analysis
 Draft required policies, procedures, and consents
 Obtain needed HIPAA-enabling technology
 Deploy ‘policy and procedure’ and technology
 Audit HIPAA polici es, test privacy measures, test security measures

GE Medical Systems Information Technologies can advise and add value at each
phase of HIPAA implementation.

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References

Appendix A – HIPAA Overview: References

General Electric Medical Systems HIPAA Overview:

http://ge.com/hipaa

Dept. of Health and Human Services, Office of the Secretary, (Dec 28, 2000).
Standards for Privacy of Individually Identifiable Health Information, Comments
and Rules, 1535 pages, Federal Register 45 CRF Parts 160 through 164, p 82783

http://www.hhs.gov/ocr/fedreg.zip

Dept. of Health and Human Services, Office of the Secretary, (Dec 28, 2000).
Standards for Privacy of Individually Identifiable Health Information, Rules only 40
pages, Federal Register 45 CRF Parts 160 through 164, p 82783

http://aspe.os.dhhs.gov/admnsimp/final/PvcTxt01.htm

HHS Fact Sheet: Administrative Simplification Under HIPAA: National Standards
For Transactions, Security And Privacy. (May 11, 2001). Retrieved from U.S.
Department of Health and Human Services Web site:

http://www.hhs.gov/news/press/2001pres/01fshipaa.html

Quarterly Industry HIPAA Survey Results - Summer 2001. (Aug 6, 2001).
Retrieved Aug 10, 2001, from Phoenix Health Systems HIPAAdvisory Web site:

http://www.hipaadvisory.com/action/survey/summer01.htm

HHS FAQ Sheet: The Rule Making Process for Administrative Simplification:
What Is Taking So Long? (July 2, 1999)
Retrieved from U.S. Department of Health and Human Services Web site:

http://aspe.os.dhhs.gov/admnsimp/8steps.htm

HIPAA Primer, Retrieved Nov 29, 2001,from Phoenix Health Sy stems
HIPAAdvisory Web site:

http://www.hipaadvisory.com/regs/HIPAAprimer1.htm

HIPAA Privacy Checklist, Retrieved Aug 10, 2001, from the American Health
Information Management Association Web site:

http://www.ahima.org/journal/pb/01.06.1.html

Information on Microsoft solut i on s fo r the healthcare industry and for a copy of
Microsoft’s HIPAA Technical White Paper.

http://www.microsoft.com/business/health

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Appendix A – HIPAA Overview: How HIPAA-Compliant Can Any Technology Be?

How HIPAA-Compliant Can Any Technology Be?

By Roy Rada, M.D., Ph.D.
Department of Information Systems
University of Maryland, Baltimore County

American history has witnessed a myriad of compliance activities; some we might
point with pride to, such as the 1906 Pure Food and Drug Act, resulting from Dr.
Harvey Wiley’s efforts to regulate the content of food. However, the role of
government in regulating business in the US has often been accompanied by
controversy and debate.

HIPAA has proved to be another battleground for compliance. Without going
further into the history, politics, law, or ethics of compliance, let’s address the
seemingly simple question of whether information technology can be compliant
with HIPAA.

How many times have you heard a vendor tout ‘my technology is HIPAA
compliant’? Some providers and payers are demanding to get HIPAA compliant
technology. Claims are commonly made by salespeople that their product is HIPAA
compliant. What’s the scoop here?

Transactions Rule

Privacy Rule

Direct compliance with HIPAA’s administrative simplification provisions is not
practical because the law itself is too indirect. It calls for rules to be developed and
enforced by the executive branch of the federal government. Furthermore, the rules
are diverse and cover, at least, transactions, privacy, and in proposed-form security.

Might an IT vendor rightfully claim to be compliant with the Transactions Rule?
‘Transaction’ refers in the HIPAA-context to provider-payer transaction. The
Transactions Rule calls for compliance with certain standards, particularly X12
formats. A health care provider might want to use information systems that support
message formats to payers that are compliant with X12, and a vendor could claim to
provide such X12-compliant forms.

This is not to say that the entity buying the technology would have an instant fix to
its ‘Transactions’ compliance problem. The Transactions Rule goes beyond the X12
formats to specify the codes that have to be used inside the fields of the format.
Achieving compliance with some coding requirements may entail change s in
behavior. However, technology could enforce the use of Transaction Rule formats
and codes and thus support compliance with the HIPAA transaction rule.

Privacy calls for changes in the way an entity manipulates information. This is
largely an administrative rather than a technical issue. However, a technology can
support the options for manipulating information and be a vital support of the entity
behavior. The technology should support behavior consistent with the Privacy
Rule.

The Privacy Rule calls for information systems that represent and audit workflow.
Exactly what the workflow should be is not precisely defined. The approach of the

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Security Rule

Appendix A – HIPAA Overview: How HIPAA-Compliant Can Any Technology Be?

Privacy Rule is like the ISO (the pre-eminent international standards organization)
approach to quality in ISO 9000. ISO 9000 says that an organization should be clear
in its goals and work consistently to those goals. ISO 9000 does not say what the
organization-specific goals should be, but an organization can be certified as ISO
9000 compliant. To be ISO 9000 compliant an organization must document its
objectives and document that its activities take it towards its objectives – nothing
more. The Privacy Rule goes beyond ISO 9000 in specifying broadly what some of
the privacy objectives are but then asks entities to be quality organizations as respect
to those objectives.

Entities must document working towards privacy objectives. Certifying compliance
for privacy would require an analysis of the organizational manual and the way the
organization implemented its manual. An IT tool should help a health care entity
have and follow the appropriate organizational manual but the tool would not make
the entity HIPAA compliant.

No security rule has been finalized for HIPAA. Yet, security is the topic that comes
closest to what an IT vendor feels is the special turf of the vendor. The typical health
care entity may be violating various security mandates, such as transmitting
information over the Internet in encrypted form. A vendor can provide tools that
encrypt messages before sending them across the Internet.

Overall...

The proposed security rule gives objectives of secure transmissions, reliable
authentication, contingency preparations, and much more. However, the proposed
rule gives flexibility to organizations in their choice of ways to achieve the
objectives and is neutral about particular technologies. The compliance argument
about security is not dissimilar to the argument about privacy: when an organization
uses a technology in a certain way to reach a certain objective, then the organization
will have behaved in a compliant way as regards that HIPAA security objective.

The bottom line is that Administrative Simplification is about Administration, and
technology can support that administration – but not replace it. An information
technology vendor should help its clients understand what parts of HIPAA
compliance are supported by the vendor’s technology. But it should not claim that
the technology is HIPAA compliant.

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B Appendix B – Summary

of MUSE Security

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For your notes

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Introduction

Appendix B – Summary of MUSE Security: Introduction

The following table is based on a MUSE CV system with 005D software with no
MUSE CV Web option. These tables are in direct response to the need for security
features in medical systems. We provide these answers to assist you in discovering
your risks and in the creation of your mitigation plan. We provide these answers to
the best of our knowledge given the requirements and current state of the product.

This document contains a summary of the Legal Requirements of Health Insurance
Portability and Accountability Act (HIPAA). It is not intended as legal advice.
Every entity must make its own judgment regarding what will be required to enable
it to comply with HIPAA. General Electric Company reserves the right to make
changes in specifications and features shown herein, or discontinue the product
described at any time without notice or obligation. Contact your GE Representative
for the most current information.

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Appendix B – Summary of MUSE Security: Background Information

Background Information

Enter any description that helps clarify the security context. The security context would include product options,

Unknown

environmental conditions, intended
Does the product Capture, Store, or Transmit any Patient identifiable data? Yes
Identify the architecture that best describes this product: Client/Server
What Operating System is this product Client based on? WIN2003
What Operating System is this product based on (or in the case of client/server products -- what is the server)? WIN2003
Which GSP Platform does the product utilize? Unknown
Can the product display a customer supplied message on boot up or login? No
Does the product provide a training mode that allows for training without corrupting the operational data? No

Network Presence

Does this product have a communications/network interface (Not including Remote Service)? Yes
Identify all of the Communications interface that this product has:

Ethernet Yes
Token-Ring No
ATM No
RF (802.11, blue tooth, other radio) No
COTS Modem Yes
Other Modem (eg SDLC) Yes
Direct Serial Yes

Other No
Does this product have a Database? Btrieve
Identify all of the Services/Protocols the product provides:

Any Direct Network db Access (JDBC, ODBC, SQL, etc) Yes

DICOM Yes

HL7 Yes

XML Yes

Hill Top Yes

Unity No

AdvantageNET No

PostScript or PCL printers Yes

SMTP or MAPI Yes

FAX Yes

SNMP Yes

FTP Yes

Telnet / X windows No

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Appendix B – Summary of MUSE Security: Transactions, Code Sets, and Identifiers

Share (NFS, SMB, etc) Yes

Customer Accessible API? Yes

Other No

None No
Identify the modes of Network Communications of Patient Identifiable Data that is supported using the above protocols:

Send Patient Identifiable Data to other systems Yes

Receive Patient Identifiable Data from other systems Yes

Provide a Query interface that other systems can use to extract Patient Identifiable Data Yes
Does this product have a Web Server? No

Transactions, Code Sets, and Identifiers

Identify all of the Code Sets this product sends or receives:

non-standard equivalents to X12N Transactions (Billing EDI transactions)? No

standard X12N Transactions (Billing EDI transactions)? No

non-standard equivalents to CDT code sets (Dental Services)? No

standard CDT code sets (Dental Services)? No

non-standard equivalents to CPT4 code sets (Physician services)? No

standard CPT4 code sets (Physician services)? No

non-standard equivalents to ICD9 code sets (Diseases, injuries, etc)? No

standard ICD9 code sets (Diseases, injuries, etc)? No

non-standard equivalents to NDC code sets (Drugs and Biotics)? No

standard NDC code sets (Drugs and Biotics)? No

non-standard equivalents to HCPCS code sets (other services)? No

standard HCPCS code sets(other services)? No

User (soft) configured codes that may be configured to include CDT, CPT4, ICD9, NDC, or HCPCS? Yes

None of the above No

Identify all of the identifiers this product supports

“National Provider Identifier” (USA Unique identifier for all individuals providing healthcare services)? No

“National Employer Identifier” (USA Unique identifier for all healthcare facilities)? No

“National Payer Identifier" (USA Unique identifier for all insurance carrier)? No

None of the above Yes

User Identification

Does the product provide for individual identification (accounts) of clinical users (excluding service users)? Yes
What is the maximum number of accounts (0<zero> ==> theoretically infinite) 1000
Does the product support passwords for authentication of the clinical users? Yes
Does the product utilize the operating system authentication for clinical users? Yes
Does the product place constraints on username? No

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Appendix B – Summary of MUSE Security: User Account Maintenance

Identify all of the authentication technologies this product supports

NT Domain Yes

MS Active Directory No

Non-NT Kerberos No

NIS / YP No

CCOW No

Other No

None No

During login does the product inform the user of the last time the system was accessed using that user account? No

Can the user authentication be augmented by a biometric, token, or other method besides passwords? Yes
Identify all of the advanced authentication the product supports:

tokens Yes

smart cards Yes

badge readers No

written signature verification No

one-time password generators No

biometric identifiers No

Certificate identification No

dial-back modems No

Other No

None No
How does the customer get these advanced authentication methods? Customer

supplied

User Account Maintenance

Identify all of the information associated with a user account:

Full Name Yes

Additional Identifier Yes

Title Yes

Department No

Phone Number Yes

E-mail Address Yes

Street Address No

FAX Number Yes

Other No

None No

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Appendix B – Summary of MUSE Security: Authorizations

Who Can administer user accounts? Multiple

Accounts

Identify all of the User Administrative controls supported

Audit Log of all account changes No

Set an account inactive without removing the account? Yes

Force a logoff of an active user? No

Automatic de-activation of an account on a specified date or number of days/time? No

Automatic de-activation of an account after a configured number of days of non-use? Yes

Other No

None No
Identify all of the User Account Reports supported:

List of all user accounts No

List of currently active users Yes

List of all user accounts with last used date/time No

Other No

None No

When an account is marked inactive or deleted does the product disable in real-time any active sessions using that ID? Yes

Does the product provide a tool for batch management of user accounts? Yes

Authorizations

Does the product support multiple levels of access control that can be assigned to user accounts? Yes
Does the product support multiple levels of access control that can be assigned to groups of user accounts? Yes
Identify all of the access control rights that can be applied to a user:

View Patient Identifiable Data on screen Yes

Print Patient Identifiable Data to paper or film Yes

Modify Patient Identifiable Data Yes

Export Patient Identifiable Data to removable digital media No

Delete Yes
Identify all the methods by which the access control right are applied:

Access at database view level No

Access at file level No

Access at file system directory level No

Time-of-Day No

Weekly Schedule No

Workstation (location) No

Other Yes

None No

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Appendix B – Summary of MUSE Security: Auto-Logoff

Does product hide functionality that the user does not have rights to (to prevent the user from even knowing a functionality

Yes

exists)?
Does the product further restrict access based on patient specific consent? No

Auto-Logoff

Identify all of the inactivity Auto Logoff capability supported:

Screen Saver (screen blanking) with no reAuthentication No

Password protected Screen Saver (screen blanking) Yes

Application Logout No

Application blanking, with re-authentication allowing continuation. No

Other No

None No
Can the administrator override any inactivity screen/application blanking? Yes
Identify how the inactivity timeout can be configured:

System Wide No

Workstation (location) Yes

Per-User No

Device to Device Authentication

Identify all of the entity authentication that is used, when communicating and the remote user is not or can not be
authenticated serial number

Mac address No

IP Address No

AE-Title No

Process identifier No

Task identifier No

Unidirectional PKI certificate challenge (ex: simple SSL) No

Bidirectional PKI certificate challenge (ex: client and server auth SSL) No

Other No

None Yes

Log All Security Events

Identify all of the Security Events that can be logged:

Machine Shutdown Yes

Machine Boot Yes

Application start Yes

Application stop Yes

No

Network link/connection failures Yes

Data Integrity failure No

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Appendix B – Summary of MUSE Security: Log All Patient Data Views

Successful User Login Yes

Failed User Login Yes

User Logout Yes

Auto-Logoff Yes

Forced logoff by administrator No

A user changed their password Yes

An admin reset/cleared a users password Yes

Attempt by a user to access function/data that they do not have access to No

User/Group account creation Yes

User/Group account deletion Yes

User/Group Access rights modification No

Other No

None No
Identify all of the contents of a Security Event log entry:

Date and Time Yes

Time to millisecond accuracy No

Identifier of the User Yes

Identifier of the device (workstation, IP, or other station identification) Yes

Event description Yes
Are these security events tracked in a different log than patient identifiable data related events? Yes
On failed authentication attempts, is the password attempted entered into the log? No
Is the log file persistent (NOT automatically overwritten or deleted)? Not limited
Is access to this log restricted to authorized individuals? Yes
Can the customer specify the list of events to track? No

Log All Patient Data Views

Identify all of the Patient Identifiable Data View events that can be logged:

Printouts Yes

Export to files Yes

Export to removable media Yes

Faxed Yes

E-Mailed Yes

View by browser Yes

View by client application No

Retrieved over network protocol (DICOM, XML, API, etc) No

De-identification No

Other No

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Appendix B – Summary of MUSE Security: Log All Patient Data Modifications

None No
Identify all of the contents of a Patient Identifiable Data View log entry:

Date and Time Yes

Time to millisecond accuracy No

Identifier of User Yes

Identifier of Device (workstation, IP, or other station identification) Yes

Identifier of the application No

Identifier of the function within the application No

Identification of the Patient Yes

How long the data was displayed No

Event description Yes
Is the log file persistent (NOT automatically overwritten or deleted)? not limited
Is access to this log restricted to authorized individuals? Yes
Can the customer specify the list of events to track? No

Log All Patient Data Modifications

Identify all of the Patient Identifiable Data Modification events that can be logged:

modification of clinical data prior to a final report (diagnosis, medications, observations, measurements, etc) Yes

modification or amendments to a final report Yes

modification of patient demographics Yes

modification of test date, time, or setup parameters Yes

modification of diagnosis Yes

None No
Identify all of the contents of a Patient Identifiable Data Modification log entry

Date and Time Yes

Time to millisecond accuracy No

Identifier of User Yes

Identifier of Device (workstation, IP, or other station identification) Yes

Identifier of the application No

Identifier of the function within the application No

Identification of the Patient Yes

Event description Yes

Is the log file persistent (NOT automatically overwritten or deleted)? not limited

Is access to this log restricted to authorized individuals? Yes

Can the customer specify the list of events to track? No

Log All Changes to the Configuration

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Appendix B – Summary of MUSE Security: Audit Log Viewing

Identify all of the Configuration Change events that can be logged:

Change of the system Date and/or Time No

Installation of patches, maintenance, FMI, hotfix, etc Yes

IP Address or other network configuration No

Analysis algorithm parameters No

Creation, modification, or deletion of output devices/API/interface/AE No

Creation, modification, or deletion of input devices/API/interface/AE No

Other No

None No
Identify all of the contents of a Configuration Change log entry:

Date and Time Yes

Time to millisecond accuracy No

Identifier of User No

Identifier of Device (workstation, IP, or other station identification) No

Identifier of the application No

Identifier of the function within the application No

Event description Yes

Is the log file persistent (NOT automatically overwritten or deleted)? date limited

Is access to this log restricted to authorized individuals? Yes

Can the customer specify the list of events to track? No

Audit Log Viewing

Is there protection against ALL modification of all log files? Yes
Is deletion of a log tracked in a different log? No
Is viewing of a log tracked in a different log? No
Does the product provide alerts based on automated advanced log analysis? No
Are the audit trail alerts tracked in an log? No
Is there a time syncronization function included and documented? Yes

Audit Log Mining

Does the product support the use of third-party audit mining packages? No
Does the product support a mechanism for creating a text based audit log (or are the audit logs already text)? No
Does the product integrate with CA Unicenter or HP Openview? No
Does the product provide searching tools for the audit logs? No
Does the product provide sorting tools for the audit logs? Yes
Identify all of the Audit Trail Reports that can be created:

Users accessing records with the same last name as the user No

Users accessing records with the same address as their address No

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Appendix B – Summary of MUSE Security: Configuration Lockdown & Security Fixes

Access to records that have not been accessed in a long time No

Access to an employee’s own patient data No

Accesses to minor’s patient data No

Accesses to terminated employees patient identifiable data No

Multiple login attempts with improper authentication No

All users that have use a specific function No

All activity of a specific user No

All accesses to a specific patient No

All activity from a specific workstation or communications link No

All login and logout activity within a period of time No

All login failures No

All Access control failures No

All Modifications to security settings No

All changes to authentication settings No

All access via remote service interface No

All changes to the audit trails configuration No

Other No

None Yes

Configuration Lockdown & Security Fixes

Is this OS configured to meet DOD - C2 Compliance? No
Have unnecessary services and protocols been turned off? Yes
Have unnecessary services and protocols been uninstalled? Yes
Are default passwords documented in any form of manual? Yes
Are passwords that are not changable used for administrative accounts? No
Is the SNMP community name set to "public" or "private"? No
Is there documentation available that describes the services and protocols that are necessary for proper operation of the

Yes

product?
Is the customer free to apply any Operating System or tool vendor fixes to the product? No
Does the M4 release contain all security fixes for the OS, database, or any other third party tools within 6 months of the

Yes

M4 date?
For Operating Systems:

The typical time window between when a patch is available and when it can be applied to a customer system is 6

Yes

months

The typical time window between when a patch is available and when it can be applied to a customer system is 12

Yes

months

The customer can get OS fixes that are no more than 12 months old Yes

Is this database configured with the minimal services and protocols running? Yes

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For Databases:

Appendix B – Summary of MUSE Security: AntiVirus

The typical time window between when a patch is available and when it can be applied to a customer system is 6

Yes

months

The typical time window between when a patch is available and when it can be applied to a customer system is 12

Yes

months

The customer can get database fixes that are no more than 12 months old Yes

Does the product include other third party tool or application (Backup software, SNMP agent, pcAnywhere,

Yes

maintenance tool, Microsoft Office, etc)
For other 3rd party tools:

The typical time window between when a patch is available and when it can be applied to a customer system is

Yes

6 months

The typical time window between when a patch is available and when it can be applied to a customer system is

Yes

12 months

The customer can get 3rd party tool fixes that are no more than 12 months old Yes
List any Third Party Applications, Tools, Libraries, Drivers? IE,

MSDE,
MDAC,
MMC,
Diske

AntiVirus

Are all product releases and maintenance releases scanned for any malicious code (Virus, Worm, Trojan)? Yes
Identify all of the Malicious Code detection supported:

Host based Intrusion Detection No

Norton AntiVirus Yes

McAfee AntiVirus Yes

Other Windows AntiVirus No

Customer supplied AntiVirus software No

Customer administrated AntiVirus Signature Files No

Tripwire or other No

None No

Integrity Controls on Data

Does the product utilize transparent end-to-end data integrity controls? (memory parity, tcp checksums, etc) Yes
Does the product enforce application managed data integrity controls like object checksums? No
Does the product support PKI based Digital Signatures to maintain data integrity? No
Does the product enforce required fields during data entry to ensure completeness of records? Yes
Does the product have a data entry validation mechanism such as double keying of patient identifiable data to ensure

No

accuracy of the data entered?
Does the product store rejected transactions with the reason for the rejection? Yes
Does the product ensure that database updates are done in a failsafe way? Yes

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Appendix B – Summary of MUSE Security: Backup and Recovery

Is there any Other form of integrity control provided? No

Backup and Recovery

How many patient records does this product store or manage? unlimited
Identify all the ways that the product protects against disasters/failures:

Export to removable media No

RAID hard drive Yes

backup of patient data only (typically to tape) Yes

backup of full system (typically to tape) Yes

UPS Yes

Off site mirroring No

Near-line storage No

Other No

None No
Backup and Recovery procedures are documented? Yes
Can the Integrity and completeness of the backup be verified by the operator through the use of offline means? Yes

Encryption

Is any form of encryption of patient identifiable data supported (not including the service interface)? No

De-Identification

Is there a bulk de-identification functionality that the user can use? (not service interface) No

Digital Signatures

Does the product provide for some form of electronic acceptance stamp on Patient Identifiable Data ? Yes
Does the product provide for a PKI based digital signature? No
Does the product support DICOM supplement 41 Digital Signature Extensions? No

Service

Is there a method that service can use to access the system in the case of an emergency when normal administration is

Yes

not possible?
Does the product have at least one login specifically for servicing the equipment? Yes
Does the product restrict service individuals with multiple levels of access control? No
Does the product support multiple individual service accounts? No
Does the product support multiple individual service accounts? No
Are Service accounts restricted from viewing, or manipulating Patient Data? No
Are all accesses to Patient Data by service restricted to de-identified data? No
Are Service actions accounted for in a log file somewhere? Manually
Are passwords that are not changeable used for Operating System administrative accounts? No
Are passwords that are not changeable used for service accounts? No
Are Service default passwords described in details in any form of manual? No

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Appendix B – Summary of MUSE Security: Service

Is the customer allowed to change the service passwords? Yes
Does the product support remote service? pcAnywhere
Does the remote service session require authentication to a service user? Yes
Can the customer tell that a remote service session is in progress? Yes
Can the customer, through automatic or manual methods, know which specific service individual is currently remotely

No

logged in?
Can the customer see what is happening in an active remote service session? Yes
Can the customer stop an active remote service session? Yes
Specify the equivilant encryption strength that a remote service session can operate over? 3DES
Is the product specific GE Remote Service network isolated from the rest of the GE intranet? No
Are access points to the GE service network protected with an ICSA equivalent firewall? No
Are remote sessions ever initiated without a Service call being logged by the customer? No

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For your notes

Appendix B – Summary of MUSE Security: Service

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C Appendix C –

21 CFR Part 11 Option

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Appendix C – 21 CFR Part 11 Option: Biometric Authentication

Biometric Authentication

The 21 CFR Part 11 option is available with MUSE CV software version 005D.02
software and higher. When this option is enabled, the Site Information window
contains two additional check boxes.

 21 CFR Part 11
 Biometric Authentication

14A

1. Use the Select button to display the Site Information window for the site which
must meet the requirements of 21 CFR Part 11.

2. Select the 21 CFR Part 11 check box.

NOTE

This check box is not checked by default. In order to have this option be
functional on the site, the check box must be checked.

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Appendix C – 21 CFR Part 11 Option: Biometric Authentication

3. If biometric authentication is being used for EVERY USER on the site, check
the Biometric Authentication check box.

21 CFR Part 11
Biometric Authentication

4. If the site has some users who use biometric authentication and some users who
do not use biometric authentication, check 21 CFR Part 11 and leave Biometric
Authentication unchecked.

21 CFR Part 11
Biometric Authentication

When Biometric Authentication is left unchecked in Site Setup, individual’s
User Setups will be used by the system when they confirm reports.

;

;

;



16A

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Site Setup Window User Setup Window Description

21 CFR Part 11 ;

Biometric Authentication 

21 CFR Part 11 ;

Biometric Authentication 

Appendix C – 21 CFR Part 11 Option: Biometric Authentication

The table below summarizes how the individual user’s Biometric
Authentication option functions.

User Biometric Authentication Summary

Users who have Biometric
Authentication checked in their User

Biometric Authentication ;

Setup window will not be prompted

for a password when they confirm
reports.

Users who do not have Biometric

Authentication checked in their User

Biometric Authentication 

Setup window will be prompted for a

password EACH TIME they confirm a
report.

Revision C MUSE™ cardiology information system C-5

2020285-023

Appendix C – 21 CFR Part 11 Option: Other 21 CFR Part 11 Features

Other 21 CFR Part 11 Features

Disable Automatic Updates to Report Data

When the 21 CFR Part 11 option is enabled, automatic updates to report data are
disabled on the MUSE system. This means that confirmed reports are not updated
when new reports for the same patient are confirmed. It also means that the MUSE
CV system does not update data entered/acquired at the cart.

 Patient demographic data (age, gender, race, height, and weight) are not updated

in confirmed data when new reports for the same patient are confirmed on the
system.

 After QTC has been calculated at the cart, the MUSE CV system does not re-

calculate QTC upon acquisition of this data.

 When user IDs have been entered at the cart, the MUSE CV system does not

assign user names to these IDs upon acquisition of this data.

Logging

When the 21 CFR Part 11 option is enabled, all changes made to patient reports are
logged and these log files are archived by the system.

C-6 MUSE™ cardiology information system Revision C

2020285-023

GE Medical Systems
Information Technologies, Inc.
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Milwaukee, WI 53223 USA
Tel: + 1 414 355 5000

1 800 558 7044 (US Only)

Fax: + 1 414 355 3790

www.gehealthcare.com

GE Medical Systems
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Germany
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Fax: + 49 761 45 43 - 233

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GE Medical Systems
Information Technologies Asia; GE (China) Co., Ltd.
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Fax: + 86 21 5208 2008