Ukuqala: Indima Ebalulekileyo Yabaxhaphazi Ekukhuseleni Imfihlo Yamayeza

Kwingxelo yoluntu, yezamayeza neyonyango ngokufuthi ibumba obunye bobona bungqina bokusetyenziswa kweziyobisi kodwa obunobungcathu obukhoyo. Utyando oluthe ngqiqweni lungaxhomekeka kwezi ngxelo ukuze lubonise umonakalo, ngoxa ummangalelwa kwityala lokusebenza kakubi esenokufuna ukuba afumane ulwazi olunzulu olukhuselayo. Noko ke, la maxwebhu anjalo anenkcazelo enzulu eyimfihlo", iingxelo zonyango, amayeza, kunye neengxelo zempilo yengqondo ezifuna ukugcinwa ziyimfihlo. Eli nqaku linika imvume esemthethweni yokufumana imvume yokufikelela kwemithetho elawulayo, kunye nemithetho esemthethweni esemthethweni. Ukuqonda xa kufuneka imvume, indlela yokufumana unyango, nemiqathango yokufikelela kwenkundla yezonyango, kunye nemiqatha yezonyango yezonyango olukhuselekileyo olubandakanya ulwazi olukhuselweyo (PI).

Isiseko esisemthethweni: HIPAA noMthetho wemfihlo

I-Inishorensi yoBulunga be-Accounting Act (HIPAA) imisa isiseko sokukhusela i-PHI. Emongweni wayo, uMthetho we-HIPAAmfisful uyawalela amagunya agqunyiweyo `njengawoogqirha, izibhedlele, amapharma, kunye namaqhinga ezempilo (""isuka kwi-Plosing PH engenagunya elisemthethweni kumguli okanye imvume esemthethweni. Isivumelwano esikhutshwe ngumgwebi okanye umgwebi, asiyo kuphela imigaqo esemthethweni kodwa ingumkhuseli oweyo ekhuselweyo kwi-Dinjini e-4. [[FLT: 0]] imiyalelo ephambili yemithetho ekhuselweyo kunye [iKLT] kunye [iNkungamele iNkuthelelwa kaNt.[5] iNt.FFoff]

Ngokungqalileyo, 45 C.F.R. . . . . (e) ilawula izicelo kunye nokutyhilwa okufunwa ngumthetho. Ithi into egqunyiweyo inokuyityhila i-PHI ngokuphendula umyalelo wenkundla okanye isiqinisekiso, ukuba ithe into ityhila ulwazi kuphela olugunyazisiweyo ngomyalelo. Umthetho uyakuvumela ukutyhila i-pursudususe kwi-acepoena, isicelo sokufumana, okanye enye inkqubo esemthethweni, kodwa kuphela ukuba iqela elifuna ulwazi lunika iziqinisekiso ezanelisayo zokuba imigudu esengqiqweni yenziwe ukuze kwaziwe umntu ngamnye okanye kufumane umgaqo wokukhusela. Isiqinisekiso sokuzichaza ezi zifunekayo kuba ikhutshwe ligosa abathanga bathanga abasebenzi bezomthetho abangooneleyo okanye ababonakalisa iimfuno ze-active. Oku kukwahlula: ukunikezelwa komgangatho ophezulu wewongameleyo kunye nokhuseleko lwezongamele.

Kufuneka Nini Ukuba Sifumane Isidanga?

Isiqinisekiso asisoloko siyimfuneko ukufumana iirekhodi zezamayeza ngokubekwa kwengxelo yamakhaya. Iimeko ezinika ingqwalaselo ziquka uhlobo lweerekhodi, imvume yomguli, ubukho beenkqubo ezingokwasemthethweni, kunye nomthetho osebenzayo karhulumente. Ngasezantsi sihlolisisa iimeko ezinyanzela isiqinisekiso.

Iingxelo Ezivakalayo

Ezinye iindidi zenkcazelo yezamayeza zifumana ukhuseleko olungakumbi phantsi komthetho wesizwe nowesizwe. Iingxelo zempilo yengqondo, iingxelo zonyango lweziyobisi (eziveliswe ngu 42 C.F.R. inxalenye 2), i-HIV/AIDS iziphumo zovavanyo lwemfuza, kwaye iinkcukacha zemfuza zisoloko zifuna isiqinisekiso okanye umyalelo okhethekileyo wenkundla kwanaxa ezinye iingxelo zinokufumaneka zidlula kwi-subpoena. Isiqinisekiso siqinisekisa ukuba ijaji ivavanya umdla womntu ngamnye kwimfuno yeligantswana. Umzekelo, kwisuth-mfono yomntu oziphetheyo apho umbhiyombi uthetha ukuba unxunguphane noxanduva, ukukhusela okunokufuna iingxelo zengqondo zomntu. Ngaphandle kogunya-mthetho, iirekhodi ezinjalo zingaphandle ngaphandle kwelungelo eliqhelekileyo.

Ukuvunywa Ngokuzithandela

Ukuba umguli (okanye ummeli womguli) unika ugunyaziso olubhaliweyo phantsi kwe-HIPAA, isiqinisekiso asiyomfuneko. Ugunyaziso kufuneka lungqale, luchaze iirekhodi eziza kutyhilwa, injongo yokutyhilwa, kunye nowamkelayo. Noko ke, kwilitha loluntu lomguli, izigulana azivumi ukugunyazisa ukufikelela kwiirekhodi zazo, ingakumbi xa ulwazi lunokuzonakalisa imeko yazo. Xa imvume ithe yanqanyuswa, iqela elicelayo kufuneka libhenele kwinkqubo esemthethweni esemthethweni. Isiqinisekiso siba ngumzila oqhelekileyo ukuba iirekhodi azifumaneki nge-spea kananjalo isaziso, ingakumbi xa iiprojectal ephikisayo zisenza izinto zabo kwi-ofisi yecala.

Ingxelo ebhaliweyo kwityala kwaye engafumanekiyo ngezinye iindlela

Kwanakwi-subpoena, amanye amaqumrhu agqunyiweyo aza kungavumi ukuvelisa iingxelo ezingekhoyo zomyalelo wenkundla okanye isiqinisekiso ngenxa yokuba esoyika ukwaphula iHIPA. Oku kuqheleke kakhulu kumarhampasi kunye neenkqubo zesibhedlele ezinemithetho elandelwayo engqongqo. Ii-Attorney kufuneka zilindele ukuba imvume ifuneke ukoyisa le miqobo. Ngaphezu koko, xa iirekhodi zibalulekile ukuseka ilungu elingundoqo lempiliso okanye ukhuseleko. Ngokunjalo, zifana nokuqinisekisa imbali yento elawulwayo kwinkohliso okanye kwityala lokungakhathaleli.

Iziphumo zokufumana umnqongo: Isikhokelo ngeNdlela

Inkqubo yokukhusela isiqinisekiso sengxelo yezamayeza ibandakanya iinkalo eziliqela ezahlukeneyo, nganye iqwalaselwe ngokwasemthethweni nangobuchule bayo.

Ukujija Intshukumo Nokuxhasa I-Affidavit

Iinkundla ezininzi zifuna iqela elifuna isiqinisekiso sokufaka intshukumo ecela umyalelo wokuvelisa iirekhodi zezamayeza. Intshukumo mayikhatshwe yi-affidavit okanye isindululo esiqalisayo:

  • Inkcazelo engqalileyo yeerekhodi ezifunwayo, kuquka uluhlu lwemihla, abanikezeli, kunye neentlobo zamaxwebhu (umz., “yonke ikhemisi enika iingxelo ze-oxycodone ukususela ngoJanuwari 2020 ukuya kuDisemba 2023”.
  • Ukubaluleka kodidi ngalunye lweengxelo kwiingxelo ezithetha okanye ezizikhuselayo, zidibanisa ingxelo nganye nombandela ongqalileyo oyinyaniso.
  • Ingxelo ekufuneka ifumaneke ngokusengqiqweni kwiingxelo ezifunekayo , yindlela ezincinci ezingenisayo, ezifana nemvume, ukudityaniswa, okanye icandelo lesithathu le-subpoena.
  • Ukuba iingxelo zifuneka ngokungxamisekileyo (umz., ukuthintela intshabalalo okanye ngenxa yemiqathango ekufuphi), isicelo sokucingisiswa ngokucokisekileyo.

IAffidavit imele isekelwe kulwazi lobuqu okanye kubungqina obucacileyo.

Isalathisi somva. Iindlebe eziphawulweyo

Kwimeko ezininzi zasekuhlaleni, isicelo sogunyaziso kufuneka sinikezelwe kuwo onke amaqela, kwaye icala elichaseneyo linethuba lokubeka into. Ngoko, kukho iimeko ezisikelwe umda apho umyalelo othile usenokuba ufanelekile khona (umzekelo, xa iqela elicelayo lifuna ugcino lwangaphambili lweerekhodi ukunqanda ukukhupha umva. Amazwe ayahluka ekubeni le miyalelo ibhalwe njengemvume okanye njengemiyalelo yenkundla ephantsi kwemithetho efunyenweyo.

Umlinganiselo Nokusikelwa Umda Kwesi silwanyana

Isiqinisekiso esisebenzayo kufuneka silungiswe ngokufutshane. Inkundla ayinakugunyazisa uhambo lokuloba. Inkundla izakuqinisekisa ukuba inyanisekile okanye ingawafaki amanqaku angenayo ngqo, akhuselwe lilungelo lomntu osebenza ngengqondo, okanye aqulathe ulwazi malunga namaqela esithathu (umz., amalungu entsapho). Isiqinisekiso sizakubonisa ixesha lokuveliswa kwemveliso kwaye inyanzelise iimeko ngendlela iirekhodi ezizakuphathwa ngayo emva kokutyhilwa, kuquka ukutywinwa kwazo phantsi komyalelo wokhuseleko.

Umahluko Obalulekileyo: Abathathi - nxaxheba, Abaphantsi Kweenqanawa, Nemiyalelo Yenkundla

Iiattorney zidla ngokudida ezi zixhobo zintathu, kodwa zisebenza imisebenzi eyahlukeneyo phantsi kweHIPAA kunye nenkqubo yelizwe.

Legal ProcessKey FeaturesHIPAA Compliance
WarrantIssued by a judge based on probable cause or a showing of relevance; requires affidavit; ex parte or noticed.Automatic compliance under 45 C.F.R. § 164.512(e)(1)(i); no notice to patient required.
SubpoenaIssued by an attorney or clerk; does not require judge approval; may be challenged.Requires either patient consent, a protective order, or satisfactory assurances of notification (45 C.F.R. § 164.512(e)(1)(ii)).
Court OrderBroader category that includes warrants; may be issued pursuant to a motion to compel.Must be reviewed to ensure it meets the “order of a court” standard; similar to warrant but often less formal.

Ngokwesiko, iinkundla ezininzi ziphatha “umyalelo wenkundla” kunye“ nomthetho ovumelekileyo” njengolinganayo neenjongo ze-HIPAA, kodwa imiyalelo iqheleke kakhulu ngokunxulumene nomthetho osebenza ngokulandelelana. Kwizindululo zasekuhlaleni, igama elithi“inkululwana” lisoloko lisetyenziswa kunye negama elithi“umyalelo wequmrhu ogunyazisa ukutyhilwa.” Ii-Atttorney kufuneka ziqinisekise imithetho yasekuhlaleni kunye nezinto ezikhethwayo zejaji.

Ukutshintsha koMthetho Karhulumente Nokukhululwa

Ngeli xesha iHIPAA imisela umgangatho karhulumente, amaphondo asenokumisela imigaqo engqongqo yokukhusela iirekhodi zezonyango. Umzekelo, i-Imfihlelo ye-Medical Information Act yaseKhalifoniya ifuna umgaqo wenkundla okanye ugunyaziso lwesigulana lokufumana iziphumo ezininzi, ngokuphumelelayo ukuphakamisa ibhar ngaphaya kwe-HIPAA. Ngokufanayo, iMental Hygiene Law yase-New York ifuna ukuqhubekeka ngendlela ekhethekileyo ngaphambi kokuba iirekhodi zempilo zengqondo zikhululwe. Xa umthetho karhulumente unikela imigaqo yemfihlo engakumbi, awukhuselwanga yi-HIPAA (45.C.F.R. 160.20). Ngoko ke, amagqwethawe-mthetho kufuneka ajonge umthetho apho iirekhodi zibekwe khona okanye apho iirekhodi zibekwe khona.

Kwezinye iinkundla zeli lizwe, “ityala” ligama elikhethekileyo elibekelwe ukulwa nolwaphulo-mthetho, kwaye abaxhasi bamatyala kufuneka basebenzise“ umyalelo wasemthethweni wemveliso” okanye “umyalelo wokunyanzela.” Ingongoma enzima yeyokuba le nkqubo kufuneka iquke uhlolo lomthetho. Iqela elingaphantsi nje elityikitywe ngumabhalane alizukwanelanga xa kujongwa impikiswano ye-mfihlo. Abaqululeki kufuneka baqaphele imibandela yezobuzwe: ukuba umqeqeshi wezempilo ukwimeko eyahlukileyo, kufuneka ukuba iqela elicela liququzele isiqinisekiso okanye umyalelo womsebenzi we-ofisi yecawa.

Iindawo Eziluncedo Zokudlala Iiathorney

Ukufumana ngokuphumelelayo iingxelo zezamayeza noluxwebhu ngogunyaziso kufuneka ucebe nokubulawa ngenyameko. Ngeli ngezantsi kunamacebiso asebenzayo.

Qala Ngohlalutyo Lwembali Ekhutshelwe Ngokucokisekileyo

Phambi kokushukunyiselwa isiqinisekiso, sebenzisa iindlela ezincinci zokungenisa izithintelo ezifanelekileyo. Iinkqubo zokuhlola iziyobisi (PDMP) ezisetyenziswa ngokusemthethweni zifumaneka kumazwe amaninzi kwaye zingabonisa ukuba zeziphi ii-pharmacs kunye nabameli abanikezele izinto ezilawulwayo kwiqela. Ngoxa iingxelo ze-PDMP ngokwazo zisenokuba nemiqathango yazo yokufikelela, zinokuxinene umlinganiselo wesicelo esifanelekileyo, ziyenze ibe lula kakhulu ukunikwa.

Yiba Nesibindi Ngesiluleko Esichukumisayo

Igqwetha lomguli liza kuvuma kumyalelo osemthethweni oza kuvumela iqela elicelayo ukuba libone iirekhodi ngelixa lithintela ukusetyenziswa kwazo kwilibhiti. Umyalelo owisiweyo ungaphepha inkqubo yogunyaziso lomphathi-mvume kwaye ukhawuleze. Kodwa ukuba icala elichaseneyo alivumi, indlela yemvume iyafuneka.

Ulungelelwaniso Olucetyiswa Kancinane

Quka isicelo sakho umyalelo ocetyiweyo ochaza iirekhodi, isakhelo sexesha, amagama abanikezi, kunye nazo naziphi na iimeko (umz., ukugcina imfihlelo, ukubuya kwamaphepha emva kokuvavanywa). Iinkundla ziyakuxabisa oku ngenxa yokuba ibonisa ukuba ucinge ngemibandela yemfihlo. Luphephe ulwimi olubanzi olufana “zonke iingxelo zezamayeza.” Endaweni yoko, yiba ngochanekileyo:“ Zonke iingxelo zonyango noGqr. John Smith ukususela ngoJanuwari 1, 2022, ukuza kuthi ga ngoku zithelekise ukuxilonga kunye nonyango lwentloko ebuhlungu yentloko entloko enke."

Lungela Ukuzihlola Ngekhamera

Abanye abagwebi bahlola iirekhodi ezikwikhamera (kwizisele) ngaphambi kokuba bagqibe ukuba banokuzikhulula kusini na. Oku kuqhelekile kwiingxelo zempilo yengqondo. Kulindele oku baze bakulungele ukuchaza isizathu sokuba irekhodi ifuneka, okanye bacebise ukuba kutheni kusekho izinto eziza kuhlala zikho.

Iziphumo Zokungabikho Kwemvume

Ukungaphumeleli ukubambelela kwimfuno ezifanelekileyo kungakhokelela kwiziphumo eziqatha. Ukuba iqela lifumana iingxelo zezamayeza ngaphandle kwemvume elungileyo okanye ugunyaziso, iingxelo zingacinywa okanye zikhutshwe kubungqina obugqithisileyo. Okubi nangakumbi, ityala lomeneyo lisenokufumana isigwebo, kuquka isohlwayo semali, iimali zegqwetha, kunye nokugxothwa kwemiqathango okanye ukhuseleko. Into egqunyiweyo etyhila iingxelo zemali ngaphandle kwemvume esemthethweni i-HPAA inokuba negunya phantsi kwe-HIPAA kwiziphumo zamakhaya eziyaphulwayo, kanye nezigwebo zolwaphulo-mthetho kwityala lokwazi kakubi. Kwimeko enye ephawulekayo, inkqubo yempilo ihlawule i-R1, 32.3 ezigidi zemali ekhutshelwe ngokungekho mthethweni kwe-mthetho yomthetho yombini ekwane. Ngoko ke, kufuneka iqinisekise ukuba i-HIPI i-hena i-hea (sesplea'A') kunye ne-A'umthetho wokwahluzo zombini.[18]

Umthetho Nemikhwa Yamvanje

Izigqibo ezininzi zakutshanje zigxininisa ukunyanzelisa kweenkundla ukuthobela ngokungqongqo imilinganiselo yemvume kwimithetho yamakhaya. Doe v. Ortho-Clinical Diagnostics, Inc. [2022], inkundla yesithili yengingqi yeMassachusetts yakwala ukuzama kommangalelwa ukufumana iingxelo zemiyalelo ebhaliweyo ngoMthetho 34 ngaphandle komyalelo wenkundla, ilawula ukuba iirekhodi zikhuselwe yi-HIPAA kwaye ifuna isiqinisekiso okanye into efanayo. Inkundla yagxininisa ukuba umthwalo uwele kwiqela elicela ukubonisa imfuneko enyanzelisayo efuna inzala eyimfihlo.

Ngokufanayo, Smith v. Johnson & Johnson (2023) ibandakanya intshukumo yemveliso apho abalawuli bekhemikhali bafuna iirekhodi zekhemisi ukubonisa ipateni yokubhalisa. Inkundla yayalela uhlolo lwekhamera yaza ekugqibeleni yakhupha kuphela ugcino-lwazi olufihlakeleyo, engavumi ukunikezela umguli ngamnye ngaphandle kwesiqinisekiso. Oku kubonisa ubuchule obukhulayo bendlela yokulawula imfihlo yezamayeza kumongo woluntu, ingakumbi apho iirekhodi zamaqela amathathu zibotshelelwe khona.

Ii-Attorney kufuneka ziqonde ukuba ingcaciso ye- “yantsonkothileyo” kwiirekhodi zempilo ye-elektroniki iyatshintsha. Ngokunyuka kolwazi lwempilo (HIES) kunye ne-EHRs esekelwe kumafu, indawo ephathekayo yeengxelo isenokuba ayicacanga. Ezinye iinkundla zibambe ukuba imvume ekhutshwe kwelinye igunya inganyanzela ukuveliswa komnikezi kwenye into ukuba umnikezi ukho kwilizwe eliphumayo. Kodwa ke, uqheliselo olungcono kukufuna isiqinisekiso kurhulumente apho iirekhodi zikhoyo okanye ukufumana umyalelo wenkundla oquququzelwe nomthetho wamaphondo omabini.

Amalungelo omguli Neendlela Zokusivavanya Isindululo Esifanelekileyo

Izigulana ezoyikayo ukuba iingxelo zazo zezamayeza ziza kubhencwa kwingxelo yezonyango azinakusuka ngaphandle kokucela uncedo. Zingafaka intshukumo yokufaka okanye ukukhusela, ziphikisa ngelithi isicelo sogunyaziso sigqithise kakhulu, asilulungisi ngokwaneleyo, okanye ziphulule ilungelo elithile (umz., ilungelo lokunyamezela kwengqondo phantsi Jaffee v. Redmond[, 518 U.S. 11966). Igqwetha lomguli limele liqinisekise ukuba imvume, ukuba ingulonke, ukuba ikhona, ibandakanya isibambiso kunye nemida yokusebenza kweengxelo ezikhoyo. Ukuba i-Roctive i-fax traced projective processs process as assss procemplation.

Ukongezelela, izigulana zisenokucela ukuba inkundla ifumane ulwazi olunolwazi olunzulu olufana namanani oKhuseleko loNtlalo-ntle, imbali yentsapho, okanye iimeko zezonyango ezingahambelaniyo. Ezinye iinkundla zimisela ingcali ekhethekileyo okanye ingcali engathathi cala-nxaxheba ukuhlola iirekhodi ngaphambi kokuba zityhilwe. Izigulana zikwamele ziqonde ukuba ziyakwazi ukuvuma ukuba zifumane inkcazelo elinganiselweyo /Ngokomzekelo, zivumela ukuzikhusela ukuba zibone iingxelo zekhemisi kuphela ngoxa zibambe amaphetshana empilo yengqondo.

Isiphelo: Ukulungelelanisa Ukufumanisa Izinto Nento Efihlakeleyo

Iimfuno eziqinileyo zokufumana iingxelo zonyango nomthetho womthetho ezikwizingxengxezo zoluntu aziyomiqobo nje ephambili; zizinto ezisisiseko zokukhusela izigulana kwilizwe elinolwazi olusoloko lusanda. Ukusuka kwi-HIPAA imfuno zesiseko sokwahluka-hlukene kombuso kunye nemeko egqwethekileyo yomthetho, imo yezomthetho ifuna ukuba amagqwetha aqhubeke ngokulumkileyo nangokuchanekileyo. Ukuba ungumntu ochasa ukhuseleko olufuna ukungqinela ilahleko okanye ummangalelwa ophendula izikhalazo, ukuqonda xa kufuneka okanye echasa enye ityala. Ngokuhlonela inkqubo yezomthetho kunye namalungelo abantu, inkqubo esemthethweni igcina ukuthenjelwa okuyimfuneko kwiimvavanyo zombini ezifanelekileyo kunye nempilo.

Ukuqhubeka ufunda, jonga [[FLT: 0] HHS HIPAA Umthetho wemfihlo, iphepha lolwazi lomthetho weCurtnell weZiko kwirekhodi zezamayeza[, nenqaku [[FLT:] ABBA ELINGQUBO ELINGQONGO loMthetho ekufunyanisweni kweerekhodi zezamayeza .