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Isaziso Sobumfihlo, Sewebhusayithi Nezinkundla Zezokuxhumana
Indlela Esibusingatha Ngayo Ubumfihlo
Ucwaningo lwezokwelapha lusekelwe ekuqoqweni nasekuhlaziyweni kolwazi oluyimfihlo kakhulu mayelana nabantu. Abantu bazosinika imininingwane yabo ebucayi kuphela lapho bezizwa besethemba futhi ababambiqhaza besebenzisa imikhuba yokusingatha ulwazi ngokuphepha. Isebenza ngaphansi kwalezi zimo, i-Synexus Clinical Research Limited (kanye nozakwabo nezinkampani eziphethe i-“Synexus,” “thina,” “nathi,” kanye “nokwethu”) iyaqaphela ukuthi uma sisingatha ulwazi mayelana nanoma imuphi umuntu, kufanele senze kanjalo ngobuqotho, sinakekele kakhulu ubumfihlo babantu, futhi sithobele imithetho yobumfihlo bolwazi nobomuntu siqu.
Le Nqubomgomo Yobumfihlo Yomhlaba Wonke (“Inqubomgomo”) ichaza izinhlobo eziyinhloko zolwazi lomuntu siqu esizicubungulayo enhlanganweni yethu yomhlaba wonke, ukuthi lolo lwazi lusetshenziswa futhi ludalulwe kanjani, kanye nokuzibophezela kwethu kubantu esisingatha ulwazi lwabo. Le Nqubomgomo ichaza imibandela ejwayelekile yokuthi sifuna ukuyithobela kanjani imithetho nezimiso zobumfihlo bolwazi, kubandakanye kodwa kungagcini nje ngemithetho kazwelonke esebenzisa uMthetho Wokuvikelwa Kolwazi Olujwayelekile wase-European Union (“EU”) 2016/679 (“uMthetho”), i-US Health Insurance Portability and Accountability Act ka-1996 (“HIPAA”), imithetho yombuso yokwephula ukuphepha yase-United States, umthetho wokuvikelwa kolwazi, eyamukelwe yizigodi eziningi ngokwandayo emhlabeni wonke, kanye nezimfuneko zobumfihlo nengasese ze-ICH Good Clinical Practice (GCP).
Uma uyisakhamuzi sesiFundazwe Sase-California, le Nqubomgomo ihambisana neSaziso Sobumfihlo Sezakhamuzi Zase-California, esibandakanya ulwazi oluthe xaxa okudingeka luhlinzekwe ngaphansi komthetho wase-California.
I-Synexus inezinqubomgomo zangaphakathi, izinqubo nezinhlelo zokuqeqeshwa ezenzelwe ukweseka ukuthobela le mithetho nale Nqubomgomo. Izinqubomgomo zethu, izinqubo nezinhlelo zokuqeqeshwa zibukezwa njalo, futhi zenganyelwa yithimba lochwepheshe bezobumfihlo abanegunya lokwengamela eliphakeme.
Yiziphi Izinhlobo Zolwazi Lomuntu Siqu I-Synexus Ezisingathayo Futhi Ngaziphi Izinhloso?
Ucwaningo Lwezokwelapha Nezempilo
Njengenhlangano ephethe izikhungo emhlabeni wonke, i-Synexus ihlinzeka ngezikhungo zophenyo zezivivinyo zezokwelapha eziqhutshwa amakhasimende ethu. Ngenxa yalokho, siqongelela, sinakekele futhi sihlaziye inqwaba yolwazi lwezempilo namasampula athathwe emzimbeni aphathelene nababambiqhaza bocwaningo. Ngokusho kwemibandela ebekwe imiThetho, i-Synexus izibheka njengesekela loMlawuli womxhasi/wekhasimende ekunqumeni ukuthi ulwazi lwezokwelapha nezempilo lucutshungulwa kanjani futhi ngasiphi isizathu njengenhlangano ephethe izikhungo.
Ukuze sithuthukise ubumfihlo, ngokuvumelana ne-GCP, amagama ababambiqhaza nezinye izihlonzi eziqondile azifakwa emarekhodini noma kumasampula asetshenziswa amakhasimende e-Synexus ngezinhloso zocwaningo.
Ulwazi Lokubuthelwa Isivivinyo Sezokwelapha
Siqongelela futhi sigcine nolwazi lokuxhumana lomuntu siqu, imininingwane mayelana nezifo zempilo nezokwelapha, kanye nezinto ezithinta ucwaningo lwezokwelapha ngabantu abasitshele ukuthi bangathanda ukubamba iqhaza ezivivinyweni zezokwelapha, ngakho siyakwazi ukubaqondanisa nesivivinyo sezokwelapha esifanele uma kudingeka. Sisebenzisa lolu lwazi ukuze sibuthe abantu ezivivinyweni zezokwelapha nokuqhuba izinhlelo ezivamile zokuhlaziya izibalo ukuze seseke ukubuthwa kweziguli.
Ulwazi Lokuhlungwa Kwezempilo
Ezimweni ezithile, i-Synexus ihlinzeka ngezinsizakalo zezempilo emiphakathini yendawo ngezinhlelo zokuhlungelwa ezempilo kwamagciwane/kwezifo ezithile. Kulo msebenzi, siqongelela amagama, imininingwane yokuxhumana, nolwazi lwezokwelapha lwababambiqhaza. Uma ukuhlola sekwenziwe, ngemvume yombambiqhaza, sizofaka ulwazi lakhe kungobolwazi yethu ukuze sikwazi ukuxhumana naye ngesizathu sokuhlola kwesikhathi esizayo noma amathuba ezivivinyo zezokwelapha, ngokuvumelana nesifo esiqondile anaso. Uma ekhetha ukungayinikezi le mvume, i-Synexus izokhipha imiphumela yokuhlolwa iyinike udokotela wombambiqhaza kuphela.
Ulwazi Lwabasebenzi Bezezimboni
Phakathi nokuqhuba umsebenzi wethu, i-Synexus izoxhumana nabasebenzi, abeluleki, osonkontileka nabanye abantu bangaphandle abaqashwe noma abasebenzelana namakhasimende ethu abamba iqhaza ocwaningweni lwezokwelapha nezempilo. I-Synexus izobhala futhi isebenzise amagama, imininingwane yokuxhumana nolunye ulwazi lwabasebenzi kulaba bantu ngezinhloso ezisemthethweni zebhizinisi, kubandakanye ukuphathwa kwamaphrojekthi nezimali. Singase sisebenzise ulwazi esilutholayo, kubandakanye amakheli e-imeyili, ukuhlinzeka ulwazi olufanele ngezinsizakalo ze-Synexus kumakhasimende ethu.
Ulwazi Lwabasebenzi Nezindaba Zabasebenzi
I-Synexus iqongelela ulwazi lomuntu siqu kubafakisicelo abafuna ukuqashwa yinkampani, kubandakanye imininingwane yangasese yokuxhumana, iziqu zemfundo nomlando wokuqashwa okudlule ukuze yenze izinqumo zokuqashwa. I-Synexus yenza ukuhlola okuhlukahlukene kwesizinda sabafakisicelo, kubandakanye nalapho umthetho uvuma khona ukuba kuhlolwe umlando wobugebengu nokuxoshwa emikhakheni ethile yomsebenzi. Uma umuntu eseqashiwe, i-Synexus iqongelela ulwazi ngabasebenzi ngezinjongo zezindaba zabasebenzi, ukwenziwa komsebenzi, amaholo nentela. I-Synexus izoqongelela futhi iqophe ulwazi lwabasebenzi ezinhlelweni ezihlukahlukene zenkampani, ngokuvumelana nemisebenzi yebhizinisi ejwayelekile. I-Synexus icubungula ulwazi olufanayo oluphathelene namanxusa, osonkontileka nabanye abantu abaseceleni abacelwa yinkampani ukuba bayihlinzeke ngemikhiqizo noma ngezinsizakalo.
Izivakashi Zewebhu
I-Synexus iqongelela ulwazi olunamagama mayelana nezivakashi ezingena kumawebhusayithi enkampani lapho luhlinzekwa khona ukuze kuhlangatshezwane nesicelo esivela kulabo bantu, isibonelo lapho umuntu osebenza nekhasimende ecela khona ulwazi ngezinsizakalo zenkampani, uchwepheshe wezempilo ethanda ukubamba iqhaza esivivinyweni sezokwelapha noma lapho othile efuna ukufaka isicelo sesikhundla somsebenzi esivulekile enkampanini. Ngokusetshenziswa kobuchwepheshe obusekelwe kumakhukhi, i-Synexus ingase iqongelele ulwazi oluhlukahlukene oluxhunyaniswe nezibonakaliso ezikukhompuyutha ezinikezwa izivakashi uma zingena kumawebhusayithi ethu. Lolu lwazi lusetshenziselwa izinhloso ezihlukahlukene, kubandakanye ukuhlaziya isikhungo nokukhangisa mathupha (bheka Izinkinga Ze-inthanethi ngezansi). Ezimweni ezithile, lezi zibonakaliso ze-inthanethi zihlobene nezibonakaliso ezingokoqobo zezivakashi uma zihlinzeka ngolwazi lwazo olunamagama njengoba kuchazwe ngenhla. Lokhu kuvumela i-Synexus ukuba ihlele imiyalezo yokukhangisa ehlobene nalabo bantu, kubandakanye nolwazi olungase lubathinte ngokuqondile.
Isikhungo Sokuxhumana
I-Synexus iqoka izikhungo ezixhumana nabathengisi ngenjongo yokuxhumana nabantu ababonise intshisekelo yokubamba iqhaza ezivivinyweni zokwelapha. Ulwazi lomuntu siqu lwalabo abathintiwe luqongelelwa kuphela ukuze kucutshungulwe isicelo sabo nokunquma ukuthi ingabe bayafaneleka yini noma cha ukwenza i-aphoyintimenti yokuvakasha kokuhlungwa ezikhungweni ze-Synexus. Izikhungo zethu zokuxhumana azixhumani nabantu abangazange ngaphambilini banikeze i-Synexus imininingwane yabo yokuxhumana. Izingcingo zingase ziqoshwe ngenhloso yokuqinisekisa ikhwalithi. Abashayayo (izingcingo eziphumayo nezingenayo) bayatshelwa uma ucingo lwabo luqoshwa.
Ukudalula Kwangaphakathi Nokwangaphandle Kolwazi Lomuntu Siqu
Ulwazi lomuntu siqu kuzokwabelwana ngalo ngaphakathi e-Synexus kanye nezinkampani ezingozakwabo nabantu bangaphandle, kubandakanye amanxusa nabahlinzeki bezinsizakalo, “uma kunesidingo sokuthi bazi” ukuze bafeze izinhloso zebhizinisi ezisemthethweni eziveziwe. Ukungena kuzingobolwazi namafolda aqukethe ulwazi lomuntu siqu kuvunyelwe kubasebenzi abafanele kuphela. I-Synexus ayihwebi noma idayise ulwazi lomuntu siqu.
Ngaphansi kwezimo ezithile, abomthetho noma iziphathimandla zingase zifune ukuthi i-Synexus idalule ulwazi oluthile lomuntu siqu njengengxenye yophenyo noma amacala asenkantolo. I-Synexus ingase idalule ulwazi lomuntu siqu kumthengisi noma omunye olandela esikhundleni uma kwenzeka kuhlanganiswa, kuhlukaniswa, kushintshwa, kuhlelwa kabusha, kuhlakazwa noma kuthengiswa noma kudluliswa i-Synexus noma enye noma yonke impahla yayo.
Izinkampani ezisebenza njengabathengisi be-Synexus kudingeka basayine izivumelwano zokuba “abacubunguli” kanye/noma zobumfihlo kanjalo bazibophezele ekucubunguleni kuphela ulwazi lomuntu siqu ngokuvumelana nezinjongo zesivumelwano futhi basebenzise izivikelo ezifanele zenhlangano nezokuphepha kobuchwepheshe.
Ukudluliselwa Kolwazi Lomuntu Siqu Emazweni Angaphandle
I-Synexus yinkampani yomhlaba wonke esebenza embonini ekhulayo emhlabeni wonke endleleni eyenza ngayo ucwaningo lwezokwelapha. Ulwazi lomuntu siqu luzodluliselwa emazweni angaphandle uma kudingeka ukuze kunakekelwe amaphrojekthi omhlaba wonke. I-Synexus igcina ulwazi lomuntu siqu kungobolwazi ezindaweni ezihlukene emhlabeni wonke, kubandakanye nelase-United States. Ezimweni ezithile, ulwazi lwe-Synexus nolomuntu siqu lwamakhasimende luzosingathwa ezinkundleni zamakhasimende ezitholakala ku-cloud ye-Inthanethi. I-Synexus iyaqaphela ukuthi amazwe amaningi emhlabeni wonke anemithetho enqanda ukusatshalaliswa kolwazi lomuntu siqu emazweni angaphandle. I-Synexus yenze amalungiselelo okuqinisekisa ukuthi ulwazi olunjalo luvikelwa ngokwanele uma kufuneka kanjalo ngokomthetho. Isibonelo, i-Synexus isebenzise iZigaba Zokuvikelwa Kolwazi Olujwayelekile (i-“SDPC”) ngenhloso yokudlulisela ulwazi oluthile lomuntu siqu lusuka ku-European Economic Area. Izakhamuzi zase-EU ezinolwazi lomuntu siqu olusingathwa ngaphansi kwala ma-SDPC zingacela ikhophi yesivumelwano e-Synexus zisebenzisa imininingwane yokuxhumana ebhalwe ngezansi. Uma izingcuphe zobumfihlo ziphansi kakhulu, isibonelo uma kuziwa ekwabeni ulwazi olunekhodi olusemqoka, i-Synexus ingase incike emvumweni enolwazi evela kubantu ukuze idlulisele ulwazi lwabo ezigungwini zomthetho ezingenazo izivikelo eziqine kakhulu zobumfihlo bolwazi.
Isaziso Nemvume
Ngesikhathi sokuqongelelwa kolwazi, i-Synexus izonikeza abantu isaziso ngolimi olucacile nolusobala mayelana nokuthi ulwazi lwabo luzosetshenziswa, ludalulwe futhi ludluliswe kanjani; ukuthi yini abangayikhetha uma kuziwa endleleni ulwazi lwabo olusingathwa ngayo; imaphi amalungelo ezolwazi abanawo ngaphansi komthetho wobumfihlo noma ngaphansi kwale Nqubomgomo; nokuthi ubani okungaxhunyanwa naye uma kunemibuzo noma izikhalazo. Lezi zaziso zobumfihlo zenzelwe izimo ezikhethekile zokuqongelelwa kolwazi. Ngokukhipha lezi zaziso, i-Synexus ifeza izibopho zayo zokungafihli lutho nokuphatha kahle abantu njengoba kufunwa yimithetho eminingi yobumfihlo bolwazi. Kuya ngendlela esetshenziswayo, isaziso singase sinikezwe umuntu ngokuqondile, sithunyelwe nge-imeyili, ngeposi, ngocingo, noma ngokusifaka kuwebhusayithi yethu.
Ezimweni eziningi, kubandakanye nalapho kufunwa khona yimithetho yobumfihlo bolwazi, kanye nalapho kuyindlela efanele yokwenza izinto, i-Synexus izofuna imvume yabantu ukuze iqongelele, isebenzise futhi idalule ulwazi lwabo ngokuvumelana nesaziso sobumfihlo esifanele. Kodwa-ke, ezimweni ezithile lapho umthetho uvuma khona, ikakhulukazi lapho ukuthola imvume kudinga umzamo omkhulu, lapho ukucutshungulwa okuhlosiwe kolwazi kuzuzisa i-Synexus noma amakhasimende ayo futhi izingcuphe zobumfihlo ziphansi, i-Synexus izoqhubeka icubungule ulwazi lomuntu siqu ngaphandle kwemvume. Futhi, i-Synexus izosebenzisa futhi idalule ulwazi lomuntu siqu ngaphandle kwemvume uma kudingwa umthetho nesinqumo senkantolo. Ngokuvumelana ne-GCP, imithetho yobumfihlo nemithetho yobumfihlo bolwazi, i-Synexus izoqongelela izimvume ezinolwazi ezidingekayo kubabambiqhaza bocwaningo egameni lamakhasimende ayo.
Ikhwalithi Yolwazi Nokugcinwa Kwamarekhodi
Ikhwalithi yolwazi nokunemba kuyizimiso ezibalulekile e-Synexus. Okubaluleke kakhulu ebuqothweni bocwaningo lwezokwelapha ukunemba kolwazi oluphathelene nababambiqhaza bocwaningo, ikakhulukazi uma luhambisana namasampula athathwe emzimbeni. Ngokuvumelana nezimfuneko zomthetho, i-Synexus isebenzisa uphiko lokuqinisekisa ikhwalithi olusebenza ngobuchwepheshe. Ngokuvamile, izaziso zethu zobumfihlo zinikeza abantu izindlela ezilula zokuqinisekisa, ukulungisa amaphutha nokushintsha ulwazi. I-Synexus igcina ulwazi lomuntu siqu ngokuvumelana nezimfuneko zezivumelwano nezomthetho.
Amalungelo Olwazi
Ezifundeni ezinemithetho yobumfihlo bolwazi, lapho kufunwa khona yizibopho zezivumelwano, i-Synexus iqinisekisa ukuthi abantu bangasebenzisa wonke amalungelo olwazi afanele uma kuziwa olwazini lwabo siqu olucutshungulwa yinkampani, kubandakanye kodwa kungagcini nje ngelungelo lokuthola nokulungisa, ukuhoxisa imvume nganoma isiphi isikhathi, ukuphikisa ukucutshungulwa kolwazi, ukucela ukusulwa kolwazi, ukunqabela izici ezithile zokucutshungulwa kolwazi, ukuvimbela ukukhangisa ngokuqondile nokucela ukudluliswa kolwazi lomuntu siqu ngendlela edijithali evamile (isib., nge-pdf) kubo noma kwenye inhlangano.
Kuzo zonke ezinye izici, uma ingekho inhloso enamandla, i-Synexus izozama ukuvumela amalungelo alandelayo olwazi ngaphansi kwale Nqubomgomo njengendlela efanele yokwenza izinto:
- ukuvumela ukufinyelelwa kwamakhophi olwazi lomuntu siqu phakathi nesikhathi esifanele;
- ukulungisa ulwazi lomuntu siqu uma lunganembile; kanye
- nokuhoxisa imvume enikezwe ngaphambilini ukuze kucutshungulwe ulwazi lomuntu siqu.
Ukuvikeleka Kolwazi
Inkampani inenqubomgomo enqala yokuvikeleka kolwazi efuna ukusebenzisa izindlela zokuvikeleka zobuchwepheshe nezenhlangano ezivikela ulwazi lomuntu siqu, ikakhulukazi ulwazi lwezokwelapha olubucayi, ukuba lungatholwa abantu abangagunyaziwe noma lulahleke. Ngokuvumelana nezimfuneko zomthetho, ikakhulukazi ngaphansi komthetho wezwe lase-U.S. neZimiso, i-Synexus ilondoloza neNqubomgomo Yokwephulwa Kwesivikelo eningiliziwe, echaza inqubo yokusingatha noma ikuphi ukwephulwa kolwazi lomuntu siqu, kubandakanye ukukhipha noma iziphi izaziso ezidingekayo eziya kubantu noma kuziphathimandla zikahulumeni.
Izinkinga Ze-inthanethi
Amakhasi eWebhu e-Synexus angase abe namalinki amawebhusayithi angaphandle kwenkampani. Amawebhusayithi axhunyanisiwe awalawulwa noma agunyazwe yi-Synexus. Le Nqubomgomo ayisebenzi kumawebhusayithi axhunyanisiwe angaphandle kwenhlangano ye-Synexus. Kunconywa ukuthi izivakashi zibukeze inqubomgomo yobumfihlo yewebhusayithi exhunyanisiwe ngayinye.
Amakhasi ethu ewebhu asebenzisa namakhukhi. Ikhukhi ifayela lolwazi elifakwa umphathi wewebhusayithi ku-hard drive yesivakashi esingena kusayithi yakhe. I-Synexus nezinkampani zangaphandle esisebenza nazo zingafaka amakhukhi ngezizathu ezilandelayo kumakhompuyutha ezivakashi ezingena kumawebhusayithi e-Synexus: ukuvumela isayithi ukuba ihlinzeke ngensizakalo ecelwa yisivakashi; ukukhumbula izivakashi ezibuyayo; ukuthuthukisa okwenziwa umsebenzisi kusayithi; ukuvumela inkampani ukuba ihlaziye isayithi; kanye nokusebenzela ukuhlinzeka ngemiyalezo yethu yezikhangiso kumawebhusayithi ethu nakwezinye izindawo eziku-inthanethi ngokusekelwe emsebenzini odlule wokuphequlula kwesivakashi.
Ubuhlobo bakho be-inthanethi ne-Synexus bungaphathwa ngokusebenzisa amasethingi atholakala kumabhrawuza amaningi e-inthanethi. Okwamanje, asiwaphenduli amasiginali athi “ungalandeleli”, kodwa amabhrawuza amaningi azovumela isivakashi ukuba sikhethe ukuthi imaphi amakhukhi angafakwa kukhompuyutha yaso futhi sisule noma sivale amakhukhi. Sicela uqaphele ukuthi ukuvala amakhukhi kungase kuvimbele isivakashi ekusebenziseni izici ezithile zamawebhusayithi e-Synexus. Ukuze uthole ulwazi olwengeziwe, sicela ubheke Inqubomgomo Yamakhukhi.
Ukuvikelwa Kobumfihlo Bezingane Ku-inthanethi
I-Synexus ayiqongeleli ulwazi ngamawebhusayithi ethu kubantu okwaziwayo ukuthi bangaphansi kweminyaka eyi-13 ubudala, futhi ayikho ingxenye yomsebenzi wethu ku-inthanethi ehloselwe noma ubani oneminyaka engaphansi kweyi-13 ubudala.
Imibuzo, Izikhalazo Nezicelo Zokusebenzisa Amalungelo
Ukuxhumana, imibuzo, izicelo zokusebenzisa amalungelo olwazi (isib., ukungena olwazini) noma izikhalazo zingathunyelwa eSikhulwini Sokuvikelwa Kolwazi, Privacy Department, Granta Park Cambridge, CB21 6GQ, United Kingdom
Ngaphansi kwesiMiso, i-Synexus Polska Sp. z o.o ewuzakwabo oyinhloko we-Synexus e-EU (“umlawuli”) ngezinhloso zokuvikelwa kolwazi, iyoba nesibopho esiyinhloko sokusingatha izindaba zokuvikelwa kolwazi ezithile amaqembu ezinkampani ase-EU. Ngezinjongo zokuthobela uMthetho, iSikhulu Sokuvikelwa Kolwazi singathintwa ngemininingwane engenhla.
Kwelase-EU, abantu banelungelo ngokomthetho lokukhononda ngendlela ulwazi lwabo olusingathwa ngayo kuziphathimandla ezengamele ezinomthwalo wokuqondisa ukuthotshelwa koMthetho. Uhlu lwazo zonke iziphathimandla ezengamele e-EU luyatholakala kuwebhusayithi ye-European Commission: http://ec.europa.eu/justice/data-protection/article-29/structure/data-protection-authorities/index_en.htm.
Isimo Somthetho Senqubomgomo Nezinguquko Zenqubomgomo
Le Nqubomgomo ayisona isivumelwano, futhi ayibeki noma imaphi amalungelo omthetho noma izibopho. I-Synexus iyaligodla ilungelo lokushintsha noma lokuchibiyela le Nqubomgomo. Isibonelo, iNqubomgomo ingase idinge ukushintshwa uma kushaywa umthetho omusha noma uchitshiyelwa. INqubomgomo ebukeziwe izofakwa ku-https://www.synexus.com/.
Igcine Ukubukezwa: 1 Januwari 2020