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Kh$A @WH@ٙaT&aPCۗerJh`~*~sڠ;S#RNBqGZ O' gةqq#u.}Un O#h}&~%ZZB[H}F;jT!mOK ,\ L<v][wBQF|\EuD AEs|#UN % 0: N 0rc w| 4  ^  m 1 1uS 72 0w 0q 0 0 0O 0 0 0D 1 $ 72 1 72f 1 72 1Q 72 1  72 1 1R 72 72  1= 72 1 0V} 72 72'7 0^ 0L 07 0 0 0 0 0! 0z" 0P# 0,$ 0% 0% 0& 0~' 0K( 0) 0) 0* 0{+ 0S, 0(- 0- 0. 0/ 0^0 0$1 01 0Nl22U9>3335:6 0U@7 07 0~8 0d9 0G: 0'; 0< 0< 0= 0C> 0> 0? 0w@ 0HA 0B 0B 0C 0nD 0@.E 0nE 0BF 0G 0G 0H 0tI 09J 0J 0<K 0UKIL 0UM 0UdM 0(M D+M AQ N]NeOSRWRX~XXHXX 04Z\\oswdc06\OCR-HP8150-508F36E0(9 Z6Times New Roman RegularX($USUS.,(;3$2#  0  .3  0  uz.3|xm.s UxCcgkosw{TrianglesTriangle Bullet3#37=CIQYag1.a.i.(1)(a)(i)1)a)i)(O;$0  2#  a  .3  0` (#(#(b$0  0` (#(#2#   .3  0 ` (#` (#(xir$0  0` (#(#0 ` (#` (#2#(  0  )3  0 (# (#($0  0` (#(#0 ` (#` (#0 (# (#2#(  a  )3  0h(#(#(F$0  0` (#(#0 ` (#` (#0 (# (#0h(#(#2#(   )3  0h(#h(#($0  0` (#(#0 ` (#` (#0 (# (#0h(#(#0h(#h(#2#  0  )3  0(#(#({$0  0` (#(#0 ` (#` (#0 (# (#0h(#(#0h(#h(#0(#(#2#  a  )3  0p(#(#(F$0  0` (#(#0 ` (#` (#0 (# (#0h(#(#0h(#h(#0(#(#0p(#(#2#     )3  0p(#p(# pDGaeimquy}Bullet ListBullets List2h-CEIMQUY]aAutoList122222222i)1)a)2(CEKQW]cioAutoList2A:A:A:A:A:A:A:A:A:(CEKQW]cioAutoList3A.A.A.A.A.A.A.A.A.(CEKQW]cioAutoList4A:A:A:A:A:A:A:A: A: (ڽCEKQW]cioAutoList6A:A:A:A:A:A:A:A:(ʽCEKQW]cioAutoList5A.A.A.A.A.A.A.A.$A.#A:(CEKQW]cioAutoList7A:A:A:A:A:A:A:A:'A:(CEKQW]cioAutoList8A.A.A.A.A.A.A.A.(.3$ !USUS.,  )A.   *'USUS.,  _&&:(# XXOCRHIPAAPrivacy  NN;(#December3,2002 r   RevisedApril3,2003 #XDXR#2G+J 0_level1  X /%4 4 <DL/23  ..  2( 4 <DL2  2D+J 0_level2   ," <DL,23  ..  2( 4 <DL2  2A+J 0_level3   ) <DL)23  ..  2( 4 <DL2  2>+J 0_level4  ` &<<DL&23  ..  2( 4 <DL2  2;+J 0_level5   #DL#23  ..  2( 4 <DL2  28+J 0_level6    DL 23  ..  2( 4 <DL2  25+J 0_level7  h DDL23  ..  2( 4 <DL2  22+J 0_level8   L23  ..  2( 4 <DL2  2/+J 0_level9    L23  ..  2( 4 <DL2  2GJ 0_levsl1  X /%4 4 <DL/23  Ԁ  2( 4 <DL2  2DJ 0_levsl2   ," <DL,23  Ԁ  2( 4 <DL2  2AJ 0_levsl3   ) <DL)23  Ԁ  2( 4 <DL2  2>J 0_levsl4  ` &<<DL&23  Ԁ  2( 4 <DL2  2;J 0_levsl5   #DL#23  Ԁ  2( 4 <DL2  28J 0_levsl6    DL 23  Ԁ  2( 4 <DL2  25J 0_levsl7  h DDL23  Ԁ  2( 4 <DL2  22J 0_levsl8   L23  Ԁ  2( 4 <DL2  2/J 0_levsl9    L23  Ԁ  2( 4 <DL2  2GJ 0_levnl1  X /%4 4 <DL/23   2( 4 <DL2  2DJ 0_levnl2   ," <DL,23   2( 4 <DL2  2AJ 0_levnl3   ) <DL)23   2( 4 <DL2  2>J 0_levnl4  ` &<<DL&23   2( 4 <DL2  2;J 0_levnl5   #DL#23   2( 4 <DL2  28J 0_levnl6    DL 23   2( 4 <DL2  25J 0_levnl7  h DDL23   2( 4 <DL2  22J 0_levnl8   L23   2( 4 <DL2  2/J 0_levnl9    L23   2( 4 <DL2  6)&4Hyperlink            (O$http://answers.hhs.gov/cgi-bin/hhs.cfg/php/enduser/std_alp.php?p_sid=UFo3G3Eg&p_lva=&p_li=&p_page=1&p_cat_lvl1=7&p_cat_lvl2=56&p\  `&Times New RomanPhttp://answers.hhs.gov/cgi-bin/hhs.cfg/php/enduser/std_alp.php?p_sid=K6SCZJFg&p_lva=&p_li=&p_page=1&p_cat_lvl1=7&p_cat_lvl2=57&yhttp://answers.hhs.gov/cgi-bin/hhs.cfg/php/enduser/std_alp.php?p_sid=f47XY6Gg&p_lva=&p_li=&p_page=1&p_cat_lvl1=7&p_cat_lvl2=%7Ehttp://answers.hhs.gov/cgi-bin/hhs.cfg/php/enduser/std_alp.php?p_sid=K6SCZJFg&p_lva=&p_li=&p_page=1&p_cat_lvl1=7&p_cat_lvl2=57&p_search_text=&p_new_search=1*+ (_2623  ..*G+M (_25   /%` ` hp x /23  ..  5+ ` hp x 5  *D+M (_24   ," hp x ,23  ..  5+ ` hp x 5  *A+M (_23  ` ) hp x )23  ..  5+ ` hp x 5  *>+M (_22   &hhp x &23  ..  5+ ` hp x 5  *;+M (_21   #p x #23  ..  5+ ` hp x 5  *8+M (_20  h  p x 23  ..  5+ ` hp x 5  *5+M (_19   pp x 23  ..  5+ ` hp x 5  *2+M (_18    x 23  ..  5+ ` hp x 5  * (_1723  Ԁ*GM (_16   /%` ` hp x /23  Ԁ  5+ ` hp x 5  *DM (_15   ," hp x ,23  Ԁ  5+ ` hp x 5  *AM (_14  ` ) hp x )23  Ԁ  5+ ` hp x 5  *>M (_13   &hhp x &23  Ԁ  5+ ` hp x 5  *;M (_12   #p x #23  Ԁ  5+ ` hp x 5  *8M (_11  h  p x 23  Ԁ  5+ ` hp x 5  *5M (_10   pp x 23  Ԁ  5+ ` hp x 5  (2M &_9    x 23  Ԁ  5+ ` hp x 5  ( &_823  (GM &_7   /%` ` hp x /23   5+ ` hp x 5  (DM &_6   ," hp x ,23   5+ ` hp x 5  (AM &_5  ` ) hp x )23   5+ ` hp x 5  (>M &_4   &hhp x &23   5+ ` hp x 5  (;M &_3   #p x #23   5+ ` hp x 5  (8M &_2  h  p x 23   5+ ` hp x 5  (5M &_1   pp x 23   5+ ` hp x 5  &2M $_    x 23   5+ ` hp x 5  <:Default Para(-2$ !USUS.,  ݃ Level 1 Level 2 Level 3 Level 4 Level 5(-2$ !USUS.,  (-2$ !USUS.,  ($'dxdnopqrC<< c  *'USUS.,  _ @ XXL %#X#LXDXLH##XDXXLXDg#LXDXXXD##9%#LXLXD#L#L #LXDXL#LXLXDO#LXDXL#LXLXDCRHI#LXDXL#LXLXDPAA#LXDXL,#LXLXDPrivacy   @  @ #LXDXLr#LXLXDKK:%##LXDXL#LXLXDDecember3,2002 r  @  @  @   #LXDXL>#LXLXDRevisedApril3,2003 4  @  @   ?+ ` hp x %#?#LXDXL##XDXXLXD]#LXDXXXD [ m) (#(#(#(#USUS.,  _XXL#LXDXLX##XDXXLXDw#LXDXXXDLXLXD#L#LsvWGCz h p @X@E'##!  (#(#  (#(##LXDXL##XDXXLXD=#LXDXXXDLXLXD#L#L#LXDXL##XDXXLXD#LXDXXXD @ LXLXD#LH#LswQA=x h p @XE!  H o"USUS.,  _ @  H o"USUS.,  _ @ http://answers.hhs.gov/cgi-bin/hhs.cfg/php/enduser/std_alp.phphttp://answers.hhs.gov/cgi-bin/hhs.cfg/php/enduser/std_alp.php?p_sid=f47XY6Gg&p_lva=&p_li=&p_page=1&p_cat_lvl1=7&p_cat_lvl2=%7Eany%7E&p_search_text=&p_new_search=1&c$""0 !USUS.,  _ -8DXXdd8@&RESEARCH   @ [45CFR164.501,164.508,164.512(_i_)]    [Seealso45CFR164.514(e),164.528,164.532]     Background  n    The_HIPAA_ԀPrivacyRuleestablishestheconditionsunderwhichprotectedhealth F  informationmaybeusedordisclosedbycoveredentitiesforresearchpurposes.Researchis 2t definedinthePrivacyRuleas, asystematicinvestigation,includingresearchdevelopment, ` testing,andevaluation,designedtodeveloporcontributeto_generalizable_Ԁknowledge.See45  L  CFR164.501.Acoveredentitymayalwaysuseordiscloseforresearchpurposeshealth 8  informationwhichhasbeendeidentified(inaccordancewith45CFR164.502(d),and $  164.514(a)(c)oftheRule)withoutregardtotheprovisionsbelow.     ThePrivacyRulealsodefinesthemeansbywhichindividualswillbeinformedofuses   anddisclosuresoftheirmedicalinformationforresearchpurposes,andtheirrightstoaccess   informationaboutthemheldbycoveredentities.Whereresearchisconcerned,thePrivacyRule ~ protectstheprivacyofindividuallyidentifiablehealthinformation,whileatthesametime j ensuringthatresearcherscontinuetohaveaccesstomedicalinformationnecessarytoconduct V vitalresearch.Currently,mostresearchinvolvinghumansubjectsoperatesundertheCommon B Rule(45CFRPart46,SubpartA)and/ortheFoodandDrugAdministrations(FDA)human .p subjectprotectionregulations(21CFRParts50and56),whichhavesomeprovisionsthatare \ similarto,butseparatefrom,thePrivacyRulesprovisionsforresearch.Thesehumansubject H protectionregulations,whichapplytomostFederallyfundedandtosomeprivatelyfunded 4 research,includeprotectionstohelpensuretheprivacyofsubjectsandtheconfidentialityof   information.ThePrivacyRulebuildsupontheseexistingFederalprotections.More   importantly,thePrivacyRulecreatesequalstandardsofprivacyprotectionforresearchgoverned  bytheexistingFederalhumansubjectregulationsandresearchthatisnot.    HowtheRuleWorks  z"   Inthecourseofconductingresearch,researchersmayobtain,create,use,and/ordisclose R$ individuallyidentifiablehealthinformation.UnderthePrivacyRule,coveredentitiesare >%  permittedtouseanddiscloseprotectedhealthinformationforresearchwithindividual *&l! authorization,orwithoutindividualauthorizationunderlimitedcircumstancessetforthinthe 'X" PrivacyRule. (D #   ResearchUse/DisclosureWithoutAuthorization.Touseordiscloseprotectedhealth )"% informationwithoutauthorizationbytheresearchparticipant,acoveredentitymustobtainoneof *#& thefollowing: +#' Ї (Dp30  "3"  32D3  0` (#(#  DocumentedInstitutionalReviewBoard(_IRB_)orPrivacyBoardApproval.  Documentationthatanalterationorwaiverofresearchparticipantsauthorization  foruse/disclosureofinformationaboutthemforresearchpurposeshasbeen   approvedbyan_IRB_ԀoraPrivacyBoard.See45_CFR_Ԁ164.512(_i_)(1)(_i_).This   provisionofthePrivacyRulemightbeused,forexample,toconductrecords r  research,whenresearchersareunabletousedeidentifiedinformation,andthe ^  researchcouldnotpracticablybeconductedifresearchparticipantsauthorization J  wererequired.3݌6x` (#` (# Ќ  0  0` (#(#Acoveredentitymayuseordiscloseprotectedhealthinformationforresearch P  purposespursuanttoawaiverofauthorizationbyan_IRB_ԀorPrivacyBoard, <  providedithasobtaineddocumentationofallofthefollowing:( ` (#` (#  (Dpp (xp"3"  0  0` (#(#3{23  0 ` (#` (#  Identificationofthe_IRB_ԀorPrivacyBoardandthedateonwhichthe   alterationorwaiverofauthorizationwasapproved;3{݌  (# (# Ќ  "3"  0  0` (#(#323  0 ` (#` (#  Astatementthatthe_IRB_ԀorPrivacyBoardhasdeterminedthatthe   alterationorwaiverofauthorization,inwholeorinpart,satisfiesthethree  criteriaintheRule;3R݌n (# (# Ќ  "3"  0  0` (#(#323  0 ` (#` (#  Abriefdescriptionoftheprotectedhealthinformationforwhichuseor Z accesshasbeendeterminedtobenecessarybythe_IRB_ԀorPrivacyBoard;3݌F (# (# Ќ  "3"  0  0` (#(#3t23  0 ` (#` (#  Astatementthatthealterationorwaiverofauthorizationhasbeen 2t reviewedandapprovedundereithernormalorexpeditedreview ` procedures;and3t݌ L (# (# Ќ  "3"  0  0` (#(#3 23  0 ` (#` (#  3 X݌  Thesignatureofthechairorothermember,asdesignatedbythechair,of 8 the_IRB_ԀorthePrivacyBoard,asapplicable.$ (# (#  (Dpx 0  0` (#(#Thefollowingthreecriteriamustbesatisfiedforan_IRB_ԀorPrivacyBoardto  approveawaiverofauthorizationunderthePrivacyRule: ` (#` (#  (xp"3"    0 ` 323  0 ` (#` (#  Theuseordisclosureofprotectedhealthinformationinvolvesnomore ~" thanaminimalrisktotheprivacyofindividuals,basedon,atleast,the j# presenceofthefollowingelements: p 3݌V$ (# (# Ќ   (xx  (-xx "3"  0  0` (#(#0 ` (#` (#3W"2-23  0 (# (#  anadequateplantoprotecttheidentifiersfromimproperuseand B%  disclosure;3W""݌.&p!(#(# Ќ  "3"  0  0` (#(#0 ` (#` (#3#2-23  0 (# (#  anadequateplantodestroytheidentifiersattheearliest '\" opportunityconsistentwithconductoftheresearch,unlessthereis (H # ahealthorresearchjustificationforretainingtheidentifiersorsuch (4!$ retentionisotherwiserequiredbylaw;and3# $݌) "%(#(# Ќ  "3"  0  0` (#(#0 ` (#` (#3%2-23  0 (# (#  adequatewrittenassurancesthattheprotectedhealthinformation * #& willnotbereusedordisclosedtoanyotherpersonorentity,except +#' asrequiredbylaw,forauthorizedoversightoftheresearchproject,  orforotherresearchforwhichtheuseordisclosureofprotected  healthinformationwouldbepermittedbythissubpart;3%.&݌ (#(# Ќ   (xx! (Dpx  (xp"3"  0  0` (#(#3)23  0 ` (#` (#  Theresearchcouldnotpracticablybeconductedwithoutthewaiveror   alteration;and3)**݌n  (# (# Ќ  "3"    0 ` 3$+23  0 ` (#` (#  Theresearchcouldnotpracticablybeconductedwithoutaccesstoanduse Z  oftheprotectedhealthinformation.0p (# (#0p(#p(#3$+i+݌F (#(# Ќ   (Dpx \)0   (#(# "3"    3L-2D3  0 `   PreparatorytoResearch.Representationsfromtheresearcher,eitherinwritingor ` orally,thattheuseordisclosureoftheprotectedhealthinformationissolelyto  L  preparearesearchprotocolorforsimilarpurposespreparatorytoresearch,thatthe 8  researcherwillnotremoveanyprotectedhealthinformationfromthecovered $  entity,andrepresentationthatprotectedhealthinformationforwhichaccessis   soughtisnecessaryfortheresearchpurpose.See45_CFR_Ԁ164.512(_i_)(1)(ii).This   provisionmightbeused,forexample,todesignaresearchstudyortoassessthe   feasibilityofconductingastudy.3L--݌ ` (#` (# Ќ  ! ! (Dpp"3"  0  312D3  0` (#(#  ResearchonProtectedHealthInformationofDecedents.Representationsfrom j theresearcher,eitherinwritingororally,thattheuseordisclosurebeingsoughtis V solelyforresearchontheprotectedhealthinformationofdecedents,thatthe B protectedhealthinformationbeingsoughtisnecessaryfortheresearch,and,atthe .p requestofthecoveredentity,documentationofthedeathoftheindividualsabout \ whominformationisbeingsought.See45_CFR_Ԁ164.512(_i_)(1)(iii).31%2݌H` (#` (# Ќ   (Dpp"3"  0  352D3  0` (#(#  LimitedDataSetswithaDataUseAgreement.Adatauseagreemententeredinto   byboththecoveredentityandtheresearcher,pursuanttowhichthecoveredentity   maydisclosealimiteddatasettothe_resercher_Ԁforresearch,publichealth,or  healthcareoperations.See45_CFR_Ԁ164.514(e).Alimiteddatasetexcludes   specifieddirectidentifiersoftheindividualorofrelatives,employers,or ! householdmembersoftheindividual.Thedatauseagreementmust:356݌z"` (#` (# Ќ   (Dpp (xp"3"  0  0` (#(#3:23  0 ` (#` (#  Establishthepermittedusesanddisclosuresofthelimiteddatasetbythe R$ recipient,consistentwiththepurposesoftheresearch,andwhichmaynot >%  includeanyuseordisclosurethatwouldviolatetheRuleifdonebythe *&l! coveredentity;3:a:݌'X" (# (# Ќ  "3"  0  0` (#(#3<23  0 ` (#` (#  Limitwhocanuseorreceivethedata;and3<j<݌  (D # (# (# "3"    0 ` 3%=23  0 ` (#` (#  Requiretherecipienttoagreetothefollowing:3%=j=݌(0!$ (# (# Ќ   (Dpx 9 (yp (-xy "3"     ` 0 3?2-23  0 (# (#  Nottouseordisclosetheinformationotherthanaspermittedby )"% thedatauseagreementorasotherwiserequiredbylaw;3?@݌*#&(#(# Ќ  "3"     ` 0 3!A2-23  0 (# (#  Useappropriatesafeguardstopreventtheuseordisclosureofthe +#' informationotherthanasprovidedforinthedatauseagreement;3!ArA݌(#(# Ќ  "3"     ` 0 3B2-23  0 (# (#  Reporttothecoveredentityanyuseordisclosureofthe  informationnotprovidedforbythedatauseagreementofwhich   therecipientbecomesaware;3BB݌   (#(# "3"     ` 0 3%  coveredentity.See45CFR164.528.Thisaccountingmustincludedisclosuresofprotected *&l! healthinformationthatoccurredduringthesixyearspriortotheindividualsrequestforan 'X" accounting,orsincetheapplicablecompliancedate(whicheverissooner),andmustinclude (D # specifiedinformationregardingeachdisclosure.Amoregeneralaccountingispermittedfor (0!$ subsequentmultipledisclosurestothesamepersonorentityforasinglepurpose.See45CFR )"% 164.528(b)(3).Amongthetypesofdisclosuresthatareexemptfromthisaccountingrequirement *#& are: +#' Ї"3"    3T2D3  0 `   Researchdisclosuresmadepursuanttoanindividualsauthorization;3TT݌` (#` (# Ќ    "3"    3U2D3  0 `   Disclosuresofthelimiteddatasettoresearcherswithadatauseagreementunder   45CFR164.514(e).3UV݌ ` (#` (# Ќ    Inaddition,fordisclosuresofprotectedhealthinformationforresearchpurposeswithout Z  theindividualsauthorizationpursuantto45CFR164.512(_i_),andthatinvolveatleast50records, F  thePrivacyRuleallowsforasimplifiedaccountingofsuchdisclosuresbycoveredentities. 2t Underthissimplifiedaccountingprovision,coveredentitiesmayprovideindividualswithalist ` ofallprotocolsforwhichthepatientsprotectedhealthinformationmayhavebeendisclosed  L  under45CFR164.512(_i_),aswellastheresearchersnameandcontactinformation.Other 8  requirementsrelatedtothissimplifiedaccountingprovisionarefoundin45CFR164.528(b)(4). $    TransitionProvisions.UnderthePrivacyRule,acoveredentitymayuseanddisclose   protectedhealthinformationthatwascreatedorreceivedforresearch,eitherbeforeorafterthe   compliancedate,ifthecoveredentityobtainedanyoneofthefollowingpriortothecompliance   date: ~ "3"  0  3\2D3  0` (#(#  Anauthorizationorotherexpresslegalpermissionfromanindividualtouseor V discloseprotectedhealthinformationfortheresearch;3\H\݌B` (#` (# Ќ  "3"  0  3v]2D3  0` (#(#  Theinformedconsentoftheindividualtoparticipateintheresearch;or3v]]݌\` (#` (# Ќ  "3"  0  3^2D3  0` (#(#  Awaiverofinformedconsentbyan_IRB_ԀinaccordancewiththeCommonRuleor 4 anexceptionunderFDAshumansubjectprotectionregulationsat21CFR50.24.3^^݌ ` (#` (# Ќ    However,ifawaiverofinformedconsentwasobtainedpriortothecompliancedate,but  informedconsentissubsequentlysoughtafterthecompliancedate,thecoveredentitymust   obtaintheindividualsauthorizationasrequiredat45CFR164.508.Forexample,iftherewasa ! temporarywaiverofinformedconsentforemergencyresearchundertheFDAshumansubject z" protectionregulations,andinformedconsentwaslatersoughtafterthecompliancedate, f# individualauthorizationwouldberequiredbeforethecoveredentitycoulduseordisclose R$ protectedhealthinformationfortheresearchafterthewaiverofinformedconsentwasnolonger >%  valid. *&l!   ThePrivacyRuleallowscoveredentitiestorelyonsuchexpresslegalpermission, (D # informedconsent,or_IRB_Ԅapprovedwaiverofinformedconsent,whichtheycreateorreceive (0!$ beforetheapplicablecompliancedate,touseanddiscloseprotectedhealthinformationfor )"% specificresearchstudies,aswellasforfutureunspecifiedresearchthatmaybeincludedinsuch *#& permission. +#'  LXDXXXFrequentlyAskedQuestionse   e0  ToseePrivacyRuleFAQs,clickthedesiredlinkbelow:6Y (#(# #XDXXLXDte#LXDXXXD X#XDXXLXDf# 4KsJO  5  JO  6fJOf   6fJ   75gLXDXXXDd4N JO  5  FAQsonResearchUsesandDisclosures6LhJO`h  7hh#XDXXLXD$h#dLXDXXXD   z   X#XDXXLXDEi#dLXDXXXDd#XDXXLXDi# X9%4 4 <DLX94O3JO  5  JO  dLXDXXXDFAQsonALLPrivacyRuleTopics dJOfj   #XDXXLXDj#LXDXXXD6RjJO   73jdLXLXDԀ R` #LXDXLk##XDXXLXDxk#mt-Fu8LDLXXdXXd8<( ` hp x 44X<LXDXXXDLXLXD(Y#LXDXL[m##XDXXLXD