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L    ThePrivacyRule(45CFRPart160andSubpartsAandEofPart164)providesthefirst $  comprehensiveFederalprotectionfortheprivacyofhealthinformation.Allsegmentsofthe   healthcareindustryhaveexpressedsupportfortheobjectiveofenhancedpatientprivacyinthe   healthcaresystem.ThePrivacyRule,asmodified,iscarefullybalancedtoprovidestrong   privacyprotectionsthatdonotinterferewithpatientaccessto,orthequalityof,healthcare   delivery. ~  XXXX  Theguidancethatfollowsismeanttocommunicateasclearlyaspossibletheprivacy V policiescontainedinthePrivacyRule.ForaparticularsegmentinthePrivacyRule,the B guidancewillprovideabriefexplanationofthesegmentandhowtheRuleworks,followedbya .p linktothe FrequentlyAskedQuestionsaboutthatprovision.YoucanseeallofthePrivacy \ Rule FrequentlyAskedQuestionsifyou#XXXX#XXXX4Z O  5  c  XXCLICKHERE  cn  6"6  7 d#XX#XX;#XX ##XXXX#XXXXoryoucangoto H #XXXX # 4]$O  5  c  XXXXhttp://answers.hhs.gov/cgibin/hhs.cfg/php/enduser/std_alp.php c   #XXXX #6T h   7$~ XXXXX ,thenselect"PrivacyofHealth 4 Information/HIPAA"fromtheCategory_dropdown_ԀlistandclicktheSearchbutton.The   guidancedoesnotaddressalloftherelevantprovisionsintheRule,althoughweanticipate   addingsegmentsinthefutureaswedevelopguidanceonmorePrivacyRulestandards.Wewill  alsobeaddingtothe FrequentlyAskedQuestionsonanongoingbasisasnewquestionsarise.   _HHS_Ԁplanstoworkexpeditiouslytoaddresstheseadditionalquestionstofacilitateunderstanding ! oftheRuleandtoencouragevoluntarycompliancewithitsrequirements.However,forafull z" understandingofonesrightsandresponsibilitiesundertheRule,itisimportanttoconsultthe f# Ruleitself.E #XXXX # R$  ThePrivacyRuleStandardsAddressed  *&l! GeneralOverview (D # IncidentalUsesandDisclosures(45CFR164.502(a)) (0!$ MinimumNecessary(45CFR164.502(b),164.514(d)) )"% PersonalRepresentatives(45CFR164.502(g)) *#& BusinessAssociates(45CFR164.502(e),164.504(e),164.532(d)and(e)) +#' _UsesandDisclosuresforTreatment,Payment,andHealthCareOperations(45CFR164.506)  Marketing(45_CFR_Ԁ164.501,164.508(a))  PublicHealth(45_CFR_Ԁ164.512(b))   Research(45_CFR_Ԁ164.501,164.508,164.512(_i_),164.514(e),164.528,164.532)   WorkersCompensationLaws(45_CFR_Ԁ164.512(l)) n  Notice(45_CFR_Ԁ164.520) Z  GovernmentAccess(45_CFR_ԀPart160,SubpartC,164.512(f)) F  Miscellaneous_FAQs_  2t @   GENERALOVERVIEWOFSTANDARDSFORPRIVACY  OFINDIVIDUALLYIDENTIFIABLEHEALTHINFORMATION   [45CFRPart160andSubpartsAandEofPart164]   D  ThefollowingoverviewprovidesanswerstogeneralquestionsregardingtheStandards n  forPrivacyofIndividuallyIdentifiableHealthInformation(thePrivacyRule),promulgatedby Z  theDepartmentofHealthandHumanServices(_HHS_). F    Toimprovetheefficiencyandeffectivenessofthehealthcaresystem,theHealth ` InsurancePortabilityandAccountabilityAct(HIPAA)of1996,PublicLaw104191,included  L   AdministrativeSimplificationprovisionsthatrequiredHHStoadoptnationalstandardsfor 8  electronichealthcaretransactions.Atthesametime,Congressrecognizedthatadvancesin $  electronictechnologycoulderodetheprivacyofhealthinformation.Consequently,Congress   incorporatedintoHIPAAprovisionsthatmandatedtheadoptionofFederalprivacyprotections   forindividuallyidentifiablehealthinformation.     InresponsetotheHIPAAmandate,_HHS_Ԁpublishedafinalregulationintheformofthe ~ PrivacyRuleinDecember2000,whichbecameeffectiveonApril14,2001.ThisRuleset j nationalstandardsfortheprotectionofhealthinformation,asappliedtothethreetypesof V coveredentities:healthplans,healthcareclearinghouses,andhealthcareproviderswhoconduct B certainhealthcaretransactionselectronically.BythecompliancedateofApril14,2003(April .p 14,2004,forsmallhealthplans),coveredentitiesmustimplementstandardstoprotectandguard \ againstthemisuseofindividuallyidentifiablehealthinformation.Failuretotimelyimplement H thesestandardsmay,undercertaincircumstances,triggertheimpositionofcivilorcriminal 4 penalties.     SecretaryTommyThompsoncalledforanadditionalopportunityforpubliccommenton  thePrivacyRuletoensurethatthePrivacyRuleachievesitsintendedpurposewithoutadversely   affectingthequalityof,orcreatingnewbarriersto,patientcare.Aftercarefulconsiderationof ! thesecomments,inMarch2002_HHS_ԀpublishedproposedmodificationstotheRule,toimprove z" _workability_Ԁandavoidunintendedconsequencesthatcouldhaveimpededpatientaccessto f# deliveryofqualityhealthcare.Followinganotherroundofpubliccomment,inAugust2002,the R$ DepartmentadoptedasafinalRulethemodificationsnecessarytoensurethatthePrivacyRule >%  workedasintended. *&l!   ThePrivacyRuleestablishes,forthefirsttime,afoundationofFederalprotectionsforthe (D # privacyofprotectedhealthinformation.TheRuledoesnotreplaceFederal,State,orotherlaw (0!$ thatgrantsindividualsevengreaterprivacyprotections,andcoveredentitiesarefreetoretainor )"% adoptmoreprotectivepoliciesorpractices. *#&  +#'  XXXX  4+ j O  5  c      RFAQsonPrivacyRule:GeneralTopicsc6$  6#O#  7 n$ #XXXX##   ____#   INCIDENTAL_ԀUSESAND_DISCLOSURES   ____[45CFR164.502(a)(1)(iii)]_  _%__ Background __   _  _Many_Ԁcustomaryhealthcarecommunicationsandpracticesplayanimportantoreven Z  essentialroleinensuringthatindividualsreceivepromptandeffectivehealthcare._Due_Ԁtothe F  natureofthesecommunicationsandpractices,aswellasthevariousenvironmentsinwhich 2t individualsreceivehealthcareorotherservicesfromcoveredentities,thepotentialexistsforan ` individualshealthinformationtobedisclosed_incidentally._ԀForexample,ahospitalvisitormay  L  overhearaprovidersconfidentialconversationwithanotherproviderorapatient,ormay 8  glimpseapatientsinformationona_signinsheetornursingstationwhiteboard._ԀThe_HIPAA $  Privacy_ԀRuleisnotintendedtoimpedethesecustomaryandessentialcommunicationsand   practicesand,thus,doesnotrequirethatallriskofincidentaluseordisclosurebeeliminatedto   satisfyitsstandards.Rather,thePrivacyRulepermitscertainincidentalusesanddisclosuresof   protectedhealthinformationtooccurwhenthecoveredentityhasinplacereasonablesafeguards   andminimumnecessarypoliciesandprocedurestoprotectanindividualsprivacy. ~ _ How_ԀtheRuleWorks  V   GeneralProvision.ThePrivacyRulepermitscertainincidentalusesanddisclosuresthat .p occurasabyproductof_another_Ԁ_permissibleorrequireduse_Ԁor_disclosure__________,aslongas____thecovered \ entityhasappliedreasonablesafeguardsandimplementedtheminimumnecessarystandard, H whereapplicable,withrespecttotheprimaryuseordisclosure.See45CFR164.502(a)(1)(iii)__._ 4 Anincidentaluseordisclosureisasecondaryuseordisclosurethatcannotreasonablybe   _prevented,_Ԁ___is_Ԁlimitedin_nature,andthatoccursasaresultofanotheruseordisclosurethatis   permittedbytheRule._Ԁ_However,an_Ԁincidentaluseordisclosure_isnotpermittedifitisa________by  _productof_anunderlying_Ԁuseordisclosure_which____violates_Ԁ___the_ԀPrivacy_Rule._     ReasonableSafeguards.Acoveredentitymusthaveinplaceappropriateadministrative, z" technical,andphysicalsafeguardsthatprotectagainstusesanddisclosuresnotpermittedbythe f# PrivacyRule,aswellasthatlimitincidentalusesordisclosures.See45CFR164.530(c).Itis R$ notexpectedthat_acoveredentitys__safeguards_Ԁguaranteetheprivacyofprotectedhealth >%  informationfromanyandallpotentialrisks._Reasonablesafeguardswillvaryfromcovered *&l! entitytocoveredentitydependingonfactors,suchasthesizeofthecoveredentityandthenature 'X" ofitsbusiness.In_Ԁ_implementing______________reasonable_Ԁsafeguards,_coveredentitiesshouldanalyzetheir (D # ownneedsandcircumstances,suchasthenatureoftheprotectedhealthinformationitholds,and (0!$ assessthepotentialriskstopatientsprivacy.Coveredentitiesshouldalsotakeintoaccount__the_ )"% potentialeffectsonpatient_care__and_Ԁ_mayconsiderotherissues,suchas_Ԁthefinancialand *#& administrative_burden_Ԁof_implementingparticular____safeguards. +#' ____ԇ  __Manyhealthcareprovidersandprofessionalshavelongmadeitapracticetoensure  reasonablesafeguardsforindividualshealthinformation!forinstance:  {c  0  {c="0` (#(#  Byspeakingquietlywhendiscussingapatientsconditionwithfamilymembersin   awaitingroomorotherpublicarea;{c==݌n ` (#` (# Ќ  0   (#(# {c  0  {c>"0` (#(#  Byavoidingusingpatientsnamesinpublichallwaysandelevators,andposting F  signstoremindemployeestoprotectpatientconfidentiality;{c>?݌2t` (#` (# Ќ  0   (#(# {c  0  {cO@"0` (#(#  Byisolatingorlockingfilecabinetsorrecordsrooms;or{cO@v@݌ L ` (#` (# Ќ  0   (#(# {c  0  {cLA"0` (#(#  Byprovidingadditionalsecurity,suchaspasswords,oncomputersmaintaining $  personalinformation.{cLAsA݌ ` (#` (# Ќ  0   (#(#   Protectionofpatientconfidentialityisanimportantpracticeformanyhealthcareand   healthinformationmanagementprofessionals;coveredentitiescanbuilduponthosecodesof   conducttodevelopthereasonablesafeguardsrequiredbythePrivacyRule._ ~   MinimumNecessary.Coveredentitiesalsomustimplementreasonableminimum V necessarypoliciesandproceduresthat_limithowmuchprotectedhealthinformationisused, B disclosed,andrequestedforcertainpurposes.Theseminimumnecessarypoliciesandprocedures .p alsoreasonablymustlimit_Ԁwhowithintheentityhasaccesstoprotectedhealth_information,_Ԁand \ underwhat_conditions,_Ԁbasedon___job_Ԁresponsibilitiesandthenatureofthe_business________._ԀThe H minimumnecessarystandarddoesnotapplytodisclosures,includingoraldisclosures,among 4 healthcareprovidersfortreatmentpurposes.___Forexample,aphysicianisnotrequiredtoapply   theminimumnecessarystandardwhendiscussingapatientsmedicalchartinformationwitha   specialistatanotherhospital.See_Ԁ45_CFR_Ԁ164.502(b)and164.514(d),andthe_factsheetand  frequentlyaskedquestionsonthiswebsiteabout______the_Ԁminimumnecessary_standard,_Ԁformore   information. !   Anincidentaluseordisclosurethatoccursasaresultofafailuretoapplyreasonable f# safeguardsortheminimumnecessarystandard,whererequired,isnotpermittedunderthe R$ Privacy_Rule. >%  __  Forexample: 'X" 0  {c  {c%L"0` (#(#  Theminimumnecessarystandardrequiresthatacoveredentitylimitwhowithin (0!$ theentityhasaccesstoprotectedhealthinformation,basedonwhoneedsaccess )"% toperformtheirjobduties.Ifahospitalemployeeisallowedtohaveroutine, *#& unimpededaccesstopatientsmedicalrecords,wheresuchaccessisnotnecessary +#' forthehospitalemployeetodohisjob,thehospitalisnotapplyingtheminimum  necessarystandard.Therefore,anyincidentaluseordisclosurethatresultsfrom  thispractice,suchasanotherworkeroverhearingthehospitalemployees   conversationaboutapatientscondition,wouldbeanunlawfuluseordisclosure   underthePrivacyRule.{c%L@L݌n ` (#` (# Ќ  0  ]% (#(# ____ __  4/  O  5  c      XXXX_FAQs_ԀonIncidentalUsesandDisclosurescP  #XXXX7Q#6PP  7 P  F  P  MINIMUMNECESSARY __  ____[45_CFR_Ԁ164.502(b),164.514(d)]_   R_ Background __ n  ____  Theminimumnecessarystandard,akeyprotectionofthe_HIPAA_ԀPrivacyRule,__isderived F  fromconfidentialitycodesandpracticesincommonusetoday.Itisbasedonsoundcurrent 2t practicethatprotectedhealthinformationshouldnotbeusedordisclosedwhenitisnot ` necessarytosatisfyaparticularpurposeorcarryoutafunction.Theminimumnecessary  L  standardrequirescoveredentitiestoevaluatetheirpracticesandenhancesafeguardsasneededto 8  limitunnecessaryorinappropriateaccesstoanddisclosureofprotectedhealthinformation.The $  PrivacyRulesrequirementsforminimumnecessaryaredesignedtobesufficientlyflexibleto   accommodatethevariouscircumstancesofanycoveredentity.   __________ How_ԀtheRuleWorks    ___  ThePrivacyRulegenerallyrequirescoveredentitiestotakereasonablestepstolimitthe j useordisclosureof,andrequestsfor,protectedhealthinformationtotheminimumnecessaryto V accomplishtheintendedpurpose.Theminimumnecessarystandarddoesnotapplytothe B following: .p {c  0  {crZ"0` (#(#  Disclosurestoorrequestsbyahealthcareproviderfortreatmentpurposes.{crZZ݌H` (#` (# Ќ  0   (#(# {c  0  {c["0` (#(#  Disclosurestotheindividualwhoisthesubjectoftheinformation.{c[[݌ ` (#` (# Ќ  0   (#(# {c  0  {c\"0` (#(#  Usesordisclosuresmadepursuanttoanindividualsauthorization.{c\\݌` (#` (# Ќ  0   (#(# {c  0  {c]"0` (#(#  UsesordisclosuresrequiredforcompliancewiththeHealthInsurancePortability ! andAccountabilityAct(_HIPAA_)AdministrativeSimplificationRules.{c]]݌z"` (#` (# Ќ  0   (#(# {c  0  {c_"0` (#(#  DisclosurestotheDepartmentofHealthandHumanServices(_HHS_)when R$ disclosureofinformationisrequiredunderthePrivacyRuleforenforcement >%  purposes.{c_D_݌*&l!` (#` (# Ќ  0   (#(# {c  0  {c`"0` (#(#  Usesordisclosuresthatarerequiredbyotherlaw.{c``݌(D #` (#` (# Ќ    Theimplementationspecificationsforthisprovisionrequireacoveredentitytodevelop )"% andimplementpoliciesandproceduresappropriateforitsownorganization,reflectingthe *#& entitysbusinesspracticesandworkforce.Whileguidancecannotanticipateeveryquestionor +#' factualapplicationoftheminimumnecessarystandardtoeachspecificindustrycontext,whereit  wouldbegenerallyhelpfulwewillseektoprovideadditionalclarificationonthisissueinthe  future.Inaddition,theDepartmentwillcontinuetomonitorthe_workability_Ԁoftheminimum   necessarystandardandconsiderproposingrevisions,whereappropriate,toensurethattheRule   doesnothindertimelyaccesstoqualityhealthcare. n    UsesandDisclosuresof,andRequestsfor,ProtectedHealthInformation.Forusesof F  protectedhealthinformation,thecoveredentityspoliciesandproceduresmustidentifythe 2t personsorclassesofpersonswithinthecoveredentitywhoneedaccesstotheinformationto ` carryouttheirjobduties,thecategoriesortypesofprotectedhealthinformationneeded,and  L  conditionsappropriatetosuchaccess.Forexample,hospitalsmayimplementpoliciesthat 8  permitdoctors,nurses,orothersinvolvedintreatmenttohaveaccesstotheentiremedical $  record,asneeded.Casebycasereviewofeachuseisnotrequired.Wheretheentiremedical   recordisnecessary,thecoveredentityspoliciesandproceduresmuststatesoexplicitlyand   includeajustification.     Forroutineorrecurringrequestsanddisclosures,thepoliciesandproceduresmaybe ~ standardprotocolsandmustlimittheprotectedhealthinformationdisclosedorrequestedtothat j whichistheminimumnecessaryforthatparticulartypeofdisclosureorrequest.Individual V reviewofeachdisclosureorrequestisnotrequired. B   Fornonroutinedisclosuresandrequests,coveredentitiesmustdevelopreasonable \ criteriafordeterminingandlimitingthedisclosureorrequesttoonlytheminimumamountof H protectedhealthinformationnecessarytoaccomplishthepurposeofanonroutinedisclosureor 4 request.Nonroutinedisclosuresandrequestsmustbereviewedonanindividualbasisin   accordancewiththesecriteriaandlimitedaccordingly.     Ofcourse,whereprotectedhealthinformationisdisclosedto,orrequestedby,healthcare   providersfortreatmentpurposes,theminimumnecessarystandarddoesnotapply. !   ReasonableReliance.Incertaincircumstances,thePrivacyRulepermitsacoveredentity f# torelyonthejudgmentofthepartyrequestingthedisclosureastotheminimumamountof R$ informationthatisneeded.Suchreliancemustbereasonableundertheparticularcircumstances >%  oftherequest.Thisrelianceispermittedwhentherequestismadeby: *&l! {c  0  {c_o"0` (#(#  Apublicofficialoragencywhostatesthattheinformationrequestedisthe (D # minimumnecessaryforapurposepermittedunder45_CFR_ԁ164.512oftheRule, (0!$ suchasforpublichealthpurposes(45_CFR_Ԁ164.512(b)).{c_oo݌)"%` (#` (# Ќ  0   (#(# {c  0  {cZq"0` (#(#  Anothercoveredentity.{cZqq݌+#'` (#` (# Ќ  0   (#(# {c  0  {c4r"0` (#(#  Aprofessionalwhoisaworkforcememberorbusinessassociateofthecovered  entityholdingtheinformationandwhostatesthattheinformationrequestedisthe   minimumnecessaryforthestatedpurpose.{c4r[r݌ ` (#` (# Ќ  0   (#(# {c  0  {cs"0` (#(#  AresearcherwithappropriatedocumentationfromanInstitutionalReviewBoard Z  (_IRB_)orPrivacyBoard.{cst݌F ` (#` (# Ќ    TheRuledoesnotrequiresuchreliance,however,andthecoveredentityalwaysretains ` discretiontomakeitsownminimumnecessarydeterminationfordisclosurestowhichthe  L  standardapplies.__ 8   JR  45 O  5  c      XXXX_FAQs_ԀonMinimumNecessary cv$  #XXXXw#6svv$  7 vfw    fv   PERSONALREPRESENTATIVES   [45_CFR_Ԁ164.502(g)]  zx Background      The_HIPAA_ԀPrivacyRuleestablishesafoundationofFederallyprotectedrightswhich f  permitindividualstocontrolcertainusesanddisclosuresoftheirprotectedhealthinformation. R  Alongwiththeserights,thePrivacyRuleprovidesindividualswiththeabilitytoaccessand >t amendthisinformation,andtherighttoanaccountingofcertaindisclosures.TheDepartment *` recognizesthattheremaybetimeswhenindividualsarelegallyorotherwiseincapableof L  exercisingtheirrights,orsimplychoosetodesignateanothertoactontheirbehalfwithrespectto 8  theserights.UndertheRule,apersonauthorized(underStateorotherapplicablelaw,e.g.,tribal $  ormilitarylaw)toactonbehalfoftheindividualinmakinghealthcarerelateddecisionsisthe   individuals personalrepresentative.Section164.502(g)provideswhen,andtowhatextent,   thepersonalrepresentativemustbetreatedastheindividualforpurposesoftheRule.Inaddition   totheseformaldesignationsofapersonalrepresentative,theRuleat45_CFR_Ԁ164.510(b)   addressessituationsinwhichpersonsareinvolvedintheindividualshealthcarebutarenot  expresslyauthorizedtoactontheindividualsbehalf. v  HowtheRuleWorks  N   GeneralProvisions.Exceptasotherwiseprovidedin45_CFR_Ԁ164.502(g),thePrivacy &\ Rulerequirescoveredentitiestotreatanindividualspersonalrepresentativeastheindividual H withrespecttousesanddisclosuresoftheindividualsprotectedhealthinformation,aswellas 4 theindividualsrightsundertheRule.     Thepersonalrepresentativestandsintheshoesoftheindividualandhastheabilitytoact  fortheindividualandexercisetheindividualsrights.Forinstance,coveredentitiesmust   providetheindividualspersonalrepresentativewithanaccountingofdisclosuresinaccordance ! with45_CFR_Ԁ164.528,aswellasprovidethepersonalrepresentativeaccesstotheindividuals " protectedhealthinformationinaccordancewith45_CFR_Ԁ164.524totheextentsuchinformation r# isrelevanttosuchrepresentation .Inadditiontoexercisingtheindividualsrightsunderthe ^$ Rule,apersonalrepresentativemayalsoauthorizedisclosuresoftheindividualsprotectedhealth J%  information. 6&l!   Ingeneral,thescopeofthepersonalrepresentativesauthoritytoactfortheindividual (D # underthePrivacyRulederivesfromhisorherauthorityunderapplicablelawtomakehealthcare (0!$ decisionsfortheindividual.Wherethepersonhasbroadauthoritytoactonthebehalfofaliving )"% individualinmakingdecisionsrelatedtohealthcare,suchasaparentwithrespecttoaminor *#& childoralegalguardianofamentallyincompetentadult,thecoveredentitymusttreatthe +#' personalrepresentativeastheindividualforallpurposesundertheRule,unlessanexception  applies.(Seebelowwithrespecttoabuse,neglectorendangermentsituations,andthe  applicationofStatelawinthecontextofparentsandminors).Wheretheauthoritytoactforthe   individualislimitedorspecifictoparticularhealthcaredecisions,thepersonalrepresentativeis   tobetreatedastheindividualonlywithrespecttoprotectedhealthinformationthatisrelevantto z  therepresentation.Forexample,apersonwithanindividualslimitedhealthcarepowerof f  attorneyregardingonlyaspecifictreatment,suchasuseofartificiallifesupport,isthat R  individualspersonalrepresentativeonlywithrespecttoprotectedhealthinformationthatrelates >t tothathealthcaredecision.Thecoveredentityshouldnottreatthatpersonastheindividualfor *` otherpurposes,suchastosignanauthorizationforthedisclosureofprotectedhealthinformation L  formarketingpurposes.Finally,wherethepersonhasauthoritytoactonthebehalfofa 8  deceasedindividualorhisestate,whichdoesnothavetoincludetheauthoritytomakedecisions $  relatedtohealthcare,thecoveredentitymusttreatthepersonalrepresentativeastheindividual   forallpurposesundertheRule.Stateorotherlawshouldbeconsultedtodeterminetheauthority   ofthepersonalrepresentativetoreceiveoraccesstheindividualsprotectedhealthinformation.     WhoMustBeRecognizedastheIndividualsPersonalRepresentative.Thefollowing  chartdisplayswhomustberecognizedasthepersonalrepresentativeforacategoryof v individuals: b   IftheIndividualIs:0  0h(#(#0h(#h(#ThePersonalRepresentativeIs::p(#(#   AnAdultor0 0 (# (#0h(#(#0h(#h(#ApersonwithlegalauthoritytomakehealthH(#(#   AnEmancipatedMinor0 h 0h(#h(#caredecisionsonbehalfoftheindividual4(#(#    `     h   Examples:0 p Healthcarepowerofattorney p(#p(#    `     h      p Courtappointedlegalguardian     `     h      p Generalpowerofattorney     AnUnemancipatedMinor0 h 0h(#h(#Aparent,guardian,orotherpersonactinginloco " parentiswithlegalauthoritytomakehealthcare r# decisionsonbehalfoftheminorchild^$(#(#    `     h   Exceptions:0 p Seeparentsandminorsdiscussion 6&l! below."'X"p(#p(#   Deceased0 0 (# (#0h(#(#0h(#h(#Apersonwithlegalauthoritytoactonbehalfofthe (0!$ decedentortheestate(notrestrictedtohealthcare )"% decisions)*#&(#(#  +#'    `     h   Examples:0 p Executoroftheestatep(#p(#    `     h      p Nextofkinorotherfamilymember     `     h      p Durablepowerofattorney     ParentsandUnemancipatedMinors.ThePrivacyRuledeferstoStateorotherapplicable z  lawsthataddresstheabilityofaparent,guardian,orotherpersonactinginlocoparentis f  (collectively, parent)toobtainhealthinformationaboutaminorchild.Inmostcasesunderthe R  Rule,theparentisthepersonalrepresentativeoftheminorchildandcanexercisetheminors >t rightswithrespecttoprotectedhealthinformation,becausetheparentusuallyhastheauthorityto *` makehealthcaredecisionsabouthisorherminorchild.Regardlessofwhetheraparentisthe L  personalrepresentative,thePrivacyRulepermitsacoveredentitytodisclosetoaparent,or 8  providetheparentwithaccessto,aminorchildsprotectedhealthinformationwhenandtothe $  extentitisexpresslypermittedorrequiredbyStateorotherlaws(includingrelevantcaselaw).   Likewise,thePrivacyRuleprohibitsacoveredentityfromdisclosingaminorchildsprotected   healthinformationtoaparent,orprovidingaparentwithaccessto,suchinformationwhenand   totheextentitisexpresslyprohibitedunderStateorotherlaws(includingrelevantcaselaw).   Thus,Stateandotherapplicablelawgovernswhensuchlawexplicitlyrequires,permits,or  prohibitsthedisclosureof,oraccessto,thehealthinformationaboutaminorchild. v   ThePrivacyRulespecifiesthreecircumstancesinwhichtheparentisnotthe personal N representativewithrespecttocertainhealthinformationabouthisorherminorchild.These :p exceptionsgenerallytracktheabilityofcertainminorstoobtainspecifiedhealthcarewithout &\ parentalconsentunderStateorotherlaws,orstandardsofprofessionalpractice.Inthese H situations,theparentdoesnotcontroltheminorshealthcaredecisions,andthusundertheRule, 4 doesnotcontroltheprotectedhealthinformationrelatedtothatcare.Thethreeexceptional   circumstanceswhenaparentisnottheminorspersonalrepresentativeare:   {c    {cF"0 `   WhenStateorotherlawdoesnotrequiretheconsentofaparentorother   personbeforeaminorcanobtainaparticularhealthcareservice,andthe ! minorconsentstothehealthcareservice;{cFm݌"` (#` (# Ќ     `  Example:0  AStatelawprovidesanadolescenttherighttoobtainmental b$ healthtreatmentwithouttheconsentofhisorherparent,andthe N%  adolescentconsentstosuchtreatmentwithouttheparentsconsent.:&p!(#(# {c  0  {c"0` (#(#  Whenacourtdeterminesorotherlawauthorizessomeoneotherthanthe (H # parenttomaketreatmentdecisionsforaminor ;{c5݌)8!$` (#` (# Ќ  0   ` Example:0(#(#Acourtmaygrantauthoritytomakehealthcaredecisionsforthe *#& minortoanadultotherthantheparent,totheminor,orthe_court +$' maymakethedecision(s)itself.(#(# {c    {cw"0 `   Whenaparentagreestoaconfidentialrelationshipbetweentheminorand   thephysician .{cw݌ ` (#` (# Ќ     `    ` Example:0  Aphysicianaskstheparentofa16yearoldifthephysiciancan n  talkwiththechildconfidentiallyaboutamedicalconditionandthe Z  parentagrees.F|(#(#   Evenintheseexceptionalcircumstances,wheretheparentisnotthe personal T  representativeoftheminor,thePrivacyRuledeferstoStateorotherlawsthatrequire,permit,  @  orprohibitthecoveredentitytodisclosetoaparent,orprovidetheparentaccessto,aminor ,  childsprotectedhealthinformation.Further,inthesesituations,ifStateorotherlawissilentor   unclearconcerningparentalaccesstotheminorsprotectedhealthinformation,acoveredentity   hasdiscretiontoprovideordenyaparentwithaccesstotheminorshealthinformation,ifdoing   soisconsistentwithStateorotherapplicablelaw,andprovidedthedecisionismadebya   licensedhealthcareprofessionalintheexerciseofprofessionaljudgment.d  d  Abuse,Neglect,andEndangermentSituations.Whenaphysicianorothercoveredentity j reasonablybelievesthatanindividual,includinganunemancipatedminor,hasbeenormaybe V subjectedtodomesticviolence,abuseorneglectbythepersonalrepresentative,orthattreatinga Bx personasanindividualspersonalrepresentativecouldendangertheindividual,thecovered .d entitymaychoosenottotreatthatpersonastheindividualspersonalrepresentative,ifinthe P exerciseofprofessionaljudgment,doingsowouldnotbeinthebestinterestsoftheindividual. < Forexample,ifaphysicianreasonablybelievesthatdisclosinginformationaboutanincompetent ( elderlyindividualtotheindividualspersonalrepresentativewouldendangerthatindividual,the  PrivacyRulepermitsthephysiciantodeclinetomakesuchdisclosure.   4x46 O  5  c      XXXX  _FAQs_ԀonPersonalReps/Parentsand_Minorscϰctic_  _#XXXX#6ctic_  7 MŰ  ! _______8  BUSINESS_Ԁ_ASSOCIATES   ____[45_CFR_Ԁ164.502(e),164.504(e),164.532(d)and(e)]_  ___ Background  `     h    _  Bylaw,the__HIPAA_ԀPrivacy_ԀRuleappliesonlytocovered_entities!__health_Ԁplans,health f  careclearinghouses,andcertainhealthcareproviders.However,mosthealthcareprovidersand R  healthplansdonotcarryoutalloftheirhealthcareactivitiesandfunctionsbythemselves. >t Instead,theyoftenusetheservicesofavarietyofotherpersonsorbusinesses._The_ԀPrivacyRule *` allows_coveredproviders_Ԁand_healthplans_Ԁ_todisclose____Ԁprotected_Ԁhealthinformationtothese L   business_associatesiftheprov______________ider__s_Ԁor_plans_Ԁ_obtain_______Ԁsatisfactoryassurancesthatthebusiness 8  associatewillusetheinformationonlyforthepurposesforwhich_itwas____engaged_Ԁbythecovered $  _entity,_Ԁ_will_Ԁsafeguardtheinformationfrom_misuse,andwillhelpthecoveredentitycomplywith   someofthecoveredentitysdutiesunderthePrivacyRule._Ԁ_ԀCoveredentitiesmaydisclose   p____rotected_Ԁhealthinformation_______to_Ԁ_____anentityinitsroleasabusiness_Ԁassociateonlytohelpthe   coveredentitycarryoutitshealthcarefunctions!notfor_thebusinessassociatesindependent_   use_orpurposes____,exceptasneededforthepropermanagementandadministrationofthebusiness  associate._ v _ How_ԀtheRuleWorks  N _  GeneralProvision.ThePrivacyRulerequiresthatacoveredentityobtainsatisfactory &\ assurancesfromitsbusinessassociatethatthebusinessassociatewillappropriatelysafeguardthe H protectedhealthinformationitreceivesorcreatesonbehalfofthecoveredentity.The 4 satisfactoryassurancesmustbeinwriting,whetherintheformofacontractorotheragreement   betweenthecoveredentityandthebusinessassociate.   ___  What_Is_Ԁa_ Business_Ԁ_Associate?_ԀA businessassociateisapersonorentitythat   performscertainfunctionsoractivities_thatinvolvetheuseordisclosureofprotectedhealth ! information_Ԁonbehalfof,orprovidesservicesto,acovered_entity__._ " _  _{c  {c"0 `   Amemberofthecoveredentitysworkforceisnotabusiness_associate.{c݌^$` (#` (# Ќ    0  {c  {c"0` (#(#  Acoveredhealthcareprovider,healthplan,orhealthcareclearinghousecanbea 6&l! businessassociateofanothercoveredentity.{c݌"'X"` (#` (# Ќ    ThePrivacyRulelistssomeofthefunctionsoractivities,aswellastheparticular (0!$ services,thatmakeapersonorentityabusinessassociate,iftheactivityorserviceinvolvesthe )"% useordisclosureofprotectedhealthinformation.Thetypesoffunctionsoractivitiesthatmay *#& makeapersonorentityabusinessassociateincludepaymentorhealthcareoperationsactivities, +#' aswellasotherfunctionsoractivitiesregulatedbytheAdministrativeSimplificationRules.  {c  0  {cz"0` (#(#  Businessassociatefunctionsandactivitiesinclude:claimsprocessingor   administration;_Ԁdataanalysis,processingoradministration;utilizationreview;   qualityassurance;billing;benefitmanagement;practicemanagement;and z  repricing.{cz݌f ` (#` (# Ќ    {c  0  {ch"0` (#(#  Businessassociateservicesare:legal;actuarial;accounting;consulting;data >t aggregation;management;administrative;accreditation;andfinancial.{ch݌*`` (#` (# Ќ    Seethedefinitionof businessassociateat45_CFR_Ԁ160.103. 8    ExamplesofBusinessAssociates.   0  {c  {c"0` (#(#  Athirdpartyadministratorthatassistsahealthplanwithclaims_processing._{c݌ ` (#` (# Ќ  0  {c  {c"0` (#(#  _ACPA_firmwhoseaccountingservicestoahealthcareproviderinvolveaccessto  protectedhealthinformation.{c݌v` (#` (# Ќ  {c  0  {c"0` (#(#  Anattorneywhoselegalservicestoahealthplaninvolveaccesstoprotected N healthinformation.{c݌:p` (#` (# Ќ  {c  0  {c"0` (#(#  Aconsultantthatperformsutilizationreviewsforahospital.{c݌H` (#` (# Ќ  {c  0  {c"0` (#(#  Ahealthcareclearinghousethattranslatesaclaimfromanonstandardformat   intoastandardtransactiononbehalfofahealthcareproviderandforwardsthe   processedtransactiontoapayer.{c݌` (#` (# Ќ  {c  0  {cX"0` (#(#  Anindependentmedical_transcriptionist_Ԁthatprovidestranscriptionservicestoa ! physician.{cX݌"` (#` (# Ќ  {c  0  {c"0` (#(#  Apharmacybenefitsmanagerthatmanagesahealthplanspharmacistnetwork.{c݌^$` (#` (# Ќ    BusinessAssociateContracts._Ԁ_______Acoveredentitys__contract_Ԁorother_writtenarrangement_ 6&l! _withitsbusinessassociatemust_Ԁcontaintheelementsspecifiedat45CFR164.504(e).For "'X" example,thecontract_must: (D # _0  {c  {c"0` (#(#  _Describe___Ԁthepermittedandrequiredusesofprotectedhealthinformationbythe )"% business_associate;{c݌*#&` (#` (# Ќ  0  +#'(#(# 0  {c  {cH"0` (#(#  Providethatthebusinessassociatewillnotuseorfurtherdisclosetheprotected  healthinformationotherthanaspermittedorrequiredbythecontractoras  requiredbylaw;and{cHc݌ ` (#` (# Ќ  0   (#(# 0  {c  {c"0` (#(#  Requirethebusinessassociatetouseappropriatesafeguardstopreventauseor z  disclosureoftheprotectedhealthinformationotherthanasprovidedforbythe f  contract.{c݌R ` (#` (# Ќ  0   (#(#   Whereacoveredentityknowsofamaterialbreachorviolationbythebusinessassociate *` ofthecontractoragreement,thecoveredentityisrequiredtotakereasonablestepstocurethe L  breachorendtheviolation,andifsuchstepsareunsuccessful,toterminatethecontractor 8  arrangement.Ifterminationofthecontractoragreementisnotfeasible,acoveredentityis $  requiredtoreporttheproblemtotheDepartmentofHealthandHumanServices(_HHS_)Office   forCivilRights(OCR).     Samplebusinessassociatecontractlanguageisavailable__on_Ԁ_the_HHS_ԀOCR_Ԁ_Privacyof   Health_ԀInformation___website_Ԁat_4eg4O  5  http://www.hhs.gov/ocr/hipaa/contractprov.html6rOrds  7egP.    TransitionProvisionsforExistingContracts.Coveredentities(otherthansmallhealth b plans)thathaveanexistingcontract(orotherwrittenagreement)withabusinessassociateprior N toOctober15,2002,arepermittedtocontinuetooperateunderthatcontractforuptoone :p additionalyearbeyondtheApril14,2003compliancedate,providedthatthecontractisnot &\ renewedormodifiedpriortoApril14,2003.Thistransitionperiodappliesonlytowritten H contractsorotherwrittenarrangements.Oralcontractsorotherarrangementsarenoteligiblefor 4 thetransitionperiod.Coveredentitieswithcontractsthatqualifyarepermittedtocontinueto   operateunderthosecontractswiththeirbusinessassociatesuntilApril14,2004,oruntilthe   contractisrenewedormodified,whicheverissooner,regardlessofwhetherthecontractmeets  theRulesapplicablecontractrequirementsat45_CFR_Ԁ164.502(e)and164.504(e).Acovered   entitymustotherwisecomplywiththePrivacyRule,suchasmakingonlypermissibledisclosures ! tothebusinessassociateandpermittingindividualstoexercisetheirrightsundertheRule. "   See45_CFR_Ԁ164.532(d)and(e). ^$   ExceptionstotheBusinessAssociateStandard.ThePrivacyRuleincludesthefollowing 6&l! exceptionstothebusinessassociatestandard.See45_CFR_Ԁ164.502(e).Inthesesituations,a "'X" coveredentityisnotrequiredtohaveabusinessassociatecontractorotherwrittenagreementin (D # placebeforeprotectedhealthinformationmaybedisclosedtothepersonorentity. (0!$   {c  {cP"0 `   Disclosuresbyacoveredentitytoahealthcareproviderfortreatmentofthe *#& individual.{cPk݌+#'` (#` (# Ќ    0  0` (#(#Forexample:` (#` (#  RSTUVWXY(y3"3"     ` 3&23  0   Ahospitalisnotrequiredtohaveabusinessassociatecontractwiththe   specialisttowhomitrefersapatientandtransmitsthepatientsmedical z  chartfortreatmentpurposes.3&k݌f  (# (# Ќ  ! ! RSTUVWXY(yyRSTUVWXY"3"  0  0` (#(#3s23  0 ` (#` (#  Aphysicianisnotrequiredtohaveabusinessassociatecontractwitha R  laboratoryasaconditionofdisclosingprotectedhealthinformationforthe >t treatmentofanindividual.3s݌*` (# (# Ќ  "3"  0  0` (#(#3*23  0 ` (#` (#  Ahospitallaboratoryisnotrequiredtohaveabusinessassociatecontract L  todiscloseprotectedhealthinformationtoareferencelaboratoryfor 8  treatmentoftheindividual.3*w݌$  (# (# Ќ  {c  0  {c"0` (#(#  Disclosurestoahealthplansponsor,suchasanemployer,byagrouphealthplan,   orbythehealthinsuranceissuerorHMOthatprovidesthehealthinsurance   benefitsorcoverageforthegrouphealthplan,providedthatthegrouphealth   plansdocumentshavebeenamendedtolimitthedisclosuresoroneofthe  exceptionsat45_CFR_Ԁ164.504(f)havebeenmet.{c݌v` (#` (# Ќ  {c  0  {cZ"0` (#(#  Thecollectionandsharingofprotectedhealthinformationbyahealthplanthatis N apublicbenefitsprogram,suchasMedicare,andanagencyotherthantheagency :p administeringthehealthplan,suchastheSocialSecurityAdministration,that &\ collectsprotectedhealthinformationtodetermineeligibilityorenrollment,or H determineseligibilityorenrollment,forthegovernmentprogram,wherethejoint 4 activitiesareauthorizedbylaw.{cZ݌ ` (#` (# Ќ  0   (#(#   OtherSituationsinWhichaBusinessAssociateContractIsNOTRequired.  0   (#(# {c  0  {c"0` (#(#  Whenahealthcareproviderdisclosesprotectedhealthinformationtoahealth ! planforpaymentpurposes,orwhenthehealthcareprovidersimplyacceptsa " discountedratetoparticipateinthehealthplansnetwork.Aproviderthat r# submitsaclaimtoahealthplanandahealthplanthatassessesandpaystheclaim ^$ areeachactingonitsownbehalfasacoveredentity,andnotasthe business J%  associateoftheother.{c݌6&l!` (#` (# Ќ  0   (#(# {c  0  {c"0` (#(#  Withpersonsororganizations(e.g.,janitorialserviceorelectrician)whose (D # functionsorservicesdonotinvolvetheuseordisclosureofprotectedhealth (0!$ information,andwhereanyaccesstoprotectedhealthinformationbysuch )"% personswouldbeincidental,ifatall.{c݌*#&` (#` (# Ќ   +#' {c  0  {c"0` (#(#  Withapersonororganizationthatactsmerelyasaconduitforprotectedhealth  information,forexample,theUSPostalService,certainprivatecouriers,andtheir  electronicequivalents.{c݌ ` (#` (# Ќ  0  {c  {c4"0` (#(#  Amongcoveredentitieswhoparticipateinanorganizedhealthcarearrangement z  (_OHCA_)tomakedisclosuresthatrelatetothejointhealthcareactivitiesofthe f  _OHCA_.{c4O݌R ` (#` (# Ќ  {c  0  {c"0` (#(#  Whereagrouphealthplanpurchasesinsurancefromahealthinsuranceissueror *` HMO.Therelationshipbetweenthegrouphealthplanandthehealthinsurance L  issuerorHMOisdefinedbythePrivacyRuleasan_OHCA_,withrespecttothe 8  individualstheyjointlyserveorhaveserved.Thus,thesecoveredentitiesare $  permittedtoshareprotectedhealthinformationthatrelatestothejointhealthcare   activitiesofthe_OHCA_.{c݌ ` (#` (# Ќ  {c  0  {c"0` (#(#  Whereonecoveredentitypurchasesahealthplanproductorotherinsurance,for   example,reinsurance,fromaninsurer.Eachentityisactingonitsownbehalf  whenthecoveredentitypurchasestheinsurancebenefits,andwhenthecovered v entitysubmitsaclaimtotheinsurerandtheinsurerpaystheclaim.{c݌b` (#` (# Ќ  {c  0  {c"0` (#(#  Todiscloseprotectedhealthinformationtoaresearcherforresearchpurposes, :p eitherwithpatientauthorization,pursuanttoawaiverunder45_CFR_Ԁ164.512(_i_), &\ orasalimiteddatasetpursuantto45_CFR_Ԁ164.514(e).Becausetheresearcheris H notconductingafunctionoractivityregulatedbytheAdministrative 4 SimplificationRules,suchaspaymentorhealthcareoperations,orprovidingone   oftheserviceslistedinthedefinitionof businessassociateat45_CFR_Ԁ160.103,   theresearcherisnotabusinessassociateofthecoveredentity,andnobusiness  associateagreementisrequired.{c݌ ` (#` (# Ќ  0   (#(# 0  {c  {c "0` (#(#  Whenafinancialinstitutionprocessesconsumerconductedfinancialtransactions " bydebit,credit,orotherpaymentcard,clearschecks,initiatesorprocesses r# electronicfundstransfers,orconductsanyotheractivitythatdirectlyfacilitatesor ^$ effectsthetransferoffundsforpaymentforhealthcareorhealthplanpremiums. J%  Whenitconductstheseactivities,thefinancialinstitutionisprovidingitsnormal 6&l! bankingorotherfinancialtransactionservicestoitscustomers;itisnot "'X" performingafunctionoractivityfor,oronbehalfof,thecoveredentity.{c %݌(D #` (#` (# Ќ  y  4Y O  5  c      XXXX_FAQs_ԀonBusiness_Associates c the  #XXXX #__6r  the  7  w _  )"% _f    USESANDDISCLOSURESFORTREATMENT,PAYMENT,ANDHEALTHCARE  OPERATIONS   [45_CFR_Ԁ164.506]     Background  z    The_HIPAA_ԀPrivacyRuleestablishesafoundationofFederalprotectionforpersonal R  healthinformation,carefullybalancedtoavoidcreatingunnecessarybarrierstothedeliveryof >t qualityhealthcare.Assuch,theRulegenerallyprohibitsacoveredentityfromusingor *` disclosingprotectedhealthinformationunlessauthorizedbypatients,exceptwherethis L  prohibitionwouldresultinunnecessaryinterferencewithaccesstoqualityhealthcareorwith 8  certainotherimportantpublicbenefitsornationalpriorities. $    Readyaccesstotreatmentandefficientpaymentforhealthcare,bothofwhichrequireuse   anddisclosureofprotectedhealthinformation,areessentialtotheeffectiveoperationofthe   healthcaresystem.Inaddition,certainhealthcareoperations"suchasadministrative,financial,   legal,andqualityimprovementactivities"conductedbyorforhealthcareprovidersandhealth  plans,areessentialtosupporttreatmentandpayment.Manyindividualsexpectthattheirhealth v informationwillbeusedanddisclosedasnecessarytotreatthem,billfortreatment,and,tosome b extent,operatethecoveredentityshealthcarebusiness.Toavoidinterferingwithan N individualsaccesstoqualityhealthcareortheefficientpaymentforsuchhealthcare,the :p PrivacyRulepermitsacoveredentitytouseanddiscloseprotectedhealthinformation,with &\ certainlimitsandprotections,fortreatment,payment,andhealthcareoperationsactivities. H  HowtheRuleWorks      WhatareTreatment,Payment,andHealthCareOperations?Thecorehealthcare  activitiesof Treatment, Payment,and HealthCareOperationsaredefinedinthePrivacy   Ruleat45_CFR_Ԁ164.501. ! {c    {c"0 `   Treatmentgenerallymeanstheprovision,coordination,ormanagementof r# healthcareandrelatedservicesamonghealthcareprovidersorbyahealthcare ^$ providerwithathirdparty,consultationbetweenhealthcareprovidersregardinga J%  patient,orthereferralofapatientfromonehealthcareprovidertoanother.{c݌6&l!` (#` (# Ќ  {c    {c"0 `   Paymentencompassesthevariousactivitiesofhealthcareproviderstoobtain (D # paymentorbereimbursedfortheirservicesandofahealthplantoobtain (0!$ premiums,tofulfilltheircoverageresponsibilitiesandprovidebenefitsunderthe )"% plan,andtoobtainorprovidereimbursementfortheprovisionofhealthcare.{c݌*#&` (#` (# Ќ   +#'   0 ` Inadditiontothegeneraldefinition,thePrivacyRuleprovidesexamplesof  commonpaymentactivitieswhichinclude,butarenotlimitedto:` (#` (#  RSTUVWXY(xyRSTUVWXY"3"     ` 3#23  0   Determiningeligibilityorcoverageunderaplanandadjudicatingclaims;3#h݌  (# (# Ќ     ` "3"  3R23  0   Riskadjustments;3R݌z  (# (# Ќ    0 ` "3"  3123  0 ` (#` (#  Billingandcollectionactivities;31^݌f  (# (# Ќ     ` "3"  3) 23  0   Reviewinghealthcareservicesformedicalnecessity,coverage, R  justificationofcharges,andthelike;3) V ݌>t (# (# Ќ   RSTUVWXY(xxRSTUVWXY"3"     ` 3!23  0   Utilizationreviewactivities;and3! "݌*` (# (# Ќ   RSTUVWXY(xxRSTUVWXY"3"     ` 3L#23  0   Disclosurestoconsumerreportingagencies(limitedtospecified L  identifyinginformationabouttheindividual,hisorherpaymenthistory, 8  andidentifyinginformationaboutthecoveredentity).3L##݌$  (# (# Ќ    {c  {c%"0 `   Healthcareoperationsarecertainadministrative,financial,legal,andquality   improvementactivitiesofacoveredentitythatarenecessarytorunitsbusiness   andtosupportthecorefunctionsoftreatmentandpayment.Theseactivities,   whicharelimitedtotheactivitieslistedinthedefinitionof healthcare  operationsat45_CFR_Ԁ164.501,include:{c%+%݌v` (#` (# Ќ  0   (#(# ! ! RSTUVWXY(xxRSTUVWXY"3"    0 ` 3E(23  0 ` (#` (#  Conductingqualityassessmentandimprovementactivities,population N basedactivitiesrelatingtoimprovinghealthorreducinghealthcarecosts, :p andcasemanagementandcarecoordination;3E((݌&\ (# (# Ќ   RSTUVWXY(xxRSTUVWXY"3"    0 ` 3*23  0 ` (#` (#  Reviewingthecompetenceorqualificationsofhealthcareprofessionals, H evaluatingproviderandhealthplanperformance,traininghealthcareand 4 nonhealthcareprofessionals,accreditation,certification,licensing,or   credentialingactivities;3**݌  (# (# Ќ  ! ! RSTUVWXY(xxRSTUVWXY"3"    0 ` 3.-23  0 ` (#` (#  Underwritingandotheractivitiesrelatingtothecreation,renewal,or  replacementofacontractofhealthinsuranceorhealthbenefits,and   ceding,securing,orplacingacontractforreinsuranceofriskrelatingto ! healthcareclaims;3.-s-݌" (# (# Ќ  ! ! RSTUVWXY(xxRSTUVWXY"3"    0 ` 3/23  0 ` (#` (#  Conductingorarrangingformedicalreview,legal,andauditingservices, r# includingfraudandabusedetectionandcomplianceprograms;3/0݌^$ (# (# Ќ  ! ! RSTUVWXY(xxRSTUVWXY"3"    0 ` 3123  0 ` (#` (#  Businessplanninganddevelopment,suchasconductingcostmanagement J%  andplanninganalysesrelatedtomanagingandoperatingtheentity;and31&2݌6&l! (# (# Ќ  ! ! RSTUVWXY(xxRSTUVWXY"3"    0 ` 3323  0 ` (#` (#  Businessmanagementandgeneraladministrativeactivities,including "'X" thoserelatedtoimplementingandcomplyingwiththePrivacyRuleand (D # otherAdministrativeSimplificationRules,customerservice,resolutionof (0!$ internalgrievances,saleortransferofassets,creatingdeidentifiedhealth )"% informationoralimiteddataset,and_fundraising_Ԁforthebenefitofthe *#& coveredentity.33?4݌+#' (# (# Ќ    GeneralProvisionsat45_CFR_Ԁ164.506.Acoveredentitymay,withouttheindividuals  authorization:   {c    {c7"0 `   Useordiscloseprotectedhealthinformationforitsowntreatment,payment,and z  healthcareoperationsactivities.{c77݌f ` (#` (# Ќ     ` Forexample: >t ! ! RSTUVWXY(xxRSTUVWXY"3"  0   ` 3923  0 (#(#  Ahospitalmayuseprotectedhealthinformationaboutanindividualto L  providehealthcaretotheindividualandmayconsultwithotherhealth 8  careprovidersabouttheindividualstreatment.399݌$  (# (# Ќ  ! ! RSTUVWXY(xxRSTUVWXY"3"    0 ` 3;23  0 ` (#` (#  Ahealthcareprovidermaydiscloseprotectedhealthinformationaboutan   individualaspartofaclaimforpaymenttoahealthplan.3;9<݌  (# (# Ќ  ! ! RSTUVWXY(xxRSTUVWXY"3"    0 ` 3>23  0 ` (#` (#  Ahealthplanmayuseprotectedhealthinformationtoprovidecustomer   servicetoitsenrollees.3>J>݌  (# (# Ќ    {c  {c\?"0 `   Acoveredentitymaydiscloseprotectedhealthinformationforthetreatment v activitiesofanyhealthcareprovider(includingprovidersnotcoveredbythe b PrivacyRule).{c\?w?݌N` (#` (# Ќ       ` Forexample: &\   ! ! RSTUVWXY(xxRSTUVWXY"3"     ` 3A23  0   Aprimarycareprovidermaysendacopyofanindividualsmedicalrecord 4 toaspecialistwhoneedstheinformationtotreattheindividual.3AA݌  (# (# Ќ  ! ! RSTUVWXY(xxRSTUVWXY"3"     ` 3C23  0   Ahospitalmaysendapatientshealthcareinstructionstoanursinghome   towhichthepatientistransferred.3CD݌ (# (# Ќ  0  0` (#(# ` (#` (# {c    {cME"0 `   Acoveredentitymaydiscloseprotectedhealthinformationtoanothercovered ! entityorahealthcareprovider(includingprovidersnotcoveredbythePrivacy " Rule)forthepaymentactivitiesoftheentitythatreceivestheinformation.{cMEtE݌r#` (#` (# Ќ       ` Forexample: J%  ! ! RSTUVWXY(xxRSTUVWXY"3"  0   ` 3G23  0 (#(#  Aphysicianmaysendanindividualshealthplancoverageinformationto "'X" alaboratorywhoneedstheinformationtobillforservicesitprovidedto (D # thephysicianwithrespecttotheindividual.3G'H݌(0!$ (# (# Ќ  ! ! RSTUVWXY(xxRSTUVWXY"3"  0  0` (#(#3FJ23  0 ` (#` (#  Ahospitalemergencydepartmentmaygiveapatientspayment )"% informationtoanambulanceserviceproviderthattransportedthepatient *#& tothehospitalinorderfortheambulanceprovidertobillforitstreatment +#' services.3FJJ݌ (# (# Ќ  {c    {cBL"0 `   Acoveredentitymaydiscloseprotectedhealthinformationtoanothercovered   entityforcertainhealthcareoperationactivitiesoftheentitythatreceivesthe   informationif:{cBLiL݌z ` (#` (# Ќ    ! ! RSTUVWXY(xxRSTUVWXY"3"  0  0` (#(#3bN23  0 ` (#` (#  Eachentityeitherhasorhadarelationshipwiththeindividualwhoisthe R  subjectoftheinformation,andtheprotectedhealthinformationpertainsto >t therelationship;and3bNN݌*` (# (# Ќ  ! ! RSTUVWXY(xxRSTUVWXY"3"  0  0` (#(#3P23  0 ` (#` (#  Thedisclosureisforaqualityrelatedhealthcareoperationsactivity(i.e., L  theactivitieslistedinparagraphs(1)and(2)ofthedefinitionof health 8  careoperationsat45_CFR_Ԁ164.501)orforthepurposeofhealthcare $  fraudandabusedetectionorcompliance.3PQ݌  (# (# Ќ  0  0` (#(#Forexample: ` (#` (#  RSTUVWXY(xxRSTUVWXY"3"     ` 3S23  0   Ahealthcareprovidermaydiscloseprotectedhealthinformationtoa  healthplanfortheplansHealthPlanEmployerDataandInformationSet v (_HEDIS_)purposes,providedthatthehealthplanhasorhadarelationship b withtheindividualwhoisthesubjectoftheinformation.3ST݌N (# (# Ќ  {c    {cV"0 `   Acoveredentitythatparticipatesinanorganizedhealthcarearrangement &\ (_OHCA_)maydiscloseprotectedhealthinformationaboutanindividualtoanother H coveredentitythatparticipatesinthe_OHCA_Ԁforanyjointhealthcareoperations 4 ofthe_OHCA_.{cV8V݌ ` (#` (# Ќ    0 ` Forexample:` (#` (#   ! ! RSTUVWXY(xxRSTUVWXY"3"  0   ` 31Y23  0 (#(#  Thephysicianswithstaffprivilegesatahospitalmayparticipateinthe ! hospitalstrainingofmedicalstudents.31YvY݌" (# (# Ќ    UsesandDisclosuresofPsychotherapyNotes.Exceptwhenpsychotherapynotesare ^$ usedbytheoriginatortocarryouttreatment,orbythecoveredentityforcertainotherlimited J%  healthcareoperations,usesanddisclosuresofpsychotherapynotesfortreatment,payment,and 6&l! healthcareoperationsrequiretheindividualsauthorization.See45_CFR_Ԁ164.508(a)(2). "'X"   MinimumNecessary.Acoveredentitymustdeveloppoliciesandproceduresthat (0!$ reasonablylimititsdisclosuresof,andrequestsfor,protectedhealthinformationforpaymentand )"% healthcareoperationstotheminimumnecessary.Acoveredentityalsoisrequiredtodevelop *#& rolebasedaccesspoliciesandproceduresthatlimitwhichmembersofitsworkforcemayhave +#' accesstoprotectedhealthinformationfortreatment,payment,andhealthcareoperations,based  onthosewhoneedaccesstotheinformationtodotheirjobs.However,coveredentitiesarenot  requiredtoapplytheminimumnecessarystandardtodisclosurestoorrequestsbyahealthcare   providerfortreatmentpurposes.Seethefactsheetandfrequentlyaskedquestionsonthis_web   siteabouttheminimumnecessarystandardformoreinformation. z    Consent.Acoveredentitymayvoluntarilychoose,butisnotrequired,toobtainthe R  individualsconsentforittouseanddiscloseinformationabouthimorherfortreatment, >t payment,andhealthcareoperations.Acoveredentitythatchoosestohaveaconsentprocesshas *` completediscretionunderthePrivacyRuletodesignaprocessthatworksbestforitsbusiness L  andconsumers. 8    A consentdocumentisnotavalidpermissiontouseordiscloseprotectedhealth   informationforapurposethatrequiresan authorizationunderthePrivacyRule(see45CFR   164.508),orwhereotherrequirementsorconditionsexistundertheRulefortheuseordisclosure   ofprotectedhealthinformation.     RighttoRequestPrivacyProtection.Individualshavetherighttorequestrestrictionson v howacoveredentitywilluseanddiscloseprotectedhealthinformationaboutthemfortreatment, b payment,andhealthcareoperations.Acoveredentityisnotrequiredtoagreetoanindividuals N requestforarestriction,butisboundbyanyrestrictionstowhichitagrees.See45CFR :p 164.522(a). &\     Individualsalsomayrequesttoreceiveconfidentialcommunicationsfromthecovered 4 entity,eitheratalternativelocationsorbyalternativemeans.Forexample,anindividualmay   requestthatherhealthcareprovidercallheratheroffice,ratherthanherhome.Ahealthcare   providermustaccommodateanindividualsreasonablerequestforsuchconfidential  communications.Ahealthplanmustaccommodateanindividualsreasonablerequestfor   confidentialcommunications,iftheindividualclearlystatesthatnotdoingsocouldendanger ! himorher.See45CFR164.522(b). "   Notice.Anyuseordisclosureofprotectedhealthinformationfortreatment,payment,or ^$ healthcareoperationsmustbeconsistentwiththecoveredentitysnoticeofprivacypractices.A J%  coveredentityisrequiredtoprovidetheindividualwithadequatenoticeofitsprivacypractices, 6&l! includingtheusesordisclosuresthecoveredentitymaymakeoftheindividualsinformationand "'X" theindividualsrightswithrespecttothatinformation.Seethefactsheetandfrequentlyasked (D # questionsonthiswebsiteaboutthenoticestandardformoreinformation. (0!$  e   4^CF O  5  c  _c  XXXXFAQs_ԀonTreatment/Payment/HealthCareOperationsc]l  #XXXXl#6lO%lment  7CFSlXXXX *#& _covid  #XXXXm#  +#' l  MARKETING  [45CFR164.501,164.508(a)(3)]  nBackground     TheHIPAAPrivacyRulegivesindividualsimportantcontrolsoverwhetherandhow f  theirprotectedhealthinformationisusedanddisclosedformarketingpurposes.Withlimited R  exceptions,theRulerequiresanindividualswrittenauthorizationbeforeauseordisclosureof >t hisorherprotectedhealthinformationcanbemadeformarketing.Soasnottointerferewith *` corehealthcarefunctions,theRuledistinguishesmarketingcommunicationsfromthose L  communicationsaboutgoodsandservicesthatareessentialforqualityhealthcare.  8  HowtheRuleWorks     ThePrivacyRuleaddressestheuseanddisclosureofprotectedhealthinformationfor   marketingpurposesby:    ZRSTUVWXY(hAxxRSTUVWXY"3"    3Ns2hA3  0 `   Definingwhatis marketingundertheRule;3Nss݌v` (#` (# Ќ  "3"    3Ct2hA3  0 `   Exceptingfromthatdefinitioncertaintreatmentorhealthcareoperations N activities;3Ct|t݌:p` (#` (# Ќ  "3"    3pu2hA3  0 `   Requiringindividualauthorizationforallusesordisclosuresofprotectedhealth H informationformarketingpurposeswithlimitedexceptions. 3puu݌4` (#` (# Ќ     Whatis Marketing?ThePrivacyRuledefines marketingasmaking a   communicationaboutaproductorservicethatencouragesrecipientsofthecommunicationto  purchaseorusetheproductorservice.Generally,ifthecommunicationis marketing,then   thecommunicationcanoccuronlyifthecoveredentityfirstobtainsanindividuals !  authorization.Thisdefinitionofmarketinghascertainexceptions,asdiscussedbelow.  " 0  Examplesof marketingcommunicationsrequiringpriorauthorizationare:^$(#(# "3"    3y2hA3  0 `   Acommunicationfromahospitalinformingformerpatientsaboutacardiac 6&l! facility,thatisnotpartofthehospital,thatcanprovideabaselineEKGfor$39, &'\" whenthecommunicationisnotforthepurposeofprovidingtreatmentadvice.3yy݌(H #` (#` (# Ќ  "3"    3}{2hA3  0 `   Acommunicationfromahealthinsurerpromotingahomeandcasualtyinsurance ) "% productofferedbythesamecompany. 3}{{݌* #&` (#` (# Ќ   +#'    WhatElseis Marketing?Marketingalsomeans: Anarrangementbetweenacovered  entityandanyotherentitywherebythecoveredentitydisclosesprotectedhealthinformationto  theotherentity,inexchangefordirectorindirectremuneration,fortheotherentityoritsaffiliate   tomakeacommunicationaboutitsownproductorservicethatencouragesrecipientsofthe   communicationtopurchaseorusethatproductorservice.Thispartofthedefinitionto z  marketinghasnoexceptions.Theindividualmustauthorizethesemarketingcommunications f  beforetheycanoccur. R    Simplyput,acoveredentitymaynotsellprotectedhealthinformationtoabusiness *` associateoranyotherthirdpartyforthatpartysownpurposes.Moreover,coveredentitiesmay L  notselllistsofpatientsorenrolleestothirdpartieswithoutobtainingauthorizationfromeach 8  persononthelist. $    Forexample,itis marketingwhen:   "3"    32hA3  0 `   Ahealthplansellsalistofitsmemberstoacompanythatsellsbloodglucose   monitors,whichintendstosendtheplansmembersbrochuresonthebenefitsof  purchasingandusingthemonitors.3݌v` (#` (# Ќ  "3"    3Z2hA3  0 `   Adrugmanufacturerreceivesalistofpatientsfromacoveredhealthcareprovider N andprovidesremuneration,thenusesthatlisttosenddiscountcouponsforanew :p antidepressantmedicationdirectlytothepatients. 3Z݌&\` (#` (# Ќ     WhatisNOT Marketing ? ThePrivacyRulecarvesoutexceptionstothedefinitionof 4 marketingunderthefollowingthreecategories: $   (1)0 ` Acommunicationisnot marketingifitismadetodescribeahealthrelated  productorservice(orpaymentforsuchproductorservice)thatisprovidedby,or   includedinaplanofbenefitsof,thecoveredentitymakingthecommunication, ! includingcommunicationsabout:"` (#` (#  RSTUVWXY(xxZRSTUVWXY"3"  0  0` (#(#323  0 ` (#` (#  Theentitiesparticipatinginahealthcareprovidernetworkorhealthplan b$ network;3P݌N%  (# (# Ќ  "3"  0  0` (#(#3J23  0 ` (#` (#  Replacementof,orenhancementsto,ahealthplan;and3J݌:&p! (# (# Ќ  "3"  0  0` (#(#3^23  0 ` (#` (#  Healthrelatedproductsorservicesavailableonlytoahealthplanenrollee &'\" thataddvalueto,butarenotpartof,aplanofbenefits.3^݌(H # (# (# Ќ  0  0` (#(#Thisexceptiontothemarketingdefinitionpermitscommunicationsbyacovered ) "% entityaboutitsownproductsorservices.* #&` (#` (#  +#' 0  0` (#(#Forexample,underthisexception,itisnot marketingwhen:` (#` (#  (8xRSTUVWXY RSTUVWXY(x8"3"     ` 3C23  0   Ahospitalusesitspatientlisttoannouncethearrivalofanewspecialty   group(e.g.,orthopedic)ortheacquisitionofnewequipment(e.g.,xray   machineormagneticresonanceimagemachine)throughageneralmailing z  orpublication.3C݌f  (# (# Ќ  "3"     ` 3923  0   AhealthplansendsamailingtosubscribersapproachingMedicare R  eligibleagewithmaterialsdescribingitsMedicaresupplementalplanand >t anapplicationform.39~݌*` (# (# Ќ  0  (2)0` (#(#Acommunicationisnot marketingifitismadefortreatmentoftheindividual.8 ` (#` (#   0 ` Forexample,underthisexception,itisnot marketingwhen: ` (#` (# "3"     ` 323  0   Apharmacyorotherhealthcareprovidermailsprescriptionrefill   reminderstopatients,orcontractswithamailhousetodoso.3+݌  (# (# Ќ  "3"     ` 3J23  0   Aprimarycarephysicianrefersanindividualtoaspecialistforafollow  uptestorprovidesfreesamplesofaprescriptiondrugtoapatient.3J݌v (# (# Ќ  0  (3)0` (#(#Acommunicationisnot marketingifitismadeforcasemanagementorcare N coordinationfortheindividual,ortodirectorrecommendalternativetreatments, :p therapies,healthcareproviders,orsettingsofcaretotheindividual.&\` (#` (#    ` Forexample,underthisexception,itisnot marketingwhen: 4 "3"     ` 323  0   Anendocrinologistsharesapatientsmedicalrecordwithseveralbehavior   managementprogramstodeterminewhichprogrambestsuitstheongoing  needsoftheindividualpatient.3Η݌  (# (# Ќ   RSTUVWXY(xxRSTUVWXY"3"     ` 323  0   Ahospitalsocialworkersharesmedicalrecordinformationwithvarious ! nursinghomesinthecourseofrecommendingthatthepatientbe " transferredfromahospitalbedtoanursinghome.3݌r# (# (# Ќ    Foranyofthethreeexceptionstothedefinitionofmarketing,theactivitymustotherwise J%  bepermissibleunderthePrivacyRule,andacoveredentitymayuseabusinessassociatetomake 6&l! thecommunication.Aswithanydisclosuretoabusinessassociate,thecoveredentitymust "'X" obtainthebusinessassociatesagreementtousetheprotectedhealthinformationonlyforthe (D # communicationactivitiesofthecoveredentity. (0!$    MarketingAuthorizationsandWhenAuthorizationsareNOTNecessary.  Exceptas *#& discussedbelow,anycommunicationthatmeetsthedefinitionofmarketingisnotpermitted, +#' unlessthecoveredentityobtainsanindividualsauthorization.Todeterminewhatconstitutesan  acceptable authorization,see45_CFR_Ԁ164.508.Ifthemarketinginvolvesdirectorindirect  remunerationtothecoveredentityfromathirdparty,the authorizationmuststatethat_such     remunerationisinvolved.See45CFR164.508(a)(3) .       Acommunicationdoesnotrequireanauthorization,evenifitismarketing,ifitisinthe n  formofafacetofacecommunicationmadebyacoveredentitytoanindividual;ora Z  promotionalgiftofnominalvalueprovidedbythecoveredentity. F| @*  Forexample,nopriorauthorizationisnecessarywhen: T  ! ! ZRSTUVWXY(hAxxRSTUVWXY"3"    3â2hA3  0 `   Ahospitalprovidesafreepackageofformulaandotherbabyproductstonew ,  mothersastheyleavethematernityward.3â݌ ` (#` (# Ќ  "3"    32hA3  0 `   Aninsuranceagentsellsahealthinsurancepolicyinpersontoacustomerand   proceedstoalsomarketacasualtyandlifeinsurancepolicyaswell. 3I݌ ` (#` (# Ќ  XXXX  4`CF O  5  FAQsonMarketingUsesandDisclosures6Oåfac  7 #XXXX#  ~   DISCLOSURESFORPUBLICHEALTHACTIVITIES  ˦@![45CFR164.512(b)]  Background     TheHIPAAPrivacyRulerecognizesthelegitimateneedforpublichealthauthoritiesand f  othersresponsibleforensuringpublichealthandsafetytohaveaccesstoprotectedhealth R  informationtocarryouttheirpublichealthmission.TheRulealsorecognizesthatpublichealth >t reportsmadebycoveredentitiesareanimportantmeansofidentifyingthreatstothehealthand *` safetyofthepublicatlarge,aswellasindividuals.Accordingly,theRulepermitscovered L  entitiestodiscloseprotectedhealthinformationwithoutauthorizationforspecifiedpublichealth 8  purposes.  $  Ѐ   HowtheRuleWorks      GeneralPublicHealthActivities.  ThePrivacyRulepermitscoveredentitiestodisclose   protectedhealthinformation,withoutauthorization,topublichealthauthoritieswhoarelegally  authorizedtoreceivesuchreportsforthepurposeofpreventingorcontrollingdisease,injury,or z disability.Thiswouldinclude,forexample,thereportingofadiseaseorinjury;reportingvital f events,suchasbirthsordeaths;andconductingpublichealthsurveillance,investigations,or R interventions.See45CFR164.512(b)(1)(_i_).Also,coveredentitiesmay,atthedirectionofa >t publichealthauthority,discloseprotectedhealthinformationtoaforeigngovernmentagencythat *` isactingincollaborationwithapublichealthauthority.See45CFR164.512(b)(1)(_i_).Covered L entitieswhoarealsoapublichealthauthoritymayuse,aswellasdisclose,protectedhealth 8 informationforthesepublichealthpurposes.See45CFR164.512(b)(2). $   A publichealthauthorityisanagencyorauthorityoftheUnitedStatesgovernment,a  State,aterritory,apoliticalsubdivisionofaStateorterritory,orIndiantribethatisresponsible   forpublichealthmattersaspartofitsofficialmandate,aswellasapersonorentityactingunder ! agrantofauthorityfrom,orunderacontractwith,apublichealthagency.See45CFR164.501. " ExamplesofapublichealthauthorityincludeStateandlocalhealthdepartments,theFoodand v# DrugAdministration(FDA),theCentersforDiseaseControlandPrevention,andthe b$ OccupationalSafetyandHealthAdministration(OSHA). N%      Generally,coveredentitiesarerequiredreasonablytolimittheprotectedhealth &'\" informationdisclosedforpublichealthpurposestotheminimumamountnecessaryto (H # accomplishthepublichealthpurpose.However,coveredentitiesarenotrequiredtomakea (4!$ minimumnecessarydeterminationforpublichealthdisclosuresthataremadepursuanttoan ) "% individualsauthorization,orfordisclosuresthatarerequiredbyotherlaw.See45CFR * #& 164.502(b).Fordisclosurestoapublichealthauthority,coveredentitiesmayreasonablyrelyon +#' aminimumnecessarydeterminationmadebythepublichealthauthorityinrequestingthe  _protectedhealthinformation.See45_CFR_Ԁ164.514(d)(3)(iii)(A).Forroutineandrecurring  publichealthdisclosures,coveredentitiesmaydevelopstandardprotocols,aspartoftheir   minimumnecessarypoliciesandprocedures,thataddressthetypesandamountofprotected   healthinformationthatmaybedisclosedforsuchpurposes.See45_CFR_Ԁ164.514(d)(3)(_i_).  z     OtherPublicHealthActivities . ThePrivacyRulerecognizestheimportantrolethat R  personsorentitiesotherthanpublichealthauthoritiesplayincertainessentialpublichealth Bx activities.Accordingly,theRulepermitscoveredentitiestodiscloseprotectedhealth .d information,withoutauthorization,tosuchpersonsorentitiesforthepublichealthactivities P  discussedbelow.  <   ZRSTUVWXY(hAxxZRSTUVWXY"3"  0  3y2hA3  0` (#(#  Childabuseorneglect. Coveredentitiesmaydiscloseprotectedhealth3y݌ ` (#` (# Ќ  0  0` (#(#informationtoreportknownorsuspectedchildabuseorneglect,ifthereportis   madetoapublichealthauthorityorotherappropriategovernmentauthoritythatis   authorizedbylawtoreceivesuchreports.Forinstance,thesocialservices   departmentofalocalgovernmentmighthavelegalauthoritytoreceivereportsof  childabuseorneglect,inwhichcase,thePrivacyRulewouldpermitacovered ~ entitytoreportsuchcasestothatauthoritywithoutobtainingindividual j authorization.Likewise,acoveredentitycouldreportsuchcasestothepolice V departmentwhenthepolicedepartmentisauthorizedbylawtoreceivesuch Bx reports.See45CFR164.512(b)(1)(ii).Seealso45CFR512(c)forinformation .d regardingdisclosuresaboutadultvictimsofabuse,neglect,ordomesticviolence .P` (#` (# "3"    32hA3  0 `   Quality,safetyoreffectivenessofaproductoractivityregulatedbytheFDA. ,  Coveredentitiesmaydiscloseprotectedhealthinformationtoapersonsubjectto  FDAjurisdiction,forpublichealthpurposesrelatedtothequality,safetyor  effectivenessofanFDA-regulatedproductoractivityforwhichthatpersonhas   responsibility.Examplesofpurposesoractivitiesforwhichsuchdisclosuresmay ! bemadeinclude,butarenotlimitedto:3݌"` (#` (# Ќ   RSTUVWXY(xxZRSTUVWXY"3"    0 ` 323  0 ` (#` (#  Collectingorreportingadverseevents(includingsimilarreportsregarding j$ foodanddietarysupplements),productdefectsorproblems(including V%  problemsregardinguseorlabeling),orbiologicalproductdeviations;3]݌B&x! (# (# Ќ  "3"    0 ` 323  0 ` (#` (#  TrackingFDA-regulatedproducts;34݌.'d" (# (# Ќ  "3"    0 ` 323  0 ` (#` (#  Enablingproductrecalls,repairs,replacementorlookback(whichincludes (P # locatingandnotifyingindividualswhoreceivedrecalledorwithdrawn )t informationmaybeusedordisclosedbycoveredentitiesforresearchpurposes.Researchis *` definedinthePrivacyRuleas, asystematicinvestigation,includingresearchdevelopment, L  testing,andevaluation,designedtodeveloporcontributeto_generalizable_Ԁknowledge.See45 8  _CFR_Ԁ164.501.Acoveredentitymayalwaysuseordiscloseforresearchpurposeshealth $  informationwhichhasbeendeidentified(inaccordancewith45_CFR_ԁ164.502(d),and   164.514(a)(c)oftheRule)withoutregardtotheprovisionsbelow.     ThePrivacyRulealsodefinesthemeansbywhichindividualswillbeinformedofuses   anddisclosuresoftheirmedicalinformationforresearchpurposes,andtheirrightstoaccess  informationaboutthemheldbycoveredentities.Whereresearchisconcerned,thePrivacyRule v protectstheprivacyofindividuallyidentifiablehealthinformation,whileatthesametime b ensuringthatresearcherscontinuetohaveaccesstomedicalinformationnecessarytoconduct N vitalresearch.Currently,mostresearchinvolvinghumansubjectsoperatesundertheCommon :p Rule(45_CFR_ԀPart46,SubpartA)and/ortheFoodandDrugAdministrations(FDA)human &\ subjectprotectionregulations(21_CFR_ԀParts50and56),whichhavesomeprovisionsthatare H similarto,butseparatefrom,thePrivacyRulesprovisionsforresearch.Thesehumansubject 4 protectionregulations,whichapplytomostFederallyfundedandtosomeprivatelyfunded   research,includeprotectionstohelpensuretheprivacyofsubjectsandtheconfidentialityof   information.ThePrivacyRulebuildsupontheseexistingFederalprotections.More  importantly,thePrivacyRulecreatesequalstandardsofprivacyprotectionforresearchgoverned   bytheexistingFederalhumansubjectregulationsandresearchthatisnot. !  HowtheRuleWorks  r#   Inthecourseofconductingresearch,researchersmayobtain,create,use,and/ordisclose J%  individuallyidentifiablehealthinformation.UnderthePrivacyRule,coveredentitiesare 6&l! permittedtouseanddiscloseprotectedhealthinformationforresearchwithindividual "'X" authorization,orwithoutindividualauthorizationunderlimitedcircumstancessetforthinthe (D # PrivacyRule. (0!$     ResearchUse/DisclosureWithoutAuthorization.Touseordiscloseprotectedhealth *#& informationwithoutauthorizationbytheresearchparticipant,acoveredentitymustobtainoneof +#' thefollowing:   ZRSTUVWXY(hAxxRSTUVWXY0  "3"  332hA3  0` (#(#  DocumentedInstitutionalReviewBoard(_IRB_)orPrivacyBoardApproval .    Documentationthatanalterationorwaiverofresearchparticipantsauthorization   foruse/disclosureofinformationaboutthemforresearchpurposeshasbeen ~  approvedbyan_IRB_ԀoraPrivacyBoard.See45_CFR_Ԁ164.512(_i_)(1)(_i_).This j  provisionofthePrivacyRulemightbeused,forexample,toconductrecords V  research,whenresearchersareunabletousedeidentifiedinformation,andthe Bx researchcouldnotpracticablybeconductedifresearchparticipantsauthorization .d wererequired.33`݌P ` (#` (# Ќ  0  0` (#(#Acoveredentitymayuseordiscloseprotectedhealthinformationforresearch (  purposespursuanttoawaiverofauthorizationbyan_IRB_ԀorPrivacyBoard,   providedithasobtaineddocumentationofallofthefollowing: ` (#` (#  ZRSTUVWXY(hAxxZRSTUVWXY RSTUVWXY(xxZRSTUVWXY"3"  0  0` (#(#323  0 ` (#` (#  Identificationofthe_IRB_ԀorPrivacyBoardandthedateonwhichthe   alterationorwaiverofauthorizationwasapproved;3݌ (# (# Ќ  "3"  0  0` (#(#3T23  0 ` (#` (#  Astatementthatthe_IRB_ԀorPrivacyBoardhasdeterminedthatthe z alterationorwaiverofauthorization,inwholeorinpart,satisfiesthethree f criteriaintheRule;3T݌R (# (# Ќ  "3"  0  0` (#(#3!23  0 ` (#` (#  Abriefdescriptionoftheprotectedhealthinformationforwhichuseor >t accesshasbeendeterminedtobenecessarybythe_IRB_ԀorPrivacyBoard;3!n݌*` (# (# Ќ  "3"  0  0` (#(#323  0 ` (#` (#  Astatementthatthealterationorwaiverofauthorizationhasbeen L reviewedandapprovedundereithernormalorexpeditedreview 8 procedures;and3݌$ (# (# Ќ  "3"  0  0` (#(#3Z23  0 ` (#` (#  3Z݌  Thesignatureofthechairorothermember,asdesignatedbythechair,of  the_IRB_ԀorthePrivacyBoard,asapplicable. (# (#  ZRSTUVWXY(hAxxRSTUVWXYI0  0` (#(#Thefollowingthreecriteriamustbesatisfiedforan_IRB_ԀorPrivacyBoardto ! approveawaiverofauthorizationunderthePrivacyRule:"` (#` (#  RSTUVWXY(xxZRSTUVWXY"3"    0 ` 323  0 ` (#` (#  Theuseordisclosureofprotectedhealthinformationinvolvesnomore b$ thanaminimalrisktotheprivacyofindividuals,basedon,atleast,the N%  presenceofthefollowingelements: p 3*݌:&p! (# (# Ќ   RSTUVWXY(xxRSTUVWXY (8xRSTUVWXY"3"  0  0` (#(#0 ` (#` (#32  A  :3  0 (# (#  anadequateplantoprotecttheidentifiersfromimproperuseand &'\" disclosure;3݌(H #(#(# Ќ  "3"  0  0` (#(#0 ` (#` (#3 2  B  :3  0 (# (#  anadequateplantodestroytheidentifiersattheearliest (4!$ opportunityconsistentwithconductoftheresearch,unlessthereis ) "% ahealthorresearchjustificationforretainingtheidentifiersorsuch * #& retentionisotherwiserequiredbylaw;and3 m݌+#'(#(# Ќ  "3"  0  0` (#(#0 ` (#` (#3B2  C  :3  0 (# (#  adequatewrittenassurancesthattheprotectedhealthinformation  willnotbereusedordisclosedtoanyotherpersonorentity,except  asrequiredbylaw,forauthorizedoversightoftheresearchproject,   orforotherresearchforwhichtheuseordisclosureofprotected   healthinformationwouldbepermittedbythissubpart;3B݌z (#(# Ќ   RSTUVWXY(x8% ZRSTUVWXY(hAxxRSTUVWXY RSTUVWXY(xxZRSTUVWXY"3"  0  0` (#(#3e23  0 ` (#` (#  Theresearchcouldnotpracticablybeconductedwithoutthewaiveror f  alteration;and3e݌R  (# (# Ќ  "3"    0 ` 323  0 ` (#` (#  Theresearchcouldnotpracticablybeconductedwithoutaccesstoanduse >t oftheprotectedhealthinformation.0p (# (#0p(#p(#3݌*`(#(# Ќ   ZRSTUVWXY(hAxxRSTUVWXY0   (#(# "3"    32hA3  0 `   PreparatorytoResearch.Representationsfromtheresearcher,eitherinwritingor 8  orally,thattheuseordisclosureoftheprotectedhealthinformationissolelyto $  preparearesearchprotocolorforsimilarpurposespreparatorytoresearch,thatthe   researcherwillnotremoveanyprotectedhealthinformationfromthecovered   entity,andrepresentationthatprotectedhealthinformationforwhichaccessis   soughtisnecessaryfortheresearchpurpose.See45_CFR_Ԁ164.512(_i_)(1)(ii).This   provisionmightbeused,forexample,todesignaresearchstudyortoassessthe  feasibilityofconductingastudy.3 ݌v` (#` (# Ќ  ! ! ZRSTUVWXY(hAxxZRSTUVWXY"3"  0  3t 2hA3  0` (#(#  ResearchonProtectedHealthInformationofDecedents.Representationsfrom N theresearcher,eitherinwritingororally,thattheuseordisclosurebeingsoughtis :p solelyforresearchontheprotectedhealthinformationofdecedents,thatthe &\ protectedhealthinformationbeingsoughtisnecessaryfortheresearch,and,atthe H requestofthecoveredentity,documentationofthedeathoftheindividualsabout 4 whominformationisbeingsought.See45_CFR_Ԁ164.512(_i_)(1)(iii).3t  ݌ ` (#` (# Ќ   ZRSTUVWXY(hAxxZRSTUVWXY"3"  0  3S 2hA3  0` (#(#  LimitedDataSetswithaDataUseAgreement.Adatauseagreemententeredinto  byboththecoveredentityandtheresearcher,pursuanttowhichthecoveredentity   maydisclosealimiteddatasettothe_resercher_Ԁforresearch,publichealth,or ! healthcareoperations.See45_CFR_Ԁ164.514(e).Alimiteddatasetexcludes " specifieddirectidentifiersoftheindividualorofrelatives,employers,or r# householdmembersoftheindividual.Thedatauseagreementmust:3S  ݌^$` (#` (# Ќ   ZRSTUVWXY(hAxxZRSTUVWXY RSTUVWXY(xxZRSTUVWXY"3"  0  0` (#(#323  0 ` (#` (#  Establishthepermittedusesanddisclosuresofthelimiteddatasetbythe 6&l! recipient,consistentwiththepurposesoftheresearch,andwhichmaynot "'X" includeanyuseordisclosurethatwouldviolatetheRuleifdonebythe (D # coveredentity;3݌(0!$ (# (# Ќ  "3"  0  0` (#(#323  0 ` (#` (#  Limitwhocanuseorreceivethedata;and3݌  )"% (# (# "3"    0 ` 323  0 ` (#` (#  Requiretherecipienttoagreetothefollowing:3݌*#& (# (# Ќ   ZRSTUVWXY(hAxxRSTUVWXY RSTUVWXY(xxZRSTUVWXY (8xRSTUVWXY"3"     ` 0 3:2  A  :3  0 (# (#  Nottouseordisclosetheinformationotherthanaspermittedby +#' thedatauseagreementorasotherwiserequiredbylaw;3:݌(#(# Ќ  "3"     ` 0 32  B  :3  0 (# (#  Useappropriatesafeguardstopreventtheuseordisclosureofthe  informationotherthanasprovidedforinthedatauseagreement;3 ݌ (#(# Ќ  "3"     ` 0 3J2  C  :3  0 (# (#  Reporttothecoveredentityanyuseordisclosureofthe   informationnotprovidedforbythedatauseagreementofwhich z  therecipientbecomesaware;3J݌  f (#(# "3"     ` 0 32  D  :3  0 (# (#  Ensurethatanyagents,includingasubcontractor,towhomthe R  recipientprovidesthelimiteddatasetagreestothesame >t restrictionsandconditionsthatapplytotherecipientwithrespect *` tothelimiteddataset;and3N݌L (#(# Ќ  "3"     ` 0 3 2  E  :3  0 (# (#  Nottoidentifytheinformationorcontacttheindividual.3 [݌8 (#(# Ќ   RSTUVWXY(x8  ResearchUse/DisclosureWithIndividualAuthorization.ThePrivacyRulealsopermits   coveredentitiestouseordiscloseprotectedhealthinformationforresearchpurposeswhena   researchparticipantauthorizestheuseordisclosureofinformationabouthimorherself.Today,   forexample,aresearchparticipantsauthorizationwilltypicallybesoughtformostclinicaltrials   andsomerecordsresearch.Inthiscase,documentationof_IRB_ԀorPrivacyBoardapprovalofa  waiverofauthorizationisnotrequiredfortheuseordisclosureofprotectedhealthinformation. v   Touseordiscloseprotectedhealthinformationwithauthorizationbytheresearch N participant,thecoveredentitymustobtainanauthorizationthatsatisfiestherequirementsof45 :p _CFR_Ԁ164.508.ThePrivacyRulehasageneralsetofauthorizationrequirementsthatapplytoall &\ usesanddisclosures,includingthoseforresearchpurposes.However,severalspecialprovisions H applytoresearchauthorizations: 4  ZRSTUVWXY(hAxxRSTUVWXY0  "3"  3f%2hA3  0` (#(#  Unlikeotherauthorizations,anauthorizationforaresearchpurposemaystatethat   theauthorizationdoesnotexpire,thatthereisnoexpirationdateorevent,orthat  theauthorizationcontinuesuntilthe endoftheresearchstudy;and3f%%݌ ` (#` (# Ќ  "3"  0  3D'2hA3  0` (#(#  Anauthorizationfortheuseordisclosureofprotectedhealthinformationfor " researchmaybecombinedwithaconsenttoparticipateintheresearch,orwith r# anyotherlegalpermissionrelatedtotheresearchstudy.3D'}'݌^$` (#` (# Ќ    AccountingforResearchDisclosures.Ingeneral,thePrivacyRulegivesindividualsthe 6&l! righttoreceiveanaccountingofcertaindisclosuresofprotectedhealthinformationmadebya "'X" coveredentity.See45_CFR_Ԁ164.528.Thisaccountingmustincludedisclosuresofprotected (D # healthinformationthatoccurredduringthesixyearspriortotheindividualsrequestforan (0!$ accounting,orsincetheapplicablecompliancedate(whicheverissooner),andmustinclude )"% specifiedinformationregardingeachdisclosure.Amoregeneralaccountingispermittedfor *#& subsequentmultipledisclosurestothesamepersonorentityforasinglepurpose.See45_CFR_ +#' 164.528(b)(3).Amongthetypesofdisclosuresthatareexemptfromthisaccountingrequirement  are:  "3"    3 -2hA3  0 `   Researchdisclosuresmadepursuanttoanindividualsauthorization;3 -C-݌ ` (#` (# Ќ    _"3"    30.2hA3  0 `   Disclosuresofthelimiteddatasettoresearcherswithadatauseagreementunder f  45CFR164.514(e).30.i.݌R ` (#` (# Ќ    Inaddition,fordisclosuresofprotectedhealthinformationforresearchpurposeswithout *` theindividualsauthorizationpursuantto45CFR164.512(_i_),andthatinvolveatleast50records, L  thePrivacyRuleallowsforasimplifiedaccountingofsuchdisclosuresbycoveredentities. 8  Underthissimplifiedaccountingprovision,coveredentitiesmayprovideindividualswithalist $  ofallprotocolsforwhichthepatientsprotectedhealthinformationmayhavebeendisclosed   under45CFR164.512(_i_),aswellastheresearchersnameandcontactinformation.Other   requirementsrelatedtothissimplifiedaccountingprovisionarefoundin45CFR164.528(b)(4).     TransitionProvision s .UnderthePrivacyRule,acoveredentitymayuseanddisclose  protectedhealthinformationthatwascreatedorreceivedforresearch,eitherbeforeorafterthe z compliancedate,ifthecoveredentityobtainedanyoneofthefollowingpriortothecompliance f date: R "3"  0  3l42hA3  0` (#(#  Anauthorizationorotherexpresslegalpermissionfromanindividualtouseor *` discloseprotectedhealthinformationfortheresearch;3l44݌L` (#` (# Ќ  "3"  0  352hA3  0` (#(#  Theinformedconsentoftheindividualtoparticipateintheresearch;or35 6݌$` (#` (# Ќ  "3"  0  362hA3  0` (#(#  Awaiverofinformedconsentbyan_IRB_ԀinaccordancewiththeCommonRuleor  anexceptionunderFDAshumansubjectprotectionregulationsat21CFR50.24.36 7݌ ` (#` (# Ќ    However,ifawaiverofinformedconsentwasobtainedpriortothecompliancedate,but " informedconsentissubsequentlysoughtafterthecompliancedate,thecoveredentitymust v# obtaintheindividualsauthorizationasrequiredat45CFR164.508.Forexample,iftherewasa b$ temporarywaiverofinformedconsentforemergencyresearchundertheFDAshumansubject N%  protectionregulations,andinformedconsentwaslatersoughtafterthecompliancedate, :&p! individualauthorizationwouldberequiredbeforethecoveredentitycoulduseordisclose &'\" protectedhealthinformationfortheresearchafterthewaiverofinformedconsentwasnolonger (H # valid. (4!$   ThePrivacyRuleallowscoveredentitiestorelyonsuchexpresslegalpermission, * #& informedconsent,or_IRB_Ԅapprovedwaiverofinformedconsent,whichtheycreateorreceive +#' beforetheapplicablecompliancedate,touseanddiscloseprotectedhealthinformationfor  specificresearchstudies,aswellasforfutureunspecifiedresearchthatmaybeincludedinsuch  permission. Q     4br< O  5  c  _XXXXFAQs_ԀonResearchUsesandDisclosuresc;>  _#XXXX|>#6=>8  7r1>  z  =  DISCLOSURESFORWORKERSCOMPENSATIONPURPOSES  [45CFR164.512(l)]?   ?Background  z    TheHIPAAPrivacyRuledoesnotapplytoentitiesthatareeitherworkerscompensation R  insurers,workerscompensationadministrativeagencies,oremployers,excepttotheextentthey >t mayotherwisebecoveredentities.However,theseentitiesneedaccesstothehealthinformation *` ofindividualswhoareinjuredonthejoborwhohaveaworkrelatedillnesstoprocessor L  adjudicateclaims,ortocoordinatecareunderworkerscompensationsystems.Generally,this 8  healthinformationisobtainedfromhealthcareproviderswhotreattheseindividualsandwho $  maybecoveredbythePrivacyRule.ThePrivacyRulerecognizesthelegitimateneedofinsurers   andotherentitiesinvolvedintheworkerscompensationsystemstohaveaccesstoindividuals   healthinformationasauthorizedbyStateorotherlaw.Duetothesignificantvariabilityamong   suchlaws,thePrivacyRulepermitsdisclosuresofhealthinformationforworkerscompensation   purposesinanumberofdifferentways.   HowtheRuleWorks  b   DisclosuresWithoutIndividualAuthorization.ThePrivacyRulepermitscoveredentities :p todiscloseprotectedhealthinformationtoworkerscompensationinsurers,Stateadministrators, &\ employers,andotherpersonsorentitiesinvolvedinworkerscompensationsystems,withoutthe H individualsauthorization: 4 {c  0  {cYG"0` (#(#  Asauthorizedbyandtotheextentnecessarytocomplywithlawsrelatingto   workerscompensationorsimilarprogramsestablishedbylawthatprovide  benefitsforworkrelatedinjuriesorillnesswithoutregardtofault.Thisincludes   programsestablishedbytheBlackLungBenefitsAct,theFederalEmployees ! CompensationAct,the_Longshore_ԀandHarborWorkersCompensationAct,and " theEnergyEmployeesOccupationalIllnessCompensationProgramAct.See45 r# CFR164.512(l).{cYGG݌^$` (#` (# Ќ  0   (#(# {c  0  {cJ"0` (#(#  TotheextentthedisclosureisrequiredbyStateorotherlaw.Thedisclosuremust 6&l! complywithandbelimitedtowhatthelawrequires.See45CFR164.512(a).{cJJ݌"'X"` (#` (# Ќ  {c    {cK"0 `   Forpurposesofobtainingpaymentforanyhealthcareprovidedtotheinjuredor (0!$ illworker.See45CFR164.502(a)(1)(ii)andthedefinitionof paymentat45 )"% CFR164.501.{cK"L݌*#&` (#` (# Ќ   +#'   DisclosuresWithIndividualAuthorization.Inaddition,coveredentitiesmaydisclose  protectedhealthinformationtoworkerscompensationinsurersandothersinvolvedinworkers  compensationsystemswheretheindividualhasprovidedhisorherauthorizationfortherelease   oftheinformationtotheentity.Theauthorizationmustcontaintheelementsandotherwisemeet   therequirementsspecifiedat45CFR164.508. z    MinimumNecessary.  Coveredentitiesarerequiredreasonablytolimittheamountof R  protectedhealthinformationdisclosedunder45CFR164.512(l)totheminimumnecessaryto Bx accomplishtheworkerscompensationpurpose.Underthisrequirement,protectedhealth .d informationmaybesharedforsuchpurposestothefullextentauthorizedbyStateorotherlaw. P    Inaddition,coveredentitiesarerequiredreasonablytolimittheamountofprotected (  healthinformationdisclosedforpaymentpurposestotheminimumnecessary.Coveredentities   arepermittedtodisclosetheamountandtypesofprotectedhealthinformationthatarenecessary   toobtainpaymentforhealthcareprovidedtoaninjuredorillworker.     Whereacoveredentityroutinelymakesdisclosuresforworkerscompensationpurposes  under45_CFR_Ԁ164.512(l)orforpaymentpurposes,thecoveredentitymaydevelopstandard z protocolsaspartofitsminimumnecessarypoliciesandproceduresthataddressthetypeand f amountofprotectedhealthinformationtobedisclosedforsuchpurposes. R   WhereprotectedhealthinformationisrequestedbyaStateworkerscompensationor *` otherpublicofficial,coveredentitiesarepermittedtoreasonablyrelyontheofficials L representationsthattheinformationrequestedistheminimumnecessaryfortheintended 8 purpose.See45_CFR_Ԁ164.514(d)(3)(iii)(A). $   Coveredentitiesarenotrequiredtomakeaminimumnecessarydeterminationwhen  disclosingprotectedhealthinformationasrequiredbyStateorotherlaw,orpursuanttothe   individualsauthorization.See45_CFR_Ԁ164.502(b). !   TheDepartmentwillactivelymonitortheeffectsofthePrivacyRule,andinparticular, v# theminimumnecessarystandard,ontheworkerscompensationsystemsandconsiderproposing b$ modifications,whereappropriate,toensurethattheRuledoesnothaveanyunintendednegative N%  effectsthatdisturbthesesystems. :&p!   Refertothefactsheetandfrequentlyaskedquestionsonthiswebsiteabouttheminimum (H # necessarystandard,orto45_CFR_Ԁ164.502(b)and164.514(d),formoreinformation. s@ (4!$ 4E O  5    c      XXXX_FAQs_ԀonWorkers'CompensationDisclosuresc![  #XXXXj[#6ZZ  7 [  * #& NOTICEOFPRIVACYPRACTICES  FORPROTECTEDHEALTHINFORMATION  [45_CFR_Ԁ164.520]\   ZBackground z    The_HIPAA_ԀPrivacyRulegivesindividualsafundamentalnewrighttobeinformedofthe R  privacypracticesoftheirhealthplansandofmostoftheirhealthcareproviders,aswellastobe >t informedoftheirprivacyrightswithrespecttotheirpersonalhealthinformation.Healthplans *` andcoveredhealthcareprovidersarerequiredtodevelopanddistributeanoticethatprovidesa L  clearexplanationoftheserightsandpractices.Thenoticeisintendedtofocusindividualson 8  privacyissuesandconcerns,andtopromptthemtohavediscussionswiththeirhealthplansand $  healthcareprovidersandexercisetheirrights.    HowtheRuleWorks      GeneralRule . ThePrivacyRuleprovidesthatanindividualhasarighttoadequatenotice  ofhowacoveredentitymayuseanddiscloseprotectedhealthinformationabouttheindividual, z aswellashisorherrightsandthecoveredentitysobligationswithrespecttothatinformation. f Mostcoveredentitiesmustdevelopandprovideindividualswiththisnoticeoftheirprivacy R practices. >t   ThePrivacyRuledoesnotrequirethefollowingcoveredentitiestodevelopanotice: L {c  0  {cc"0` (#(#  Healthcareclearinghouses,iftheonlyprotectedhealthinformationtheycreateor $ receiveisasabusinessassociateofanothercoveredentity.See45_CFR_  164.500(b)(1).{ccc݌` (#` (# Ќ  0   (#(# {c  0  {cNe"0` (#(#  Acorrectionalinstitutionthatisacoveredentity(e.g.,thathasacoveredhealth ! careprovidercomponent).{cNeue݌"` (#` (# Ќ  0   (#(# {c  0  {cf"0` (#(#  Agrouphealthplanthatprovidesbenefitsonlythroughoneormorecontractsof b$ insurancewithhealthinsuranceissuersor_HMOs_,andthatdoesnotcreateor N%  receiveprotectedhealthinformationotherthansummaryhealthinformationor :&p! enrollmentor_disenrollment_Ԁinformation.{cff݌&'\"` (#` (# Ќ    See45_CFR_Ԁ164.520(a).  (4!$    ContentoftheNotice.Coveredentitiesarerequiredtoprovideanoticeinplainlanguage * #& thatdescribes:  +#' Ї{c    {ci"0 `   Howthecoveredentitymayuseanddiscloseprotectedhealthinformationabout  anindividual.{cii݌` (#` (# Ќ    {c    {cj"0 `   Theindividualsrightswithrespecttotheinformationandhowtheindividual   mayexercisetheserights,includinghowtheindividualmaycomplaintothe ~  coveredentity.{cjk݌j ` (#` (# Ќ    {c    {cel"0 `   Thecoveredentityslegaldutieswithrespecttotheinformation,includinga Bx statementthatthecoveredentityisrequiredbylawtomaintaintheprivacyof .d protectedhealthinformation.{cell݌P ` (#` (# Ќ    {c    {cm"0 `   Whomindividualscancontactforfurtherinformationaboutthecoveredentitys (  privacypolicies.{cmn݌ ` (#` (# Ќ    Thenoticemustincludeaneffectivedate.See45_CFR_Ԁ164.520(b)forthespecific   requirementsfordevelopingthecontentofthenotice.     Acoveredentityisrequiredtopromptlyreviseanddistributeitsnoticewheneveritmakes z materialchangestoanyofitsprivacypractices.See45_CFR_Ԁ164.520(b)(3),164.520(c)(1)(_i_)(C) f forhealthplans,and164.520(c)(2)(iv)forcoveredhealthcareproviderswithdirecttreatment R relationshipswithindividuals. >t     ProvidingtheNotice. L {c  0  {cr"0` (#(#  Acoveredentitymustmakeitsnoticeavailabletoanypersonwhoasksforit.{cr'r݌$` (#` (# Ќ  {c  0  {cr"0` (#(#  Acoveredentitymustprominentlypostandmakeavailableitsnoticeonanyweb  siteitmaintainsthatprovidesinformationaboutitscustomerservicesorbenefits.{crs݌ ` (#` (# Ќ  {c  0  {cHt"0` (#(#  HealthPlansmustalso:{cHtot݌"` (#` (# Ќ  0   (#(#  RSTUVWXY(yxZRSTUVWXY"3"  0  0` (#(#3u23  0 ` (#` (#  Providethenoticetoindividualsthencoveredbytheplannolaterthan b$ April14,2003(April14,2004,forsmallhealthplans)andtonew N%  enrolleesatthetimeofenrollment.3uu݌:&p! (# (# Ќ  "3"  0  0` (#(#3_w23  0 ` (#` (#  Providearevisednoticetoindividualsthencoveredbytheplanwithin60 &'\" daysofamaterialrevision.3_ww݌(H # (# (# Ќ  "3"  0  0` (#(#3x23  0 ` (#` (#  Notifyindividualsthencoveredbytheplanoftheavailabilityofandhow (4!$ toobtainthenoticeatleastonceeverythreeyears.3xy݌) "% (# (# Ќ  {c  0  {c+z"0` (#(#  CoveredDirectTreatmentProvidersmustalso:{c+zRz݌+#'` (#` (# Ќ  0  _ (#(# ! ! RSTUVWXY(yyRSTUVWXY"3"  0  0` (#(#3{23  0 ` (#` (#  Providethenoticetotheindividualnolaterthanthedateoffirstservice  delivery(aftertheApril14,2003compliancedateofthePrivacyRule)   and,exceptinanemergencytreatmentsituation,makeagoodfaitheffort   toobtaintheindividualswrittenacknowledgmentofreceiptofthenotice. z  Ifanacknowledgmentcannotbeobtained,theprovidermustdocumenthis f  orhereffortstoobtaintheacknowledgmentandthereasonwhyitwasnot R  obtained.3{ |݌>t (# (# Ќ  "3"  0  0` (#(#3~23  0 ` (#` (#  WhenfirstservicedeliverytoanindividualisprovidedovertheInternet, *` throughemail,orotherwiseelectronically,theprovidermustsendan L  electronicnoticeautomaticallyandcontemporaneouslyinresponsetothe 8  individualsfirstrequestforservice.Theprovidermustmakeagoodfaith $  efforttoobtainareturnreceiptorothertransmissionfromtheindividualin   responsetoreceivingthenotice.3~@݌  (# (# Ќ  "3"  0  0` (#(#3с23  0 ` (#` (#  Inanemergencytreatmentsituation,providethenoticeassoonasitis   reasonablypracticabletodosoaftertheemergencysituationhasended.In   thesesituations,providersarenotrequiredtomakeagoodfaitheffortto  obtainawrittenacknowledgmentfromindividuals.3с݌v (# (# Ќ  "3"  0  0` (#(#323  0 ` (#` (#  Makethelatestnotice(i.e.,theonethatreflectsanychangesinprivacy b policies)availableattheprovidersofficeorfacilityforindividualsto N requesttotakewiththem,andpostitinaclearandprominentlocationat :p thefacility.3K݌&\ (# (# Ќ  0   (#(# {c  0  {c."0` (#(#  Acoveredentitymayemailthenoticetoanindividualiftheindividualagreesto 4 receiveanelectronicnotice.{c.U݌ ` (#` (# Ќ    See45CFR164.520(c)forthespecificrequirementsforprovidingthenotice.      OrganizationalOptions.  ! 0  {c  {c"0` (#(#  Anycoveredentity,includingahybridentityoranaffiliatedcoveredentity,may r# choosetodevelopmorethanonenotice,suchaswhenanentityperformsdifferent b$ typesofcoveredfunctions(i.e.,thefunctionsthatmakeitahealthplan,ahealth N%  careprovider,orahealthcareclearinghouse)andtherearevariationsinits :&p! privacypracticesamongthesecoveredfunctions.Coveredentitiesareencouraged &'\" toprovideindividualswiththemostspecificnoticepossible.{c3݌(H #` (#` (# Ќ  {c    {c"0 `   Coveredentitiesthatparticipateinanorganizedhealthcarearrangementmay ) "% choosetoproduceasingle,jointnoticeifcertainrequirementsaremet.For * #& example,thejointnoticemustdescribethecoveredentitiesandtheservice +#' deliverysitestowhichitapplies.Ifanyoneoftheparticipating coveredentities  providesthejointnoticetoanindividual,thenoticedistributionrequirement with    respecttothatindividualismetforallofthecoveredentities.See45CFR   164.520(d). {c݌ ` (#` (# Ќ  ]o]XXXX  4T? O  5  c      _FAQs_ԀonNoticeofPrivacy_Practicescider  6Rfider  7#XXXX&# n  E  Z    RESTRICTIONSONGOVERNMENTACCESS  TOHEALTHINFORMATION   [45CFRPart160,SubpartC;164.512(f)]   1 Background  z    Underthe_HIPAA_ԀPrivacyRule,governmentoperatedhealthplansandhealthcare R  providersmustmeetsubstantiallythesamerequirementsasprivateonesforprotectingthe >t privacyofindividualidentifiablehealthinformation.Forinstance,governmentrunhealthplans, *` suchasMedicareandMedicaidplans,musttakevirtuallythesamestepstoprotecttheclaims L  andhealthinformationthattheyreceivefrombeneficiariesasprivateinsuranceplansorhealth 8  maintenanceorganizations(HMO).Inaddition,allFederalagenciesmustalsomeetthe $  requirementsofthePrivacyActof1974,whichrestrictswhatinformationaboutindividual   citizens!includinganypersonalhealthinformation!canbesharedwithotheragenciesandwith   thepublic.     Theonlynewauthorityforgovernmentinvolvesenforcementoftheprotectionsinthe  PrivacyRuleitself.Toensurethatcoveredentitiesprotectpatientsprivacyasrequired,theRule v requiresthathealthplans,hospitals,andothercoveredentitiescooperatewitheffortsbythe b DepartmentofHealthandHumanServices(_HHS_)OfficeforCivilRights(OCR)toinvestigate N complaintsorotherwiseensurecompliance. :p     XXXX!#XXXXJ#  4U O  5  c      XXXX_FAQs_ԀonDisclosuresforRuleEnforcementcpider  #XXXX)#6ȗider  7!fXXXX    #XXXX=#XXXX#XXXX# 4V$ O  5  c      XXXX_FAQs_ԀonDisclosuresforLawEnforcementPurposescider  #XXXXR#6ݚider  7XXXX  #XXXXn#4Wj O  5  c      XXXX_FAQs_ԀonPrivacyRule:GeneralTopicscpan  #XXXX;#6Ɲڝider  7nxXXXX ! #XXXXK#dXXXXd#XXXX#