ÿWPCe Sî â«ñ§Ó Í@ïcI3?—a™Ò,Òq8?—]p˜¼vbg1µ÷ÿÿù_°8E5ÁXG< %nÛ@ s3+µp…g7‚…o}–Ž)}´fÃ-¬ŒÒsR$å Ê£q*Iê"YžÝw`õqï8#œ˜Û|íõ²oo ˆÔÑ?h®¸ÇC’ž×jOµoÊŒb1ûj¥ÇsÊoωe?8•_Cå{¼BDÒšQ0±N=ÇDŽ©m:»CšX/×Ë^§þò¾ÍÌì6VØån#L –ˇ?eìaSõJÀlÖ†ï˜È¶:íסÍØÎ Ô ÈÚq€ˆ$@ÿ˯EvÄÔ¤úY÷K¡<3©˜Sô@Zì" H ª.Ý ìMÕ EÞÜ$ÇÁ&7d5Àv­Úâ[q)°ÍCÓ´•w—7ÓõiÆÿZ3K…ÌllæîÖþ7+YÚ7nûø¥£2>ó—ÒïåiÖö ±q}.$zìkã7y\É!?¤¥ö÷Tú–8=Ì\Ò]"}ÇÄåÆ̼‰K™d¸̬Ky(½Îlª¶ü6nB|+^?Îf1è‚rµ0ºbhi®’ ¦§[y?¬d•1-Aj9;UüÂP׬MIÅÆ´ú€È§@9ÐØÙúQÙ ÿ2×#! U Nã %1^ 7 0(Cb kww4¡° m²²²²²²²²²²²²²²²²²²²²²²²UNÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉÉUN˜HP LaserJet 4 Plus,ä,,,,,ä0(ÈhH  Z6Times New Roman RegularXJi]'ä($¡¡- ù -eedL}& (L:)ÌÇ3|x$ÿU‹ÿÀÀÀ(ÖÃ9 Z ‹6Times New Roman Regular(uHš Z‹6Times New Roman RegularÝ ƒ!ÝÝ  ÝÔ_Ôò òÒ°ÒÔ_Ôó óññÑ€ÑÑ8€N…XXdðdð8ÑññññÑ ý ÑññññOctoberÔ_Ô€29,€1999ññÐ ° Ðò òà ` àó óFor€the€reasons€set€forth€in€the€preamble,€it€is€proposed€to€amend€45€CFR€subtitleÐ  ð ÐA€by€adding€a€new€Ô_ÔsubchapterÔ_Ô€C,€consisting€of€parts€160€through€164,€to€read€as€follows:Ìò òÔ_ÔSUBCHAPTERÔ_Ô€C€„€ADMINISTRATIVE€DATA€STANDARDS€AND€RELATEDÐ €Ð ÐREQUIREMENTSÌPARTÌ160€„„€GENERAL€ADMINISTRATIVE€REQUIREMENTSÌ161„163€ð!ð€[RESERVED]Ð @  Ð164€ð!ð€SECURITY€AND€PRIVACYÐ 0 € ÐPART€160€ð!ð€GENERAL€ADMINISTRATIVE€REQUIREMENTSÐ  p  ÐSubpart€A€ð!ð€General€ProvisionsÐ `  Ðó óSec.Ð P  Ð160.101à0 ¸ àStatutory€basis€and€purpose.Ðð@ ¸ (#¸ (# Ð160.102à0 ¸ àApplicability.Ðà0 ¸ (#¸ (# Ð160.103à0 ¸ àDefinitions.ÐÐ ¸ (#¸ (# Ð160.104à0 ¸ àEffective€dates€of€a€modification€to€a€standard€or€implementationÐ À Ðspecification.Ð ¸ (#¸ (# ÐÌò òSubpart€B€ð!ð€Preemption€of€State€LawÐ à Ðó ó160.201à0 ¸ àApplicability.Ѐи (#¸ (# Ð160.202à0 ¸ àDefinitions.ÐpÀ¸ (#¸ (# Ð160.203à0 ¸ àGeneral€rule€and€exceptions.Ð`°¸ (#¸ (# Ð160.204à0 ¸ àProcess€for€requesting€exception€determinations€or€advisory€opinions.ÐP ¸ (#¸ (# ÐÌò òó óà0 ` àAuthority:€42€U.S.C.€1320d„2€and€1320d„4.ò òÐ0€` (#` (# ÐÌSubpart€A€„€General€Provisionsó óÐ ` Ððð€160.101à ¸ àòòStatutory€basis€and€purposeóó.Ð P Ðà ` àThe€requirements€of€this€Ô_ÔsubchapterÔ_Ô€implement€sections€1171€through€1179€of€theÏSocial€Security€Act,€as€amended,€which€require€HHS€to€adopt€national€standards€toÏenable€the€electronic€exchange€of€health€information€in€the€health€care€system.€€TheÏrequirements€of€this€Ô_ÔsubchapterÔ_Ô€also€implement€section€264€of€Pub.€L€104„191,€whichÏrequires€that€HHS€adopt€national€standards€with€respect€to€the€privacy€of€individuallyÏidentifiable€health€information€transmitted€in€connection€with€the€transactions€describedÏin€section€1173(a)(1)€of€the€Social€Security€Act.€€The€purpose€of€these€provisions€is€toÏpromote€administrative€simplification.Ìðð€160.102à ¸ àòòApplicabilityóó.Ð p&À!$ Ðà ` àExcept€as€otherwise€provided,€the€standards,€requirements,€and€implementationÏspecifications€adopted€or€designated€under€the€parts€of€this€Ô_ÔsubchapterÔ_Ô€apply€to€any€entityÏthat€is:Ìà ` à(a)€A€health€plan;Ìà ` à(b)€A€health€care€clearinghouse;€and€Ìà ` àÔ_Ô(c)Ô_Ô€A€health€care€provider€who€transmits€any€health€information€in€electronic€formÏin€connection€with€a€transaction€covered€by€this€Ô_ÔsubchapterÔ_Ô.ÌÑ  ÑÓB.` °` ¸ hÀpÈ xÐ (#°œXBÓðð€160.103à ¸ àòòDefinitionsóó.Ð ð-@),ý  ÐÔ_ÔÓB.°°` ¸ hÀpÈ xÐ (#` °XBÓÓ XÓExcept€as€otherwise€provided,€the€following€definitions€apply€to€this€subchapter:ÌòòActóó€means€the€Social€Security€Act,€as€amended.òòóóò òó óÐ Xð ÐòòCovered€entityóó€means€an€entity€described€in€ðð€160.102.Ð Hà ÐòòHealth€careóó€means€the€provision€of€care,€services,€or€supplies€to€a€patient€andÐ 8 Ð Ðincludes€any:€Ì(1)€Preventive,€diagnostic,€therapeutic,€rehabilitative,€maintenance,€or€palliativeÏcare,€counseling,€service,€or€procedure€with€respect€to€the€physical€or€mental€condition,€orÏfunctional€status,€of€a€patient€or€affecting€the€structure€or€function€of€the€body;ÌÑ  Ñ(2)€Sale€or€dispensing€of€a€drug,€device,€equipment,€or€other€item€pursuant€to€aÏprescription;€orÌ(3)€Procurement€or€banking€of€blood,€sperm,€organs,€or€any€other€tissue€forÏadministration€to€patients.ÌòòHealth€care€clearinghouseóó€means€a€public€or€private€entity€that€processes€orÐ ¨@  Ðfacilitates€the€processing€of€nonstandard€data€elements€of€health€information€into€standardÏdata€elements.€€The€entity€receives€health€care€transactions€from€health€care€providers€orÏother€entities,€translates€the€data€from€a€given€format€into€one€acceptable€to€the€intendedÏpayer€or€payers,€and€forwards€the€processed€transaction€to€appropriate€payers€andÏclearinghouses.€€Billing€services,€repricing€companies,€community€health€managementÏinformation€systems,€community€health€information€systems,€and€ð ðvalue„addedððÏnetworks€and€switches€are€considered€to€be€health€care€clearinghouses€for€purposes€ofÏthis€part,€if€they€perform€the€functions€of€health€care€clearinghouses€as€described€in€theÏpreceding€sentences.€ÌÑ  ÑòòHealth€care€provideróó€means€a€provider€of€services€as€defined€in€section€1861(u)€ofÐ   Ðthe€Act,€a€provider€of€medical€or€health€services€as€defined€in€section€1861(s)€of€the€Act,Ïand€any€other€person€or€organization€who€furnishes,€bills,€or€is€paid€for€health€careÏservices€or€supplies€in€the€normal€course€of€business.€ÌòòHealth€informationóó€means€any€information,€whether€oral€or€recorded€in€any€formÐ È` Ðor€medium,€that:€Ì(1)€Is€created€or€received€by€a€health€care€provider,€health€plan,€public€healthÏauthority,€employer,€life€insurer,€school€or€university,€or€health€care€clearinghouse;€andÌÑ  Ñ(2)€Relates€to€the€past,€present,€or€future€physical€or€mental€health€or€condition€ofÏan€individual,€the€provision€of€health€care€to€an€individual,€or€the€past,€present,€or€futureÏpayment€for€the€provision€of€health€care€to€an€individual.ÌòòHealth€planóó€means€an€individual€or€group€plan€that€provides,€or€pays€the€cost€of,Ð X%ð! Ðmedical€care.€€Such€term€includes,€when€applied€to€government€funded€or€assistedÏprograms,€the€components€of€the€government€agency€administering€the€program.€€ð ðHealthÏplanðð€includes€the€following,€singly€or€in€combination:ÌÑ  Ñ(1)€òòóó€A€group€health€plan,€defined€as€an€employee€welfare€benefit€plan€(as€currentlyÐ )°"% Ðdefined€in€section€3(1)€of€the€Employee€Retirement€Income€and€Security€Act€of€1974,€29ÏU.S.C.€1002(1)),€including€insured€and€self„insured€plans,€to€the€extent€that€the€planÏprovides€medical€care€(as€defined€in€section€2791(a)(2)€of€the€Public€Health€Service€Act,Ï42€U.S.C.€300gg„91(a)(2)),€including€items€and€services€paid€for€as€medical€care,€toÏemployees€or€their€dependents€directly€or€through€insurance€or€otherwise,€that:Ð È-`'* Ð(i)€Has€50€or€more€participants;€orÌ(ii)€Is€administered€by€an€entity€other€than€the€employer€that€established€andÏmaintains€the€plan.Ì(2)€òòóó€A€health€insurance€issuer,€defined€as€an€insurance€company,€insuranceÐ 8 Ð Ðservice,€or€insurance€organization€that€is€licensed€to€engage€in€the€business€of€insuranceÏin€a€State€and€is€subject€to€State€or€other€law€that€regulates€insurance.Ì(3)€òòóó€A€health€maintenance€organization,€defined€as€a€federally€qualified€healthÐ    Ðmaintenance€organization,€an€organization€recognized€as€a€health€maintenanceÏorganization€under€State€law,€or€a€similar€organization€regulated€for€solvency€under€StateÏlaw€in€the€same€manner€and€to€the€same€extent€as€such€a€health€maintenance€organization.Ì(4)€Part€A€or€Part€B€of€the€Medicare€program€under€title€XVIII€of€the€Act.ÌÑ  Ñ(5)€The€Medicaid€program€under€title€XIX€of€the€Act.Ì(6)€A€Medicare€supplemental€policy€(as€defined€in€section€1882(g)(1)€of€the€Act,Ï42€U.S.C.€1395ss).Ì(7)€A€long„term€care€policy,€including€a€nursing€home€fixed„indemnity€policy.Ì(8)€An€employee€welfare€benefit€plan€or€any€other€arrangement€that€is€establishedÏor€maintained€for€the€purpose€of€offering€or€providing€health€benefits€to€the€employees€ofÏtwo€or€more€employers.Ì(9)€The€health€care€program€for€active€military€personnel€under€title€10€of€theÏUnited€States€Code.Ì(10)€The€veterans€health€care€program€under€38€U.S.C.€chapter€17.ÌÑ  Ñ(11)€The€Civilian€Health€and€Medical€Program€of€the€Uniformed€ServicesÏ(CHAMPUS),€as€defined€in€10€U.S.C.€1072(4).Ì(12)€The€Indian€Health€Service€program€under€the€Indian€Health€CareÏImprovement€Act€(25€U.S.C.€1601,€òòet€seqóó.).Ð è€ Ð(13)€The€Federal€Employees€Health€Benefits€Program€under€5€U.S.C.€chapter€89.Ì(14)€An€approved€State€child€health€plan€for€child€health€assistance€that€meets€theÏrequirements€of€section€2103€of€the€Act.Ì(15)€A€Medicare€Plus€Choice€organization€as€defined€in€42€CFR€422.2,€with€aÏcontract€under€42€CFR€part€422,€subpart€K.ÌÑ  Ñ(16)€Any€other€individual€or€group€health€plan,€or€combination€thereof,€thatÏprovides€or€pays€for€the€cost€of€medical€care.ÌòòSecretaryóó€means€the€Secretary€of€Health€and€Human€Services€and€any€otherÐ h$  Ðofficer€or€employee€of€the€Department€of€Health€and€Human€Services€to€whom€theÏauthority€involved€has€been€delegated.€ÌòòSmall€health€planóó€means€a€health€plan€with€annual€receipts€of€$5€million€or€less.Ð 8'Ð # ÐòòStandardóó€means€a€prescribed€set€of€rules,€conditions,€or€requirements€concerningÐ ((À!$ Ðclassification€of€components,€specification€of€materials,€performance€or€operations,€orÏdelineation€of€procedures,€in€describing€products,€systems,€services€or€practices.€ÌòòStateóó€includes€the€50€States,€the€District€of€Columbia,€the€Commonwealth€ofÐ ø*$' ÐPuerto€Rico,€the€Virgin€Islands,€and€Guam.€€ÌòòTransactionóó€means€the€exchange€of€information€between€two€parties€to€carry€outÐ Ø,p&) Ðfinancial€or€administrative€activities€related€to€health€care.€€It€includes€the€following:Ð È-`'* Ð(1)€Health€claims€or€equivalent€encounter€information;Ì(2)€Health€care€payment€and€remittance€advice;Ì(3)€Coordination€of€benefits;Ì(4)€Health€claims€status;Ì(5)€Enrollment€and€disenrollment€in€a€health€plan;Ì(6)€Eligibility€for€a€health€plan;Ì(7)€Health€plan€premium€payments;Ì(8)€Referral€certification€and€authorization;Ì(9)€First€report€of€injury;Ì(10)€Health€claims€attachments;€andÌ(11)€Other€transactions€as€the€Secretary€may€prescribe€by€regulation.ÌÓ XÓðð€160.104€òòóó€òòEffective€dates€of€a€modification€to€a€standard€or€implementationÐ ¸P  Ðspecificationóó.Ð ¨@  ÐÓB.°°` ¸ hÀpÈ xÐ (#°°XBÓà ` àThe€Secretary€may€modify€a€standard€or€implementation€specification€after€theÏfirst€year€in€which€the€standard€or€implementation€specification€is€required€to€be€used,€butÏnot€more€frequently€than€once€every€12€months.€€If€the€Secretary€adopts€a€modification€toÏa€standard€or€implementation€specification,€the€implementation€date€of€the€modifiedÏstandard€or€implementation€specification€may€be€no€earlier€than€180€days€following€theÏadoption€of€the€modification.€€The€Secretary€will€determine€the€actual€date,€taking€intoÏaccount€the€time€needed€to€comply€due€to€the€nature€and€extent€of€the€modification.€€TheÏSecretary€may€extend€the€time€for€compliance€for€small€health€plans.Ìò òSubpart€B€ð!ð€Preemption€of€State€Lawó óÐ ° ÐÓ °ÓÓB.` °` ¸ hÀpÈ xÐ (#°°XBÓÓ PûÓðð€160.201à ¸ àòòApplicabilityóó.Ð   ÐÓ °ÓÓB.°°` ¸ hÀpÈ xÐ (#` °XBÓÓ XPûÓThe€provisions€of€this€subpart€apply€to€determinations€and€advisory€opinionsÏissued€by€the€Secretary€pursuant€to€42€U.S.C.€1320d„7.ÌÓ °ÓÓ PûXÓÑ  ÑÓB.` °` ¸ hÀpÈ xÐ (#°°XBÓðð€160.202à ¸ àòòDefinitionsóó.Ð Øp ÐÓ °ÓÓB.°°` ¸ hÀpÈ xÐ (#` °XBÓÓ XPûÓFor€the€purpose€of€this€subpart,€the€following€terms€have€the€following€meanings:ÌòòContraryóó,€when€used€to€compare€a€provision€of€State€law€to€a€standard,Ð ¸P Ðrequirement,€or€implementation€specification€adopted€under€this€subchapter,€means:Ì(1)€A€party€would€find€it€impossible€to€comply€with€both€the€State€and€federalÏrequirements;€or€Ì(2)€The€provision€of€State€law€stands€as€an€obstacle€to€the€accomplishment€andÏexecution€of€the€full€purposes€and€objectives€of€part€C€of€title€XI€of€the€Act€or€section€264Ïof€Pub.€L.€104„191,€as€applicable.ÌòòMore€stringentóó€means,€in€the€context€of€a€comparison€of€a€provision€of€State€lawÐ H&à" Ðand€a€standard,€requirement,€or€implementation€specification€adopted€under€subpart€E€ofÏpart€164€of€this€subchapter,€a€law€which€meets€one€or€more€of€the€following€criteria,€asÏapplicable:Ì(1)€With€respect€to€a€use€or€disclosure,€provides€a€more€limited€use€or€disclosureÏ(in€terms€of€the€number€of€potential€recipients€of€the€information,€the€amount€ofÏinformation€to€be€disclosed,€or€the€circumstances€under€which€information€may€beÏdisclosed).ÌÑ  Ñ(2)€With€respect€to€the€rights€of€individuals€of€access€to€or€amendment€ofÐ È-`'* Ðindividually€identifiable€health€information,€permits€greater€rights€or€access€orÏamendment,€as€applicable,€òòprovided,€however,€thatóó€nothing€in€this€subchapter€shall€beÐ Xð Ðconstrued€to€preempt€any€State€law€to€the€extent€that€it€authorizes€or€prohibits€disclosureÏof€protected€health€information€regarding€a€minor€to€a€parent,€guardian€or€person€actingÏòòin€loco€parentisóó€of€such€minor.Ð ( À ÐÑ  Ñ(3)€With€respect€to€penalties,€provides€greater€penalties.ÌÑ  Ñ(4)€With€respect€to€information€to€be€provided€to€an€individual€about€a€proposedÏuse,€disclosure,€rights,€remedies,€and€similar€issues,€provides€the€greater€amount€ofÏinformation.Ì(5)€With€respect€to€form€or€substance€of€authorizations€for€use€or€disclosure€ofÏinformation,€provides€requirements€that€narrow€the€scope€or€duration,€increase€theÏdifficulty€of€obtaining,€or€reduce€the€coercive€effect€of€the€circumstances€surrounding€theÏauthorization.Ì(6)€With€respect€to€recordkeeping€or€accounting€requirements,€provides€for€theÏretention€or€reporting€of€more€detailed€information€or€for€a€longer€duration.Ì(7)€With€respect€to€any€other€matter,€provides€greater€privacy€protection€for€theÏindividual.€ÌÑ  ÑòòRelates€to€the€privacy€of€individually€identifiable€health€informationóó€means,€withÐ Xð Ðrespect€to€a€State€law,€that€the€State€law€has€the€specific€purpose€of€protecting€the€privacyÏof€health€information€or€the€effect€of€affecting€the€privacy€of€health€information€in€aÏdirect,€clear,€and€substantial€way.€ÌòòState€lawóó€means€a€law,€decision,€rule,€regulation,€or€other€State€action€having€theÐ ° Ðeffect€of€law.€ÌÓ XÓðð€160.203à ¸ àòòGeneral€rule€and€exceptionsóó.Ð ø ÐÓB.°°` ¸ hÀpÈ xÐ (#°°XBÓà ` àòòGeneral€ruleóó.€€A€standard,€requirement,€or€implementation€specification€adoptedÐ è€ Ðunder€or€pursuant€to€this€subchapter€that€is€contrary€to€a€provision€of€State€law€preemptsÏthe€provision€of€State€law.€€This€general€rule€applies,€except€where€one€or€more€of€theÏfollowing€conditions€is€met:Ìà ` à(a)€A€determination€is€made€by€the€Secretary€pursuant€to€ðð€160.204(a)€that€theÏprovision€of€State€law:Ìà ` à(1)€Is€necessary:Ìà ` à(i)€To€prevent€fraud€and€abuse;Ìà ` à(ii)€To€ensure€appropriate€State€regulation€of€insurance€and€health€plans;Ìà ` à(iii)€For€State€reporting€on€health€care€delivery€or€costs;€orÌà ` à(iv)€For€other€purposes€related€to€improving€the€Medicare€program,€the€MedicaidÏprogram,€or€the€efficiency€and€effectiveness€of€the€health€care€system;€or€ò òó óÐ 8'Ð # Ðà ` à(2)€Addresses€controlled€substances.ÌÑ  Ñà ` à(b)€The€provision€of€State€law€relates€to€the€privacy€of€health€information€and€isÏmore€stringent€than€a€standard,€requirement,€or€implementation€specification€adoptedÏunder€subpart€E€of€part€164€of€this€subchapter.Ìà ` à(c)€The€provision€of€State€law,€or€the€State€established€procedures,€are€establishedÏunder€a€State€law€providing€for€the€reporting€of€disease€or€injury,€child€abuse,€birth,€orÏdeath,€or€for€the€conduct€of€public€health€surveillance,€investigation,€or€intervention.Ð È-`'* Ðà ` à(d)€The€provision€of€State€law€requires€a€health€plan€to€report,€or€to€provide€accessÏto,€information€for€the€purpose€of€management€audits,€financial€audits,€programÏmonitoring€and€evaluation,€facility€licensure€or€certification,€or€individual€licensure€orÏcertification.Ìðð€160.204à ¸ àòòProcess€for€requesting€exception€determinations€or€advisory€opinionsóó.Ð ( À Ð(a)€òòDeterminationsóó.€€Ð  ° Ð(1)€òòóó€A€State€may€submit€a€written€request€to€the€Secretary€to€except€a€provision€of€StateÐ    Ðlaw€from€preemption€under€ðð€160.203(a).€€The€request€must€include€the€followingÏinformation:Ì(i)€The€State€law€for€which€the€exception€is€requested;Ì(ii)€The€particular€standard(s),€requirement(s),€or€implementation€specification(s)€forÏwhich€the€exception€is€requested;ÌÑ  Ñ(iii)€The€part€of€the€standard€or€other€provision€that€will€not€be€implemented€based€on€theÏexception€or€the€additional€data€to€be€collected€based€on€the€exception,€as€appropriate;Ì(iv)€How€health€care€providers,€health€plans,€and€other€entities€would€be€affected€by€theÏexception;ÌÑ  Ñ(v)€The€length€of€time€for€which€the€exception€would€be€in€effect,€if€less€than€three€years;Ì(vi)€The€reasons€why€the€State€law€should€not€be€preempted€by€the€federal€standard,Ïrequirement,€or€implementation€specification,€including€how€the€State€law€meets€one€orÏmore€of€the€criteria€at€ðð160.203(a);€andÌÑ  Ñ(vii)€Any€other€information€the€Secretary€may€request€in€order€to€make€the€determination.Ì(2)€Requests€for€exception€under€this€section€must€be€submitted€to€the€Secretary€at€anÏaddress€which€will€be€published€in€the€òòFederal€Registeróó.€€Until€the€SecretaryððsÐ   Ðdetermination€is€made,€the€standard,€requirement,€or€implementation€specification€underÏthis€subchapter€remains€in€effect.Ì(3)€The€Secretaryððs€determination€under€this€paragraph€will€be€made€on€the€basis€of€theÏextent€to€which€the€information€provided€and€other€factors€demonstrate€that€one€or€moreÏof€the€€criteria€at€ðð€160.203(a)€has€been€met.€€If€it€is€determined€that€the€federal€standard,Ïrequirement,€or€implementation€specification€accomplishes€the€purposes€of€the€criterionÏor€criteria€at€ðð€160.203(a)€as€well€as€or€better€than€the€State€law€for€which€the€request€isÏmade,€the€request€will€be€denied.Ì(4)€An€exception€granted€under€this€paragraph€is€effective€for€three€years€or€for€suchÏlesser€time€as€is€specified€in€the€determination€granting€the€request.€Ì(5)€If€an€exception€is€granted€under€this€paragraph,€the€exception€has€effect€only€withÏrespect€to€transactions€taking€place€wholly€within€the€State€for€which€the€exception€wasÏrequested.Ì(6)€Any€change€to€the€standard,€requirement,€or€implementation€specification€or€provisionÏof€State€law€upon€which€an€exception€was€granted€requires€a€new€request€for€anÏexception.€€Absent€such€a€request€and€a€favorable€determination€thereon,€the€standard,Ïrequirement,€or€implementation€specification€remains€in€effect.€€The€responsibility€forÏâ ârecognizing€the€need€for€and€making€the€request€lies€with€the€original€requestor.Ð è+€%( Ð(7)€The€Secretary€may€seek€changes€to€a€standard,€requirement,€or€implementationÏspecification€based€on€requested€exceptions€or€may€urge€the€requesting€State€or€otherÏorganizations€or€persons€to€do€so.Ìâ â(8)€Determinations€made€by€the€Secretary€pursuant€to€this€paragraph€will€be€publishedÏannually€in€the€òòFederal€Registeróó.Ð ( À Ð(b)€òòAdvisory€opinionsóó.Ð  ° Ð(1)€The€Secretary€may€issue€advisory€opinions€as€to€whether€a€provision€of€State€lawÏconstitutes€an€exception€under€ðð€160.203(b)€to€the€general€rule€of€preemption€under€thatÏsection.€€The€Secretary€may€issue€such€opinions€at€the€request€of€a€State€or€at€theÏSecretaryððs€own€initiative.Ì(2)€òòóó€A€State€may€submit€a€written€request€to€the€Secretary€for€an€advisory€opinion€underÐ È`  Ðthis€paragraph.€€The€request€must€include€the€following€information:Ì(i)€The€State€law€for€which€the€exception€is€requested;Ì(ii)€The€particular€standard(s),€requirement(s),€or€implementation€specification(s)€forÏwhich€the€exception€is€requested;Ì(iii)€How€health€care€providers,€health€plans,€and€other€entities€would€be€affected€by€theÏexception;ÌÑ  Ñ(iv)€The€reasons€why€the€State€law€should€not€be€preempted€by€the€federal€standard,Ïrequirement,€or€implementation€specification,€including€how€the€State€law€meets€theÏcriteria€at€ðð€160.203(b);€andÌ(v)€Any€other€information€the€Secretary€may€request€in€order€to€issue€the€advisoryÏopinion.Ì(3)€The€requirements€of€paragraphs€(a)(2),€(a)(5)„(a)(7)€of€this€section€apply€to€requestsÏfor€advisory€opinions€under€this€paragraph.Ì(4)€The€Secretaryððs€decision€under€this€paragraph€will€be€made€on€the€basis€of€the€extentÏto€which€the€information€provided€and€other€factors€demonstrate€that€the€criteria€at€ððÏ160.203(b)€are€met.Ìà ` à(5)€Advisory€opinions€made€by€the€Secretary€pursuant€to€this€paragraph€will€beÏpublished€annually€in€the€òòFederal€Registeróó.Ð ¨ @ Ðò òPARTS€161„163€ð!ð€[RESERVED]Ð ˜!0 ÐPART€164€ð!ð€SECURITY€AND€PRIVACYÐ ˆ"  ÐSubpart€A€ð!ð€General€ProvisionsÐ x# Ðó óññÓÓññSec.Ð h$  Ð164.102à0 ¸ àStatutory€basis.ÐX%ð!¸ (#¸ (# ÐññÓv^Óññ164.104à0 ¸ àApplicability.ÐH&à"¸ (#¸ (# Ðò òSubparts€B„D€ð!ð€[Reserved]Ð 8'Ð # ÐSubpart€E€ð!ð€Privacy€of€Individually€Identifiable€Health€InformationÐ ((À!$ Ðó óññÓÓññ164.502à0 ¸ àApplicability.Ð)°"%¸ (#¸ (# Ð164.504à0 ¸ àDefinitions.Ð* #&¸ (#¸ (# Ð164.506à0 ¸ àUses€and€disclosures€of€protected€health€information:€general€rules.Ðø*$'¸ (#¸ (# Ð164.508à0 ¸ àUses€and€disclosures€for€which€individual€authorization€is€required.Ðè+€%(¸ (#¸ (# Ð164.510à0 ¸ àUses€and€disclosures€for€which€individual€authorization€is€not€required.ÐØ,p&)¸ (#¸ (# Ð164.512à0 ¸ àNotice€to€individuals€of€information€practices.ÐÈ-`'*¸ (#¸ (# Ð164.514à0 ¸ àAccess€of€individuals€to€protected€health€information.Ðh¸ (#¸ (# Ð164.515à0 ¸ àAccounting€for€disclosures€of€protected€health€information.ÐXð¸ (#¸ (# Ð164.516à0 ¸ àAmendment€and€correction.ÐHภ(#¸ (# Ð164.518à0 ¸ àAdministrative€requirements.Ð8 и (#¸ (# Ð164.520à0 ¸ àDocumentation€of€policies€and€procedures.Ð( À¸ (#¸ (# Ð164.522à0 ¸ àCompliance€and€enforcement.Ð °¸ (#¸ (# ÐññÓÏ_Óññ164.524à0 ¸ àEffective€date.Ð  ¸ (#¸ (# ÐAppendix€to€Subpart€E€of€Part€164€ð!ð€Model€Authorization€FormÐ ø  Ðà ` àAuthority:€42€U.S.C.€1320d„2€and€1320d„4.Ìò òSubpart€A€ð!ð€General€ProvisionsÐ Øp  Ðó óðð€164.102€à ¸ àòòStatutory€basisóó.Ð È`  Ðà ` àThe€provisions€of€this€part€are€adopted€pursuant€to€the€Secretaryððs€authority€toÏprescribe€standards,€requirements,€and€implementation€standards€under€part€C€of€title€XIÏof€the€Act€and€section€264€of€Public€Law€104„191.Ìðð€164.104à ¸ àòòApplicabilityóó.Ð ˆ  Ðà ` àExcept€as€otherwise€provided,€the€provisions€of€this€part€apply€to€covered€entities:Ïhealth€plans,€health€care€clearinghouses,€and€health€care€providers€who€transmit€healthÏinformation€in€electronic€form€in€connection€with€any€transaction€referred€to€in€sectionÏ1173(a)(1)€of€the€Act.ÌÓB.°°` ¸ hÀpÈ xÐ (#°°XBÓò òSubparts€B„D€ð!ð€[Reserved]Ð 8Ð ÐSubpart€E€ð!ð€Privacy€of€Individually€Identifiable€Health€InformationÐ (À Ðó óÓ °ÓÓB.` °` ¸ hÀpÈ xÐ (#°°XBÓÓ PûÓðð€164.502à ¸ àòòApplicability.óóÐ ° ÐÓ °ÓÓB.°°` ¸ hÀpÈ xÐ (#` °XBÓÓ XPûÓIn€addition€to€the€applicable€provisions€of€part€160€of€this€subchapter€and€exceptÏas€otherwise€herein€provided,€the€requirements,€standards,€and€implementationÏspecifications€of€this€subpart€apply€to€covered€entities€with€respect€to€protected€healthÏinformation.ÌÓ °ÓÓB.` °` ¸ hÀpÈ xÐ (#°°XBÓÓ PûXÓðð€164.504à ¸ àòòDefinitions.Ð È` ÐÓ PûÓóóÓ X°ÓÓB.°` ¸ hÀpÈ xÐ (#` °XBÓAs€used€in€this€subpart,€the€following€terms€have€the€following€meanings:Ð ¸P ÐÓ XÓÓB.°°` ¸ hÀpÈ xÐ (#°XBÓÓ XÓòòBusiness€partneróó€means,€with€respect€to€a€covered€entity,€a€person€to€whom€theÐ ¨ @ Ðcovered€entity€discloses€protected€health€information€so€that€the€person€can€carry€out,Ïassist€with€the€performance€of,€or€perform€on€behalf€of,€a€function€or€activity€for€theÏcovered€entity.€€ð ðBusiness€partnerðð€includes€contractors€or€other€persons€who€receiveÏprotected€health€information€from€the€covered€entity€(or€from€another€business€partner€ofÏthe€covered€entity)€for€the€purposes€described€in€the€previous€sentence,€including€lawyers,Ïauditors,€consultants,€third„party€administrators,€health€care€clearinghouses,€dataÏprocessing€firms,€billing€firms,€and€other€covered€entities.€€ð ðBusiness€partnerðð€excludesÏpersons€who€are€within€the€covered€entityððs€workforce,€as€defined€in€this€section.€€òòÐ ((À!$ ÐDesignated€record€setóó€means€a€group€of€records€under€the€control€of€a€coveredÐ )°"% Ðentity€from€which€information€is€retrieved€by€the€name€of€the€individual€or€by€someÏidentifying€number,€symbol,€or€other€identifying€particular€assigned€to€the€individual€andÏwhich€is€used€by€the€covered€entity€to€make€decisions€about€the€individual.€€For€purposesÏof€this€paragraph,€the€term€ð ðrecordðð€means€any€item,€collection,€or€grouping€of€protectedÏhealth€information€€maintained,€collected,€used,€or€disseminated€by€a€covered€entity.òòÐ È-`'* ÐDisclosureóó€means€the€release,€transfer,€provision€of€access€to,€or€divulging€in€anyÐ h Ðother€manner€of€information€outside€the€entity€holding€the€information.ÌòòHealth€care€operationsóó€means€the€following€activities€undertaken€by€or€on€behalfÐ Hà Ðof€a€covered€entity€that€is€a€health€plan€or€health€care€provider€for€the€purpose€of€carryingÏout€the€management€functions€of€such€entity€necessary€for€the€support€of€treatment€orÏpayment:Ì(1)€Conducting€quality€assessment€and€improvement€activities,€includingÏoutcomes€evaluation€and€development€of€clinical€guidelinesò òó ó;Ð ø  Ð(2)€Reviewing€the€competence€or€qualifications€of€health€care€professionals,Ïevaluating€practitioner€and€provider€performance,€health€plan€performance,€conductingÏtraining€programs€in€which€undergraduate€and€graduate€students€and€trainees€in€areas€ofÏhealth€care€learn€under€supervision€to€practice€as€health€care€providers,€accreditation,Ïcertification,€licensing€or€credentialing€activities;Ì(3)€Insurance€rating€and€other€insurance€activities€relating€to€the€renewal€of€aÏcontract€for€insurance,€including€underwritingò òó ó,€experience€rating,€and€reinsurance,€butÐ ˆ  Ðonly€when€the€individuals€are€already€enrolled€in€the€health€plan€conducting€suchÏactivities€and€the€use€or€disclosure€of€protected€health€information€relates€to€an€existingÏcontract€of€insurance€(including€the€renewal€of€such€a€contract)ò òó ó;Ð Xð Ð(4)€Conducting€or€arranging€for€medical€review€and€auditing€services,€includingÏfraud€and€abuse€detection€and€compliance€programs;€and€Ì(5)€Compiling€and€analyzing€information€in€anticipation€of€or€for€use€in€a€civil€orÏcriminal€legal€proceeding.ÌòòHealth€oversight€agencyóó€means€an€agency,€person€or€entity,€including€theÐ   Ðemployees€or€agents€thereof,€€Ì(1)€That€is:€Ì(i)€A€public€agency;€or€Ì(ii)€A€person€or€entity€acting€under€grant€of€authority€from€or€contract€with€aÏpublic€agency;€and€Ì(2)€Which€performs€or€oversees€the€performance€of€any€audit;€investigation;Ïinspection;€licensure€or€discipline;€civil,€criminal,€or€administrative€proceeding€or€action;Ïor€other€activity€necessary€for€appropriate€oversight€of€the€health€care€system,€ofÏgovernment€benefit€programs€for€which€health€information€is€relevant€to€beneficiaryÏeligibility,€or€of€government€regulatory€programs€for€which€health€information€isÏnecessary€for€determining€compliance€with€program€standards.Ìòòò òó óIndividualóó€means€the€person€who€is€the€subject€of€protected€health€information,Ð H&à" Ðexcept€that:Ì(1)€ð ðIndividualðð€includes:Ì(i)€With€respect€to€adults€and€emancipated€minors,€€legal€representatives€(such€asÏcourt„appointed€guardians€or€persons€with€a€power€of€attorney),€to€the€extent€to€whichÏapplicable€law€permits€such€legal€representatives€to€exercise€the€personððs€rights€in€suchÏcontexts.€€òòóóÐ è+€%( Ð(ii)€With€respect€to€unemancipated€minors,€a€parent,€guardian,€or€person€acting€òòinÐ Ø,p&) Ðloco€parentisóó,€òòprovided€thatóó€when€a€minor€lawfully€obtains€a€health€care€service€withoutÐ È-`'* Ðthe€consent€of€or€notification€to€a€parent,€guardian,€or€other€person€acting€òòin€loco€parentisóó,Ð h Ðthe€minor€shall€have€the€exclusive€right€to€exercise€the€rights€of€an€individual€under€thisÏsubpart€with€respect€to€the€protected€health€information€relating€to€such€care.Ì(iii)€With€respect€to€deceased€persons,€an€executor,€administrator,€or€other€personÏauthorized€under€applicable€law€to€act€on€behalf€of€the€decedentððs€estate.€Ì(2)€ð ðIndividualðð€excludes:Ì(i)€Foreign€military€and€diplomatic€personnel€and€their€dependents€who€receiveÏhealth€care€provided€by€or€paid€for€by€the€Department€of€Defense€or€other€federal€agency,Ïor€by€an€entity€acting€on€its€behalf,€pursuant€to€a€country„to„country€agreement€or€federalÏstatute;€andÌ(ii)€Overseas€foreign€national€beneficiaries€of€health€care€provided€by€theÏDepartment€of€Defense€or€other€federal€agency,€or€by€a€non„governmental€organizationÏacting€on€its€behalf.ÌòòIndividually€identifiable€health€informationóó€is€information€that€is€a€subset€ofÐ ˜0  Ðhealth€information,€including€demographic€information€collected€from€an€individual,€andÏthat:Ì(1)€Is€created€by€or€received€from€a€health€care€provider,€health€plan,€employer,€orÏhealth€care€clearinghouse;€andÌ(2)€Relates€to€the€past,€present,€or€future€physical€or€mental€health€or€condition€ofÏan€individual,€the€provision€of€health€care€to€an€individual,€or€the€past,€present,€or€futureÏpayment€for€the€provision€of€health€care€to€an€individual,€andÌ(i)€Which€identifies€the€individual,€or€Ì(ii)€With€respect€to€which€there€is€a€reasonable€basis€to€believe€that€theÏinformation€can€be€used€to€identify€the€individual.ÌòòLaw€enforcement€officialóó€means€an€officer€of€an€agency€or€authority€of€the€UnitedÐ è€ ÐStates,€a€State,€a€territory,€a€political€subdivision€of€a€State€or€territory,€or€an€Indian€tribe,Ïwho€is€empowered€by€law€to€conduct:Ì(1)€An€investigation€or€official€proceeding€inquiring€into€a€violation€of,€or€failureÏto€comply€with,€any€law;€orÌ(2)€A€criminal,€civil,€or€administrative€proceeding€arising€from€a€violation€of,€orÏfailure€to€comply€with,€any€law.€€ÌòòPaymentóó€means:Ð x# Ð(1)€The€activities€undertaken€by€or€on€behalf€of€a€covered€entity€that€is:€Ì(i)€€A€health€plan,€or€by€a€business€partner€on€behalf€of€a€health€plan,€to€obtainÏpremiums€or€to€determine€or€fulfill€its€responsibility€for€coverage€under€the€health€planÏand€for€provision€of€benefits€under€the€health€plan;€orÌ(ii)€€A€health€care€provider€or€health€plan,€or€a€business€partner€on€behalf€of€suchÏprovider€or€plan,€to€obtain€reimbursement€for€the€provision€of€health€care.€Ì(2)€Activities€that€constitute€payment€include:Ì(i)€Determinations€of€coverage,€improving€methods€of€paying€or€coverageÏpolicies,€adjudication€or€subrogation€of€health€benefit€claims;€Ì(ii)€Risk€adjusting€amounts€due€based€on€enrollee€health€status€and€demographicÏcharacteristics;Ð È-`'* Ð(iii)€Billing,€claims€management,€and€medical€data€processing;Ì(iv)€Review€of€health€care€services€with€respect€to€medical€necessity,€coverageÏunder€a€health€plan,€appropriateness€of€care,€or€justification€of€charges;€andÌ(v)€Utilization€review€activities,€including€precertification€and€preauthorization€ofÏservices.ÌòòProtected€health€informationóó€means€individually€identifiable€health€informationÐ  ° Ðthat€is€or€has€been€electronically€transmitted€or€electronically€maintained€by€a€coveredÏentity€and€includes€such€information€in€any€other€form.€€ÌÓ XÓà ` à(1)€For€purposes€of€this€definition,€Ìà ` à(i)€ð ðElectronically€transmittedðð€includes€information€exchanged€with€a€computerÏusing€electronic€media,€such€as€the€movement€of€information€from€one€location€toÏanother€by€magnetic€or€optical€media,€transmissions€over€the€Internet,€Extranet,€leasedÏlines,€dial„up€lines,€private€networks,€telephone€voice€response,€and€ð ðfaxbackðð€systems.Ìà ` à(ii)€ð ðElectronically€maintainedðð€means€information€stored€by€a€computer€or€onÏany€electronic€medium€from€which€information€may€be€retrieved€by€a€computer,€such€asÏelectronic€memory€chips,€magnetic€tape,€magnetic€disk,€or€compact€disc€optical€media.Ìà ` à(2)€ð ðProtected€health€informationðð€excludes:Ìà ` à(i)€Individually€identifiable€health€information€in€education€records€covered€by€theÏFamily€Educational€Right€and€Privacy€Act,€as€amended,€20€U.S.C.€1232g;€andÌà ` à(ii)€Individually€identifiable€health€information€of€inmates€of€correctionalÏfacilities€and€detainees€in€detention€facilities.ÌÑ  Ñà ` àòòPublic€health€authorityóó€means€an€agency€or€authority€of€the€United€States,€a€State,Ð ° Ða€territory,€a€political€subdivision€of€a€State€or€territory,€or€an€Indian€tribe€that€isÏresponsible€for€public€health€matters€as€part€of€its€official€mandate.€Ìà ` àòòResearchóó€means€òòóóa€systematic€investigation,€including€research€development,Ð è€ Ðtesting€and€evaluation,€designed€to€develop€or€contribute€to€generalizable€knowledge.€Ïð ðGeneralizable€knowledgeðð€is€knowledge€related€to€health€that€can€be€applied€toÏpopulations€outside€of€the€population€served€by€the€covered€entity.òòóóÐ ¸P ÐòòóóÑ  Ñà ` àòòTreatmentóó€means€the€provision€of€health€care€by,€or€the€coordination€of€healthÐ ¨ @ Ðcare€(including€health€care€management€of€the€individual€through€risk€assessmentò òó ó,€caseÐ ˜!0 Ðmanagement,€and€disease€management)€among,€health€care€providers;€the€referral€of€aÏpatient€from€one€provider€to€another;€or€the€coordination€of€health€care€or€other€servicesÏamong€health€care€providers€and€third€parties€authorized€by€the€health€plan€or€theÏindividual.Ìà ` àòòò òó óUseóó€means€the€employment,€application,€utilization,€examination,€or€analysis€ofÐ H&à" Ðinformation€within€an€entity€that€holds€the€information.Ìà ` àòòWorkforceóó€means€employees,€volunteers,€trainees,€and€other€persons€under€theÐ ((À!$ Ðdirect€control€of€a€covered€entity,€including€persons€providing€labor€on€an€unpaid€basis.Ìðð€164.506à0 ¸ àòòUses€and€disclosures€of€protected€health€information:€general€rules.óóÐ* #&¸ (#¸ (# Ðà ` à(a)€€òòStandardóó.€€A€covered€entity€may€not€use€or€disclose€an€individualððs€protectedÐ ø*$' Ðhealth€information,€except€as€otherwise€permitted€or€required€by€this€part€or€as€required€toÏcomply€with€applicable€requirements€of€this€subchapter.Ìà ` à(1)€òòPermitted€uses€and€disclosuresóó.€€A€covered€entity€is€permitted€to€use€orÐ È-`'* Ðdisclose€protected€health€information€as€follows:Ìà ` à(i)€Except€for€research€information€unrelated€to€treatment,€to€carry€out€treatment,Ïpayment,€or€health€care€operations;Ìà ` à(ii)€Pursuant€to€an€authorization€by€the€individual€that€complies€with€ðð€164.508;€orÌà ` à(iii)€As€permitted€by€and€in€compliance€with€this€section€or€ðð€164.510.Ìà ` à(2)€òòRequired€disclosuresóó.€€A€covered€entity€is€required€to€disclose€protected€healthÐ  ° Ðinformation:Ìà ` à(i)€To€an€individual,€when€a€request€is€made€under€ðð€164.514;€orÌà ` à(ii)€When€required€by€the€Secretary€under€ðð€164.522€to€investigate€or€determineÏthe€entityððs€compliance€with€this€part.Ìà ` àòòóó(b)(1)€òòStandard:€minimum€necessaryóó.ò òó ó€€€A€covered€entity€must€make€all€reasonableÐ È`  Ðefforts€€not€to€use€or€disclose€more€than€the€minimum€amount€of€protected€healthÏinformation€necessary€to€accomplish€the€intended€purpose€of€the€use€or€disclosure.€€ThisÏrequirement€does€not€apply€to€uses€or€disclosures€that€are:Ìà ` à(i)€Made€in€accordance€with€ðððð€164.508(a)(1),€164.514,€or€164.522;Ìà ` à(ii)€Required€by€law€and€permitted€under€ðð€164.510;Ìà ` à(iii)€Required€for€compliance€with€applicable€requirements€of€this€subchapter;€orÌà ` à(iv)€Made€by€a€covered€health€care€provider€to€a€covered€health€plan,€when€theÏinformation€is€requested€for€audit€and€related€purposes.Ìà ` à(2)€òòImplementation€specification:€proceduresóó.€€To€comply€with€the€standard€in€thisÐ 8Ð Ðparagraph,€a€covered€entity€must€have€procedures€to:Ìà ` à(i)€Identify€appropriate€persons€within€the€entity€to€determine€what€informationÏshould€be€used€or€disclosed€consistent€with€the€minimum€necessary€standard;Ìà ` à(ii)€Ensure€that€the€persons€identified€under€paragraph€(b)(2)(i)€of€this€sectionÏmake€the€minimum€necessary€determinations,€when€required;Ìà ` à(iii)€Within€the€limits€of€the€entityððs€technological€capabilities,€provide€for€theÏmaking€of€such€determinations€individually.Ìà ` à(3)€òòImplementation€specification:€relianceóó.€€When€making€disclosures€to€publicÐ ¸P Ðofficials€that€are€permitted€under€ðð€164.510€but€not€required€by€other€law,€a€coveredÏentity€may€reasonably€rely€on€the€representations€of€such€officials€that€the€informationÏrequested€is€the€minimum€necessary€for€the€stated€purpose(s).Ìà ` à(c)(1)€òòStandard:€right€of€an€individual€to€restrict€uses€and€disclosuresóó.€€(i)€€AÐ x# Ðcovered€entity€that€is€a€health€care€provider€must€permit€individuals€to€request€that€uses€orÏdisclosures€of€protected€health€information€for€treatment,€payment,€or€health€careÏoperations€be€restricted,€and,€if€the€requested€restrictions€are€agreed€to€by€the€provider,Ïnot€make€uses€or€disclosures€inconsistent€with€such€restrictions.ò òó óÐ 8'Ð # Ðà ` à(ii)€€This€requirement€does€not€apply:Ìà ` à(A)€To€uses€or€disclosures€permitted€under€ðð€164.510;€Ìà ` à(B)€When€the€health€care€services€provided€are€emergency€services€or€theÏinformation€is€requested€pursuant€to€ðð€164.510(k);€andÌà ` à(C)€To€disclosures€to€the€Secretary€pursuant€to€ðð€164.522.Ìà ` à(iii)€A€provider€is€not€required€to€agree€to€a€requested€restriction.Ìà ` à(2)€òòImplementation€specificationsóó.€€A€covered€entity€must€have€procedures€that:Ð È-`'* Ðà ` à(i)€Provide€individuals€an€opportunity€to€request€a€restriction€on€the€uses€andÏdisclosures€of€their€protected€health€information;Ìà ` à(ii)€Provide€that€restrictions€that€are€agreed€to€by€the€entity€are€reduced€to€writingÏor€otherwise€documented;Ìà ` à(iii)€Enable€the€entity€to€honor€such€restrictions;€andÌà ` à(iv)€Provide€for€the€notification€of€others€to€whom€such€information€is€disclosedÏof€such€restriction.Ìò òó óà ` à(d)(1)€òòStandard:€use€or€disclosure€of€de„identified€protected€health€informationóó.Ð ø  ÐThe€requirements€of€this€subpart€do€not€apply€to€protected€health€information€that€aÏcovered€entity€has€de„identified,€òòprovided,€however,€thatóó:Ð Øp  Ðà ` à(i)€Disclosure€of€a€key€or€other€device€designed€to€enable€coded€or€otherwise€de„¼identified€information€to€be€re„identified€constitutes€disclosure€of€protected€healthÏinformation;€and€Ìà ` à(ii)€If€a€covered€entity€re„identifies€de„identified€information,€it€may€use€orÏdisclose€such€re„identified€information€only€in€accordance€with€this€subpart.€€Ìà ` à(2)€òòImplementation€specificationsóó.€€(i)€€A€covered€entity€may€use€protected€healthÐ x Ðinformation€to€create€de„identified€information€by€removing,€coding,€encrypting,€orÏotherwise€eliminating€or€concealing€the€information€that€makes€such€informationÏindividually€identifiable.Ìà ` à(ii)€€Information€is€presumed€not€to€be€individually€identifiable€(de„identified),€if:Ìà ` à(A)€The€following€identifiers€have€been€removed€or€otherwise€concealed:Ìà ` à(òò1óó)€Name;Ð ° Ðà ` à(òò2óó)€Address,€including€street€address,€city,€county,€zip€code,€and€equivalentÐ   Ðgeocodes;Ìà ` à(òò3óó)€Names€of€relatives;Ð è€ Ðà ` à(òò4óó)€Name€of€employers;Ð Øp Ðà ` à(òò5óó)€Birth€date;Ð È` Ðà ` à(òò6óó)€Telephone€numbers;Ð ¸P Ðà ` à(òò7óó)€Fax€numbers;Ð ¨ @ Ðà ` à(òò8óó)€Electronic€mail€addresses;Ð ˜!0 Ðà ` à(òò9óó)€Social€security€number;Ð ˆ"  Ðà ` à(òò10óó)€Medical€record€number;Ð x# Ðà ` à(òò11óó)€Health€plan€beneficiary€number;Ð h$  Ðà ` à(òò12óó)€Account€number;Ð X%ð! Ðà ` à(òò13óó)€Certificate/license€number;Ð H&à" Ðà ` à(òò14óó)€Any€vehicle€or€other€device€serial€number;Ð 8'Ð # Ðà ` à(òò15óó)€Web€Universal€Resource€Locator€(URL);Ð ((À!$ Ðà ` à(òò16óó)€ò òó óInternet€Protocol€(IP)€address€number;€Ð )°"% Ðà ` à(òò17óó)€Finger€or€voice€prints;€Ð * #& Ðà ` à(òò18óó)€Photographic€images;€andÐ ø*$' Ðà ` à(òò19óó)€Any€other€unique€identifying€number,€characteristic,€or€code€that€the€coveredÐ è+€%( Ðentity€has€reason€to€believe€may€be€available€to€an€anticipated€recipient€of€theÏinformation;€andÐ È-`'* Ðà ` à(B)€The€covered€entity€has€no€reason€to€believe€that€any€anticipated€recipient€ofÏsuch€information€could€use€the€information,€alone€or€in€combination€with€otherÏinformation,€to€identify€an€individual.òòóóÐ Hà Ðà ` à(iii)€Notwithstanding€paragraph€(d)(2)(ii)€of€this€section,€entities€with€appropriateÏstatistical€experience€and€expertise€may€treat€information€as€de„identified,€if€they€includeÏinformation€listed€in€paragraph€(d)(2)(ii)€of€this€section€and€they€determine€that€theÏprobability€of€identifying€individuals€with€such€identifying€information€retained€is€veryÏlow,€or€may€remove€additional€information,€if€they€have€a€reasonable€basis€to€believeÏsuch€additional€information€could€be€used€to€identify€an€individual.òòóóÐ è € Ðà ` à(e)(1)€€òòStandards:€business€partnersóó.€(i)€€Except€for€disclosures€of€protected€healthÐ Øp  Ðinformation€by€a€covered€entity€that€is€a€health€care€provider€to€another€health€careÏprovider€for€consultation€or€referral€purposes,€a€covered€entity€may€not€disclose€protectedÏhealth€information€to€a€business€partner€without€satisfactory€assurance€from€the€businessÏpartner€that€it€will€appropriately€safeguard€the€information.Ìà ` à(ii)€A€covered€entity€must€take€reasonable€steps€to€ensure€that€each€businessÏpartner€complies€with€the€requirements€of€this€subpart€with€respect€to€any€task€or€otherÏactivity€it€performs€on€behalf€of€the€entity,€to€the€extent€the€covered€entity€would€beÏrequired€to€comply€with€such€requirements.€€à p àò òó óÐ Xð Ðà ` à(2)€òòImplementation€specificationsóó.€€Ð Hà Ðà ` à(i)òòóó€€For€the€purposes€of€this€section,€ð ðsatisfactory€assuranceðð€means€a€contractÐ 8Ð Ðbetween€the€covered€entity€and€the€business€partner€to€which€such€information€is€to€beÏdisclosed€that€establishes€the€permitted€and€required€uses€and€disclosures€of€suchÏinformation€by€the€partner.€€The€contract€must€provide€that€the€business€partner€will:Ìà ` à(A)€Not€use€or€further€disclose€the€information€other€than€as€permitted€or€requiredÏby€the€contract;Ìà ` à(B)€Not€use€or€further€disclose€the€information€in€a€manner€that€would€violate€theÏrequirements€of€this€subpart,€if€done€by€the€covered€entity;Ìà ` à(C)€Use€appropriate€safeguards€to€prevent€use€or€disclosure€of€the€informationÏother€than€as€provided€for€by€its€contract;€Ìà ` à(D)€Report€to€the€covered€entity€any€use€or€disclosure€of€the€information€notÏprovided€for€by€its€contract€of€which€it€becomes€aware;Ìà ` à(E)€Ensure€that€any€subcontractors€or€agents€to€whom€it€provides€protected€healthÏinformation€received€from€the€covered€entity€agree€to€the€same€restrictions€and€conditionsÏthat€apply€to€the€business€partner€with€respect€to€such€information;Ìà ` à(F)€Make€available€protected€health€information€in€accordance€with€ðð€164.514(a);Ìà ` à(G)€Make€its€internal€practices,€books,€and€records€relating€to€the€use€andÏdisclosure€of€protected€health€information€received€from€the€covered€entity€available€toÏthe€Secretary€for€purposes€of€determining€the€covered€entityððs€compliance€with€thisÏsubpart;€€Ìà ` à(H)€At€termination€of€the€contract,€return€or€destroy€all€protected€healthÏinformation€received€from€the€covered€entity€that€the€business€partner€still€maintains€inÏany€form€and€retain€no€copies€of€such€information;€andÌà ` à(I)€Incorporate€any€amendments€or€corrections€to€protected€health€informationÐ È-`'* Ðwhen€notified€pursuant€to€ðð€164.516(c)(3).Ìà ` à(ii)€The€contract€required€by€paragraph€(e)(2)(i)€of€this€section€must:Ìà ` à(A)€State€that€the€individuals€whose€protected€health€information€is€disclosedÏunder€the€contract€are€intended€third€party€beneficiaries€of€the€contract;€and€€€Ìà ` à(B)€Authorize€the€covered€entity€to€terminate€the€contract,€if€the€covered€entityÏdetermines€that€the€business€partner€has€violated€a€material€term€of€the€contract€requiredÏby€this€paragraph.Ìà ` à(iii)€A€material€breach€by€a€business€partner€of€its€obligations€under€the€contractÏrequired€by€paragraph€(e)(2)(i)€of€this€section€will€be€considered€to€be€noncompliance€ofÏthe€covered€entity€with€the€applicable€requirements€of€this€subpart,€if€the€covered€entityÏknew€or€reasonably€should€have€known€of€such€breach€and€failed€to€take€reasonable€stepsÏto€cure€the€breach€or€terminate€the€contract.€Ìà ` à(f)€òòStandard:€deceased€individualsóó.€€A€covered€entity€must€comply€with€theÐ ¨@  Ðrequirements€of€this€subpart€with€respect€to€the€protected€health€information€of€aÏdeceased€individual€for€two€years€following€the€death€of€such€individual.€€ThisÏrequirement€does€not€apply€to€uses€or€disclosures€for€research€purposes.Ìà ` à(g)€òòStandard:€uses€and€disclosures€consistent€with€noticeóó.€€Except€as€provided€by€ððÐ h Ð164.520(g)(2),€a€covered€entity€that€is€required€by€ðð€164.512€to€have€a€notice€may€not€useÏor€disclose€protected€health€information€in€a€manner€inconsistent€with€such€notice.Ìðð€164.508à0 ¸ àòòUses€and€disclosures€for€which€individual€authorization€is€required.€óóÐ8и (#¸ (# Ðà ` à(a)€òòStandardóó.€An€authorization€executed€in€accordance€with€this€section€is€requiredÐ (À Ðin€order€for€the€covered€entity€to€use€or€disclose€protected€health€information€in€theÏfollowing€situations:Ìà ` à(1)€òòRequest€by€individualóó.€€Where€the€individual€requests€the€covered€entity€to€useÐ ø Ðor€disclose€the€information.€Ìà ` à(2)€òòRequest€by€covered€entityóó.€€(i)€Where€the€covered€entity€requests€theÐ Øp Ðindividual€to€authorize€the€use€or€disclosure€of€the€information.€€The€covered€entity€mustÏrequest€and€obtain€an€authorization€from€the€individual€for€all€uses€and€disclosures€thatÏare€not:Ìà ` à(A)€Except€as€provided€in€paragraph€(a)(3)€of€this€section,€compatible€with€orÏdirectly€related€to€treatment,€payment,€or€health€care€operations;Ìà ` à(B)€Covered€by€ðð€164.510;€Ìà ` à(C)€Covered€by€paragraph€(a)(1)€of€this€section;€orÌà ` à(D)€Required€by€this€subpart.Ìà ` à€(ii)€€Uses€and€disclosures€of€protected€health€information€for€which€individualÏauthorization€is€required€include,€but€are€not€limited€to,€the€following:Ìà ` à(A)€Use€for€marketing€of€health€and€non„health€items€and€services€by€the€coveredÏentity;Ìà ` à(B)€Disclosure€by€sale,€rental,€or€barter;Ìà ` à(C)€Use€and€disclosure€to€non„health€related€divisions€of€the€covered€entity,€e.g.,Ïfor€use€in€marketing€life€or€casualty€insurance€or€banking€services;Ìà ` à(D)€Disclosure,€prior€to€an€individualððs€enrollment€in€a€health€plan,€to€the€healthÏplan€or€health€care€provider€for€making€eligibility€or€enrollment€determinations€relatingÐ È-`'* Ðto€the€individual€or€for€underwriting€or€risk€rating€determinationsò òó ó;Ð h Ðà ` à(E)€Disclosure€to€an€employer€for€use€in€employment€determinations;€and€€Ìà ` à(F)€€Use€or€disclosure€for€fundraising€purposes.Ìà ` à(iii)€A€covered€entity€may€not€condition€the€provision€to€an€individual€ofÏtreatment€or€payment€on€the€provision€by€the€individual€of€a€requested€authorization€forÏuse€or€disclosure,€except€where€the€authorization€is€requested€in€connection€with€aÏclinical€trial.Ìà ` à(iv)€Except€where€required€by€law,€a€covered€entity€may€not€require€an€individualÏto€sign€an€authorization€for€use€or€disclosure€of€protected€health€information€forÏtreatment,€payment,€or€health€care€operations€purposes.Ìà ` à(3)€òòAuthorization€required:€special€casesóó.€€(i)€Except€as€otherwise€required€by€thisÐ È`  Ðsubpart€or€permitted€under€ðð€164.510,€a€covered€entity€must€obtain€the€authorization€ofÏthe€individual€for€the€following€uses€and€disclosures€of€protected€health€informationÏabout€the€individual:Ìà ` àòòóó(A)€Use€by€a€person€other€than€the€creator,€or€disclosure,€of€psychotherapy€notes;Ð ˆ  ÐandÌà ` à(B)€Use€or€disclosure€of€research€information€unrelated€to€treatment.Ìà ` à(ii)€The€requirements€of€paragraphs€(b)€through€(e)€of€this€section€apply€to€suchÏauthorizations,€as€appropriate.Ìà ` à(iii)€A€covered€entity€may€not€condition€treatment,€enrollment€in€a€health€plan,€orÏpayment€on€a€requirement€that€the€individual€authorize€use€or€disclosure€ofÏpsychotherapy€notes€relating€to€the€individual.ò òó óÐ ° Ðà ` à(iv)€For€purposes€of€this€section:Ìà ` à(A)€òòPsychotherapy€notesóó€means€notes€recorded€(in€any€medium)€by€a€health€careÐ ø Ðprovider€who€is€a€mental€health€professional€documenting€or€analyzing€the€contents€ofÏconversation€during€a€private€counseling€session€or€a€group,€joint,€or€family€counselingÏsession.€€For€purposes€of€this€definition,€€ð ðpsychotherapy€notesðð€excludes€medicationÏprescription€and€monitoring,€counseling€session€start€and€stop€times,€the€modalities€andÏfrequencies€of€treatment€furnished,€results€of€clinical€tests,€and€any€summary€of€theÏfollowing€items:€diagnosis,€functional€status,€the€treatment€plan,€symptoms,€prognosisÏand€progress€to€date.Ìà ` à(B)€òòResearch€information€unrelated€to€treatmentóó€means€health€information€that€isÐ x# Ðreceived€or€created€by€a€covered€entity€in€the€course€of€conducting€research,€for€whichÏthere€is€insufficient€scientific€and€medical€evidence€regarding€the€validity€or€utility€of€theÏinformation€such€that€it€should€not€be€used€for€the€purpose€of€providing€health€care,€andÏwith€respect€to€which€the€covered€entity€has€not€requested€payment€from€a€third€partyÏpayor.Ìà ` à(b)€òòGeneral€implementation€specifications€for€authorizationsóó.€€(1)€òòGeneralÐ )°"% Ðrequirementsóó.€€A€copy€of€the€model€form€which€appears€in€Appendix€A€hereto,€ò òó óor€aÐ * #& Ðdocument€that€contains€the€elements€listed€in€paragraphs€(c)€or€(d)€of€this€section,€asÏapplicable,€must€be€accepted€by€the€covered€entity.Ìà ` à(2)€òòDefective€authorizationsóó.€€There€is€no€ð ðauthorizationðð€within€the€meaning€ofÐ Ø,p&) Ðthis€section,€if€the€submitted€form€has€any€of€the€following€defects:Ð È-`'* Ðà ` à(i)€The€expiration€date€has€passed;Ìà ` à(ii)€The€form€has€not€been€filled€out€completely;Ìà ` à(iii)€The€authorization€is€known€by€the€covered€entity€to€have€been€revoked;Ìà ` à(iv)€The€form€lacks€an€element€required€by€paragraph€(c)€or€(d)€of€this€section,€asÏapplicable;Ìà ` à(v)€The€information€on€the€form€is€known€by€the€covered€entity€to€be€false.Ìà ` à(3)€òòCompound€authorizationsóó.€€Except€where€authorization€is€requested€inÐ    Ðconnection€with€a€clinical€trial,€an€authorization€for€use€or€disclosure€of€protected€healthÏinformation€for€purposes€other€than€treatment€or€payment€may€not€be€in€the€sameÏdocument€as€an€authorization€for€or€consent€to€treatment€or€payment.Ìà ` à(c)€òòImplementation€specifications€for€authorizations€requested€by€an€individualóó.€Ð È`  Ð(1)€òòRequired€elementsóó.€€Before€a€covered€entity€may€use€or€disclose€protected€healthÐ ¸P  Ðinformation€of€an€individual€pursuant€to€a€request€from€the€individual,€it€must€obtain€aÏcompleted€authorization€for€use€or€disclosure€executed€by€the€individual€that€contains€atÏleast€the€following€elements:Ìà ` à(i)€A€description€of€the€information€to€be€used€or€disclosed€that€identifies€theÏinformation€in€a€specific€and€meaningful€fashion;Ìà ` à(ii)€The€name€of€the€covered€entity,€or€class€of€entities€or€persons,€authorized€toÏmake€the€requested€use€or€disclosure;Ìà ` à(iii)€The€name€or€other€specific€identification€of€the€person(s)€or€entity(ies),€whichÏmay€include€the€covered€entity€itself,€to€whom€the€covered€entity€may€make€the€requestedÏuse€or€disclosure;€Ìà ` à(iv)€An€expiration€date;€Ìà ` à(v)€Signature€and€date;Ìà ` à(vi)€€If€the€authorization€is€executed€by€a€legal€representative€or€other€personÏauthorized€to€act€for€the€individual,€a€description€of€his€or€her€authority€to€act€orÏrelationship€to€the€individual;Ìà ` à(vii)€A€statement€in€which€the€individual€acknowledges€that€he€or€she€has€the€rightÏto€revoke€the€authorization,€except€to€the€extent€that€information€has€already€beenÏreleased€under€the€authorization;€andÌà ` à(viii)€A€statement€in€which€the€individual€acknowledges€that€information€used€orÏdisclosed€to€any€entity€other€than€a€health€plan€or€health€care€provider€may€no€longer€beÏprotected€by€the€federal€privacy€law.Ìà ` à(2)€òòPlain€language€requirementóó.€€The€model€form€at€Appendix€A€to€this€subpartÐ X%ð! Ðmay€be€used.€€If€the€model€form€at€Appendix€A€to€this€subpart€is€not€used,€theÏauthorization€form€must€be€written€in€plain€language.Ìà ` à(d)€òòImplementation€specifications€for€authorizations€for€uses€and€disclosuresÐ ((À!$ Ðrequested€by€covered€entitiesóó.€€(1)€òòRequired€elementsóó.€€Before€a€covered€entity€may€use€orÐ )°"% Ðdisclose€protected€health€information€of€an€individual€pursuant€to€a€request€that€it€hasÏmade,€it€must€obtain€a€completed€authorization€for€use€or€disclosure€executed€by€theÏindividual€that€meets€the€requirements€of€paragraph€(c)€of€this€section€and€contains€theÏfollowing€additional€elements:Ìà ` à(i)€Except€where€the€authorization€is€requested€for€a€clinical€trial,€a€statement€thatÐ È-`'* Ðit€will€not€condition€treatment€or€payment€on€the€individualððs€providing€authorization€forÏthe€requested€use€or€disclosure;Ìà ` à(ii)€A€description€of€the€purpose(s)€of€the€requested€use€or€disclosure;Ìò òó óà ` àò òó ó(iii)€A€statement€that€the€individual€may:Ð 8 Ð Ðà ` à(A)€Inspect€or€copy€the€protected€health€information€to€be€used€or€disclosed€asÏprovided€in€ðð€164.514;€andÌà ` à(B)€Refuse€to€sign€the€authorization;€andÌà ` à(iv)€Where€use€or€disclosure€of€the€requested€information€will€result€in€financialÏgain€to€the€entity,€a€statement€that€such€gain€will€result.Ìà ` à(2)€òòRequired€proceduresóó.€€In€requesting€authorization€from€an€individual€underÐ Øp  Ðthis€paragraph,€a€covered€entity€must:€Ìà ` à(i)€Have€procedures€designed€to€enable€it€to€request€only€the€minimum€amount€ofÏprotected€health€information€necessary€to€accomplish€the€purpose€for€which€the€request€isÏmade;€and€Ìà ` à(ii)€Provide€the€individual€with€a€copy€of€the€executed€authorization.Ìà ` à(e)€òòRevocation€of€authorizationsóó.€€An€individual€may€revoke€an€authorization€toÐ x Ðuse€or€disclose€his€or€her€protected€health€information€at€any€time,€except€to€the€extentÏthat€the€covered€entity€has€taken€action€in€reliance€thereon.Ìðð€164.510à0 ¸ àòòUses€and€disclosures€for€which€individual€authorization€is€not€required.óóÐHภ(#¸ (# Ðà ` àòòóóA€covered€entity€may€use€or€disclose€protected€health€information,€for€purposesÐ 8Ð Ðother€than€treatment,€payment,€or€health€care€operations,€without€the€authorization€of€theÏindividual,€in€the€situations€covered€by€this€section€and€subject€to€the€applicableÏrequirements€provided€for€by€this€section.Ìà ` à(a)€òòGeneral€requirementsóó.€€In€using€or€disclosing€protected€health€informationÐ ø Ðunder€this€section:€€Ìà ` à(1)€òòVerificationóó.€€A€covered€entity€must€comply€with€any€applicable€verificationÐ Øp Ðrequirements€under€ðð€164.518(c).€Ìà ` à(2)€òòHealth€care€clearinghousesóó.€€A€health€care€clearinghouse€that€uses€or€disclosesÐ ¸P Ðprotected€health€information€it€maintains€as€a€business€partner€of€a€covered€entity€may€notÏmake€uses€or€disclosures€otherwise€permitted€under€this€section€that€are€not€permitted€byÏthe€terms€of€its€contract€with€the€covered€entity€under€ðð€164.506(e).Ìòòóóà ` àò òó ó(b)€òòDisclosures€and€uses€for€public€health€activitiesóó.€€(1)€òòPermitted€disclosuresóó.€€AÐ x# Ðcovered€entity€may€disclose€protected€health€information€for€the€public€health€activitiesÏand€purposes€described€in€this€paragraph€to:Ìà ` à(i)€€òòóóA€public€health€authority€that€is€authorized€by€law€to€collect€or€receive€suchÐ H&à" Ðinformation€for€the€purpose€of€preventing€or€controlling€disease,€injury,€or€disability,Ïincluding,€but€not€limited€to,€the€reporting€of€disease,€injury,€vital€events€such€as€birth€orÏdeath,€and€the€conduct€of€public€health€surveillance,€public€health€investigations,€andÏpublic€health€interventions;Ìà ` à(ii)€A€public€health€authority€or€other€appropriate€authority€authorized€by€law€toÏreceive€reports€of€child€abuse€or€neglect;Ìà ` à(iii)€A€person€or€entity€other€than€a€governmental€authority€that€ò òó ócan€demonstrateÐ Ø,p&) Ðor€demonstrates€that€it€is€acting€to€comply€with€requirements€or€direction€of€a€publicÐ È-`'* Ðhealth€authority;€orÌà ` à(iv)€A€person€who€may€have€been€exposed€to€a€communicable€disease€or€mayÏotherwise€be€at€risk€of€contracting€or€spreading€a€disease€or€condition€and€is€authorizedÏby€law€to€be€notified€as€necessary€in€the€conduct€of€a€public€health€intervention€orÏinvestigation.Ìà ` à(2)€òòPermitted€useóó.€€Where€the€covered€entity€also€is€a€public€health€authority,€theÐ  ° Ðcovered€entity€is€permitted€to€use€protected€health€information€in€all€cases€in€which€it€isÏpermitted€to€disclose€such€information€for€public€health€activities€under€paragraph€(b)(1)Ïof€this€section.Ìà ` à(c)€òòDisclosures€and€uses€for€health€oversight€activitiesóó.€€(1)€òòPermitted€disclosuresóó.€Ð Øp  ÐA€covered€entity€may€disclose€protected€health€information€to€a€health€oversight€agencyÏfor€oversight€activities€authorized€by€law,€including€audit,€investigation,€inspection,€civil,Ïcriminal,€or€administrative€proceeding€or€action,€or€other€activity€necessary€forÏappropriate€oversight€of:Ìà ` à(i)€The€health€care€system;Ìà ` à(ii)€Government€benefit€programs€for€which€health€information€is€relevant€toÏbeneficiary€eligibility;€or€Ìà ` à(iii)€Government€regulatory€programs€for€which€health€information€is€necessaryÏfor€determining€compliance€with€program€standards.Ìà ` à(2)€òòPermitted€useóó.€€Where€a€covered€entity€is€itself€a€health€oversight€agency,€theÐ 8Ð Ðcovered€entity€may€use€protected€health€information€for€health€oversight€activitiesÏdescribed€by€paragraph€(c)(1)€of€this€section.Ìà ` à(d)òòóó€òòDisclosures€and€uses€for€judicial€and€administrative€proceedingsóó.€€(1)Ð   ÐòòPermitted€disclosuresóó.€€A€covered€entity€may€disclose€protected€health€information€in€theÐ ø Ðcourse€of€any€judicial€or€administrative€proceeding:Ìà ` à(i)€In€response€to€an€order€of€a€court€or€administrative€tribunal;€or€Ìà ` à(ii)€Where€the€individual€is€a€party€to€the€proceeding€and€his€or€her€medicalÏcondition€or€history€is€at€issue€and€the€disclosure€is€pursuant€to€lawful€process€orÏotherwise€authorized€by€law.Ìà ` à(2)€òòPermitted€useóó.€€Where€the€covered€entity€is€itself€a€government€agency,€theÐ ˜!0 Ðcovered€entity€may€use€protected€health€information€in€all€cases€in€which€it€is€permittedÏto€disclose€such€information€in€the€course€of€any€judicial€or€administrative€proceedingÏunder€paragraph€(d)(1)€of€this€section.Ìà ` à(3)€òòAdditional€restrictionóó.€€(i)€Where€the€request€for€disclosure€of€protected€healthÐ X%ð! Ðinformation€is€accompanied€by€a€court€order,€the€covered€entity€may€disclose€only€thatÏprotected€health€information€which€the€court€order€authorizes€to€be€disclosed.Ìà ` à(ii)€Where€the€request€for€disclosure€of€protected€health€information€is€notÏaccompanied€by€a€court€order,€the€covered€entity€may€not€disclose€the€informationÏrequested€unless€a€request€authorized€by€law€has€been€made€by€the€agency€requesting€theÏinformation€or€by€legal€counsel€representing€a€party€to€litigation,€with€a€written€statementÏcertifying€that€the€protected€health€information€requested€concerns€a€litigant€to€theÏproceeding€and€that€the€health€condition€of€such€litigant€is€at€issue€at€such€proceeding.€Ìòòóóà ` à(e)€òòDisclosures€to€coroners€and€medical€examinersóó.€€A€covered€entity€mayÐ È-`'* Ðdisclose€protected€health€information€to€a€coroner€or€medical€examiner,€consistent€withÏapplicable€law,€for€the€purposes€of€identifying€a€deceased€person€or€determining€a€causeÏof€death.ò òó óÐ Hà Ðà ` à(f)€€òòDisclosures€for€law€enforcement€purposesóó.€€A€covered€entity€may€discloseÐ 8 Ð Ðprotected€health€information€to€a€law€enforcement€official€if:ò òó óÐ ( À Ðà ` à(1)€òòPursuant€to€processóó.€(i)€The€law€enforcement€official€is€conducting€orÐ  ° Ðsupervising€a€law€enforcement€inquiry€or€proceeding€authorized€by€law€and€the€disclosureÏis:Ìà ` à(A)€Pursuant€to€a€warrant,€subpoena,€or€order€issued€by€a€judicial€officer€thatÏdocuments€a€finding€by€the€judicial€officer;Ìà ` à(B)€Pursuant€to€aò òó ó€grand€jury€subpoena;€orÐ È`  Ðà ` à(C)€Pursuant€to€an€administrative€request,€including€an€administrative€subpoena€orÏsummons,€a€civil€investigative€demand,€or€similar€process€authorized€under€ò òó ólaw,€òòprovidedÐ ¨@  Ðthatóó:Ð ˜0  Ðà ` à(òò1óó)€The€information€sought€is€relevant€and€material€to€a€legitimate€lawÐ ˆ  Ðenforcement€inquiry;Ìà ` à(òò2óó)€The€request€is€as€specific€and€narrowly€drawn€as€is€reasonably€practicable;€andÐ h Ðà ` à(òò3óó)€De„identified€information€could€not€reasonably€be€used.Ð Xð Ðà ` à(ii)€For€the€purposes€of€this€paragraph,€ð ðlaw€enforcement€inquiry€or€proceedingððÏmeans:Ìà ` à(A)€An€investigation€or€official€proceeding€inquiring€into€a€violation€of,€or€failureÏto€comply€with,€law;€orÌà ` à(B)€A€criminal,€civil,€or€administrative€proceeding€arising€from€a€violation€of,€orÏfailure€to€comply€with,€law.Ìà ` à(2)€òòLimited€information€for€identifying€purposesóó.€€The€disclosure€is€for€theÐ è€ Ðpurpose€of€identifying€a€suspect,€fugitive,€material€witness,€or€missing€person,€òòprovidedÐ Øp Ðthatóó,€the€covered€entity€may€disclose€only€the€following€information:Ð È` Ðà ` à(i)€Name;Ìà ` à(ii)€Address;Ìà ` à(iii)€Social€security€number;Ìà ` à(iv)€Date€of€birth;Ìà ` à(v)€Place€of€birth;Ìà ` à(vi)€Type€of€injury€or€other€distinguishing€characteristic;€andÌà ` à(vii)€Date€and€time€of€treatment.Ìà ` à(3)€òòInformation€about€a€victim€of€crime€or€abuseóó.€€The€disclosure€is€of€theÐ H&à" Ðprotected€health€information€of€an€individual€who€is€or€is€suspected€to€be€a€victim€of€aÏcrime,€abuse,€or€other€harm,€if€the€law€enforcement€official€represents€that:Ìà ` à(i)€Such€information€is€needed€to€determine€whether€a€violation€of€law€by€a€personÏother€than€the€victim€has€occurred;€andÌà ` à(ii)€Immediate€law€enforcement€activity€that€depends€upon€obtaining€suchÏinformation€may€be€necessary.Ìà ` à(4)€òòIntelligence€and€national€security€activitiesóó.€€The€disclosure€is:€Ð Ø,p&) Ðà ` à(i)€For€the€conduct€of€lawful€intelligence€activities€conducted€pursuant€to€theÐ È-`'* ÐNational€Security€Act€(50€U.S.C.€401,€òòet€seq.óó);Ð h Ðà ` à(ii)€Made€in€connection€with€providing€protective€services€to€the€President€orÏother€persons€pursuant€to€18€U.S.C.€3056;€orÌà ` à(iii)€Made€pursuant€to€22€U.S.C.€2709(a)(3).Ìà ` à(5)€òòHealth€care€fraudóó.€€The€covered€entity€believes€in€good€faith€that€theÐ ( À Ðinformation€disclosed€constitutes€evidence€of€criminal€conduct:Ìà ` à(i)€That€arises€out€of€and€is€directly€related€to:Ìà ` à(A)€The€receipt€of€health€care€or€payment€for€health€care,€including€a€fraudulentÏclaim€for€health€care;€Ìà ` à(B)€Qualification€for€or€receipt€of€benefits,€payments,€or€services€based€on€aÏfraudulent€statement€or€material€misrepresentation€of€the€health€of€the€individual;Ìà ` à(ii)€That€occurred€on€the€premises€of€the€covered€entity;€orÌà ` à(iii)€Was€witnessed€by€a€member€of€the€covered€entityððs€workforce.Ìà ` à(5)€òòUrgent€circumstancesóó.€€The€disclosure€is€of€the€protected€health€information€ofÐ ˜0  Ðan€individual€who€is€or€is€suspected€to€be€a€victim€of€a€crime,€abuse,€or€other€harm,€if€theÏlaw€enforcement€official€represents€that:Ìà ` à(i)€Such€information€is€needed€to€determine€whether€a€violation€of€law€by€a€personÏother€than€the€victim€has€occurred;€andÌà ` à(ii)€Immediate€law€enforcement€activity€that€depends€upon€obtaining€suchÏinformation€may€be€necessary.Ìà ` àòòò òó óóó(g)€òòDisclosures€and€uses€for€governmental€health€data€systemsóó.€€(1)€òòPermittedÐ (À Ðdisclosuresóó.€€A€covered€entity€may€disclose€protected€health€information€to€a€governmentÐ ° Ðagency,€or€private€entity€acting€on€behalf€of€a€government€agency,€for€inclusion€in€aÏgovernmental€health€data€system€that€collects€health€data€for€analysis€in€support€ofÏpolicy,€planning,€regulatory,€or€management€functions€authorized€by€law.€Ìà ` à(2)€òòPermitted€usesóó.€€Where€a€covered€entity€is€itself€a€government€agency€thatÐ Øp Ðcollects€health€data€for€analysis€in€support€of€policy,€planning,€regulatory,€or€managementÏfunctions,€the€covered€entity€may€use€protected€health€information€in€all€cases€in€which€itÏis€permitted€to€disclose€such€information€for€government€health€data€systems€underÏparagraph€(g)(1)€of€this€section.Ìà ` à(h)€€òòDisclosures€of€directory€informationóó.€€€(1)€òòIndividuals€with€capacityóó.€€ForÐ ˆ"  Ðindividuals€with€the€capacity€to€make€their€own€health€care€decisions,€a€covered€entityÏthat€is€a€health€care€provider€may€disclose€protected€health€information€for€directoryÏpurposes,€òòprovided€thatóó,€the€individual€has€agreed€to€such€disclosure.Ð X%ð! Ðà ` à(2)€òòIncapacitated€individualsóó.€€For€individuals€who€are€incapacitated,€a€coveredÐ H&à" Ðentity€that€is€a€health€care€provider€may,€at€its€discretion€and€consistent€with€goodÏmedical€practice€and€any€prior€expressions€of€preference€of€which€the€covered€entity€isÏaware,€disclose€protected€health€information€for€directory€purposes.Ìà ` à(3)€òòInformation€to€be€disclosedóó.€€The€information€that€may€be€disclosed€forÐ * #& Ðdirectory€purposes€pursuant€to€paragraphs€(h)(1)€and€(2)€of€this€section,€is€limited€to:Ìà ` à(i)€Name€of€the€individual;Ìà ` à(ii)€Location€of€the€individual€in€the€health€care€providerððs€facility;€andÌà ` à(iii)€Description€of€the€individualððs€condition€in€general€terms€that€do€notÐ È-`'* Ðcommunicate€specific€medical€information€about€the€individual.Ìà ` à(i)€òòDisclosures€for€banking€and€payment€processesóó.€€òòóóA€covered€entity€mayÐ Xð Ðdisclose,€in€connection€with€routine€banking€activities€or€payment€by€debit,€credit,€orÏother€payment€card,€or€other€payment€means,€the€minimum€amount€of€protected€healthÏinformation€necessary€to€complete€a€banking€or€payment€activity€to:Ìà ` à(1)òòóó€òòFinancial€institutionsóó.€€An€entity€engaged€in€the€activities€of€a€financialÐ  ° Ðinstitution€(as€defined€in€section€1101€of€the€Right€to€Financial€Privacy€Act€of€1978);€orÌà ` à(2)€òòEntities€acting€on€behalf€of€financial€institutionsóó.€€An€entity€engaged€inÐ ø  Ðauthorizing,€processing,€clearing,€settling,€billing,€transferring,€reconciling,€or€collectingÏpayments,€for€an€entity€described€in€paragraph€(i)(1)€of€this€section.Ìà ` àòòóóò òó ó(j)€òòUses€and€disclosures€for€research€purposesóó.€òòóó€A€covered€entity€may€use€orÐ È`  Ðdisclose€protected€health€information€for€research,€regardless€of€the€source€of€funding€ofÏthe€research,€òòprovided€that,óó€the€covered€entity€has€obtained€written€documentation€of€theÐ ¨@  Ðfollowing:Ìà ` à(1)€òòWaiver€of€authorizationóó.€€A€waiver,€in€whole€or€in€part,€of€authorization€forÐ ˆ  Ðuse€or€disclosure€of€protected€health€information€that€has€been€approved€by€either:Ìà ` à(i)€€An€Institutional€Review€Board,€established€in€accordance€with€7€CFR€1c.107,Ï10€CFR€745.107,€14€CFR€1230.107,€15€CFR€27.107,€16€CFR€1028.107,€21€CFR€56.107,Ï22€CFR€225.107,€28€CFR€46.107.32€CFR€219.107,€34€CFR€97.107,€38€CFR€16.107,€40ÏCFR€26.107.45€CFR€46.107,€45€CFR€690.107,€or€49€CFR€11.107;€orÌà ` à(ii)€A€privacy€board€that:€Ìà ` à(A)€Has€members€with€varying€backgrounds€and€appropriate€professionalÏcompetency€as€necessary€to€review€the€research€protocol;€Ìà ` à(B)€Includes€at€least€one€member€who€is€not€affiliated€with€the€entity€conductingÏthe€research€or€related€to€a€person€who€is€affiliated€with€such€entity;€and€Ìà ` à(C)€Does€not€have€any€member€participating€in€a€review€of€any€project€in€whichÏthe€member€has€a€conflict€of€interest.Ìà ` à(2)€òòDate€of€approvalóó.€€The€date€of€approval€of€the€waiver,€in€whole€or€in€part,€ofÐ ¸P Ðauthorization€by€an€Institutional€Review€Board€or€privacy€board.Ìà ` à(3)€òòCriteriaóó.€€The€Institutional€Review€Board€or€privacy€board€has€determined€thatÐ ˜!0 Ðthe€waiver,€in€whole€or€in€part,€of€authorization€satisfies€the€following€criteria:Ìà ` à(i)€The€use€or€disclosure€of€protected€health€information€involves€no€more€thanÏminimal€risk€to€the€subjects;Ìà ` à(ii)€The€waiver€will€not€adversely€affect€the€rights€and€welfare€of€the€subjects;Ìà ` à(iii)€The€research€could€not€practicably€be€conducted€without€the€waiver;Ìà ` à(iv)€Whenever€appropriate,€the€subjects€will€be€provided€with€additional€pertinentÏinformation€after€participation;Ìà ` à(v)€The€research€could€not€practicably€be€conducted€without€access€to€and€use€ofÏthe€protected€health€information;Ìà ` à(vi)€The€research€is€of€sufficient€importance€ò òó óso€as€to€outweigh€the€intrusion€of€theÐ ø*$' Ðprivacy€of€the€individual€whose€information€is€subject€to€the€disclosure;Ìà ` à(vii)€There€is€an€adequate€plan€to€protect€the€identifiers€from€improper€use€andÏdisclosure;€andÐ È-`'* Ðà ` à(viii)€There€is€an€adequate€plan€to€destroy€the€identifiers€at€the€earliest€opportunityÏconsistent€with€conduct€of€the€research,€unless€there€is€a€health€or€research€justificationÏfor€retaining€the€identifiers.Ìà ` à(4)€òòRequired€signature.óó€The€written€documentation€must€be€signed€by€the€chair€of,Ð 8 Ð Ðas€applicable,€the€Institutional€Review€Board€or€the€privacy€board.Ìà ` à(k)€òòUses€and€disclosures€in€emergency€circumstancesóó.€òòóóññÔ†ÿÿÔññÔ‡"XÆXXXÔ€(1)€òòPermitted€disclosuresóó.€Ð  ° ÐA€covered€entity€may,€consistent€with€applicable€law€and€standards€of€ethical€conduct€andÏbased€on€a€reasonable€belief€that€the€use€or€disclosure€is€necessary€to€prevent€or€lessen€aÏserious€and€imminent€threat€to€the€health€or€safety€of€an€individual€or€the€public,€use€orÏdisclose€protected€health€informationÔ#†XN…XX"XÆœ$#ÔññÔ‡ÿÿuested€useÔññññÔ†ÿÿÔññÔ‡"XÆXXXN…Ô€to€a€person€or€persons€reasonably€able€to€prevent€orÐ Üt  Ðlessen€the€threat,€including€the€target€of€the€threatÔ#†XN…XX"XÆ“&#ÔññÔ‡ÿÿnably€be€uÔññññÔ†ÿÿÔññÔ‡"XÆXXXN…Ô.€€Ð È`  Ðà ` à(2)€òòPresumption€of€reasonable€beliefóó.€€A€covered€entity€that€makes€a€disclosureÐ ´L  Ðpursuant€to€paragraph€(k)(1)€of€this€section€is€presumed€to€have€acted€under€a€reasonableÏbelief,€if€the€disclosure€is€made€in€good€faith€based€upon€a€credible€representation€by€aÏperson€with€apparent€knowledge€or€authority€(such€as€a€doctor€or€law€enforcement€orÏother€government€official).ò òó óÐ dü  Ðà ` àÔ#†XN…XX"XÆœ'#ÔññÔ‡ÿÿ` à(iiiÔññòòóó(l)€òòDisclosures€to€next„of„kinóó.€€òòò òó óóó(1)€òòPermitted€disclosuresóó.€€A€covered€entity€mayÐ Pè Ðdisclose€protected€health€information€ò òó óto€a€person€who€is€a€next„of„kin,€other€familyÐ @Ø Ðmember,€or€close€personal€friend€of€an€individual€who€possesses€the€capacity€to€make€hisÏor€her€own€health€care€decisions,€if:Ìà ` à€(i)€The€individual€has€verbally€agreed€to€the€disclosure;€orÌà ` à(ii)€In€circumstances€where€such€agreement€cannot€practicably€or€reasonably€beÏobtained,€only€the€protected€health€information€that€is€directly€relevant€to€the€personððsÏinvolvement€in€the€individualððs€health€care€is€disclosed,€consistent€with€good€healthÏprofessional€practices€and€ethics.Ìà ` à(2)€òòNext„of„kin€definedóó.€€For€purposes€of€this€paragraph,€ð ðnext„of„kinðð€is€definedÐ ÀX Ðas€defined€under€applicable€law.òòóóÐ °H Ðà ` à(m)€€òòUses€and€disclosures€for€specialized€classes.óó€€(1)€òòMilitary€purposesóó.€€€AÐ  8 Ðcovered€entity€that€is€a€health€care€provider€or€health€plan€providing€health€care€toÏindividuals€who€are€Armed€Forces€personnel€may€use€and€disclose€protected€healthÏinformation€for€activities€deemed€necessary€by€appropriate€military€command€authoritiesÏto€assure€the€proper€execution€of€the€military€mission,€where€the€appropriate€militaryÏauthority€has€published€by€notice€in€the€òòFederal€Registeróó€the€following€information:Ð P$è  Ðà ` à(i)€Appropriate€military€command€authorities;Ìà ` à(ii)€The€circumstances€for€which€use€or€disclosure€without€individualÏauthorization€would€be€required;€andÌà ` à(iii)€Activities€for€which€such€use€or€disclosure€would€occur€in€order€to€assureÏproper€execution€of€the€military€mission.Ìà ` à(2)€òòDepartment€of€Veterans€Affairsóó.€€The€Department€of€Veterans€Affairs€may€useÐ ð)ˆ#& Ðand€disclose€protected€health€information€among€components€of€the€Department€thatÏdetermine€eligibility€for€or€entitlement€to,€or€that€provide,€benefits€under€lawsÏadministered€by€the€Secretary€of€Veterans€Affairs.Ìà ` à(3)€òòIntelligence€communityóó.€€A€covered€entity€may€disclose€protected€healthÐ °-H'* Ðinformation€of€an€individual€who€is€an€employee€of€the€intelligence€community,€asÏdefined€in€Section€4€of€the€National€Security€Act,€50€U.S.C.€€401a,€and€his€or€herÏdependents,€if€such€dependents€are€being€considered€for€posting€abroad,€to€intelligenceÏcommunity€agencies,€where€authorized€by€law.Ìà ` à(4)€òòDepartment€of€Stateóó.€€The€Department€of€State€may€use€protected€healthÐ ( À Ðinformation€about€the€following€individuals€for€the€following€purposes:Ìà ` à(i)€As€to€applicants€to€the€Foreign€Service,€for€medical€clearance€determinationsÏabout€physical€fitness€to€serve€in€the€Foreign€Service€on€a€worldwide€basis,€includingÏabout€medical€and€mental€conditions€limiting€assignability€abroad;€determinations€ofÏconformance€to€occupational€physical€standards,€where€applicable;€and€determinations€ofÏsuitability.Ìà ` à(ii)€As€to€members€of€the€Foreign€Service€and€other€United€States€GovernmentÏemployees€assigned€to€serve€abroad€under€Chief€of€Mission€authority,€for€medicalÏclearance€determinations€for€assignment€to€posts€abroad,€including€medical€and€mentalÏconditions€limiting€such€assignment;€determinations€of€conformance€to€occupationalÏphysical€standards,€where€applicable;€determinations€about€continued€fitness€for€duty,Ïsuitability,€€and€continuation€of€service€at€post€(including€decisions€on€curtailment);Ïseparation€medical€examinations;€and€determinations€of€eligibility€of€members€of€theÏForeign€Service€for€disability€retirement€(whether€on€application€of€the€employee€or€theÏSecretary€of€State).Ìà ` à(iii)€As€to€eligible€family€members€of€Foreign€Service€or€other€United€StatesÏGovernment€employees,€for€medical€clearance€determinations€as€described€in€paragraphÏ(m)(4)(ii)€of€this€section€to€permit€eligible€family€members€to€accompany€employees€toÏposts€abroad€on€Government€orders;€determinations€regarding€family€members€remainingÏat€post;€and€separation€medical€examinations.Ìà ` à(n)€€òòUses€and€disclosures€otherwise€required€by€lawóó.€€A€covered€entity€may€use€orÐ Øp Ðdisclose€protected€health€information€where€such€use€or€disclosure€is€required€by€law€andÏthe€use€or€disclosure€meets€all€relevant€requirements€of€such€law.€€This€paragraph€doesÏnot€apply€to€uses€or€disclosures€that€are€covered€by€paragraphs€(b)€through€(m)€of€thisÏsection.Ìðð€164.512à0 ¸ àòòNotice€to€individuals€of€information€practicesóó.Ј" ¸ (#¸ (# Ðà ` à(a)€òòStandardóó.€€An€individual€has€a€right€to€adequate€notice€of€the€policies€andÐ x# Ðprocedures€of€a€covered€entity€that€is€a€health€plan€or€a€health€care€provider€with€respectÏto€protected€health€information.Ìà ` à(b)€òòStandard€for€notice€proceduresóó.€A€covered€entity€that€is€a€health€plan€or€healthÐ H&à" Ðcare€provider€must€have€procedures€that€provide€adequate€notice€to€individuals€of€theirÏrights€and€the€procedures€for€exercising€their€rights€under€this€subpart€with€respect€toÏprotected€health€information€about€themòòóó.Ð )°"% Ðà ` à(c)€òòGeneral€implementation€specificationóó.€€A€covered€entity€that€has€and€followsÐ * #& Ðprocedures€that€meet€the€requirements€of€this€section€will€be€presumed€to€have€providedÏadequate€notice€under€this€section.òòÐ è+€%( Ðóóà ` à(d)€òòImplementation€specifications:€content€of€noticeóó.€€(1)€òòRequired€elementsóó.€Ð Ø,p&) ÐNotices€required€to€be€provided€under€this€section€must€include€in€plain€language€aÐ È-`'* Ðstatement€of€each€of€the€following€elements:Ìà ` à(i)€òòUses€and€disclosuresóó.€The€uses€and€disclosures,€and€the€entityððs€policies€andÐ Xð Ðprocedures€with€respect€to€such€uses€and€disclosures,€must€be€described€€in€sufficientÏdetail€to€put€the€individual€on€notice€of€the€uses€and€disclosures€expected€to€be€made€ofÏhis€or€her€protected€health€information.€€Such€statement€must:Ìà ` à(A)€Describe€the€uses€and€disclosures€that€will€be€made€without€individualÏauthorization;€and€Ìà ` à(B)€Distinguish€between€those€uses€and€disclosures€the€entity€makes€that€areÏrequired€by€law€and€those€that€are€permitted€but€not€required€by€law.€Ìà ` à(ii)€òòRequired€statementsóó.€€State€that:Ð Øp  Ðà ` à(A)€Other€uses€and€disclosures€will€be€made€only€with€the€individualððsÏauthorization€and€that€such€authorization€may€be€revoked;Ìà ` à(B)òòóó€An€individual€may€request€that€certain€uses€and€disclosures€of€his€or€herÐ ¨@  Ðprotected€health€information€be€restricted,€and€the€covered€entity€is€not€required€to€agreeÏto€such€a€request;Ìà ` à(C)òòóóò òó ó€An€individual€has€the€right€to€request,€and€a€description€of€the€procedures€forÐ x Ðexercising,€the€following€with€respect€to€his€or€her€protected€health€information:Ìà ` à(òò1óó)€Inspection€and€copying;Ð Xð Ðà ` à(òò2óó)€Amendment€or€correction;€and€Ð Hà Ðà ` à(òò3óó)€An€accounting€of€the€disclosures€of€such€information€by€the€covered€entity;€Ð 8Ð Ðà ` à(D)€òòóóThe€covered€entity€is€required€by€law€to€protect€the€privacy€of€its€individuallyÐ (À Ðidentifiable€health€information,€provide€a€notice€of€its€policies€and€procedures€withÏrespect€to€such€information,€and€abide€by€the€terms€of€the€notice€currently€in€effect;€Ìà ` à(E)òòóó€The€entity€may€change€its€policies€and€procedures€relating€to€protected€healthÐ ø Ðinformation€at€any€time,€with€a€description€of€how€individuals€will€be€informed€ofÏmaterial€changes;€andÌà ` à(F)òòóó€Individuals€may€complain€to€the€covered€entity€and€to€the€Secretary€if€theyÐ È` Ðbelieve€that€their€privacy€rights€have€been€violated.Ìà ` à(iii)€òòContactóó.€€The€name€and€telephone€number€of€a€contact€person€or€officeÐ ¨ @ Ðrequired€by€ðð€164.518(a)(2).Ìà ` à(iv)€òòDateóó.€€The€date€the€version€of€the€notice€was€produced.Ð ˆ"  Ðà ` à(2)€òòRevisionsóó.€€A€covered€health€plan€or€health€care€provider€may€change€itsÐ x# Ðpolicies€or€procedures€required€by€this€subpart€at€any€time.€€When€a€covered€health€planÏor€health€care€provider€materially€revises€its€policies€and€procedures,€it€must€update€itsÏnotice€as€provided€for€by€ðð€164.520(g).€Ìà ` à(e)€òòImplementation€specifications:€provision€of€noticeóó.€€A€covered€entity€mustÐ 8'Ð # Ðmake€the€notice€required€by€this€section€available:Ìà ` à(1)€òòGeneral€requirementóó.€€On€request;€andÐ )°"% Ðà ` à(2)€òòSpecific€requirementsóó.€€As€follows:Ð * #& Ðà ` à(i)€òòHealth€plansóó.€€Health€plans€must€provide€a€copy€of€the€notice€to€an€individualÐ ø*$' Ðcovered€by€the€plan:Ìà ` à(A)€As€of€the€date€on€which€the€health€plan€is€required€to€be€in€compliance€withÏthis€subpart;Ð È-`'* Ðà ` à(B)€After€the€date€described€in€paragraph€(e)(2)(i)(A)€of€this€section,€atÏenrollment;€Ìà ` à(C)€After€enrollment,€within€60€days€of€a€material€revision€to€the€content€of€theÏnotice;€and€Ìà ` à(D)€No€less€frequently€than€once€every€three€years.€€Ìà ` à(ii)€òòHealth€care€providersóó.€€A€health€care€provider€must:Ð  ° Ðà ` à(A)€During€the€one€year€period€following€the€date€by€which€the€provider€isÏrequired€to€come€into€compliance€with€this€subpart,€provide€a€copy€to€individualsÏcurrently€served€by€the€provider€at€the€first€service€delivery€to€such€individuals€duringÏsuch€period,€òòprovided€thatóó,€where€service€is€not€provided€through€a€face„to„face€contact,Ð Øp  Ðthe€provider€must€provide€the€notice€in€an€appropriate€manner€within€a€reasonable€periodÏof€time€following€first€service€delivery;Ìà ` àòòóó(B)€After€the€one€year€period€provided€for€by€paragraph€(e)(2)(ii)(A)€of€thisÐ ¨@  Ðsection,€provide€a€copy€to€individuals€served€by€the€provider€at€the€first€service€deliveryÏto€such€individuals,€òòprovided€thatóó,€where€service€is€not€provided€through€a€face„to„faceÐ ˆ  Ðcontact,€the€provider€must€provide€the€notice€in€an€appropriate€manner€within€aÏreasonable€period€of€time€following€first€service€delivery;€and€€Ìà ` à(C)€ò òó óPost€a€copy€of€the€notice€in€a€clear€and€prominent€location€where€it€isÐ Xð Ðreasonable€to€expect€individuals€seeking€service€from€the€provider€to€be€able€to€read€theÏnotice.€€Any€revision€to€the€notice€must€be€posted€promptly.Ìòòóóðð€164.514à0 ¸ àòòAccess€of€individuals€to€protected€health€informationóóÐ(À¸ (#¸ (# Ðà ` à(a)€òòStandard:€right€of€accessóó.€€An€individual€has€a€right€of€access€to,€whichÐ ° Ðincludes€a€right€to€inspect€and€obtain€a€copy€of,€his€or€her€protected€health€information€inÏdesignated€record€sets€of€a€covered€entity€that€is€a€health€plan€or€a€health€care€provider,Ïincluding€such€information€in€a€business€partnerððs€designated€record€set€that€is€not€aÏduplicate€of€the€information€held€by€the€provider€or€plan,€for€so€long€as€the€information€isÏmaintained.à ¸ àÐ È` Ðà ` à(b)€òòStandard:€denial€of€access€to€protected€health€informationóó.€€(1)€òòGroundsóó.€Ð ¸P ÐExcept€where€the€protected€health€information€to€which€access€is€requested€is€subject€to€5ÏU.S.C.€552a,€a€covered€entity€may€deny€a€request€for€access€under€paragraph€(a)€of€thisÏsection€where:Ìà ` à(i)€A€licensed€health€care€professional€has€determined€that,€in€the€exercise€ofÏreasonable€professional€judgment,€the€inspection€and€copying€requested€is€reasonablyÏlikely€to€endanger€the€life€or€physical€safety€of€the€individual€or€another€person;Ìà ` à(ii)€The€information€is€about€another€person€(other€than€a€health€care€provider)Ïand€a€licensed€€health€care€professional€has€determined€that€the€inspection€and€copyingÏrequested€is€reasonably€likely€to€cause€substantial€harm€to€such€other€person;Ìà ` à(iii)€The€information€was€obtained€under€a€promise€of€confidentiality€fromÏsomeone€other€than€a€health€care€provider€and€such€access€would€be€likely€to€reveal€theÏsource€of€the€information;Ìà ` à(iv)€The€information€was€obtained€by€a€covered€entity€that€is€a€health€careÏprovider€in€the€course€of€a€clinical€trial,€the€individual€has€agreed€to€the€denial€of€accessÏwhen€consenting€to€participate€in€the€trial€(if€the€individualððs€consent€to€participate€wasÐ È-`'* Ðobtained),€and€the€clinical€trial€is€in€progress;€orÌà ` à(v)€The€information€was€compiled€in€reasonable€anticipation€of,€or€for€use€in,€aÏlegal€proceeding.Ìà ` à(2)€òòOther€information€availableóó.€Where€a€denial€of€protected€health€information€isÐ 8 Ð Ðmade€pursuant€to€paragraph€(b)(1)€of€this€section,€the€covered€entity€must€make€any€otherÏprotected€health€information€requested€available€to€the€individual€to€the€extent€possibleÏconsistent€with€the€denial.Ìà ` à(c)€òòStandard:€procedures€to€protect€rights€of€accessóó.€€A€covered€entity€that€is€aÐ ø  Ðhealth€plan€or€a€health€care€provider€must€have€procedures€that€enable€individuals€toÏexercise€their€rights€under€paragraph€(a)€of€this€section.€Ìà ` à(d)€òòImplementation€specifications:€access€to€protected€health€informationóó.€€TheÐ È`  Ðprocedures€required€by€paragraph€(c)€of€this€section€must:Ìà ` à(1)€òòMeans€of€requestóó.€€Provide€a€means€by€which€an€individual€can€requestÐ ¨@  Ðinspection€or€a€copy€of€protected€health€information€about€him€or€her.Ìà ` à(2)òòóó€òòTime€limitóó.€€Provide€for€taking€action€on€such€requests€as€soon€as€possible€butÐ ˆ  Ðnot€later€than€30€days€following€receipt€of€the€request.Ìà ` à(3)òòóó€òòRequest€acceptedóó.€€Where€the€request€is€accepted,€provide:Ð h Ðà ` à(i)€For€notification€of€the€individual€of€the€decision€and€of€any€steps€necessary€toÏfulfill€the€request;€Ìà ` à(ii)€The€information€requested€in€the€form€or€format€requested,€if€it€is€readilyÏproducible€in€such€form€or€format;€Ìà ` à(iii)€For€facilitating€the€process€of€inspection€and€copying;€andÌà ` à(iv)€òòóóFor€a€reasonable,€cost„based€fee€for€copying€health€information€providedÐ   Ðpursuant€to€this€paragraph,€if€deemed€desirable€by€the€entity.Ìà ` à(4)òòóó€òòRequest€deniedóó.€Where€the€request€is€denied€in€whole€or€in€part,€provide€theÐ è€ Ðindividual€with€a€written€statement€in€plain€language€of:Ìà ` à(i)€The€basis€for€the€denial;€andÌà ` à(ii)€A€description€of€how€the€individual€may€complain€to€the€covered€entityÏpursuant€to€the€complaint€procedures€established€in€ðð€164.518(d)(2)€or€to€the€SecretaryÏpursuant€to€the€procedures€established€in€ðð€164.522(b).€€The€description€must€include:€Ìà ` à(A)€€The€name€and€telephone€number€of€the€contact€person€or€office€required€by€ððÏ164.518(a)(2);€andÌà ` à(B)€Information€relevant€to€filing€a€complaint€with€the€Secretary€under€ððÏ164.522(b).Ìðð164.515€òòAccounting€for€disclosures€of€protected€health€informationóó.Ð H&à" Ðà ` à(a)€€òòStandard:€right€to€an€accounting€of€disclosures€of€protected€healthÐ 8'Ð # Ðinformationóó.€€An€individual€has€a€right€to€receive€an€accounting€of€all€disclosures€ofÐ ((À!$ Ðprotected€health€information€made€by€a€covered€entity€as€long€as€such€information€isÏmaintained€by€the€entity,€except€for€disclosures:€Ìà ` à(1)€For€treatment,€payment€and€health€care€operations;€and€Ìà ` à(2)€To€health€oversight€or€law€enforcement€agencies,€if€the€health€oversight€or€lawÏenforcement€agency€has€provided€a€written€request€stating€that€the€exclusion€is€necessaryÏbecause€disclosure€would€be€reasonably€likely€to€impede€the€agencyððs€activities€andÐ È-`'* Ðspecifying€the€time€for€which€such€exclusion€is€required.Ìà ` à(b)€òòStandard:€procedures€for€accountingóó.€€A€covered€entity€must€have€proceduresÐ Xð Ðto€give€individuals€an€accurate€accounting€of€disclosures€for€which€an€accounting€isÏrequired€by€paragraph€(a)€of€this€section.òòóóÐ 8 Ð Ðà ` à(c)€€òòImplementation€specifications:€accounting€proceduresóó.€€The€proceduresÐ ( À Ðrequired€by€paragraph€(b)€of€this€section€must:Ìà ` à(1)€€Provide€for€an€accounting€of€the€following:€Ìà ` à(i)€The€date€of€each€disclosure;Ìà ` à(ii)€The€name€and€address€of€the€organization€or€person€who€received€theÏprotected€health€information;€Ìà ` à(iii)€A€brief€description€of€the€information€disclosed;Ìà ` à(iv)€For€disclosures€other€than€those€made€at€the€request€of€the€individual,€theÏpurpose€for€which€the€information€was€disclosed;€and€Ìà ` à(v)€Provision€of€copies€of€all€requests€for€disclosure.Ìà ` à(2)€Provide€the€accounting€to€the€individual€as€soon€as€possible,€but€no€later€thanÏ30€days€of€receipt€of€the€request€therefor.Ìà ` à(3)€€Provide€for€a€means€of€accounting€for€as€long€as€the€entity€maintains€theÏprotected€health€information.Ìà ` à(4)€€Provide€for€a€means€of€requiring€business€partners€to€provide€such€anÏaccounting€upon€request€of€the€covered€entity.Ìðð€164.516à0 ¸ àòòAmendment€and€correctionóó.Ð(À¸ (#¸ (# Ðà ` à(a)€òòStandard:€right€to€request€amendment€or€correctionóó.€€(1)€òòRight€to€requestóó.€€AnÐ ° Ðindividual€has€the€right€to€request€a€covered€entity€that€is€a€health€plan€or€health€careÏprovider€to€amend€or€correct€protected€health€information€about€him€or€her€in€designatedÏrecord€sets€of€the€covered€entity€for€as€long€as€the€covered€entity€maintains€theÏinformation.Ìà ` à(2)€òòGrounds€for€denial€of€requestóó.€€A€covered€entity€may€deny€a€request€forÐ È` Ðamendment€or€correction€of€the€individualððs€protected€health€information,€if€it€determinesÏthat€the€information€that€is€the€subject€of€the€request:Ìà ` à(i)€Was€not€created€by€the€covered€entity;Ìà ` à(ii)€Would€not€be€available€for€inspection€and€copying€under€ðð€164.514;€orÌà ` à(iii)€Is€accurate€and€complete.Ìà ` à(b)€òòStandard:€amendment€and€correction€proceduresóó.€A€covered€entity€that€is€aÐ h$  Ðhealth€plan€or€health€care€provider€must€have€procedures€to€enable€individuals€to€requestÏamendment€or€correction,€to€determine€whether€the€requests€should€be€granted€or€denied,€Ïand€to€disseminate€amendments€or€corrections€to€its€business€partners€and€others€to€whomÏerroneous€information€has€been€disclosed.€Ìà ` à(c)€òòImplementation€specifications:€proceduresóó.€€The€procedures€required€byÐ )°"% Ðparagraph€(b)€of€this€section€must€provide€that€the€covered€entity€will:Ìà ` à(1)€òòMeans€of€requestóó.€€Provide€a€means€by€which€an€individual€can€requestÐ ø*$' Ðamendment€or€correction€of€his€or€her€protected€health€information.Ìà ` à(2)€òòTime€limitóó.€€Take€action€on€such€request€within€60€days€of€receipt€of€theÐ Ø,p&) Ðrequest;Ð È-`'* Ðà ` à(3)€òòRequest€acceptedóó.€€Where€the€request€is€accepted€in€whole€or€in€part:Ð h Ðà ` à(i)€As€otherwise€required€by€this€part,€make€the€appropriate€amendments€orÏcorrections;Ìà ` à(ii)€As€otherwise€required€by€this€part,€identify€the€challenged€entries€as€amendedÏor€corrected€and€indicate€their€location;Ìà ` à(iii)€Make€reasonable€efforts€to€notify:Ìà ` à(A)€Persons,€organizations,€or€other€entities€the€individual€identifies€as€needing€toÏbe€notified;€andÌà ` à(B)€Persons,€organizations,€or€other€entities,€including€business€partners,€who€theÏcovered€entity€knows€have€received€the€erroneous€or€incomplete€information€and€whoÏmay€have€relied,€or€could€foreseeably€rely,€on€such€information€to€the€detriment€of€theÏindividual;€andÌà ` à(iv)€Notify€the€individual€of€the€decision€to€correct€or€amend€the€information.Ìà ` à(4)€òòRequest€deniedóó.€òòóó€Where€the€request€is€denied€in€whole€or€in€part:Ð ˜0  Ðà ` à(i)€Provide€the€individual€with€a€written€statement€in€plain€language€of:Ìà ` à(A)€The€basis€for€the€denial;Ìà ` à(B)€A€description€of€how€the€individual€may€file€a€written€statement€ofÏdisagreement€with€the€denial;€andÌà ` à(C)€A€description€of€how€the€individual€may€complain€to€the€covered€entityÏpursuant€to€the€complaint€procedures€established€in€ðð€164.518(d)€or€to€the€SecretaryÏpursuant€to€the€procedures€established€in€ðð€164.522(b).€€The€description€must€include:€Ìà ` à(òò1óó)€€The€name€and€telephone€number€of€the€contact€person€or€office€required€by€ððÐ ° Ð164.518(a)(2);€andÌà ` à(òò2óó)€Information€relevant€to€filing€a€complaint€with€the€Secretary€under€ððÐ ø Ð164.522(b).Ìà ` à(ii)òòóó€The€procedures€of€the€covered€entity€must:Ð Øp Ðà ` à(A)€€Permit€the€individual€to€file€a€statement€of€the€individualððs€disagreement€withÏthe€denial€and€the€basis€of€such€disagreement.Ìà ` à(B)€Provide€for€inclusion€of€the€covered€entityððs€statement€of€denial€and€theÏindividualððs€statement€of€disagreement€with€any€subsequent€disclosure€of€the€informationÏto€which€the€disagreement€relates,€òòprovided,€however,€thatóó€the€covered€entity€mayÐ ˆ"  Ðestablish€a€limit€to€the€length€of€the€statement€of€disagreement,€and€may€summarize€theÏstatement€of€disagreement€if€necessary.Ìà ` à(C)€Permit€the€covered€entity€to€provide€a€rebuttal€to€the€statement€ofÏdisagreement€in€subsequent€disclosures€under€paragraph€(c)(4)(ii)(B)€of€this€section.Ìà ` à(d)€òòStandard:€effectuating€a€notice€of€amendment€or€correctionóó.€€Any€coveredÐ 8'Ð # Ðentity€that€receives€a€notice€of€amendment€or€correction€must€have€procedures€in€place€toÏmake€the€amendment€or€correction€in€any€of€its€designated€record€sets€and€to€notify€itsÏbusiness€partners,€as€appropriate,€of€necessary€amendments€or€corrections€of€protectedÏhealth€information.Ìà ` à(e)€òòImplementation€specification:€effectuating€a€notice€of€amendment€orÐ è+€%( Ðcorrectionóó.€€The€procedures€required€by€paragraph€(d)€of€this€section€must€specify€tòòóóheÐ Ø,p&) Ðprocess€for€correction€or€amendment€of€information€in€all€appropriate€designated€recordÐ È-`'* Ðsets€maintained€by€the€covered€entity€and€its€business€partnersòòóó.Ð h Ððð€164.518à0 ¸ àòòAdministrative€requirementsóó.ÐXð¸ (#¸ (# Ðà ` àExcept€as€otherwise€provided,€a€covered€entity€must€meet€the€requirements€of€thisÏsection.Ìà ` à(a)€òòDesignated€privacy€official:€standardóó.€(1)€òòResponsibilities€of€designatedÐ ( À Ðprivacy€officialóó.€€A€covered€entity€must€designate€a€privacy€official€who€is€responsible€forÐ  ° Ðthe€development€and€implementation€of€the€privacy€policies€and€procedures€of€the€entity.Ìà ` à(2)€òòContact€person€or€officeóó.€€A€covered€entity€must€designate€a€contact€person€orÐ ø  Ðoffice€who€is€responsible€for€receiving€complaints€under€this€section€and€who€is€able€toÏprovide€further€information€about€matters€covered€by€the€notice€required€by€ðð€164.512.€€IfÏa€covered€entity€designates€a€contact€person,€it€may€designate€the€privacy€official€as€theÏcontact€person.Ìà ` à(b)€òòTrainingóó.€€(1)€òòStandardóó.€€All€members€of€the€covered€entityððs€workforce€who,Ð ¨@  Ðby€virtue€of€their€positions,€are€likely€to€obtain€access€to€protected€health€informationÏmust€receive€training€on€the€entityððs€policies€and€procedures€required€by€this€subpart€thatÏare€relevant€to€carrying€out€their€function€within€the€entity.Ìà ` à(2)€òòImplementation€specificationóó.€€A€covered€entity€must€train€all€members€of€itsÐ h Ðworkforce€who,€by€virtue€of€their€positions,€are€likely€to€obtain€access€to€protected€healthÏinformation.€€Such€training€must€meet€the€following€requirements:€€Ìà ` à(i)€The€training€must€occur:Ìà ` à(A)€For€members€of€the€covered€entityððs€workforce€as€of€the€date€on€which€thisÏsubpart€becomes€applicable€to€such€entity,€by€such€date;€andÌà ` à(B)€For€persons€joining€the€covered€entityððs€workforce€after€the€date€in€paragraphÏ(b)(2)(i)(A)€of€this€section,€within€a€reasonable€period€after€the€person€joins€theÏworkforce.€Ìà ` à(ii)€The€covered€entity€must€require€members€of€its€workforce€trained€as€requiredÏby€this€section€to€sign,€upon€completing€training,€a€certification.€€The€certification€mustÏstate:Ìà ` à(A)€The€date€of€training;€andÌà ` à(B)€That€the€person€completing€the€training€will€honor€all€of€the€entityððs€policiesÏand€procedures€required€by€this€subpart.Ìà ` à(iii)€The€covered€entity€must€require€members€of€its€workforce€trained€as€requiredÏby€this€section€to€sign,€at€least€once€every€three€years,€a€statement€certifying€that€theÏperson€will€honor€all€of€the€entityððs€policies€and€procedures€required€by€this€subpart.Ìà ` à(iv)€The€covered€entity€must€provide€all€members€of€its€workforce€with€access€toÏprotected€health€information€within€the€entity€with€further€training,€as€relevant€to€theirÏfunction€within€the€entity,€whenever€the€entity€materially€changes€its€privacy€policies€orÏprocedures.Ìà ` à(c)€òòSafeguardsóó.€(1)€òòStandardóó.€€A€covered€entity€must€have€in€place€appropriateÐ * #& Ðadministrative,€technical,€and€physical€safeguards€to€protect€the€privacy€of€protectedÏhealth€information.Ìà ` à(2)€òòImplementation€specification:€verification€proceduresóó.€€A€covered€entity€mustÐ Ø,p&) Ðhave€administrative,€technical,€and€physical€procedures€in€place€to€protect€the€privacy€ofÐ È-`'* Ðprotected€health€information.€€Such€procedures€must€include€adequate€procedures€forÏverification€of€the€identity€and/or€authority,€as€required€by€this€subpart,€of€personsÏrequesting€such€information,€where€such€identity€or€authority€is€not€known€to€the€entity,Ïas€follows:Ìà ` à(i)òòóó€The€covered€entity€must€use€procedures€that€are€reasonably€likely€to€establishÐ ( À Ðthat€the€individual€or€person€making€the€request€has€the€appropriate€identity€for€the€use€orÏdisclosure€requested,€except€for€uses€and€disclosures€that€are:Ìà ` à(A)€Permitted€by€this€subpart€and€made€on€a€routine€basis€to€persons€or€otherÏentities€with€which€the€covered€entity€interacts€in€the€normal€course€of€business€orÏotherwise€known€to€the€covered€entity;€orÌà ` à(B)€Covered€by€paragraphs€(c)(2)(ii),€(iii),€or€(iv)€of€this€section.Ìà ` à(ii)òòóó€When€the€request€for€information€is€made€by€a€government€agency€under€ððÐ ¸P  Ð164.510€(b),€ðð€164.510(c),€ðð€164.510(e),€ðð€164.510(f),€ðð€164.510(g),€ðð€164.510(m),€ððÏ164.510(n),€or€ðð€164.522,€and€the€identity€and/or€authority€are€not€known€to€the€coveredÏentity,€the€covered€entity€may€not€disclose€such€information€without€reasonable€evidenceÏof€identity€and/or€authority€to€obtain€the€information.òòóóÐ x Ðà ` à(A)€For€purposes€of€this€paragraph,€ð ðreasonable€evidence€of€identityðð€means:Ìà ` à(òò1óó)€€A€written€request€on€the€agencyððs€letterhead;Ð Xð Ðà ` à(òò2óó)€Presentation€of€an€agency€identification€badge€or€official€credentials;€orÐ Hà Ðà ` à(òò3óó)€Similar€proof€of€government€status.Ð 8Ð Ðà ` à(B)€For€purposes€of€this€paragraph,€ð ðreasonable€evidence€of€authorityðð€means:Ìà ` à(òò1óó)€A€written€statement€of€the€legal€authority€under€which€the€information€isÐ ° Ðrequested;€a€request€for€disclosure€made€by€official€legal€process€issued€by€a€grand€jury€orÏa€judicial€or€administrative€body€is€presumed€to€constitute€reasonable€legal€authority;€or€€Ìà ` à(òò2óó)€Where€the€request€is€made€orally,€an€oral€statement€of€such€authority.Ð è€ Ðà ` à(iii)€When€the€request€for€information€is€made€by€a€person€or€entity€acting€onÏbehalf€of€a€government€agency€under€ðð€164.510(b),€ðð€164.510(c),€ðð€164.510(g),€or€ððÏ164.510(n),€and€the€identity€and/or€authority€are€not€known€to€the€covered€entity,€theÏcovered€entity€may€not€disclose€such€information€without€reasonable€evidence€of€identityÏand/or€authority€to€obtain€the€information.€Ìà ` à(A)€For€the€purposes€of€this€paragraph,€ð ðreasonable€evidence€of€identityðð€means:Ìà ` à(òò1óó)€€A€written€statement€from€the€government€agency,€on€the€agencyððs€letterhead,Ð x# Ðthat€the€person€or€entity€is€acting€under€the€agencyððs€authority;€orÌà ` à(òò2óó)€Other€evidence€or€documentation,€such€as€a€contract€for€services,Ð X%ð! Ðmemorandum€of€understanding,€or€purchase€order,€that€establishes€that€the€person€orÏentity€is€acting€on€behalf€of€or€under€the€agencyððs€authority.Ìà ` à(B)€For€the€purposes€of€this€paragraph,€ð ðreasonable€evidence€of€authorityðð€meansÏa€statement€that€complies€with€paragraph€(c)(ii)(B)€of€this€sectionòòóó.Ð )°"% Ðà ` à(iv)€For€uses€and€disclosures€under€ðð€164.510(d),€ðð€164.510(h),€or€ðð€164.510(j),Ïcompliance€with€the€applicable€requirements€of€those€sections€constitutes€adequateÏverification€under€this€section.Ìà ` à(v)€òòóó(A)€€A€covered€entity€may€reasonably€rely€on€evidence€of€identity€and€legalÐ Ø,p&) Ðauthority€that€meets€the€requirements€of€this€paragraph.Ð È-`'* Ðà ` à(B)€Where€presentation€of€particular€documentation€or€statements€are€required€byÏthis€subpart€as€a€condition€of€disclosure,€a€covered€entity€may€reasonably€rely€onÏdocumentation€or€statements€that€on€their€face€meet€the€applicable€requirements.Ìà ` à(3)€òòImplementation€specification:€other€safeguardsóó.€€A€covered€entity€must€haveÐ 8 Ð ÐsññÔ†ÿÿÔññÔ‡ÖXÆXXXN…Ôafeguards€to€ensure€that€information€is€not€used€in€violation€of€the€requirements€of€thisÐ ( À Ðsubpart€or€by€Ô#†XN…XXÖXÆy¡#ÔññÔ‡ÿÿ€requestóÔññmembers€of€its€workforceññÔ†ÿÿÔññÔ‡ÖXÆXXXN…Ô€or€components€of€the€entity€or€employees€andÐ ( À Ðother€persons€associated€with,€or€components€of,€its€business€partners€who€are€notÏauthorized€to€access€the€information.Ô#†XN…XXÖXÆ—¢#ÔññÔ‡ÿÿ€requestóÔññ€€Ð  ¬ Ðà ` à(4)€òòImplementation€specification:€disclosures€by€whistleblowersóó.€€A€coveredÐ ¬ Ðentity€is€not€considered€to€have€violated€the€requirements€of€this€subpart€where€a€memberÏof€its€workforce€or€an€employee€or€other€person€associated€with€a€business€partnerÏdiscloses€protected€health€information€that€such€member€or€other€person€believes€isÏevidence€of€a€violation€of€law€to:Ìà ` à(i)€The€law€enforcement€official€or€oversight€agency€authorized€to€enforce€suchÏlaw;€orÌà ` à(ii)€An€attorney,€for€the€purpose€of€determining€whether€a€violation€of€law€hasÏoccurred€or€assessing€what€remedies€or€actions€at€law€may€be€available€to€the€employeeòòóó.Ð ”, Ðà ` à(d)€òòComplaints€to€the€covered€entityóó.€€(1)€òòStandardóó.€A€covered€entity€that€is€aÐ „ Ðhealth€plan€or€health€care€provider€must€provide€a€process€whereby€individuals€may€make€Ïcomplaints€concerning€the€entityððs€compliance€with€the€requirements€established€by€thisÏsubpart.€ò òó óÐ Tì Ðà ` à(2)€òòImplementation€specificationsóó.€A€covered€entity€that€is€a€health€plan€or€healthÐ DÜ Ðcare€provider€must€develop€and€implement€procedures€under€which€an€individual€may€fileÏa€complaint€alleging€that€the€covered€entity€failed€to€comply€with€one€or€moreÏrequirements€of€this€subpart.€€Such€procedures€must€provide€for:Ìà ` à(i)€The€identification€of€the€contact€person€or€office€required€by€paragraph€(a)(2)Ïof€this€section;€andÌà ` à(ii)€Maintenance€by€the€covered€entity€of€a€record€of€all€complaints€and€theirÏdisposition,€if€any.Ìà ` à(e)€òòSanctions:€standardóó.€€A€covered€entity€must€develop€and€apply€whenÐ Ä!\ Ðappropriate€sanctions€against€members€of€its€workforce€who€fail€to€comply€with€theÏpolicies€and€procedures€of€the€covered€entity€or€the€requirements€of€this€subpart€inÏconnection€with€protected€health€information€held€by€the€covered€entity€or€its€businessÏpartners.òòóóÐ „%! Ðà ` à(f)€òòDuty€to€mitigate:€standardóó.€€A€covered€entity€must€have€procedures€forÐ t& " Ðmitigating,€to€the€extent€practicable,€any€deleterious€effect€of€a€use€or€disclosure€ofÏprotected€health€information€in€violation€of€this€subpart.ÌññÔ†ÿÿÔññÔ‡ÖXÆXXXN…Ôðð164.520à0 ¸ àòòDocumentation€of€policies€and€proceduresóó.ÐD)Ü"%¸ (#¸ (# Ðà ` à(a)€òòStandardóó.€€A€covered€entity€must€adequately€document€its€compliance€with€theÐ 0*È#& Ðapplicable€requirements€of€this€subpart.Ìà ` à(b)€òòImplementation€specification:€generalóó.€€A€covered€entity€must€document€itsÐ , %( Ðpolicies€and€procedures€for€complying€with€the€applicable€requirements€of€this€subpart.€ÏSuch€documentation€must€include,€but€is€not€limited€to,€documentation€that€meets€theÐ à-x'* Ðrequirements€of€paragraphs€(c)€through€(g)€of€this€section.Ìà ` à(c)€òòImplementation€specification:€uses€and€disclosuresóó.€€With€respect€to€uses€byÐ Tì Ðthe€covered€entity€or€its€business€partners€of€protected€health€information,€a€coveredÏentity€must€document€its€policies€and€procedures€regarding:Ìà ` à(1)€Uses€and€disclosures€of€such€information,€including:Ìà ` à(i)€Uses€and€disclosures€with€authorization,€including€for€revocation€ofÏauthorizations;€andÌà ` à(ii)€Uses€and€disclosures€without€authorization,€including:Ìà ` à(A)€For€treatment,€payment,€and€health€care€operations;€Ìà ` à(B)€For€disclosures€to€business€partners,€including€monitoring€and€mitigation;€andÌà ` à(C)€For€uses€and€disclosures€pursuant€to€ðð€164.510.Ìà ` à(2)€For€implementation€of€the€minimum€necessary€requirement€of€ðð€164.506(b).Ìà ` à(3)€For€implementation€of€the€right€to€request€a€restriction€under€ðð€164.506(c),Ïincluding:Ìà ` à(A)€Who,€if€anyone,€in€the€covered€entity€is€authorized€to€agree€to€such€a€request;ÏandÌà ` à(B)€How€restrictions€agreed€to€are€implemented.Ìà ` à(4)€For€creation€of€de„identified€information€in€accordance€with€ðð€164.506(d).Ìà ` à(d)€òòImplementation€specification:€individual€rightsóó.€A€covered€entity€mustÐ ˜ Ðdocument€its€policies€and€procedures€under€ðððð€164.512,€164.514,€164.515,€and€164.516,Ïas€applicable,€including:Ìà ` à(1)€How€notices€will€be€disseminated€in€accordance€with€ðð€164.512;Ìà ` à(2)€Designated€record€sets€to€which€access€will€be€granted€under€ðð€164.514;Ìà ` à(3)€Grounds€for€denying€requests€for€access€under€ðð€164.514;Ìà ` à(4)€Copying€fees,€if€any;Ìà ` à(5)€Procedures€for€providing€accounting€pursuant€to€ðð€164.515;Ìà ` à(6)€Procedures€for€accepting€or€denying€requests€for€amendment€or€correctionÏunder€ðð€164.516;Ìà ` à(7)€How€other€entities€will€be€notified€of€amendments€or€corrections€acceptedÏunder€ðð€164.516;€andÌà ` à(8)€Identification€of€persons€responsible€for€making€decisions€or€otherwise€takingÏaction,€including€serving€as€a€contact€person,€under€ðððð€164.512,€164.514,€164.515,€andÏ164.516.Ìà ` à(e)€€€òòImplementation€specification:€administrative€requirementsóó.€€A€covered€entityÐ Ô$l! Ðmust€provide€documentation€of€its€procedures€for€complying€with€ðð€164.518,€including:Ìà ` à(1)€Identification€of€the€persons€or€offices€required€by€ðð€164.518(a)€and€theirÏduties;Ìà ` à(2)€Training€provided€as€required€by€ðð€164.518(b);€Ìà ` à(3)€How€access€to€protected€health€information€is€regulated€by€the€covered€entityÏand€its€business€partners,€including€safeguards€required€by€ðð€164.518(c);Ìà ` à(4)€For€a€covered€entity€that€is€a€health€plan€or€health€care€provider,€for€receivingÏcomplaints€under€ðð€164.518(d);Ìà ` à(5)€Sanctions,€and€the€application€thereof,€required€by€ðð€164.518(e);€andÐ  -¸&* Ðà ` à(6)€Procedures€for€mitigation€under€ðð€164.518(f).€Ìà ` à(f)€òòImplementation€specification:€specific€documentation€requiredóó.€€A€coveredÐ Tì Ðentity€must€retain€documentation€of€the€following€for€six€years€from€when€theÏdocumentation€is€created,€unless€a€longer€period€applies€under€this€subpart:Ìà ` à(1)€Restrictions€agreed€to€pursuant€to€ðð€164.506(c);Ìà ` à(2)€Contracts€pursuant€to€ðð€164.506(e);Ìà ` à(3)€Authorization€forms€used€pursuant€to€ðð€164.508;Ô#†XN…XXÖXÆé¬#ÔññÔ‡ÿÿ€requestóÔññññÔ†ÿÿÔññÔ‡ÖXÆXXXN…ÔÐ ð ˆ Ðà ` à(4)€Samples€of€all€notices€issued€pursuant€to€ðð€164.512;Ìà ` à(5)€Written€statements€required€by€ðð€164.514;Ô#†XN…XXÖXƵ½#ÔññÔ‡ÿÿ€requestóÔññññÔ†ÿÿÔññÔ‡ÖXÆXXXN…ÔÐ È ` Ðà ` à(6)€The€accounting€required€by€ðð€164.515;Ô#†XN…XXÖXÆؾ#ÔññÔ‡ÿÿ€requestóÔññÐ ´L  Ðà ` à(7)€Documents€relating€to€denials€of€requests€for€amendment€and€correctionÏpursuant€to€ðð€164.516;€Ìà ` à(8)€Certifications€under€ðð€164.518(b);€andÌà ` à(9)€Complaints€received€and€any€responses€thereto€pursuant€to€ðð€164.518(d).Ìà ` à(g)€òòImplementation€specification:€change€in€policy€or€procedureóó.€€(1)€Except€asÐ `ø  Ðprovided€in€paragraph€(g)(2)€of€this€section,€a€covered€entity€may€not€implement€a€changeÏto€a€policy€or€procedure€required€or€permitted€under€this€subpart€until€it€has€made€theÏappropriate€changes€to€the€documentation€required€by€this€section€and€the€notice€requiredÏby€ðð€164.512.Ìà ` à(2)€Where€the€covered€entity€determines€that€a€compelling€reason€exists€to€make€aÏuse€or€disclosure€or€take€another€action€permitted€under€this€subpart€that€its€notice€andÏpolicies€and€procedures€do€not€permit,€it€may€make€the€use€or€disclosure€or€take€the€otherÏaction€if:€Ìà ` à(1)€It€documents€the€reasons€supporting€the€use,€disclosure,€or€other€action;€andÌà ` à(2)€Within€30€days€of€the€use,€disclosure,€or€other€action,€changes€its€notice,Ïpolicies€and€procedures€to€permit€such€use,€disclosure,€or€other€action.Ìðð€164.522à0 ¸ àòòCompliance€and€enforcementóó.Р8¸ (#¸ (# Ðà ` à(a)€òòPrinciples€for€achieving€complianceóó.Ð ( Ðà ` à(1)€òòCooperationóó.€€The€Secretary€will,€to€the€extent€practicable,€seek€theÐ €  Ðcooperation€of€covered€entities€in€obtaining€compliance€with€the€requirements€establishedÏunder€this€subpart.Ìà ` à(2)€òòAssistanceóó.€€The€Secretary€may€provide€technical€assistance€to€covered€entitiesÐ P#è Ðto€help€them€comply€voluntarily€with€this€subpart.Ìà ` à(b)€òòIndividual€complaints€to€the€Secretaryóó.€€An€individual€who€believes€that€aÐ 0%È! Ðcovered€entity€is€not€complying€with€the€requirements€of€this€subpart€may€file€aÏcomplaint€with€the€Secretary,€òòprovided€thatóó,€where€the€complaint€relates€to€the€allegedÐ '¨ # Ðfailure€of€a€covered€entity€to€amend€or€correct€protected€health€information€pursuant€to€ððÏ164.516,€the€Secretary€may€determine€whether€the€covered€entity€has€followedÏprocedures€that€comply€with€ðð€164.516,€but€will€not€determine€whether€the€informationÏinvolved€is€accurate,€complete,€or€whether€errors€or€omissions€might€have€an€adverseÏeffect€on€the€individual.Ìà ` à(1)€òòRequirements€for€filing€complaintsóó.€€Complaints€under€this€section€must€meetÐ °,H&) Ðthe€following€requirements:Ð  -8'* Ðà ` à(i)òòóó€A€complaint€must€be€filed€in€writing,€either€on€paper€or€electronically.€Ð h Ðà ` à(ii)€òòóóA€complaint€should€name€the€entity€that€is€the€subject€of€the€complaint€andÐ Xð Ðdescribe€in€detail€the€acts€or€omissions€believed€to€be€in€violation€of€the€requirements€ofÏthis€subpart.Ìà ` à(iii)òòóó€The€Secretary€may€prescribe€additional€requirements€for€the€filing€ofÐ ( À Ðcomplaints,€as€well€as€the€place€and€manner€of€filing,€by€notice€in€the€òòFederal€Registeróó.€Ð  ° Ðà ` à(2)€òòInvestigationóó.€€The€Secretary€may€investigate€complaints€filed€under€thisÐ    Ðsection.€€Such€investigation€may€include€a€review€of€the€pertinent€policies,€practices,€andÏprocedures€of€the€covered€entity€and€of€the€circumstances€regarding€any€alleged€acts€orÏomissions€concerning€compliance.Ìà ` à(c)€òòCompliance€reviewsóó.€€The€Secretary€may€conduct€compliance€reviews€toÐ È`  Ðdetermine€whether€covered€entities€are€complying€with€this€subpart.Ìà ` à(d)€òòResponsibilities€of€covered€entitiesóó.Ð ¨@  Ðà ` à(1)€òòProvide€records€and€compliance€reportsóó.€A€covered€entity€must€keep€suchÐ ˜0  Ðrecords€and€submit€such€compliance€reports,€in€such€time€and€manner€and€containingÏsuch€information,€as€the€Secretary€may€determine€to€be€necessary€to€enable€the€SecretaryÏto€ascertain€whether€the€covered€entity€has€complied€or€is€complying€with€theÏrequirements€of€this€subpart.Ìà ` à(2)òòóó€òòCooperate€with€periodic€compliance€reviewsóó.€€The€covered€entity€shallÐ Hà Ðcooperate€with€the€Secretary€if€the€Secretary€undertakes€a€review€of€the€policies,Ïprocedures,€and€practices€of€a€covered€entity€to€determine€whether€it€is€complying€withÏthis€subpart.Ìà ` à(3)€òòPermit€access€to€informationóó.€€A€covered€entity€must€permit€access€by€theÐ   ÐSecretary€during€normal€business€hours€to€its€books,€records,€accounts,€and€other€sourcesÏof€information,€including€protected€health€information,€and€its€facilities,€that€are€pertinentÏto€ascertaining€compliance€with€this€subpart.€€Where€any€information€required€of€aÏcovered€entity€under€this€section€is€in€the€exclusive€possession€of€any€other€agency,Ïinstitution,€or€person€and€the€other€agency,€institution,€or€person€fails€or€refuses€to€furnishÏthe€information,€the€covered€entity€must€so€certify€and€set€forth€what€efforts€it€has€madeÏto€obtain€the€information.€€Protected€health€information€obtained€in€connection€with€aÏcompliance€review€or€investigation€under€this€subpart€will€not€be€disclosed€by€theÏSecretary,€except€where€necessary€to€enable€the€Secretary€to€ascertain€compliance€withÏthis€subpart,€in€formal€enforcement€proceedings,€or€where€otherwise€required€by€law.Ìà ` à(4)€òòRefrain€from€intimidating€or€retaliatory€actsóó.€€A€covered€entity€may€notÐ X%ð! Ðintimidate,€threaten,€coerce,€discriminate€against,€or€take€other€retaliatory€action€againstÏany€individual€for€the€filing€of€a€complaint€under€this€section,€for€testifying,€assisting,Ïparticipating€in€any€manner€in€an€investigation,€compliance€review,€proceeding€or€hearingÏunder€this€Act,€or€opposing€any€act€or€practice€made€unlawful€by€this€subpart.Ìà ` à(e)€òòSecretarial€action€regarding€complaints€and€compliance€reviewsóó.€òòóóÐ * #& Ðà ` à(1)€òòResolution€where€noncompliance€is€indicatedóó.€€(i)€€If€an€investigation€pursuantÐ ø*$' Ðto€paragraph€(b)(2)€of€this€section€or€a€compliance€review€pursuant€to€paragraph€(c)€ofÏthis€section€indicates€a€failure€to€comply,€the€Secretary€will€so€inform€the€covered€entityÏand,€where€the€matter€arose€from€a€complaint,€the€individual,€and€resolve€the€matter€byÐ È-`'* Ðinformal€means€whenever€possible.€€Ìà ` à(ii)€€If€the€Secretary€determines€that€the€matter€cannot€be€resolved€by€informalÏmeans,€the€Secretary€may€issue€written€findings€documenting€the€non„compliance€to€theÏcovered€entity€and,€where€the€matter€arose€from€a€complaint,€to€the€complainant.€€TheÏSecretary€may€use€such€findings€as€a€basis€for€initiating€action€under€section€1176€of€theÏAct€or€initiating€a€criminal€referral€under€section€1177.Ìà ` à(2)€òòResolution€where€no€violation€is€foundóó.€€If€an€investigation€or€complianceÐ    Ðreview€does€not€warrant€action€pursuant€to€paragraph€(e)(1)€of€this€section,€the€SecretaryÏwill€so€inform€the€covered€entity€and,€where€the€matter€arose€from€a€complaint,€theÏindividual€in€writing.Ìðð€164.524à0 ¸ àòòEffective€dateóó.ÐÈ` ¸ (#¸ (# Ðà ` àA€covered€entity€must€be€in€compliance€with€this€subpart€not€later€than€24€monthsÏfollowing€the€effective€date€of€this€ruleòòóó,€except€that€a€covered€entity€that€is€a€small€healthÐ ¨@  Ðplan€must€be€in€compliance€with€this€subpart€not€later€than€36€months€following€theÏeffective€date€of€the€rule.ññÔ TS ÔññšññÔ†ÿÿÔÔ†XÿÿÔÔ  ÔÔ US ÔÔ TS Ôññ