consent policy design group - ct.gov-connecticut's ...€¦ · consent policy design group...
TRANSCRIPT
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ConsentPolicyDesignGroupMeeting#2April23,2019Facilitatedby:MichaelMatthews,CedarBridgeGroupDr.RossMartin,CedarBridgeGroup
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Agenda
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AgendaItem Time
Welcome&introductions 1:00pm
Publiccomment 1:10pm
ReviewofConsentDesignGrouprole,workplan,schedule,anddesiredoutcomes 1:15pm
Completereviewoffederalregulatorylandscape;follow-uponquestionsfromMeeting1;addressadditionalquestionsandcommentsfrommembers
1:20pm
CurrentstateofconsentpoliciesinConnecticut:generalissuesandspecialcases(minors,SDIs,publichealth,mentalhealth,etc.)
1:30pm
High-leveloverviewofborderingstatepolicies 1:50pm
Wrap-upandmeetingadjournment 2:00pm
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TheConsentPolicyDesignGroupØ StacyBeck,RN,BSN*– Anthem/ClinicalQualityProgramDirectorØ PatChecko,DrPH*– ConsumerAdvocateØ CarrieGray,MSIA– UConnHealth/HIPAASecurityOfficerØ SusanIsrael,MD– PatientPrivacyAdvocate/PsychiatristØ RobRioux,MA*– CHCACT/NetworkDirectorØ RachelRudnick,JD– UConn/AVP,ChiefPrivacyOfficerØ NicScibelli,MSW*– WheelerClinic/CIO
*HealthITAdvisoryCouncilMember
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TheSupportTeamStateofConnecticut
AllanHackneyHealthInformationTechnologyOfficer
Chair,HITAdvisoryCouncil
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CedarBridgeGroupCarolRobinson
MichaelMatthews,MSPHRossMartin,MD,MHA
ChrisRobinson
VelaturaTimPletcher,DHA,MSLisaMoon,PhD,RN
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ConsentPolicyDesignGroup– WorkplanMeeting Focus Meeting ObjectivesMeeting 1 – 4/9/2019 1pm – 2pmKickoff and orientation
• Review and discuss project charter and proposed process for achieving desired outcomes
• Orientation on relevant policies and procedures and semantic alignment / shared understanding of key terms
Meeting 2 – 4/23/2019 1pm – 2pmCurrent consent policies
• Establish understanding around current state of consent policies in Connecticut and bordering states
• Consider draft language for a HIPAA TPO consent policy for recommendation to Advisory Council
Meeting 3 – 5/7/2019 1pm – 2pmFocus on TPO consent draft
• Review proposed process for the development of a consent policy framework, based on HIE use case requirements
• Discuss stakeholder engagement and communication needs
Meeting 4 – 5/21/2019 1pm – 2pmMatching use cases to consent model
• Review and discuss received input from Advisory Council or other stakeholders
• Review use cases where individual consent is required by state or federal law, or areas of ambiguity
Meeting 5 – 6/4/2019 1pm – 2pmUse Case A discussion
• Discuss the pros/cons of a statewide consent policy framework vs. HIE Entity consent policy framework to determine
scope
Meeting 6 – 6/18/2019 1pm – 2pmUse Case B discussion
• Discuss the various ways that consent could be collected and possible roles for organizations in the consent process
• Establish high-level understanding of technical architecture for electronic consent management solutions• Discuss workflows that could provide individuals with information and the ability to manage preferences
Meeting 7 – 7/9/2019 1pm – 2pmReview draft consent framework
recommendations – structure and process
• Review and discuss strawman options
• Develop draft recommendations for consent policy framework
Meeting 8 – 7/23/2019 1pm – 2pmVote on draft recommendations
• Finalize and approve recommendations
• Discuss stakeholder / general population engagement and communication process
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RoleoftheConsentPolicyDesignGroupØ Analyzeexistingconsentpoliciesfromotherstates,reviewrelevantpoliciesandlegislation,anddiscussissuesandbarrierstohealthinformationexchange.
Ø DevelopandrecommendaninitialapproachtopatientconsentinsupportofthefirstwaveofrecommendedHIEusecasesunderHIPAATPO.
Ø RecommendanongoingprocessandstructureforevolvingtheconsentmodelforsupportingtheHIEEntityandfutureusecases.
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Consentpolicydesignprocess
8
Consent Policy Design Group recommendations
are presented to the Health IT Advisory
Council.
Advisory Council reviews and approves / amends
recommendations.
Advisory Council presents their recommendations to the newly formed HIE
Entity.
These recommendations will inform the leadership
of the HIE Entity in the formulation of their policy framework.
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ConsentPolicyDesignGroup
Level-settingDiscussionPoints
Ø Thepatientisthe“NorthStar”inallourdeliberations.Ø Consentpoliciesshouldbedevelopedinaflexiblewaytoallowforadaptationsovertime,astheregulatoryenvironmentwillcontinuetochange.
Ø Thereisanimmediate-termneedforaconsentpolicythatalignswiththecurrentHIPAArequirementsandpermissionsforsharingpersonallyidentifiableinformation(PII)fortreatment,payment,andhealthcareoperations.
Ø Aconsentmanagementsolutionthatgivesindividualstheabilitytomanagetheirconsentpreferenceswillneedtofitwithintheworkflowsofproviderorganizationsaswellasmeettheneedsofconsumers/patients.
Ø ConsentpoliciesmustconsiderliabilityrisksforallpartiesinvolvedintheHIEEntity.
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ConsentRequiresMultipleElements…10
Policy
Technology
Patient Engagement
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WhataretheFedsthinking?Ø Recentfederallaws,regulations,proposedrules,andpublicationssettheframeforthefutureofhealthinformationexchange▫ TheHealthInsurancePortabilityandAccountabilityActof1996(HIPAA)▫ TheHealthInformationTechnologyforEconomicandClinicalHealthActof2009(HITECH)▫ NEW:
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Draft Trusted Exchange Framework (TEFCA) ONC (1/5/2018)
Request for Information on updates to HIPAA HHS (12/14/2018)NPRM on the 21st Century Cures Act: Interoperability and Patient Access Proposed Rule (and related RFIs)CMS (2/11/2019)NPRM on the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification ProgramONC (3/4/2019)
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WhataretheFedsthinking?MajorThemes:Ø Less:SpecificfunctionalityrequirementswithintheEHR(e.g.,medicationlist).Ø More:Coreinteroperabilityanddataflowcapabilities(e.g.,APIs).Ø Heavypushtowardstandards-basedAPIs(ApplicationProgrammingInterfaces),i.e.,HL7FHIR®,tomakeinteroperabilitysimplerandfastertoimplement.Forproviders,thismeansthatacertifiedproductshouldbeabletoconnect“withoutspecialeffort”,meaningthattheseAPIsare:▫ Standardized – builtonmoderncomputingstandardssuchasRESTfulinterfacesandXML/JSONandtestedinreal-worldsettingspriortocertification▫ Transparent – vendorsmustprovidefreelyaccessible,cleardocumentationonhowtocallAPIsandwhatisreturned.▫ Pro-competitive– vendorsmustnotinterferewithaprovider’sabilitytouseacompetitor’sAPIandconnectittotheirEHRorothercertifiedtechnology
Ø Noinformationblocking – allactorsmustnotactinwaysthatimpededataflow(withexceptions)
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ONCNPRM– ConsentManagementØ The2015CertificationEditioncontainedtwo“datasegmentationforprivacy”(DS4P)criteria,butwereneverrequiredforcertificationorusedinanyHHSprograms.Sincethattime,moreworkhasbeendoneonsimplifyingconsentprotocolsandmakingthemeasiertoimplementinanAPI-drivenenvironment.
Ø Consent2Share (C2S)isanopensourceapplicationfordatasegmentationandconsentmanagement.
Ø C2Senablesdatasegmentationandconsentmanagementfordisclosureofseveraldiscretecategoriesofsensitivehealthdatarelatedtoconditionsandtreatmentsincluding:alcohol,tobaccoandsubstanceusedisorders(includingopioidusedisorder),behavioralhealth,HIV/AIDS,andsexualityandreproductivehealth.
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ONCNPRM– ConsentManagementØ SAMHSAcreatedaConsentImplementationGuidethatdescribeshowtheConsent2ShareapplicationandassociatedaccesscontrolsolutionusestheFHIRConsentresourcetorepresentandpersistpatientconsentfortreatment,research,ordisclosure.
Ø NotethatthespecificationrequirestheuseofFHIRRelease3,whichisstillatrialstandardandnotaballotedstandard(allothercertificationrequirementsreferenceFHIRRelease2,aballotedstandard).
Ø ONCisproposingtousethisspecificationasacertificationrequirement.
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ConnecticutLawsandRegulations:DISCLAIMERThefollowingslideshighlightsomeofthestatutesandpoliciesthatmayhaveanimpactonthedesignofconsentpoliciesthatwillgovernhealthinformationexchangeunderthenewhealthinformationexchangeentity.ItisnotintendedtobeanexhaustivereviewofallConnecticutlawsthatmayapplytothedesignofconsentpoliciesfortheHIE.Thesehighlightedexamplesareintendedtoinformthedesignworkbyillustratingexceptionsandotherspecialcasesthatwillneedtobeaccountedforwhenbuildingouttheexchangeandthepoliciesthatgoverntheexchange.
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Minors– GeneralConsent• Aminoris(withsomeexceptions)apersonunder18yearsofage.• Consentofaminor’sparentorguardianisgenerallyrequiredpriortothedisclosureofhealthcareinformationabouttheminor. Inthosecircumstanceswhenaminormaylegallyauthorizethetreatmentwithoutparentalconsent(outpatientmentalhealthtreatment,substanceabusetreatment,orvenerealdiseasetreatment,emancipation),thenonlytheminorcanconsenttothereleaseoftheinformation.
Resources:▫ CTOLRResearchReport:https://www.cga.ct.gov/2013/rpt/2013-R-0382.htm
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Minors– ExceptionsforParentalConsent• Minorsobtainingoutpatientmentalhealthtreatment:▫ 1992CTlawenableslicensedmentalhealthprofessionalstoprovidecounselingtominors(under18withnospecificminimumage)withoutparentalconsent.▫ Thereareotherprovisions,buttherelevantissuehereisthatifaprovideristreatingaminorunderthisstatutetheproviderisprohibitedfromnotifyingtheparent(s)/guardianofthetreatmentorfromdisclosinginformationaboutthetreatmentwithouttheminor’sconsent.Itisadvisedthatsuchconsentbeinwriting.▫ HIEwillneedtobeabletomanagethisconsentifanyinformationisprovidedfromlicensedmentalhealthproviders.Thisdoesn'tapplytoallminortreatment,justtreatmentthatwasrequestedbyaminorwithoutparentalconsent.
Resources:� OverviewfromSocialWorkersSite:http://naswct.org/professional-information/links/outpatient-mental-health/� Regulation:https://www.cga.ct.gov/current/pub/chap_368a.htm#sec_19a-14c� JudicialBranch:https://www.jud.ct.gov/juv_infoguide/IJCP_MedicalTreatmentMinors.html#fnContent40
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Minors– ExceptionsforParentalConsent• Minorsobtainingsubstanceabusetreatment:▫ Ifthepersonseekingtreatmentorrehabilitationforalcoholdependenceordrugdependenceisaminor,thefactthattheminorsoughtsuchtreatmentorrehabilitationorthattheminorisreceivingsuchtreatmentorrehabilitation,shallnotbereportedordisclosedtotheparentsorlegalguardianoftheminorwithouttheminor’sconsent. Theminormaygivelegalconsenttoreceiptofsuchtreatmentandrehabilitation.Aminorshallbepersonallyliableforallcostsandexpensesforalcoholanddrugdependencytreatmentaffordedtotheminorattheminor’srequestundersection17a-682.▫ Thecommissionermayuseormakeavailabletoauthorizedpersonsinformationfrompatients'recordsforpurposesofconductingscientificresearch,managementaudits,financialauditsorprogramevaluation,providedsuchinformationshallnotbeutilizedinamannerthatdisclosesapatient'snameorotheridentifyinginformation.
Resources:� Regulation:https://www.cga.ct.gov/current/pub/chap_319j.htm#sec_17a-688� JUSTIAhttps://law.justia.com/codes/connecticut/2012/title-17a/chapter-319j/section-17a-688
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Minors– ExceptionsforParentalConsent
• Minorsobtainingvenerealdiseasetreatment:▫ Adoctormayexamineandtreataminorforvenerealdisease. Recordsofthetreatmentareconfidentialandmaynotbedisclosedtotheparentorguardian.Theminorisfinanciallyresponsibleforthetreatment,andpaymentmaynotbesoughtfromtheparentorguardian.Iftheminorisunder12yearsofage,however,thetreatingphysicianmustreportittoDCF.
Resources:
� Regulation:https://www.cga.ct.gov/current/pub/chap_368e.htm#sec_19a-216
� CTJudicialInfoGuide:https://www.jud.ct.gov/juv_infoguide/IJCP_MedicalTreatmentMinors.html#fnContent42
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Minors– ExceptionsforParentalConsent• Emancipatedminors:▫ Aminorwhoisatleast16yearsofagemaypetitionthecourtforemancipation.Theeffectofemancipationistoreleasetheparentorguardianfromallobligationsofguardianshipandallowstheemancipatedminortoassumetheresponsibilitiesofanadult,includingconsentingtomedical,dentalorpsychiatriccare.
Resources:� Regulation:https://www.cga.ct.gov/current/pub/chap_815t.htm#sec_46b-150e� CTJudicialInfoGuide:https://www.jud.ct.gov/juv_infoguide/IJCP_MedicalTreatmentMinors.html#fnContent47
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Minors– ConsentDesignConsiderations• Theconsentpolicywillneedtoaddressissuesrelatedtofullyemancipatedminorsandfor“conditionallyemancipated”minorsthatareabletoprovidetheirownconsentundercertainconditions.• ThistopicisofinterestbecauseitappliestogeneralhealthinformationexchangeunderTPOrules.
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TheCommissioner’sList(reportablediseases,illnesses,labs,etc.)• Ahealthcareprovidershallreporteachcaseoccurringinsuchprovider'spractice,ofanydiseaseonthecommissioner'slistofreportablediseases,emergencyillnessesandhealthconditionstothedirectorofhealthofthetown,cityorboroughinwhichsuchcaseresidesandtotheDepartmentofPublicHealth,nolaterthantwelvehoursaftersuchprovider'srecognitionofthedisease.
Resources:▫ CTGeneralStatute:https://www.cga.ct.gov/current/pub/chap_368e.htm#sec_19a-215
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Source: CT.gov
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HIEOperations
• ThestateagenciesthatparticipateintheConnecticutHealthInformationNetwork,subjecttofederalrestrictionsondisclosureorredisclosureof
information,maydisclosepersonallyidentifiableinformationheldin
agencydatabasestotheadministratoroftheConnecticutHealth
InformationNetworkanditssubcontractorsforthepurposesof(1)
networkdevelopmentandverification,and(2)dataintegrationand
aggregationtoenableresponsetonetworkqueries.
• Suchdisclosuremustoccurincompliancewithstateandfederallaws(e.g.HIPAAandFERPA).Thenetworkadministratorandtheirsubcontractors
maynotfurtherdisclosepersonallyidentifiableinformation.
Resources:
▫ CTGeneralStatute:https://www.cga.ct.gov/current/pub/chap_368a.htm#sec_19a-25f
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HIVStatus• NopersonwhoobtainsconfidentialHIV-relatedinformationmaydiscloseorbecompelledtodisclosesuchinformation,excepttothefollowing:▫ Theindividual/guardian▫ Someonewithareleaseofinformation▫ Authorizedpublichealthofficer▫ Healthcareproviderwhenknowledgeisnecessarytoprovidecare▫ Healthcareworkerexposedtobodilyfluids▫ 8otherexceptions• Anyonewiththedisclosedinformationcannotfurtherdisclose.
Resources:▫ CTGeneralStatute:https://www.cga.ct.gov/current/pub/chap_368x.htm#sec_19a-583
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CancerRegistry• TheDepartmentofPublicHealthmustmaintainatumorregistrytohousereportsoftumorsdiagnosedortreatedinConnecticut.Hospitals,clinicallaboratories,andhealthcareprovidersmustreportdemographic,treatment,andmedicalinformationtotheRegistryasspecifiedbythedepartment.• DPH shallbeprovidedsuchaccesstorecordsofanyhealthcareprovider,asthedepartmentdeemsnecessary,toperformcasefindingorotherqualityimprovementaudits.
Resources:▫ CTGeneralStatute:https://www.cga.ct.gov/current/pub/chap_368a.htm#sec_19a-72
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RegionalStateConsentPolicies– ExamplesState Policy ScopeMaine Opt-Out Applies to the state-designated HIE
Maryland Opt-Out (Opt-In for some services) Applies to state-designated HIE and all qualifying HIEs in the state
Massachusetts Opt-In/Opt-Out Applies to all providers and state-funded plans
New Hampshire Opt-Out Applies to the state-created HIE
New Jersey Opt-Out NJHIN is a network of networks that includes several Health Information Organizations
New York Opt-In Applies only to qualified entities certified by the state of New York to participate in the Statewide Health Information Network for New York (SHIN-NY)
Rhode Island Opt-In Applies to the state-designated HIE
Vermont Opt-In Applies to providers participating in VHIE and Vermont State Blueprint for Health HIEs
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StatewideHealthInformationNetworkforNewYork(SHIN-NY)• TheNewYorkmodelforconsentgenerallyfitsinthe"opt-in"bucket.• Network-of-networksconsistingofeightregionalnetworks(QualifiedEntitiesorQEs)
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Bronx RHIO
HealtheConnections
HEALTHeLINK
Healthix
Hixny
NY Care Information Gateway (NYCIG)
Rochester RHIOSource: NYeC
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StatewideHealthInformationNetworkforNewYork(SHIN-NY)• SHIN-NYreliesonaconsent-to-accessratherthanaconsent-to-disclosemodel.Underaconsent-to-accessmodel,patientinformationisuploadedbyparticipantstotheQEwithoutpatientconsentunderabusinessassociateagreement.However,thedatamaintainedbytheQEisgenerallynotavailabletoparticipantsuntilthepatientprovidesconsentauthorizingtheparticipanttoaccessthepatient’sinformation.• Noactiveconsentisrequiredforpoint-to-pointexchangebetweenproviderwithacarerelationshipwiththepatient(e.g.,labresultsreportingfororderedlabs;Directmessaging)• HospitalsandhealthcarefacilitieswithcertifiedEHRsarerequiredtoparticipateinSHIN-NY
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StatewideHealthInformationNetworkforNewYork
(SHIN-NY)
• PrivacyandSecurityPoliciesandProceduresforQes andtheirParticipantsinNewYorkState(revisedDecember2018)
▫ DrivestherequirementsforconsentandotherpolicyrequirementsforQualifiedEntities(QEs)participatinginSHIN-NY.
▫ Coreconsentdiscussionisonpp9-19withadditionaltopicsthroughp27.▫ https://health.ny.gov/technology/regulations/shin-ny/docs/privacy_and_security_policies.pdf
• NYeCSHIN-NYConsentWhitepaper(February2017)▫ Excellentsummaryofconsentoptionsthatcaninformourdiscussion▫ UsefuldiscussionaboutthedevelopmentofaSHIN-NYWideConsentModel
� Thecurrentmodelrequiresthatconsentbeobtainedbyeveryhealthcareproviderwhowishesto
access.QEsmayofferblanketconsent,buttherearerulesforinformingpatientswhenparticipantsin
theexchangechange.
� Proposedoptionwouldcreateoneconsentformtogovernallappropriateaccesstopatientinformation.
▫ http://www.nyehealth.org/nyec16/wp-content/uploads/2017/02/SHIN-NY_consent_white_paper_022817.pdf
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MassHIway (Massachusetts)• CombinationOpt-In/Opt-Outmodel• Directmessaging(secureprovider-to-provideremail):▫ MassHIway usersmaytransmitinformationviaHIway DirectMessagingandmyimplementalocalopt-inand/oropt-outprocessthatappliestotheuseofHIway DirectMessagingbytheirorganization,butarenotrequiredtodoso.▫ AlignsDirectwithmakingaphonecallorsendingafax.
34Source: Mass HIway
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MassHIway (Massachusetts)• HIway-sponsoredServices(notethatnoneareavailableyet):
� Opt-in.HIway participantsmustprovideeachpatientand/ortheirlegalrepresentativeswithwrittennoticeofhowtheorganizationusesHIway-sponsoredservices.� Writtennotice(inmultiplelanguagesifrequired)mustbeprovidedviainclusioninaNoticeofPrivacyPractices,apatienthandout,oraletter,emailorotherpersonalelectroniccommunicationtothepatient.
� Thewrittennoticemustdescribethemannerandmeansthatthepatientcanopt-outofHIway-sponsoredservices.
� Opt-out.TheMassHIway oritsdesigneeadministersacentralizedopt-outsystem.Patientsand/ortheirauthorizeddesignees(includingtheprovider)maynotifytheMassHIway oritsdesigneedirectlyiftheychoosetooptout.
� Localopt-inopt-out.HIway participantsmaychoosetoimplementtheirownlocalopt-inand/oropt-outprocessthatappliestotheuseofHIway-sponsoredServicesbytheirorganization,butarenotrequiredtodoso.
35Source: Mass HIway
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ChesapeakeRegionalInformationSystemforourPatients(CRISP– Maryland)• Opt-Out▫ PatientinformedthroughrequiredadditionstoHIPAANoticeofPrivacyPractices(NPP)forallParticipatingEntities.▫ NPPlanguagemustinformthepatientonhowtooptoutofCRISP.▫ Opt-outformsmustbeavailabletopatientsreceivingcarefromParticipatingEntities.AlsoavailableonlineandbycallingCRISP.▫ Lowopt-outrate(<0.5%).• Opt-Inforsomeservices▫ Researchrequiresconsentinmostinstances▫ Servicescoveredby42CFRPart2(substanceabusetreatment),someancillaryservices.
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HIEConsentFormExamples• CamdenHIE(NJ):https://www.camdenhealth.org/wp-content/uploads/2017/12/CAMDEN-HIE-OPT-OUT.pdf• CRISP(MD,DC):https://crisphealth.org/wp-content/uploads/2019/02/Optout-Form-English-2019.pdf• SHIN-NY(NY):https://health.ny.gov/technology/regulations/shin-ny/docs/privacy_and_security_policies.pdf (appendix)• SoutheastNebraskaBehavioralHealthInformationNetwork:https://healthit.ahrq.gov/sites/default/files/docs/behavioral-health-consent-022713.pdf• St.JosephHealth(CA):http://www.stjhs.org/documents/HIE/48795330_SJH_HIE_OptInForm.pdf• CurrentCare (RI):http://www.currentcareri.com/Portals/0/Uploads/Documents/CC_and_CC4Me_Dual_Enrollment_Form-031017F.pdf▫ Onlineenrollment:https://enroll.currentcareri.org/
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39
ConsentPolicyDesignGroup– WorkplanMeeting Focus Meeting ObjectivesMeeting 1 – 4/9/2019 1pm – 2pmKickoff and orientation
• Review and discuss project charter and proposed process for achieving desired outcomes
• Orientation on relevant policies and procedures and semantic alignment / shared understanding of key terms
Meeting 2 – 4/23/2019 1pm – 2pmCurrent consent policies
• Establish understanding around current state of consent policies in Connecticut and bordering states
• Consider draft language for a HIPAA TPO consent policy for recommendation to Advisory Council
Meeting 3 – 5/7/2019 1pm – 2pmFocus on TPO consent draft
• Review proposed process for the development of a consent policy framework, based on HIE use case requirements
• Discuss stakeholder engagement and communication needs
Meeting 4 – 5/21/2019 1pm – 2pmMatching use cases to consent model
• Review and discuss received input from Advisory Council or other stakeholders
• Review use cases where individual consent is required by state or federal law, or areas of ambiguity
Meeting 5 – 6/4/2019 1pm – 2pmUse Case A discussion
• Discuss the pros/cons of a statewide consent policy framework vs. HIE Entity consent policy framework to determine
scope
Meeting 6 – 6/18/2019 1pm – 2pmUse Case B discussion
• Discuss the various ways that consent could be collected and possible roles for organizations in the consent process
• Establish high-level understanding of technical architecture for electronic consent management solutions
• Discuss workflows that could provide individuals with information and the ability to manage preferences
Meeting 7 – 7/9/2019 1pm – 2pmReview draft consent framework
recommendations – structure and process
• Review and discuss strawman options
• Develop draft recommendations for consent policy framework
Meeting 8 – 7/23/2019 1pm – 2pmVote on draft recommendations
• Finalize and approve recommendations
• Discuss stakeholder / general population engagement and communication process
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ImportantAcronyms(RedFontIndicatesNewEntry)• ADT– Admission,DischargeandTransfermessage• API– ApplicationProgrammingInterface• C2S– ConsenttoShare• CMMI – CenterforMedicareandMedicaidInnovation• CMS– CentersforMedicareandMedicaidServices• DS4P– DataSegmentationforPrivacy• EHI – ElectronicHealthInformation(ONCNPRMon21stCenturyCuresAct)
• EHR – ElectronicHealthRecord• FERPA– FamilyEducationalRightsandPrivacyAct• HIE – HealthInformationExchange• HIN – HealthInformationNetwork(TEFCA)• HIO– HealthInformationOrganization• HIPAA– HealthInsurancePortabilityandAccountabilityActof1996
• HITECH– HealthInformationTechnologyforEconomicandClinicalHealthActof2009
• HL7FHIR® – HealthLevel7FastHealthInteroperabilityResources
• NPP– HIPAANoticeofPrivacyPractices• NPRM– NoticeofProposedRulemaking• OCR– OfficeofCivilRights
• ONC– OfficeoftheNationalCoordinatorforHealthInformationTechnology
• QE– QualifiedEntity(NY)• PHI – ProtectedHealthInformation(HIPAA)• QHIN – QualifiedHealthInformationNetwork(TEFCA)• RCE – RecognizedCoordinatingEntity(TEFCA)• RFI– RequestforInformation• SAMHSA– SubstanceAbuseandMentalHealthServicesAdministration
• SHIN-NY– StatewideHealthInformationNetworkforNewYork
• TEFCA – TrustedExchangeFrameworkandCommonAgreement
• TPO– Treatment,PaymentandOperations• USCDI – UnitedStatesCoreDataforInteroperability(21stCenturyCuresAct)
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WhataretheFedsthinking?– TEFCAØ TrustedExchangeFrameworkandCommonAgreement(TEFCA)▫ The21st CenturyCuresActof2016requiredONCto“developorsupportatrustedexchangeframework,includingacommonagreementamonghealthinformationnetworksnationally.”▫ DraftTrustedExchangeFrameworkwasreleasedbyONCon1/5/2018(nofinalframeworkhasbeenreleasedasof3/26/2019).▫ Establishesaminimumsetofrequirementstoenableappropriatehealthinformationexchangeamongnetworks.▫ Establishesprinciplesfortrustedexchangetoserveasguardrailstoengendertrustamonghealthinformationnetworks(HINs).
42
Source: ONC
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HowwilltheTrustedExchangeFrameworkwork?
43
Source: ONC
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Whatisincluded(andnotincluded)inTEFCA?INCLUDED:Ø AminimumfloorintheareaswherethereiscurrentlyvariationbetweenHINsthatcausesalackofinteroperability.
Ø ObligationtorespondtoBroadcastorDirectedQueriesforallthePermittedPurposesoutlinedintheTrustedExchangeFramework.
Ø QualifiedHINsmustexchangeallofthedataspecifiedintheUSCDItotheextentsuchdataisthenavailableandhasbeenrequested.
Ø BasesetofexpectationsforhowQualifiedHealthInformationNetworksconnectwitheachother.
NOTINCLUDED:Ø Nofullend-to-endagreementthatwouldbeanetnewagreement.
Ø NoexpectationthateveryHINwillservesameconstituentsorusecases.(i.e.,norequirementthatQualifiedHINsinitiateBroadcastorDirectedQueriesforallofthePermittedPurposesoutlinedintheTrustedExchangeFramework)
Ø Notdictatinginternaltechnologyorinfrastructurerequirements.
Ø NolimitationonadditionalagreementstosupportusescasesotherthanBroadcastQueryandDirectedQueryfortheTrustedExchange
Ø Frameworkspecifiedpermittedpurposes.
44
Source: ONC
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WhataretheFedsthinking?– HHSHIPAARFIØ HHSsoughtcommentsonmodifyingHIPAArulestoimprovecoordinatedcare.Specificallyon:▫ Promotinginformationsharingfortreatmentandcarecoordinationand/orcasemanagementbyamendingthePrivacyRuletoencourage,incentivize,orrequirecoveredentitiestodiscloseprotectedhealthinformation(PHI)toothercoveredentities.▫ Encouragingcoveredentities,particularlyproviders,tosharetreatmentinformationwithparents,lovedones,andcaregiversofadultsfacinghealthemergencies,withaparticularfocusontheopioidcrisis.▫ ImplementingtheHITECHActrequirementtoinclude,inanaccountingofdisclosures,disclosuresfortreatment,payment,andhealthcareoperations(TPO)fromanelectronichealthrecord(EHR)inamannerthatprovideshelpfulinformationtoindividuals,whileminimizingregulatoryburdensanddisincentivestotheadoptionanduseofinteroperableEHRs.
NOTE:HHSreceived1,337commentsinresponsetothisRFI.
45
Source: Federal Register
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WhataretheFedsthinking?– HHSHIPAARFI(continued)Ø HHSsoughtcommentsonmodifyingHIPAArulestoimprovecoordinatedcare.Specificallyon:▫ Eliminatingormodifyingtherequirementforcoveredhealthcareproviderstomakeagoodfaithefforttoobtainindividuals'writtenacknowledgmentofreceiptofproviders'NoticeofPrivacyPractices,toreduceburdenandfreeupresourcesforcoveredentitiestodevotetocoordinatedcarewithoutcompromisingtransparencyoranindividual'sawarenessofhisorherrights.▫ OCRthereforerequestsinputonwhetheritshouldmodifyorotherwiseclarifyprovisionsofthePrivacyRuletoencouragecoveredentitiestosharePHIwithnon-coveredentitieswhenneededtocoordinatecareandproviderelatedhealthcareservicesandsupport forindividualsinthesesituations.▫ Shouldhealthcareclearinghousesbesubjecttotheindividualaccessrequirements,therebyrequiringhealthcareclearinghousestoprovideindividualswithaccesstotheirPHIinadesignatedrecordsetuponrequest?
46
Source: Federal Register
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WhataretheFedsthinking?– CMSNPRM
Ø OnFebruary11,2019,theCenterforMedicareandMedicaid
Services(CMS)issuedaNoticeofProposedRulemakingon
improvinginteroperabilityofEHRsandpatientaccesstotheirdata.
ThecommentperiodforthisruleendsonMay3,2019.
Ø InadditiontotheNPRM,CMSalsoissuedtworelatedrequestsfor
information(RFIs)onimprovingpatientmatchingandapproaches
tointeroperabilityinlong-term,post-acute,mentalhealth,andother
ancillarycaresettings.
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CMSNPRM– InteroperabilityandPatientAccessØ Highlightsofproposedrules:▫ PatientaccesstodatathroughApplicationProgrammingInterfaces(APIs):ParticipatingpayersmustcreateFHIR®-basedAPIstomakepatientclaimsandotherhealthinformationavailabletopatientsthroughthird-partyapplicationsanddevelopers.▫ Healthinformationexchangeandcarecoordinationacrosspayers:Payersmustsharepatientdatawhentheytransitiontoanewplan.▫ APIaccesstopublishedproviderdirectorydata:PayersmustmakeprovidernetworksavailabletoenrolleesandprospectiveenrolleesthroughAPItechnology.▫ Carecoordinationthroughtrustedexchangenetworks:CMSproposesrequiringMAorganizations(includingMA-PDplans),Medicaidmanagedcareplans,CHIPmanagedcareentities,andQHPissuersintheFFEstoparticipateintrustnetworkstoimproveinteroperability.
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CMSNPRM– InteroperabilityandPatientAccess(continued)Ø Highlightsofproposedrules:▫ ImprovingtheDualEligibleexperiencebyincreasingfrequencyoffederal-statedataexchanges:MoretimelylistsofDualEligibles fromstates.▫ Publicreportingandpreventionofinformationblocking:Publiclypostwhichhospitalsarenotattestingtopreventionofinformationblocking.▫ Providerdigitalcontactinformation:AdditionofdigitalcontactinfototheNationalPlanandProviderEnumerationSystem(NPPES)▫ RevisionstoConditionsofParticipationforHospitalsandCriticalAccessHospitals: requirementforparticipationtosendadmission-discharge-transfer(ADT)notifications.▫ Advancinginteroperabilityininnovativemodels: GrantopportunitiesthroughtheCenterforMedicareandMedicaidInnovation(CMMI)
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WhataretheFedsthinking?– ONCNPRM
50
Source: ONC
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ONCNPRM– HighlightsØ NewAcronymAlert:EHI– ElectronicHealthInformation▫ ONCproposedrulesapplyexplicitlytohealthinformationinelectronicform.▫ Definedaselectronicprotectedhealthinformationthatidentifiestheindividualandistransmittedbyormaintainedinelectronicmedia,thatrelatestothepast,present,orfuturehealthorconditionofanindividual.
Ø Regulatedactors:▫ HealthCareProvider▫ HealthITDeveloper▫ HealthInformationExchange▫ HealthInformationNetwork
Ø VendorsthathaveonecertifiedproducthavetocomplywithrulesforALLoftheirsoftwareproducts(i.e.,can’thaveonenarrowsolutionthatiscertifiedandclaimalltheotherpiecesaren’tpartofthecertifiedsolution).
51
Source: ONC
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ONCNPRM– InformationBlocking:7Exceptions
Ø Preventingharm
▫ ActorhasareasonablebeliefthatthepracticeofnotsharingEHIwilldirectlyandsubstantiallyreducethelikelihoodofharmtoapatient(e.g.mentalhealth).
Ø Promotingtheprivacyofelectronichealthinformation
▫ ActormayengageinpracticesthatprotecttheprivacyofEHI,basedonsub-exceptionsfocusedonscenariosthatrecognizeexistingprivacylawsandprivacy-protectivepractices(WhatConnecticutlawscouldbeimpactedbythisexception?)
Ø Promotingthesecurityofelectronichealthinformation
▫ Thepracticemustbedirectlyrelatedtosafeguardingtheconfidentiality,integrity,andavailabilityofEHI.Ageneralprohibitionisnotacceptable.
52
Source: ONC
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ONCNPRM– InformationBlocking:7ExceptionsØ Recoveringcostsreasonablyincurred▫ Actormayrecovercoststhatreasonablyincurred,inprovidingaccess,exchange,oruseofEHI(cannotbearbitraryordiscriminatory).
Ø Respondingtorequeststhatareinfeasible▫ Actormaydeclinetoprovideaccess,exchange,oruseofEHIifitimposesasubstantialburdenthatisunreasonable(difficulttoclaimifusingcertifiedtech).
Ø Licensingofinteroperabilityelementsonreasonableandnon-discriminatoryterms▫ TechnologylicensesthatarenecessarytoenableEHIaccessmustbeofferedonreasonableandnon-discriminatoryterms.
Ø MaintainingandimprovinghealthITperformance▫ HealthITcanbemadetemporarilyunavailableinordertoperformmaintenanceorimprovementstothehealthIT,butfornolongerthannecessarytoachievethemaintenanceorimprovements
53
Source: ONC