General Electric 2034539-048A MUSE V8 ADVANCED SECURITY GUIDE_SM_2034539-048_A MUSETM Cardiology Information System Advanced Security Guide Software Version 8.0 2034539-048 A

GEHealthcare

MUSE™CardiologyInformationSystem

AdvancedSecurityGuide

SoftwareVersion8.0
2034539-048A

MUSECardiologyInformation
Systems
English
©2011GeneralElectricCompany.
AllRightsReserved.

TheinformationinthismanualonlyappliestoMUSE™CardiologyInformationSystemsoftwareversion8.Itdoesnotapplytoearlier
softwareversions.Duetocontinuingproductinnovation,specicationsinthismanualaresubjecttochangewithoutnotice.

MUSEandInSitearetrademarksownedbyGEMedicalSystemsInformationTechnologies,Inc.,aGeneralElectricCompanygoingtomarket
asGEHealthcare.Allothertrademarkscontainedhereinarethepropertyoftheirrespectiveowners.

Thedocumentpartnumberandrevisionappearatthebottomofeachpage.Therevisionidentiesthedocument’supdatelevel.The
revisionhistoryofthisdocumentissummarizedinthefollowingtable.

Revision

A

Date

29March2011InitialRelease

Comment

2

MUSE™CardiologyInformationSystem

2034539-048A

29March2011

Contents

1Introduction

SecurityFeaturesOverview........................................................................5

RegulatoryandSafetyInformation.............................................................5

SafetyConventions...................................................................................6

SafetyHazards.........................................................................................6

DocumentConventions...............................................................................6

TypographicalConventions.........................................................................6

Illustrations.............................................................................................7

Notes....................................................................................................7

2MUSESecurityFeatures

ChecklistforMUSESecurityFeatures.........................................................9

MUSEFeaturesthatRequirePolicies/Procedures.....................................10

AccessControlSecurity.............................................................................11

ChangingtheDefaultSystemAccounts....................................................12

3UserAuthentication

WindowsAuthenticationvs.MUSEAuthentication..................................13

AllowingMUSEAuthentication..................................................................13

UnattendedWorkstationSecurity............................................................14

4Accounting/Logging

PrintLog....................................................................................................17

ChangeLog...............................................................................................17

EditChangeLog........................................................................................19

ProcessLog...............................................................................................19

MUSEAdministratorAccount......................................................................11

MUSEBackgroundAccount........................................................................12

SettingUpSecurityforanUnattendedWorkstation...........................................15

LoggingSystemSecurityEvents...............................................................20

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3

5MUSEWeb

ConguringIIStoLogWebsiteActivityonMUSEWeb.............................23

SettingupClientBrowserfor128-bitEncryption......................................24

6Anti-VirusSoftwareandSecurityUpdates

Anti-VirusSoftware...................................................................................25

SecurityUpdates.......................................................................................25

AAppendixA—HIPAAOverview

HIPAAIntroduction....................................................................................27

HIPAALawOverview.................................................................................27

PrivacyandCondentiality.......................................................................29

ElectronicHealthTransactionsandCodeSetsStandards........................30

BAppendixB—SummaryofMUSESecurity

Introduction..............................................................................................33

CAppendixC—21CFRPart11Option

Introduction..............................................................................................47

ElectronicSignature..................................................................................47

Other/RelatedFeatures............................................................................48

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Introduction

SecurityFeaturesOverview

TheMUSE™CardiologyInformationSystem(alsoreferredtoastheMUSEsystem)has
severalsecurityfeatureswhich,whenproperlyusedandcongured,cansupport
U.S.A.facilitiesincomplyingwiththeHealthInsurancePortabilityandAccountability
Act(HIPAA)SecurityandElectronicSignatureStandards.Thesenewsecuritystandards
weredesignedtoprotectpatient’shealthinformationfromimproperaccess,
alteration,andlosswhenitismaintainedortransmittedelectronically.

FormoreinformationontheHIPAASecurityandElectronicSignatureStandardsrefer
tothefollowinglink:

http://ge.com/hipaa

CompliancewiththeHIPAASecurityandElectronicSignatureStandardscannotbe
attainedsolelythroughtheuseofthesecurityfeaturesontheMUSEsystem.Sites
whichusetheMUSEsystemtomaintainandtransmitpatienthealthinformation,must
usethesecurityfeaturesinconjunctionwithasecurityplanwhichprovidesforthe
usertrainingandsecurephysicalaccesstopatienthealthinformation.

1

Thisdocumentisprovidedtodescribehowtoproperlysetupandusethesecurity
featuresontheMUSEsystem.Theresponsibilityofdevelopingthesecurityplanfor
usertrainingandsecurephysicalaccesstopatienthealthlieswiththeenduser .

Ifyouhaveanyquestionsorneedassistancewithanyofthesesecuritysetups,call
theGEHealthcareSupportCenterat1-800-558-7044.

RegulatoryandSafetyInformation

Thissectionprovidesinformationaboutthesafeuseandregulatorycomplianceof
thisdevice.Familiarizeyourselfwiththisinformationandreadandunderstandall
instructionsbeforeattemptingtousethisdevice.Thesystemsoftwareisconsidered
medicalsoftware.Assuch,itwasdesignedandmanufacturedtotheappropriate
medicalregulationsandcontrols.AnyexceptionsarenotedintheCompliance
Information-Exceptionssection.

NOTE:

Disregardingthesafetyinformationprovidedisconsideredabnormaluseof
thisdeviceandcouldresultininjury,lossofdata,andvoidanyexistingproduct
warranties.

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5

Introduction

SafetyConventions

AHazardisasourceofpotentialinjurytoaperson,property,ortheproduct.

ThismanualusesthetermsDANGER,WARNING,andCAUTIONtopointouthazards
andtodesignateadegreeorlevelofseriousness.Familiarizeyourselfwiththe
followingdenitionsandtheirsignicance.

DenitionsofSafetyConventions

SafetyHazards

WARNING:

DocumentConventions

Safety
Convention

DANGER

WARNING

CAUTION

Denition

Indicatesanimminenthazard,which,ifnotavoided,willresultindeath
orseriousinjury.

Indicatesapotentialhazardorunsafepractice,which,ifnotavoided,
couldresultindeathorseriousinjury.

Indicatesapotentialhazardorunsafepractice,which,ifnotavoided,
couldresultinminorpersonalinjuryorproduct/propertydamage.

INCORRECTTREATMENT:Someofthecommunicationsprotocolsusedinthis
product(CSIandDCP)donotprovideencryptionorauthenticationatthistime.
TheseprotocolsareusedtosendclinicaldatatotheMUSEsystemfromECGcarts
andotherclinicaldevices.

Youshouldtakeappropriatestepstosecuretheprivacyofcommunicationson
yournetworkwhenusingthisproduct.

Thismanualusesthefollowingconventions.

TypographicalConventions

ConventionDescription

BoldTextIndicateskeysonthekeyboard,texttoenter,orhardwareitemssuchas

Italicized-Bold

Text

CTRL+ESC

6

buttonsorswitchesontheequipment.

Indicatessoftwaretermsthatidentifymenuitems,buttonsoroptionsin
variouswindows.

Indicatesakeyboardoperation.Aplus(+)signbetweenthenamesoftwo
keysindicatesthatwhileholdingtherstkey,youshouldpressandrelease
thesecondkey.Forexample,PressCTRL+ESCmeanstopressandholdthe
CTRLkeyandthenpressandreleasetheESCkey.

MUSE™CardiologyInformationSystem

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ConventionDescription

<space>

Enter

>

Introduction

Indicatesthatyoumustpressthespacebar.Wheninstructionsaregiven
fortypingaprecisetextstringwithoneormorespaces,thepointwhere
youmustpressthespacebarisindicatedas:<space>.Thisensuresthat
thecorrectnumberofspacesareinsertedinthecorrectpositionswithin
theliteraltextstring.Thepurposeofthe<>bracketsistodistinguishthe
commandfromtheliteraltextwithinthestring.

IndicatesthatyoumustpresstheEnterorReturnkeyonthekeyboard.Do
nottypeEnter.

Thegreaterthansymbol,orrightanglebracket,isaconcisemethodto
indicateasequenceofmenuselections.

Forexample,thestatement“Fromthemainmenu,selectSystem>Setup>
OptionstoopentheOptionActivationwindow”replacesthefollowing:

1.Fromthemainmenu,selectSystemtoopentheSystemmenu.

2.FromtheSystemmenu,selectSetuptoopentheSetupmenu.

3.FromtheSetupmenu,selectOptionstoopentheOptionActivation

window.

Illustrations

Notes

Allillustrationsinthemanualareprovidedasexamplesonly.Dependingonsystem
conguration,screensthatappearinthemanualmaydifferfromthescreensasthey
appearonyoursystem.

Allpatientnamesanddataarectitious.Anysimilaritytoactualpersonsis
coincidental.

Notesprovideapplicationtipsoradditionalinformationthat,whileuseful,arenot
essentialtothecorrectoperationoftheproduct.Theyarecalledoutfromthebody
textthroughaagwordandindentation,asfollows:

NOTE:

ThetiporadditionalinformationappearsindentedbelowtheNOTEagword.

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Introduction

8

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MUSESecurityFeatures

ChecklistforMUSESecurityFeatures

WhensettingupsecurityontheMUSEsystem,usethefollowingchecklistasa
reminderofsecurityfeaturesavailableonthesystemthataddressbothHIPAAand
FDA21CFRPart11requirements.Shadedfeaturesarenotrequiredfor21CFRPart11
compliance,butareconsideredgoodsecuritypractices.

2

FDA
Requirement

Authentication
&
Authorization

MUSEFeature

Access
Control
Security

User
Authentication

Unattended
Workstation
Security

CongurationRecommendedSolution

MUSEUsers’
Password

Windows
Authentication

Logoutor
Lockout
ScreenSavers

MUSEAdmin,MUSEBkgnd,
andMUSEUsers’
passwordsshouldadhere
tofacility’sbestpracticeor
policy.

WindowsUsersshouldbe
mappedtoMUSEUsers.

AllowOnlyWindows
Authenticationoptionis

installed

Allworkstationsare
conguredtouseLogout

ScreenSaverorLockout
ScreenSaver.

1

r

r

r

1.EnablingthisfeaturerequirestheassistanceoftheGEHealthcareSupportCenter .Pleasedial1-800-558-7044torequestassistance
withactivatingthisfeature.

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MUSESecurityFeatures

FDA
Requirement

Accounting&
Tracking

Web
Encryption&
Logging

DataIntegrityAntiVirusAntiVirus

MUSEFeature

Windows
EventLog

AuditTrailsEditorSecurityEnabletheChangeLog.

Secure
Conguration

MUSEWeb

CongurationRecommendedSolution

AuditPolicyTheWindowsutility“Audit

RemoteQuery

UserEntered
Destination

SSL
Encryption

SSLLogging

Software
Conguration

Policy”issetontheMUSE
serverandallworkstations
tologcertainevents.

TheRemoteQueryfeature
isdisabled.

TheUserEntered
Destinationfeatureis
disabled.

TheMUSEleserverisset
touseSSLtoforce128-bit
encryption.

TheMUSEleserverisset
touseIIStologMUSEWeb
activities.

Virusprotectionsoftware
isinstalledandproperly
conguredontheMUSEle
serverandallworkstations.

r

r
r

r

r

r

r

MUSEFeaturesthatRequirePolicies/Procedures

ThefollowingMUSEfeaturesrequirepoliciesandprocedurestoachievesecurity
compliance.

PoliciesandProceduresRequiredforHIPAA&21CFRPartIISecurityCompliance

MUSEFeature

HL7Device

Folder,FTPFolder,EmailPatientDataleavingthesystem,thus,no

MUSEAPI

Fax

WhyaPolicy/ProcedureisNeeded

PatientDataleavingthesystem,thus,no
longerchangeloggingorprotectingaccess
ofrecords.

longerchangeloggingorprotectingaccess
ofrecords.

Dataisleavingthesystemandmaynotbe
underanysecuritycontrol.

Faxedinformationcanbeviewedbyanyone,
thusapolicyshouldbeinplaceregarding
coverpages,andcondentialityofpatient
information.Workwithyourlegaldepartment
indevelopingthesepolicies/procedures.

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PoliciesandProceduresRequiredforHIPAA&21CFRPartIISecurityCompliance

MUSESecurityFeatures

AccessControlSecurity

RemoteQuery

AllowinguserstoenterdestinationDataisleavingthesystemandmaynotbe

PoliciesandProceduresRequiredfor21CFRPartIISecurityCompliance

Feature

AcquiringECGsrequiresTechniciansto
enterIDNumberatcart

Dataisleavingthesystemandmaynotbe
underanysecuritycontrol.

underanysecuritycontrol.

WhyaPolicy/ProcedureisNeeded

Dataleavesthesystemandnotunderany
securitycontrol

TheMUSEsystemrequirestwoWindowsuseraccounts:

•MuseAdmin–usedbyGEHealthcareservicepersonneltoaccessandworkon

thesystem

•MuseBkgnd–usedbytheMUSEsystemtorunbackgroundWindowsServices

AccountnamesandpasswordsfortheMUSEAdminandMUSEBkgndWindowsuser
accountsaremanagedthroughWindowslikeanyotherWindowsuseraccount.
Bothaccountsshouldhavepasswordsthataresettoneverexpire.Ifthepasswords
change,GEHealthcareservicepersonnelmaynotbeabletologintothesystemto
providesupport,andthebackgroundserviceswillfailtostart,causingtheMUSE
systemtostopfunctioning.AllotherusersoftheMUSEsystemcanusetheirnormal
WindowsusercredentialstoaccesstheMUSEsystem.InsidetheMUSEapplication,
theusersaresetupwiththeirdomain\useraccountinformation.Nopassword
informationisrequiredwhenconguringaMUSEuser.Theuserpasswordscanbe
controlledorchangedthroughWindowsasrequired.

Thefollowingsectionsdescribestheseaccounts,howtheyareused,andthesystem
requirements.TheserequirementsaremetbyfollowingtheinstructionsintheMUSE
CardiologyInformationSystemInstallationManual.

MUSEAdministratorAccount

TheMuseAdminaccountisusedbyGEHealthcareservicepersonneltologintothe
MUSEsystemtoperforminitialsetupandconguration,andtoprovideongoing
serviceandsupport.

Thisaccountmustmeetthefollowingrequirements:

•NeedstobeamemberoftheWindowsAdministratorsGroupontheMUSEle

server.

•MustbeassignedasystemadministratorroleinSQLserver.Forinstructions

onaddingasystemadministratorroleinSQLserver,seetheMUSECardiology
InformationSystemInstallationManual.

•Shouldbeadomainaccountwheneverpossible.Asanalternative,itcanbean

accountlocaltotheMUSEleserver.

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MUSESecurityFeatures

•BoththeaccountnameandpasswordfortheMUSEAdminaccountcanbe

•Thecustomershouldnotusethisaccountforanypurposeandshouldinstead

MUSEBackgroundAccount

TheMuseBkgndaccountisusedtostarttheMUSErelatedbackgroundservicesonthe
MUSEleserver.Thisaccountneedstomeetthefollowingrequirements:

•NeedstobeamemberoftheWindowsAdministratorsGroupontheMUSEle

•MustbeassignedasystemadministratorroleinSQLserver.Forinstructions

•Mustnotbesubjecttoanypoliciesthatwouldnotallowtheaccountthe“LogonAs

determinedbythecustomer,butmustbesharedwithGEHealthcareservice
personnelsothattheycanusethataccountwhentheyworkontheMUSEsystem.
Forinstructionsonchangingtheaccountnameandpassword,seetheMUSE
CardiologyInformationSystemServiceManual.

createanaccountforeachindividualuserusingthesystem.

server.

onaddingasystemadministratorroleinSQLserver,seetheMUSECardiology
InformationSystemInstallationManual.

Service”right,sincethatrightisarequirementfortheaccounttobeabletostart
theMUSErelatedbackgroundservices.

•Shouldbeadomainaccountwheneverpossible.Asanalternative,itcanbean

accountlocaltotheMUSEleserver.

•BoththeaccountnameandpasswordfortheMUSEAdminaccountcanbe

determinedbythecustomer,butmustbesharedwithGEHealthcareservice
personnelsothattheycanusethataccountwhentheyworkontheMUSEsystem.
Forinstructionsonchangingtheaccountnameandpassword,seetheMUSE
CardiologyInformationSystemServiceManual.

•Thecustomershouldnotusethisaccountforanypurposeandshouldinstead

createanaccountforeachindividualuserusingthesystem.

ChangingtheDefaultSystemAccounts

CustomersusingWindowsauthenticationmaychoosetochangetheWindows
accountnames,accountpasswords,orbothtoaddresssecurityissuesortocomply
withchangesinnetworkstandardsatanytime(see“WindowsAuthenticationvs.

MUSEAuthentication”onpage13).Thenameandpasswordchangesaremadeusing

theLocalUsersandGroupsfunctionoftheAdministrativeToolsontheMUSEle
server.Inaddition,severalcommandlineutilitiesmustberuntoensurethatthe
changesarereectedintheMUSEsystem.

CustomersusingMUSEauthentication,maychoosetochangethepasswordsforthe
defaultaccountsatanytime(see“WindowsAuthenticationvs.MUSEAuthentication”

onpage13).Theycannot,however ,changetheaccountnames.Thepassword

changesaremadeusingthestandardMUSEUserSetupfunction.

FordetailedinstructionsonchangingtheWindowsaccountnames,theWindows
accountpasswords,ortheMUSEaccountpasswords,refertotheMUSE™Cardiology
InformationSystemServiceManual.

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UserAuthentication

MUSEprovidestwotypesofuserauthentication:

•WindowsAuthentication

•MUSEAuthentication

WindowsAuthenticationvs.MUSE Authentication

UsingWindowsAuthenticationonaMUSEworkstationnotonlyeliminatesasecond
logonusingMUSEauthentication,butalsosupportsahigherlevelofsecurityasis
recommendedtomeetHIPAAcompliancestandards.

MUSEauthenticationismostcommonlyusedonaclientworkstationthatissharedby
multipleusers,andwherethoseusersdonotwanttologoutofWindowsandlogback
intoruntheMUSEapplicationandberecognizedasadifferentuser .Eachpersonthat
runstheMUSEapplicationonthesharedworkstationcanlogintoMUSEwiththeirown
usernameandpassword.TohelpmeetHIPAAcompliance,policiesandprocedures
willneedtobeinplacewhenusingMUSEauthentication.

3

UsingWindowsauthentication,usersarenotrequiredtologintotheMUSEapplication
separately.WhentheMUSEapplicationislaunched,MUSEwillautomaticallylogthem
inastheproperuser,basedontheuserthatisloggedintoWindowsonthatcomputer.
Windowsauthenticationsupportsahigherlevelofsecurityasrecommendedtomeet
HIPAAcompliancestandards.

AllowingMUSEAuthentication

Bydefault,thesystemallowseitherMUSEorWindowsauthentication.Todisable
MUSEauthenticationonthesystemsothatWindowsauthenticationcanbeused,
contacttheGEHealthcareSupportCenterat1-800-558-7044,orcontactyour
regionalsupportcenterifyouareoutsidetheUnitedStates.

IfMUSEauthenticationisallowed,itcanbeenabledatindividualworkstations
byaddingthefollowingswitchtotheshortcutthatisusedtolaunchMUSE:

-museauthenticate.

IfMUSEauthenticationisdisabledandausertriestologinusingMUSEauthentication,
amessagewillappearstatingMUSEauthenticationisnotenabled.

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UserAuthentication

IfauserisloggedintotheMUSEsystemusingtheircorrectWindowsauthentication,
anerrormessageappears,buttheywillbeallowedintothesystem.

IfauserisloggedintotheMUSEsystemasadifferentuser,andlogsinusingMUSE
authentication,anerrormessageappearsandtheywillnotbeallowedintothesystem.

UnattendedWorkstationSecurity

Twooptionsareavailableforsettinguplogout/lockoutsecurityonworkstationsthat
areleftunattendedforaspeciedamountoftime:

•Logout—Whenaworkstationisinactive(nomouseorkeyboardinput)fora

speciedamountoftime,thecurrentuserwillbeloggedoffWindows,andthe
MUSEsessionwillend.

•Lockout—Whenaworkstationisinactiveforaspeciedamountoftime,the

screensaverselectedintheControlPanelisactivated.

Thefollowingtablesummarizesthesetwooptionsforunattendedworkstation
security.Besureyouunderstandhoweachoptionimpactstheuserbeforechoosing
oneofthem.Informallsystemusersabouthowtheunattendedworkstationsecurity
optionaffectstheiruseofthesystem.

DifferencesbetweentheTwoOptionsforUnattendedWorkstationSecurity

Item

Accesswillbeterminated
afterapredeterminedtime
ofinactivity

Requiresauthentication
tologbackintotheMUSE
system

Theworkstationislocked

Userscanunlockworkstation

TheMUSEapplicationexits

LogoutScreenSaver

WINEXIT

YesYes

YesYes

NoYes

N/A

Yes

LockoutScreenSaverLogon

withPasswordProtected

•Lastuser

•Administrator

•No,ifthelastuserunlocks
theworkstation

•Yes,iftheAdministrator
unlockstheworkstation

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MUSE™CardiologyInformationSystem

2034539-048A

DifferencesbetweentheTwoOptionsforUnattendedWorkstationSecurity

UserAuthentication

Item

Loseunsavedchanges

Possibilityoflockingarecord
thatwasbeingeditedwhen
thescreensavertookcontrol.

2

.

LogoutScreenSaver

Yes

Yes

SettingUpSecurityforanUnattendedWorkstation

Therearetwowaysyoucansetupsecurityforanunattendedworkstation.

•WINEXITcanbeusedifyouarerunningWindowsXP .

•SettingupascheduledtaskcanbeusednomatterwhichWindowsversionyou

areusing.

ConguringtheWinexit.scrScreensaverforWindowsXP

IfyouarerunningWindowsXP,theWinexit.scrscreensaverforcestheusertoquit
programsandlogoffafterasetperiodofinactivity.Toinstallthewinexitscreensaver
onatypicalWindowsXPsystem,usethefollowinginstructionsortheinstructions
foundathttp://support.microsoft.com/kb/314999.

WINEXIT

LockoutScreenSaverLogon

withPasswordProtected

•No,ifthelastuserunlocks
theworkstation

•Yes,iftheAdministrator
unlockstheworkstation

•No,ifthelastuserunlocks
theworkstation

•Yes,iftheAdministrator
unlockstheworkstation

1.DownloadthelefromtheWindows2003ResourceKitat

http://www.microsoft.com/downloads/en/details.aspx?FamilyID=
9D467A69-57FF-4AE7-96EE-B18C4790CFFD&=en,oruseWindowsExplorer

tolocatetheWinexit.scrleintheWindows2000ResourceKitfolderonyour
harddrive.

2.Right-clicktheWinexit.scrle,andthenclickInstall.

TheDisplayPropertiesdialogboxopenswiththeScreenSavertabactive.and
theLogoffScreenSaverentryisautomaticallyselected.

3.ClickSettings.

4.SelecttheForceapplicationterminationcheckboxtoforceprogramstoquit.

5.IntheCountdownfornsecondsbox,typethenumberofsecondsthelogoff
dialogboxwillappearbeforetheuserisloggedoff.

6.IntheLogoffMessagebox,typethemessagethatappearsduringthelogoff
countdown.

7.ClickOK.

8.IntheDisplayPropertiesdialogbox,clickPreview.

2.Ifarecordislocked,amessagewillbedisplayedindicatingtherecordisbeingusedbyanotherworkstation.Themessagewilldisplaythe
NodeIDoftheworkstationthathaslockedtherecord.Tounlocktherecord,auserwithsufcientprivilegescanlogontheworkstation
whichhaslockedtherecordandstarttheMUSEapplication.

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UserAuthentication

9.ReviewtheAutoLogoffdialogbox.

10.ClickCancel.

11.ClickOKtosavethesettings.

AlternativetoWINEXIT

Theotherwaytologoffusersafterinactivityistousethepssshutdown.exeprogram
fromsysinternals.Thisprogramwilllogoutthecurrentlyloggedinuseronthe
systemwhereitisinstalled.Youcanusethesystemschedulertorunthistaskafter
thesystemhasbeenidle.

1.Logontohttp://technet.microsoft.com/en-us/sysinternals/bb897541.aspxfor

2.PlacetheleintotheC:\windowsfolder.

3.Scheduleataskasthelocaladministratorusingc:\windows\psshutdown.exe

4.UndertheScheduletab>ScheduleTask,selectWhenidle.

Itdisplaysthelogoffmessageandthecountdowntimer.

instructionsanddownloadthesysinternalspsshutdown.execommand.

-o-f.

5.IntheeldWhenthecomputerhasbeenidlefor,enterthenumberofminutes

beforeautomaticshutdown.

6.UndertheSettingstab,leavethe72hoursatthetopasis.SelectOnlystart
thetaskifthecomputerhasbeenidleforatleast:,andenterthenumberof
minutesthatthecomputercanbeidle.

7.Leaveifthecomputerhasnotbeenidlethatlong,retryforupto:atzero.

8.Leaveallotherboxesbeyondthispointempty.

9.Exitthescreen.

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MUSE™CardiologyInformationSystem

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Accounting/Logging

PrintLog

4

OutboundeventsrefertodatathatissentoutoftheMUSEsystem,suchaspatient
tests,reports,sendingoutlistsforprinting,andsoon.

Thesystemlogsthefollowingoutboundevents:

•PrintingtoPostscriptandPCLprinters

•Fax

•CSI

•Email

•HL7

ChangeLog

•Folder

•FTPFolder

TheseoutboundeventscanbeviewedinthePrintLog.ToopenthePrintLog,select
Status>PrintLog.

RefertotheMUSECardiologyInformationSystemsOperatorManualforinstructionson
conguringthePrintLog.

TheChangeLogtrackschangestopatientdataandmayfacilitatendingatest
thathadincorrectdataenteredonthedeviceandhassincebeencorrectedinthe
MUSEsystem.

TheChangeLogfunctionmustbeactivatedwithinSystem>Setup>Sites>Test
TypeSettings.AllchangesmadetoarecordappearintheChangeLog.Thisincludes
changestopatientdemographics,testmeasurements,anddiagnosticstatements
withintheinterpretivewindow.

NOTE:

YoucannotviewtheChangeLogattheSerialComparisonlayout.

1.AttheEditlist,openapatienttest.

2.SelecttheClericaltab.

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Accounting/Logging

3.ClicktheChangeLogbuttontoopentheChangeLogwindow.

Eachtimeyoumakeachangetoapatienttest(includingchangesmadeatthe
HIS),thechangesarerecorded.Afteratestisupdatedorsavedinthedatabase,
thechangesaresavedbydate.

4.Toviewthechangelogdetails,double-clickonachangeditemtoexpandit.

TheChangeLogEntryDetailswindowopens.

Thiswindowishelpfulwhendisplayinglongeldssuchasthediagnosis.

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MUSE™CardiologyInformationSystem

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5.ToprinttheChangeLog:

6.Toenablethedisplayofsupplementaltesteldsthataregeneratedand

7.ClickClosewhennishedtoexittheChangeLog.

EditChangeLog

TheEditChangeLogisalistofchangesmadetoatest’spatientID,name(rst
andlast),location,dateandtime.Thelogexiststofacilitatendingatestthathad
incorrectdataenteredonthedeviceandwascorrectedinthesystem.

Accounting/Logging

a.ClickthePrintbutton

TheSelectDeviceandFormattingOptionswindowopens.

b.MaketheappropriatechoicesandclickOKtoprintthelog.

maintainedbytheMUSEsystem,selecttheShowChangesforVirtualFields
checkbox.Examplesofsomeoftheseeldsare:EditTime,EditDateand
identicationcodesthatuniquelyidentifythepatienttotheMUSEsystem.

ProcessLog

TheProcessLogisalistofalloftheprocessesthesystemran.Thislogincludes
processescurrentlyrunningandthosethatterminatedsuccessfully.Youcanidentify
currentprocessesbecausetheydonothaveanendtime.Processeswithanoldstart
timeandnoendtimehavemostlikelyfailedandcanbeinvestigatedforissues.

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Accounting/Logging

LoggingSystemSecurityEvents

TheMUSEapplicationserverandworkstationsshouldbeconguredtologWindows
securityeventstotheWindowsViewer.Ateachleserverandworkstation,repeat
thefollowingstepstosetupthisaudit.

1.ClickStart>Programs>AdministrativeTools>LocalSecurityPolicy.

TheLocalSecuritySettingswindowopens.

2.SelectLocalPolicies>AuditPolicy.

3.Clickoneacheventandselectthecheckboxesindicatedinthefollowingtable.

Event

Auditaccountlogonevents

Auditaccountmanagement

Auditdirectoryserviceaccess

Auditlogonevents

Auditobjectaccess

Auditpolicychange

Auditprivilegeuse

Auditprocesstracking

Auditsystemevents

20

MUSE™CardiologyInformationSystem

Success

üü

üü

üü

üü

Failure

ü
ü

ü

ü
ü

2034539-048A

4.ClickOKtosaveyourchanges.

5.ClosetheLocalSecuritySettingswindow.

Accounting/Logging

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21

Accounting/Logging

22

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MUSEWeb

InternetInformationServices(IIS)isrequiredontheMUSEWebserver.Toaccessthe
MUSEWeb,theusermusthavetheirbrowserconguredfor128-bitencryption.

Fordetailedprocedures,seetheMUSEWebServerInstructionGuidetoEnablingSSL.

ConguringIIStoLogWebsiteActivityonMUSE
Web

TheMUSEapplicationservershouldbeconguredtoenableloggingWebsiteactivity
asfollows:

1.Right-clickMyComputerandselectManage.

2.ExpandServices&Application>InternetApplicationServices>Websitesin
thelistfoundintheTreelist(leftpanel).

3.Right-clickonMUSEWebsiteandselectPropertiesintheWebsitetab.

4.MakesurethattheEnableLoggingcheckboxisselectedintheWebsitetab.

5.ForActivelogformat,makesureitisW3CExtendedLogFileFormat.

6.SelectProperties.....

a.SelecttheGeneraltab.
b.SelectWeeklyforNewLogTimePeriod.
c.MakesuretheLogledirectoryis%WinDir%\System32\LogFiles.
d.SelecttheAdvancedtab.
e.Add/delete/verifycheckmarkstoobtainthefollowingExtendedLogging

Options.

5

ü
ü
ü
ü

ü

2034539-048A

Date

Time

ClientIPAddress

UserName

ServiceName

ServerName

MUSE™CardiologyInformationSystem

ü

URIQuery

HttpStatus

Win32Status

BytesSent

BytesReceived

TimeTaken

23

MUSEWeb

ü

ü

f.ClickOKtoclosetheLoggingPropertieswindow.

g.ClickOKtoclosetheWebsitePropertieswindow.

ServerIP

ServerPort

MethodCookie

ProtocolVersion

UserAgent

Referred

SettingupClientBrowserfor128-bitEncryption

TheMUSEWebserverwillonlyallow128-bitencryptionaccesses.Userswillneedto
updatetheirInternetExplorer(IE)5.0or6.0tohave“HighEncryptionPack”installed.

NOTE:

TheHighEncryptionPackcanbedownloadedfromtheMicrosoftWebsite.

ThefollowingstepsdescribehowtodeterminetheIEencryptionlevel.

1.StartInternetExplorer.

2.SelectHelp>AboutInternetExplorer.

3.IfCipherStrengthislessthan128-bit,youwillneedtoinstallHighEncryption
Pack.

24

MUSE™CardiologyInformationSystem

2034539-048A

Anti-VirusSoftwareandSecurity Updates

Anti-VirusSoftware

GEHealthcarehasvalidatedtheproperoperationoftheMUSEsystemwithNorton
Anti-VirusCorporateEditionandMcAfeeNetShieldinstalled.Eitherofthesetwovirus
protectionsoftwareapplicationscanbeinstalledonthesystemwithoutaffecting
functionorperformance.

Anti-virussoftwareisnotprovidedwiththeMUSEsystem.Itremainsthecustomer’s
responsibilitytoacquireandinstallanti-virussoftwareontheirMUSEsystemperthe
recommendationsofthemanufactureroftheanti-virussoftware.

SeetheMUSEPre-InstallationManualforadditionalinformationoninstallinganti-virus
softwareontheMUSEsystem.Whenproperlyused,anti-virussoftwarecanprotect
theMUSEsystemfromvirusinfectionandthesubsequentdatacorruptionwhichcan
resultfromavirusinfection.However,ifimproperlycongured,anti-virussoftware
cancausesystemdegradation.

6

SecurityUpdates

AlistofvirusesthatposeasignicantthreattoGEHealthcarecustomers’product
securityispostedontheGEHealthcareProductSecuritywebsite.

Asnewvulnerabilitiesandpotentialsecurityissuesarise,GEHealthcaremakesevery
efforttoquicklyidentifyandnotifycustomersofapprovedxes.Timeisrequired
forGEHealthcaretoidentifythevulnerability,testthex,andrunavalidationtest
ontheproductforsafetyandfunctionality.OnlyafterthisrigorousprocessdoesGE
Healthcarereleasetheofcialpatch.Whilewerecognizetheurgencytocorrectthese
problems,wemustensurethattheintegrityofthesystemisnotcompromised.

AftersecuritypatchesarevalidatedforspecicGEHealthcareproducts,the
informationisaddedtotheProductSecuritywebsite.Youcandownloadthepatch
directlyfromthewebsiteofthesoftwaremanufacturer(Microsoft,andsoforth)and

2034539-048A

MUSE™CardiologyInformationSystem

25

Anti-VirusSoftwareandSecurityUpdates

applyittoyourGEHealthcareproduct.Tocheckonthelatestinformationregarding
validatedsecuritypatches:

1.BrowsetotheGEHealthcareProductSecuritywebsite:http://

prodsecdb.gehealthcare.com

TheSingleSignOn(SSO)windowopens.

2.EnteryourSSOnumberandpasswordandclickLogIn..

IfyoudonothaveanSSOnumber,clicktheSignUplinktoobtainone.

3.UsethefeaturesontheGEHealthcareProductSecurityDatabaseWebsiteto
determinesecuritypatchesthatyoucanapplytoyoursystem.

26

MUSE™CardiologyInformationSystem

2034539-048A

AppendixA—HIPAAOverview

HIPAAIntroduction

ThefutureofhealthcareintheUnitedStateschangedonAugust2,1996when
theHealthInsurancePortabilityandAccountabilityAct(HIPAA)becamelaw.The
complexandfar-reachingfederallegislationsignicantlyaffectseverypersonand
organizationinvolvedinhealthcare.HIPAArulesspelloutstandardsandrequirements
forprotectingthecondentiality,security,andintegrityofallhealthinformation.

HIPAALawOverview

TheprimarygoalsofHIPAAarequanticationofconsumerhealthcarerightsalong
withimprovedprivacyandsecurityofmedicalrecords.Thetwomaincomponents
ofHIPAAareHealthCarePortabilityandAdministrativeSimplication.TheHealth
CarePortabilitylegislationbecameeffectivein1996.ThePortabilitypartofHIPAA
iswellunderstoodandwassuccessfullyimplementedbytheU.S.governmentand
themedicalindustryin1996and1997.ThePortabilitylegislationguaranteesthe
followingrightstohealthcareconsumers:

A

•Improvedavailabilityandaccessibilityofhealthinsurance

•Guaranteedrightofportabilityandcontinuityofhealthinsurancecoveragefor

individualsandgroups

•Prohibitionofdiscriminationbasedonhealthstatus

HIPAA’sAdministrativeSimplicationprovisioniscomposedoffourpartsandinvolves
thesehealthcareissues:

•Standardizationofelectronictransfersofpatienthealth,administrative,and

nancialdata

•Privacyandsecuritystandardsprotectingthecondentialityandintegrityofhealth

information

•Uniquehealthidentiersforindividuals,employers,healthplans,andhealthcare

providers

Eachpartwilleventuallyproduceavarietyofrulesandstandards.Manyoftherules
andstandardsareunderdevelopment.Astherulesandstandardsarenalized

2034539-048A

MUSE™CardiologyInformationSystem

27

AppendixA—HIPAAOverview

andbecomelaw,theywillhavedifferentcompliancedeadlines.Thefourpartsof
AdministrativeSimplicationare:

•ElectronicHealthTransactionsStandards

•UniqueIdentiers

•Security&ElectronicSignatureStandards

•Privacy&CondentialityStandards

HIPAA’scomplexityconfusescustomers.EventheHIPAAnamecausesconfusion.
RecentlythescopeofthetermHIPAAchanged.InitiallyHIPAAreferredtoallparts
ofthelegislation.CurrentusagenarrowsHIPAA’smeaningtotherulesgenerated
fromtheAdministrativeSimplicationsubsection.GEHealthcarefollowscommon
usage,andunlessotherwisenoted,HIPAAreferstotherulesdevelopedfromthe
AdministrativeSimplicationsubsection.

ThemaincomponentsofHIPAAandtheirrelationshipsarepresentedinthefollowing
diagram.

TheHIPAAcomponentwiththegreatestimpactonGEHealthcarecustomersisthe
PrivacyStandard,asdenedintheAdministrativeSimplicationsubsection.TheFinal
VersionofthePrivacyStandard,(StandardsforPrivacyofIndividuallyIdentiable
HealthInformation,45CFRParts160and164),waspublishedintheFederalRegister
onDecember20,2000.

TheHIPAAimplementationandenforcementschedulespansseveralyears.The
PrivacyStandardbecomesenforceableonApril14,2003.Thefollowingtable
summarizestheHHSreleasestatusandtimetablefortheHIPAArules.

28

MUSE™CardiologyInformationSystem

2034539-048A

AppendixA—HIPAAOverview

HIPAARulesandRulemakingTimetable

StandardPublicationDateFinalRulingRequired

Compliance

1.Insurance
Portability

2.Electronic
Transactions&Code

3

Sets

3.Privacy&
Condentiality

4.NationalProvider
Identier

5.NationalEmployer
Identier

6.Security

7.NationalHealth
PlanIdentier

8.Claims
Enforcement
Procedures

9.NationalIndividual
Identier

4

August02,1996August02,1996

May07,1998August17,2000

November03,1999December28,2000April14,2003

May7,1998

June16,1998

August12,1998

InDevelopment

InDevelopment

Withdrawn

Expected2002

Expected2002

Expected2002
––

––

––

July01,1997

October16,2003

–

–

–

PrivacyandCondentiality

TheFinalRuleforPrivacywaspublishedDecember28,2000.Compliancewillbe
requiredonApril14,2003formostcoveredentities.Ingeneral,privacyisaboutwho
hastherighttoaccesspersonallyidentiablehealthinformation.Therulecoversall
individuallyidentiablehealthinformationinthehandsofcoveredentities,regardless
ofwhethertheinformationisorhasbeeninelectronicform.ThePrivacystandards
limitthenon-consensualuseandreleaseofprivatehealthinformation;givespatients
newrightstoaccesstheirmedicalrecordsandtherighttoknowwhoelseaccessed
them;restrictmostdisclosureofhealthinformationtotheminimumneededforthe
intendedpurpose;establishesnewcriminalandcivilsanctionsforimproperuseor
disclosure;establishesnewrequirementsforaccesstorecordsbyresearchersand
others.

3.InJanuary,2002theBushAdministrationextendedthedeadlineforthe‘ElectronicTransactions&CodeSets’fromOct2002untilOctober

2003.

4.AlthoughtheHIPAAlawcalledforauniquehealthidentierforindividuals,HHSandCongressindenitelypostponedanyefforttodevelop
suchastandard.(HHSFactSheet,AdministrativeSimplication,2001)

2034539-048A

MUSE™CardiologyInformationSystem

29

AppendixA—HIPAAOverview

ThePrivacyandCondentialityregulationsincorporatevebasicpatientrightsrelated
tohealthcareinformation:

•ConsumerControl:Theregulationprovidesconsumerswithcriticalnewrightsto

controlthereleaseoftheirmedicalinformation.

•Boundaries:Withfewexceptions,anindividual’shealthcareinformationshouldbe

usedforhealthpurposesonly,includingtreatmentandpayment.

•Accountability:UnderHIPAA,forthersttime,therewillbespecicfederalpenalties

ifapatient’srighttoprivacyisviolated.

•PublicResponsibility:Thenewstandardsreecttheneedtobalanceprivacy

protectionswiththepublicresponsibilitytosupportsuchnationalprioritiesas
protectingpublichealth,conductingmedicalresearch,improvingthequalityof
care,andghtinghealthcarefraudandabuse.

•Security:Itistheresponsibilityoforganizationsthatareentrustedwithhealth

informationtoprotectitagainstdeliberateorinadvertentmisuseordisclosure.

ElectronicHealthTransactionsandCodeSets Standards

Healthcareorganizationsroutinelystoreandtransmitmedicalinformationin
electronicformat.Electronicmedicalinformationismanipulatedthroughawide
varietyofencodingschemesandformats.Standardelectronicdatainterchange
improvestheefciencyofhealthcaredelivery.Nationalstandardsmakeiteasierfor
healthplans,doctors,hospitals,andotherhealthcareproviderstoprocessclaims
andothertransactions(HHSFactSheet,AdministrativeSimplication,2001).The
governmentandthemedicalindustryperceivestandardizedrepresentationsof
routinemedicaldataasbenecialforallpartiesinvolved.TheTransactionsStandards
mandatesuseofstandardizedelectronicformatsdevelopedbytheAmericanNational
StandardsInstitute(ANSI).TheCodeSetStandardsrequireuseofthemostcommonly
usedmedicalterminologycodesets.Finalstandardsforelectronictransactionsand
codesetswerereleasedinAugust2000.TheoriginalcompliancedeadlineofOctober
2002wasextendedtoOctober2003.

TheTransactionsStandardsspecifytheformatandcontentofthefollowingmedical
transactions:

•Healthclaimsorequivalentencounterinformationtransfer

•Healthclaimsattachments

•Enrollmentanddisenrollmentactionsinahealthplan

•Eligibilitystatusinahealthplan

•Healthcarepaymentandremittanceadvice

•Healthplanpremiumpayments

•Firstreportofinjury

•Healthclaimstatus

•Referralcerticationandauthorization

TheHealthorganizationsmustadoptstandardcodesetsforallhealthtransactions.
Codesetsarealphanumericidentiersrepresentingmedicaldata.Medicalcoding
systemsdescribediseases,injuries,andotherhealthproblems,aswellascauses,
symptoms,andactionstaken.Allpartiesexchangingmedicaltransactionsmust

30

MUSE™CardiologyInformationSystem

2034539-048A

AppendixA—HIPAAOverview

generateandacceptthesamecoding.Consistentcodingreducesmistakes,
duplicationofeffort,andcosts.HIPAAspeciesthefollowingcommonlyusedcode
sets:

•InternationalClassicationofDiseases,9thEdition,ClinicalModication,(ICD-9-CM),

Vols1,2,3

•NationalDrugCodes(NDC)

•CodeonDentalProceduresandNomenclature

•HealthCareFinancingAdministrationCommonProcedureCodingSystem(HCPCS)

•CurrentProceduralTerminology,FourthEdition(CPT-4)

TheTransactionsStandardsregulateinformationrelatedtohealthinsurancestatus
andremittance.GEHealthcarecardiologyproductsareclinicalsystemsandrarely
(ifever)processthehealthinsuranceandremittanceinformationaffectedbythe
TransactionsStandards.TheGEHealthcarecardiologyproductsarenotaffected
bytheTransactionsStandards.

TheCodeSetStandardsregulateuseofclinicalmedicalinformation.TheCodeSet
StandardsmayaffectGEHealthcarecardiologyequipment.Thecardiologyequipment
mayneedtosupportinputofcodesetvalueswhentestinformationisacquired.

2034539-048A

MUSE™CardiologyInformationSystem

31

AppendixA—HIPAAOverview

32

MUSE™CardiologyInformationSystem

2034539-048A

AppendixB—SummaryofMUSE
Security

Introduction

TheGEHealthcareProductSecuritywebsitehastheHIMSSManufacturerDisclosure
StatementforMedicalDeviceSecurityorMDS2formfordifferentMUSEversions.

Thisformhassomeofthesameanswersasthosefoundinthissection.See

http://prodsecdb.gehealthcare.com/andloginwithyourSingleSignOn(SSO).Ifyou

donothaveanSSO,clicktheSignUplinktoobtainone.

ThefollowingtableisbasedonaMUSEsystemrunningversion8withouttheMUSE
Weboption.Thesetablesareindirectresponsetotheneedforsecurityfeaturesin
medicalsystems.GEHealthcareprovidestheseanswerstoassistyouindiscovering
yourrisksandinthecreationofyourmitigationplan.GEHealthcareprovidesthese
answerstothebestofourknowledgegiventherequirementsandcurrentstateof
theproduct.

B

ThisdocumentcontainsasummaryoftheLegalRequirementsoftheHealthInsurance
PortabilityandAccountabilityAct(HIPAA).Itisnotintendedaslegaladvice.Every
entitymustmakeitsownjudgmentregardingwhatwillberequiredtoenableitto
complywithHIPAA.GeneralElectricCompanyreservestherighttomakechangesin
specicationsandfeaturesshownherein,ordiscontinuetheproductdescribedatany
timewithoutnoticeorobligation.ContactyourGEHealthcarerepresentativefor
themostcurrentinformation.

BackgroundInformation

Enteranydescriptionthathelpsclarifythesecuritycontext.Thesecurity
contextwouldincludeproductoptions,environmentalconditions,andso
forth.

DoestheproductCapture,Store,orTransmitanyPatientidentiabledata?

Identifythearchitecturethatbestdescribesthisproduct:

WhatOperatingSystemisthisproductClientbasedon?WindowsXP

WhatOperatingSystemisthisproductbasedon(orinthecaseof
client/serverproducts–whatistheserver)?

WhichGSPPlatformdoestheproductutilize?

2034539-048A

MUSE™CardiologyInformationSystem

Unknown

Yes

3tier
application

WIN2003

None

33

AppendixB—SummaryofMUSESecurity

Cantheproductdisplayacustomersuppliedmessageonbootuporlogin?Yes&No,the

Doestheproductprovideatrainingmodethatallowsfortrainingwithout
corruptingtheoperationaldata?

Doesthisproducthaveacommunications/networkinterface(Notincluding
RemoteService)?

IdentifyalloftheCommunicationsinterfacesthatthisproducthas:

Ethernet

Token-Ring

ATMNo

RF(802.11,bluetooth,otherradio)

COTSModem

OtherModem(egSDLC)

DirectSerial

Other

DoesthisproducthaveaDatabase?

application
cannot,but
Windowscan
atlogin

No

NetworkPresence

Yes

Yes

No

No

Yes

No

Yes

No

Yes,SQL
Server2005

IdentifyalloftheServices/Protocolstheproductprovides:

AnyDirectNetworkdbAccess(JDBC,ODBC,SQL,etc)

DICOM

HL7Yes

XMLYes

HillTop

Unity

AdvantageNET

PostScriptorPCLprinters

SMTPorMAPI

FAXYes

SNMP

FTPYes

Telnet/Xwindows

Share(NFS,SMB,etc.)

CustomerAccessibleAPI?

Other

NoneNo

Yes

No

Yes

No

No

Yes

Yes

Yes

No

Yes

Yes

No

34

MUSE™CardiologyInformationSystem

2034539-048A

AppendixB—SummaryofMUSESecurity

IdentifythemodesofNetworkCommunicationsofPatientIdentiableDatathatissupported
usingtheaboveprotocols:

SendPatientIdentiableDatatoothersystems

ReceivePatientIdentiableDatafromothersystems

ProvideaQueryinterfacethatothersystemscanusetoextractPatient

Yes

Yes

Yes

IdentiableData

DoesthisproducthaveaWebServer?

Yes

Transactions,CodeSets,andIdentiers

IdentifyalloftheCodeSetsthisproductsendsorreceives:

non-standardequivalentstoX12NTransactions(BillingEDItransactions)?

standardX12NTransactions(BillingEDItransactions)?

non-standardequivalentstoCDTcodesets(DentalServices)?

standardCDTcodesets(DentalServices)?

No

No

No

No

non-standardequivalentstoCPT4codesets(Physicianservices)?

standardCPT4codesets(Physicianservices)?

non-standardequivalentstoICD9codesets(Diseases,injuries,etc)?

standardICD9codesets(Diseases,injuries,etc)?

non-standardequivalentstoNDCcodesets(DrugsandBiotics)?

standardNDCcodesets(DrugsandBiotics)?

non-standardequivalentstoHCPCScodesets(otherservices)?

standardHCPCScodesets(otherservices)?

User(soft)conguredcodesthatmaybeconguredtoincludeCDT,CPT4,
ICD9,NDC,orHCPCS?

Noneoftheabove

Identifyalloftheidentiersthisproductsupports

“NationalProviderIdentier”(USAUniqueidentierforallindividuals
providinghealthcareservices)?

“NationalEmployerIdentier”(USAUniqueidentierforallhealthcare
facilities)?

“NationalPayerIdentier”(USAUniqueidentierforallinsurancecarriers)?

Noneoftheabove

No

No

No

No

No

No

No

No

Yes

No

No

No

No

Yes

UserIdentication

Doestheproductprovideforindividualidentication(accounts)ofclinical

Yes

users(excludingserviceusers)?

Whatisthemaximumnumberofaccounts(0<zero>==>theoretically

10,000

innite)

2034539-048A

MUSE™CardiologyInformationSystem

35

AppendixB—SummaryofMUSESecurity

Doestheproductsupportpasswordsforauthenticationoftheclinicalusers?

Doestheproductutilizetheoperatingsystemauthenticationforclinical

Yes

Yes

users?

Doestheproductplaceconstraintsonusername?16char.max

Identifyalloftheauthenticationtechnologiesthisproductsupports

WindowsDomain

MicrosoftActiveDirectory

Non-WindowsKerberos

NIS/YP

CCOW

Other

Yes

Yes

No

No

No

No

NoneNo

Duringlogindoestheproductinformtheuserofthelasttimethesystem

No

wasaccessedusingthatuseraccount?

Cantheuserauthenticationbeaugmentedbyabiometric,token,orother

Yes

methodbesidespasswords?

Identifyalloftheadvancedauthenticationtheproductsupports:

tokens

smartcards

badgereaders

writtensignatureverication

one-timepasswordgenerators

biometricidentiers

Certicateidentication

dial-backmodems

Other

Yes

Yes

No

No

No

No

No

No

No

NoneNo

Howdoesthecustomergettheseadvancedauthenticationmethods?

Customer
supplied

UserAccountMaintenance

Identifyalloftheinformationassociatedwithauseraccount:

FullName

AdditionalIdentier

Title

Yes

Yes

Yes

DepartmentNo

PhoneNumber

E-mailAddress

36

MUSE™CardiologyInformationSystem

Yes

Yes

2034539-048A

AppendixB—SummaryofMUSESecurity

StreetAddress

FAXNumber

Other

NoneNo

Whocanadministeruseraccounts?Multiple

IdentifyalloftheUserAdministrativecontrolssupported

AuditLogofallaccountchanges

Setanaccountinactivewithoutremovingtheaccount?

Forcealogoffofanactiveuser?

Automaticde-activationofanaccountonaspecieddateornumberof
days/time?

Automaticde-activationofanaccountafteracongurednumberofdays
ofnon-use?

Other

NoneNo

IdentifyalloftheUserAccountReportssupported:

Listofalluseraccounts

Listofcurrentlyactiveusers

Listofalluseraccountswithlastuseddate/time

Other

NoneNo

No

Yes

No

Accounts

No

Yes

No

No

No

No

Yes

Yes

No

No

Whenanaccountismarkedinactiveordeleteddoestheproductdisablein

Yes

real-timeanyactivesessionsusingthatID?

Doestheproductprovideatoolforbatchmanagementofuseraccounts?

Yes

Authorizations

Doestheproductsupportmultiplelevelsofaccesscontrolthatcanbe

Yes

assignedtouseraccounts?

Doestheproductsupportmultiplelevelsofaccesscontrolthatcanbe

Yes

assignedtogroupsofuseraccounts?

Identifyalloftheaccesscontrolrightsthatcanbeappliedtoauser:

ViewPatientIdentiableDataonscreen

PrintPatientIdentiableDatatopaperorlm

ModifyPatientIdentiableData

2034539-048A

MUSE™CardiologyInformationSystem

Yes

Yes

Yes

37

AppendixB—SummaryofMUSESecurity

ExportPatientIdentiableDatatoremovabledigitalmedia

Delete
Identifyallthemethodsbywhichtheaccesscontrolrightareapplied:

Accessatdatabaseviewlevel

Accessatlelevel

Accessatlesystemdirectorylevel

Time-of-Day

WeeklySchedule

Workstation(location)

Other

NoneNo

Doesproducthidefunctionalitythattheuserdoesnothaverightsto(to
preventtheuserfromevenknowingafunctionalityexists)?

Doestheproductfurtherrestrictaccessbasedonpatientspecicconsent?

Auto-Logoff

IdentifyalloftheinactivityAutoLogoffcapabilitysupported:

UnprotectedScreenSaver

PasswordprotectedScreenSaver(screenblanking)

ApplicationLogout

Applicationblanking,withre-authenticationallowingcontinuation.

Other

NoneNo

Cantheadministratoroverrideanyinactivityscreen/applicationblanking?

No

Yes

No

No

No

No

No

No

Yes

Yes

No

Yes

Yes

No

No

No

Yes

Identifyhowtheinactivitytimeoutcanbecongured:

SystemWide

Workstation(location)

No

Yes

Per-UserYes

DevicetoDeviceAuthentication

Identifyalloftheentityauthenticationthatisused,whencommunicating
andtheremoteuserisnotorcannotbeauthenticatedserialnumber

Macaddress

IPAddress

AE-Title

Processidentier

Taskidentier

UnidirectionalPKIcerticatechallenge(ex:simpleSSL)

38

MUSE™CardiologyInformationSystem

No

No

No

No

No

No

2034539-048A

AppendixB—SummaryofMUSESecurity

BidirectionalPKIcerticatechallenge(ex:clientandserverauthSSL)

Other

NoneYes

LogAllSecurityEvents

IdentifyalloftheSecurityEventsthatcanbelogged:

MachineShutdown

MachineBoot

Applicationstart

Applicationstop

Networklink/connectionfailures

DataIntegrityfailure

SuccessfulUserLogin

FailedUserLogin

UserLogoutYes

Auto-Logoff

Forcedlogoffbyadministrator

Auserchangedtheirpassword

Anadminreset/clearedauserspassword

Attemptbyausertoaccessfunction/datathattheydonothaveaccessto

User/Groupaccountcreation

User/Groupaccountdeletion

User/GroupAccessrightsmodication

Other

NoneNo

No

No

Yes

Yes

Yes

Yes

Yes

No

Yes

Yes

Yes

No

Yes

Yes

No

Yes

Yes

No

No

IdentifyallofthecontentsofaSecurityEventlogentry:

DateandTime

Timetomillisecondaccuracy

IdentieroftheUser

Identierofthedevice(workstation,IP ,orotherstationidentication)

Eventdescription

Arethesesecurityeventstrackedinadifferentlogthanpatientidentiable

Yes

No

Yes

Yes

Yes

Yes

datarelatedevents?

Onfailedauthenticationattempts,isthepasswordattemptedenteredinto

No

thelog?

Istheloglepersistent(NOTautomaticallyoverwrittenordeleted)?Notlimited

Isaccesstothislogrestrictedtoauthorizedindividuals?

Canthecustomerspecifythelistofeventstotrack?

2034539-048A

MUSE™CardiologyInformationSystem

Yes

No

39

AppendixB—SummaryofMUSESecurity

IdentifyallofthePatientIdentiableDataVieweventsthatcanbelogged:

Printouts

Exporttoles

LogAllPatientDataViews

Yes

Yes

Exporttoremovablemedia

Faxed

E-Mailed

Viewbybrowser

Viewbyclientapplication

Retrievedovernetworkprotocol(DICOM,XML,API,etc.)

De-identication

Other

NoneNo

IdentifyallofthecontentsofaPatientIdentiableDataViewlogentry:

DateandTime

Timetomillisecondaccuracy

IdentierofUser

IdentierofDevice(workstation,IP,orotherstationidentication)

Identieroftheapplication

Identierofthefunctionwithintheapplication

IdenticationofthePatient

Howlongthedatawasdisplayed

Eventdescription

Yes

Yes

Yes

Yes

No

No

No

No

Yes

No

Yes

Yes

No

No

Yes

No

Yes

Istheloglepersistent(NOTautomaticallyoverwrittenordeleted)?Notlimited

Isaccesstothislogrestrictedtoauthorizedindividuals?

Canthecustomerspecifythelistofeventstotrack?

Yes

No

LogAllPatientDataModications

IdentifyallofthePatientIdentiableDataModicationeventsthatcanbe
logged:

Modicationofclinicaldatapriortoanalreport(diagnosis,medications,

Yes

observations,measurements,etc.)

Modicationoramendmentstoanalreport

Modicationofpatientdemographics

Modicationoftestdate,time,orsetupparameters

Modicationofdiagnosis

40

MUSE™CardiologyInformationSystem

Yes

Yes

Yes

Yes

2034539-048A

AppendixB—SummaryofMUSESecurity

NoneNo

IdentifyallofthecontentsofaPatientIdentiableDataModicationlogentry

DateandTime

Timetomillisecondaccuracy

IdentierofUser

IdentierofDevice(workstation,IP,orotherstationidentication)

Yes

No

Yes

Yes

Identieroftheapplication

Identierofthefunctionwithintheapplication

IdenticationofthePatient

Eventdescription

Istheloglepersistent(NOTautomaticallyoverwrittenordeleted)?Notlimited

Isaccesstothislogrestrictedtoauthorizedindividuals?

Canthecustomerspecifythelistofeventstotrack?

LogAllChangestotheConguration

IdentifyalloftheCongurationChangeeventsthatcanbelogged:

ChangeofthesystemDateand/orTime

Installationofpatches,maintenance,FMI,hotx,etc.

IPAddressorothernetworkconguration

Analysisalgorithmparameters

Creation,modication,ordeletionofoutputdevices/API/interface/AE

Creation,modication,ordeletionofinputdevices/API/interface/AE

Other

NoneNo

No

No

Yes

Yes

Yes

No

No

Yes

No

No

No

No

No

IdentifyallofthecontentsofaCongurationChangelogentry:

DateandTime

Timetomillisecondaccuracy

IdentierofUser

IdentierofDevice(workstation,IP,orotherstationidentication)

Identieroftheapplication

Identierofthefunctionwithintheapplication

Eventdescription

Yes

No

No

No

No

No

Yes

Istheloglepersistent(NOTautomaticallyoverwrittenordeleted)?Datelimited

Isaccesstothislogrestrictedtoauthorizedindividuals?

Canthecustomerspecifythelistofeventstotrack?

Yes

No

AuditLogViewing

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AppendixB—SummaryofMUSESecurity

IsthereprotectionagainstALLmodicationofalllogles?

Isdeletionofalogtrackedinadifferentlog?

Isviewingofalogtrackedinadifferentlog?

Doestheproductprovidealertsbasedonautomatedadvancedlog
analysis?

Aretheaudittrailalertstrackedinalog?

Isthereatimesynchronizationfunctionincludedanddocumented?

AuditLogMining

Doestheproductsupporttheuseofthird-partyauditminingpackages?

Doestheproductsupportamechanismforcreatingatextbasedauditlog
(oraretheauditlogsalreadytext)?

DoestheproductintegratewithCAUnicenterorHPOpenview?

Doestheproductprovidesearchingtoolsfortheauditlogs?

Doestheproductprovidesortingtoolsfortheauditlogs?

IdentifyalloftheAuditTrailReportsthatcanbecreated:

Usersaccessingrecordswiththesamelastnameastheuser

Usersaccessingrecordswiththesameaddressastheiraddress

Accesstorecordsthathavenotbeenaccessedinalongtime

Accesstoanemployee’sownpatientdata

Accessestominor’spatientdata

Accessestoterminatedemployeespatientidentiabledata

Multipleloginattemptswithimproperauthentication

Allusersthathaveuseaspecicfunction

Allactivityofaspecicuser

Yes

No

No

No

No

Yes

No

No

No

No

Yes

No

No

No

No

No

No

No

No

No

Allaccessestoaspecicpatient

Allactivityfromaspecicworkstationorcommunicationslink

Allloginandlogoutactivitywithinaperiodoftime

Allloginfailures

AllAccesscontrolfailures

AllModicationstosecuritysettings

Allchangestoauthenticationsettings

Allaccessviaremoteserviceinterface

Allchangestotheaudittrailsconguration

Other

No

No

No

No

No

No

No

No

No

No

NoneYes

CongurationLockdown&SecurityFixes

42

MUSE™CardiologyInformationSystem

2034539-048A

AppendixB—SummaryofMUSESecurity

IsthisOSconguredtomeetDOD-C2Compliance?

Haveunnecessaryservicesandprotocolsbeenturnedoff?

Haveunnecessaryservicesandprotocolsbeenuninstalled?

Aredefaultpasswordsdocumentedinanyformofmanual?

Arepasswordsthatarenotchangeableusedforadministrativeaccounts?

IstheSNMPcommunitynamesetto"public"or"private"?

Istheredocumentationavailablethatdescribestheservicesandprotocols
thatarenecessaryforproperoperationoftheproduct?

IsthecustomerfreetoapplyanyOperatingSystemortoolvendorxes
totheproduct?

DoestheM4releasecontainallsecurityxesfortheOS,database,orany
otherthirdpartytoolswithin6monthsoftheM4date?

ForOperatingSystems:

Thetypicaltimewindowbetweenwhenapatchisavailableandwhenit
canbeappliedtoacustomersystemis6months

Thetypicaltimewindowbetweenwhenapatchisavailableandwhenitcan
beappliedtoacustomersystemis12months

ThecustomercangetOSxesthatarenomorethan12monthsold

Isthisdatabaseconguredwiththeminimalservicesandprotocols
running?

No

Yes

Yes

Yes

No

No

Yes

No

Yes

Yes

Yes

Yes

Yes

ForDatabases:

Thetypicaltimewindowbetweenwhenapatchisavailableandwhenit
canbeappliedtoacustomersystemis6months

Thetypicaltimewindowbetweenwhenapatchisavailableandwhenitcan
beappliedtoacustomersystemis12months

Thecustomercangetdatabasexesthatarenomorethan12monthsold

Doestheproductincludeotherthirdpartytoolorapplication(Backup
software,SNMPagent,pcAnywhere,maintenancetool,MicrosoftOfce,etc.)

Forother3rdpartytools:

Thetypicaltimewindowbetweenwhenapatchisavailableandwhenit
canbeappliedtoacustomersystemis6months

Thetypicaltimewindowbetweenwhenapatchisavailableandwhenitcan
beappliedtoacustomersystemis12months

Thecustomercanget3rdpartytoolxesthatarenomorethan12months
old

ListanyThirdPartyApplications,Tools,Libraries,Drivers?

Yes

Yes

Yes

Yes

Yes

Yes

Yes

InSite2,
Antivirus
software,
Digiboard,IE,
MSDE,MDAC,
MMC,Disk

AntiVirus

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AppendixB—SummaryofMUSESecurity

Areallproductreleasesandmaintenancereleasesscannedforany
maliciouscode(Virus,Worm,Trojan)?

IdentifyalloftheMaliciousCodedetectionsupported:

HostbasedIntrusionDetection

NortonAntiVirus

McAfeeAntiVirus

OtherWindowsAntiVirus

CustomersuppliedAntiVirussoftware

CustomeradministratedAntiVirusSignatureFiles

Tripwireorother

NoneNo

IntegrityControlsonData

Doestheproductutilizetransparentend-to-enddataintegritycontrols?
(memoryparity,tcpchecksums,etc.)

Doestheproductenforceapplicationmanageddataintegritycontrolslike
objectchecksums?

DoestheproductsupportPKIbasedDigitalSignaturestomaintaindata
integrity?

Doestheproductenforcerequiredeldsduringdataentrytoensure
completenessofrecords?

Doestheproducthaveadataentryvalidationmechanismsuchasdouble
keyingofpatientidentiabledatatoensureaccuracyofthedataentered?

Doestheproductstorerejectedtransactionswiththereasonforthe
rejection?

Doestheproductensurethatdatabaseupdatesaredoneinafail-safeway?

IsthereanyOtherformofintegritycontrolprovided?

Yes

No

Yes

Yes

No

No

No

No

Yes

No

No

Yes

No

Yes

Yes

No

BackupandRecovery

Howmanypatientrecordsdoesthisproductstoreormanage?Unlimited

Identifyallthewaysthattheproductprotectsagainstdisasters/failures:

Exporttoremovablemedia

RAIDharddrive

backupofpatientdataonly(typicallytotape)

backupoffullsystem(typicallytotape)

UPS

Offsitemirroring

Near-linestorage

Other

No

Yes

Yes

Yes

Yes

No

No

No

NoneNo

BackupandRecoveryproceduresaredocumented?

44

MUSE™CardiologyInformationSystem

Yes

2034539-048A

AppendixB—SummaryofMUSESecurity

CantheIntegrityandcompletenessofthebackupbeveriedbythe
operatorthroughtheuseofofinemeans?

Encryption

Isanyformofencryptionofpatientidentiabledatasupported(not
includingtheserviceinterface)?

De-Identication

Isthereabulkde-identicationfunctionalitythattheusercanuse?(not
serviceinterface)

DigitalSignatures

Doestheproductprovideforsomeformofelectronicacceptancestamp
onPatientIdentiableData?

DoestheproductprovideforaPKIbaseddigitalsignature?

DoestheproductsupportDICOMsupplement41DigitalSignature
Extensions?

Service

Isthereamethodthatservicecanusetoaccessthesysteminthecaseof
anemergencywhennormaladministrationisnotpossible?

Doestheproducthaveatleastoneloginspecicallyforservicingthe
equipment?

Doestheproductrestrictserviceindividualswithmultiplelevelsofaccess
control?

Doestheproductsupportmultipleindividualserviceaccounts?

AreServiceaccountsrestrictedfromviewing,ormanipulatingPatientData?

Yes

Yes

No

Yes

No

No

Yes

Yes

No

Yes

No

AreallaccessestoPatientDatabyservicerestrictedtode-identieddata?

AreServiceactionsaccountedforinaloglesomewhere?Manually

ArepasswordsthatarenotchangeableusedforOperatingSystem
administrativeaccounts?

Arepasswordsthatarenotchangeableusedforserviceaccounts?

AreServicedefaultpasswordsdescribedindetailsinanyformofmanual?

Isthecustomerallowedtochangetheservicepasswords?

Doestheproductsupportremoteservice?

Doestheremoteservicesessionrequireauthenticationtoaserviceuser?

Canthecustomertellthataremoteservicesessionisinprogress?

Canthecustomer,throughautomaticormanualmethods,knowwhich
specicserviceindividualiscurrentlyremotelyloggedin?

Canthecustomerseewhatishappeninginanactiveremoteservice
session?

Canthecustomerstopanactiveremoteservicesession?

Specifytheequivalentencryptionstrengththataremoteservicesession
canoperateover?

No

No

No

No

Yes

Yes

Yes

Yes

No

Yes

Yes

3DES

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AppendixB—SummaryofMUSESecurity

IstheproductspecicGERemoteServicenetworkisolatedfromtherestof
theGEintranet?

AreaccesspointstotheGEservicenetworkprotectedwithanICSA
equivalentrewall?

AreremotesessionseverinitiatedwithoutaServicecallbeingloggedby
thecustomer?

No

No

No

46

MUSE™CardiologyInformationSystem

2034539-048A

AppendixC—21CFRPart11Option

Introduction

TheFDAhasissuedregulationsregardingelectronicrecordsandelectronicsignatures
called21CFRPart11.TheregulationsarerequiredforcustomerswhousetheMUSE
asasystemtosupportclinicaltrials.Thissectiondescribesthe21CFRpart11
functionalityontheMUSEsystem.

Thisoption,whenactivated,willdisableautomaticchangestopatientdata,require
entryofareasonforchangestopatientdata,andallowsyoutoenableasecond
optiontopromptforapasswordwhenpatientdataischanged.

ElectronicSignature

21CFRPart11statesthatusersmustbepromptedforapasswordoneachsitewhen
theyarenotbiometricallyauthenticated.The21CFRPart11optionisavailablewith
MUSEsoftwareversion7.xsoftware.Whenthisoptionisenabled,theSiteInformation
windowcontainstwoadditionalcheckboxes.

C

•Enable21CFRPart11

•RequirePasswordPromptwhensaving

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AppendixC—21CFRPart11Option

1.Toenable21CFRPart11,atSystem>Setup>Sites>Advanced,selectthe

2.IfbiometricauthenticationisbeingusedforEVERYUSERonthesite,selectthe

3.Ifthesitehassomeuserswhousebiometricauthenticationandsomeusers

Enable21CFRPart11checkbox.

RequirePasswordPromptwhenSavingcheckbox.

whodonotusebiometricauthentication,selectthe21CFRPart11checkbox
andleaveRequirePasswordPromptwhenSavingunchecked.

WhenRequirePasswordPromptwhenSavingisleftuncheckedinSiteSetup,
theindividual’susersetupswillbeusedbythesystemwhenareportissaved.

Thefollowingtablesummarizeshowtheindividualuser’sRequirePassword
PromptwhenSavingoptionfunctions.

UserElectronicSignatureSummary

SiteSetupWindowUserSetupWindow

21CFRPart11þ
RequirePasswordPrompt

whenSaving¨
21CFRPart11þ

RequirePasswordPrompt
whenSaving¨

21CFRPart11þ
RequirePasswordPrompt

whenSavingþ

RequirePasswordPrompt
whenSavingþ

RequirePasswordPrompt
whenSaving¨

RequirePasswordPrompt
whenSavingþ

-or-

RequirePasswordPrompt
whenSaving¨

PromptforPasswordon

eachSave?

Yes,forthatuseratthat

site.

No

Yes,forallusersatthat

site.

Other/RelatedFeatures

Inadditiontopromptingtheuserforapasswordwhensavingarecord,enablingthe
21CFRPart11optionalsoaffectsthefollowingfeatures:

48

MUSE™CardiologyInformationSystem

2034539-048A

AppendixC—21CFRPart11Option

Feature

PatientDataMerge

Description

Bydefaultthesystemmergesstored
patientdata(age,gender ,race,height,and
weight)whenanewlyacquiredordiagnosis
completetestisopenedintheeditor.Ifthe21
CFRPart11optionisenabled,thesystemwill
notmergethatdatawhenanunconrmed
testisopened.

QTCCalculationBydefault,thesystemrecalculatesQTCdata

whenitisacquiredfromthecart.Ifthe21
CFRPart11optionisenabled,thisdataisno
longerrecalculateduponitsacquisition.

UserNameRetrievalBydefault,thesystemassignsusernames

whenitacquiresIDsthatwereenteredatthe
card.Ifthe21CFRPart11optionisenabled,
thesystemnolongerassignsusernamesto
theseIDs.

ElectronicSignatureMessageTheMUSEsystemwilldisplaythe21CFR

Part11eSignatureMessagewhenthe
passwordpromptappears.Thismessage
canbemodiedinSystem>Setup>Sites

>Advanced.

ReasonforChangeTheMUSEsystemwillprompttheuserfor

areasonforchangeswhenupdatingor
discardingpatientdata.Thereasoncanbe
chosenfromalistorifOtherisselected,the
usercantypeareason.

ChangeLogThisfeaturelogschangestopatientdata.

EnabletheChangeLogatSystem>Setup
>Sites>TestTypeSettings,selecttheLog
Changescheckboxesforeachtesttype.See

Chapter4“Accounting/Logging”onpage17

forinstructionsonhowtoviewtheChange

Log.

SignatureMessageinDiagnosis

TheMUSEsystemcanbeconguredtoplace
asignaturemessageinthediagnosiswhen
thetestisconrmed.Enablethesignature
messageatSystem>Setup>Sites>Test

TypeSettings,selecttheSignatureMessage
inDiagnosischeckboxesforthedesiredtest

types.

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AppendixC—21CFRPart11Option

50

MUSE™CardiologyInformationSystem

2034539-048A

GEMedicalSystems
InformationTechnologies,Inc.
8200WestTowerAvenue
Milwaukee,WI53223USA
Tel:[phone]

[phone](USOnly)

Fax:[phone]

GEMedicalSystems
InformationTechnologiesGmbH
MunzingerStraße5
D-79111FreiburgGermany
Tel:[phone]
Fax:[phone]

AsiaHeadquarters

GEMedicalSystems
InformationTechnologies,Inc.
Asia;GE(China)Co.,Ltd.
No.1HuatuoRoad
ZhangjiangHi-techParkPudong
Shanghai,People’sRepublicofChina201203
Tel:[phone]
Fax:[phone]

GEMedicalSystemsInformationTechnologies,Inc.,aGeneralElectricCompany,goingtomarketas
GEHealthcare.

www.gehealthcare.com