Ngaba abakhupha iimveliso kunye nabaSebenzi be-Defibrillators baxakeka?

St. Jude kunye noCyber ​​Ukuxhatshazwa kweeMveliso zezoNyango

Ekupheleni konyaka we-2016 nakwiminyaka yokuqala ye-2017, iingxelo zeendaba zaphakamisa i-specter yokuba abantu abaneenjongo ezingalunganga banokuthi badibanise idilesi yonyango ekhuselweyo kwaye bangela iingxaki ezinzulu. Ngokukodwa, izixhobo ezikulo mbuzo zithengiswa nguSt. Jude Medical, Inc., kwaye zibandakanya i- pacemakers (ephethe i- sinus bradycardia kunye ne- block block ), i- defibrillators (i-ICDs) eyenza i- ventricular tachycardia kunye ne- fibrillation ye-ventricular ) kunye nezixhobo ze-CRT ( ukuphazamiseka kwentliziyo ).

Ezi ngxelo zingabangela ukwesaba phakathi kwabantu abanezixhobo zonyango ngaphandle kokubeka umba ngokwaneleyo.

Ngaba zifakelwe izixhobo zengqondo ezisemngciphekweni wokuhlaselwa kwe-cyber? Ewe, kuba nayiphi idivaysi yedijithali ebandakanya ukunxibelelana nge-wireless okungenani kunobungozi, kubandakanywa i-pacemakers, ii-ICD kunye nama-CRT. Kodwa kude kube ngoku, ukuhlaselwa kwe-cyber okwenene nakweyiphi yalezi zixhobo ezifake izicelo akuzange kubhalwe phantsi. Kwaye (sibonga inxalenye enkulu kuluntu olusandul 'ulwaziso ngokutsha, zombini izixhobo zonyango kunye nezopolitiko), i-FDA kunye nabenzi beefowuni ngoku basebenzisana kanzima ukuze banqamle nantoni na.

St Jude Jude Cardiac Devices and Hacking

Ibali lokuqala laphuka ngo-Agasti, ngo-2016 xa i-shorton-distributer Carson Block yamemezela esidlangalaleni ukuba uSt. Jude wayethengise ngamakhulu amawaka abanikezeli be-pacemakers, i-defibrillators kunye nezixhobo ze-CRT ezazisengozini kakhulu.

I-Block yathi inkampani ye-cybersecurity eyayibambisene nayo (MedSec Holdings, Inc.), yenze uphando olunzulu kwaye yafumanisa ukuba izixhobo zaseSt. Jude zazisengozini ngokukhawuleza (ngokuchaseneyo neentlobo ezifanayo zeedivayisi zonyango ezithengiswa nguMedtronic, Boston Scientific, kunye nezinye iinkampani).

Ngokukodwa, utshilo iBlock, i-St Jude systems "yayingenanto yokuzikhusela," njengezixhobo zokunciphisa, ukubethela izixhobo, kunye nezixhobo zokuchaswa ngokutsha, uhlobo oluqhelekileyo olusetyenziswa yiyo yonke imboni.

Ubuthathaka obuthatywayo buhlobene nokude, ukubeka iliso olungenazintambo kuzo zonke ezi zixhobo ezakhele kuzo. Ezi nkqubo zengqesho ezingenazintambo zenzelwe ukufumanisa ngokuzenzekelayo iingxaki zedivayisi ezikhulayo ngaphambi kokuba zikwazi ukulimaza, kwaye zixubushe ezi ngxaki ngokukhawuleza ugqirha. Esi sici esilawula kude, esiqeshwe ngabo bonke abavelisi beefowuni, siye saqulunqwa ukuba siphucule ngokukodwa ukhuseleko lwezigulane ezinemveliso. Inkqubo yokuqapha yaseSt. Yude ibizwa ngokuba yi "Merlin.net."

Izigxeko zokuvimbela zazintle kakhulu kwaye zenze ukuba kubekho ukukhawuleza kwintengo yaseSt Jude-eyayikujoliswe ngokuchanekileyo. Ingqalelo, ngaphambi kokuba enze izigwebo zakhe ngeSt Jude, inkampani yaseBlock (Muddy Waters, LLC), ithathe isikhundla esifutshane eSt. Jude. Oku kwakuthetha ukuba inkampani yeBloke yayimile ukwenza izigidi zeedola ukuba isitokisi saSt Jude siyancipha, kwaye sahlala silinganiselwe ngokwaneleyo ukukhawuleza ukuthengwa kokuvunyelwene ngu-Abbott Labs.

Emva kokuhlasela kweBlock, iSt Jude yaxoshwa ngokukhawuleza ngokukhishwa kwamaphephandaba ngokugqithiseleyo ukuba izibango zeBlock "zinyani." USude wabuye wamangalela uMaddy Waters, LLC ngenxa yokutshutshiswa kolwazi lobuxoki ukuze asebenzise iSt Jude amanani entengo. Okwangoku, abaphandi abazimeleyo bajonga umbuzo waseSt Jude umngcipheko kwaye bafika kwizigqibo ezahlukeneyo. Elinye iqela liqinisekisile ukuba izixhobo zaseSt. Jude zazisengozini ekuhlaselweni kwe-cyber; elinye iqela lagqiba ukuba babengenalo. Yonke imbango yachithwa kwi-lap of the FDA, eyaqalisa uphando olomeleleyo, kwaye ingancinci yavakala kwimiba embalwa.

Ngaloo xesha isitokhwe saSt. Jude safumana ezininzi zexabiso elilahlekileyo, kwaye ekupheleni konyaka we-2016 ukufunyanwa ngu-Abbott kwagqitywa ngempumelelo.

Emva koko, ngoJanuwari, ngo-2017, izinto ezimbini zenzeke kanyekanye. Okokuqala, i-FDA ikhuphe isitatimende esibonisa ukuba kukho iingxaki ze-cybersecurity kunye nezixhobo zonyango zeSt Jude, kwaye ukuba le ntsholongwane inokubangela ukuba i-cyber intrusions kunye nokuxhaphazwa okunokuthi kungonakalisa izigulane. Nangona kunjalo, i-FDA ibonise ukuba akukho bubungqina obufunyenweyo bokuthi ukukhwabanisa kwenzeka ngokwenene kunoma yimuphi umntu.

Okwesibini, uSt. UJude ukhulule iprojekti ye-software ye-cybersecurity eyenzelwe ukunciphisa kakhulu amathuba okungena kwizixhobo ezifakekayo. Inkqubo yesofthiwe yenzelwe ukuzifaka ngokwazo ngokuzenzekelayo nangenethiwekhi ngaphandle kweSt. Jude Merlin.net. I-FDA isincomo ukuba izigulane ezinezixhobo ziqhubeke nokusebenzisa inkqubo ye-Monitor ye-wireless ye-St Jude, kuba "izibonelelo zempilo kwizigulane ezisetyenziswayo ngokuqhubekayo kwesi sixhobo zigqithisele ingozi yokuphepha kwe-cybersecurity."

Kuphi Oku kusishiya?

Oku kukhankanywe ngokucacileyo kakhulu kuchaza inyaniso njengoko sikwaziyo kuluntu. Njengomntu owayebandakanyeke ngokuphambili kwiprogram yokuqala yokuqwalasela (ngaphandle kweSt. Jude), ndiyichaza yonke into ngale ndlela ilandelayo: Kubonakala ngathi kukho ukukhuseleka kwe-cybersecurity kwinkqubo yaseSt. , kwaye ezi zintlupheko zibonakala zingekho eziqhelekileyo kumashishini amakhulu. (Ngoko, ukuphika kukaSt. UJude kubonakala kuye kwagqithiswa.)

Ukongezelela, kubonakala ukuba uSt. UJude washukunyiswa ngokukhawuleza ukulungisa lo mkhuhlane, esebenza ngokubambisana ne-FDA, kwaye ukuba la ma nyathelo ekugqibeleni anyaneliswa yi-FDA. Enyanisweni, ukugweba ngokubambisana kwe-FDA kunye nokuba inobungozi yayisetyenziswe ngokwaneleyo nge-patch software, intsingiselo kaSt. Jude ibonakala ingaba nzima kakhulu njengoko yayitsho nguMnu Block ngo-2016. ( Ngoko ke, iingxelo zokuqala zikaMnu. Block zibonakala zigqwetshiwe). Ukongezelela, izilungiso zenziwe ngaphambi kokuba umntu akhuphe.

Ingaba uMongameli uBlock ulwaphulo olunomdla (apho ukuqhubela umgangatho weSt Jude's stock price was standing to net bucks), mhlawumbi kuye kwabangela ukuba ahlole iimeko ezinokubakho izingozi ze-cyber ezinokwenzeka, kodwa lo ngumbuzo ukuba inkundla zenze isigqibo .

Kuba ngoku kubonakala ngathi, kunye ne-software yokulungiswa kwenkqubo yesofthiwe, abantu abaneSt Jude amadivaysi abanaso isizathu esithile sokuxhalabeleka ngokuhlaselwa.

Kutheni i-Implantable Cardiac Devices ezixhatshazwayo kwi-Cyber ​​Attack?

Okwangoku abaninzi bethu bayaqonda ukuba nayiphina idijithali esisetyenziswayo ebomini bethu ebandakanya ukunxibelelana nge-wireless okungenani kunobungozi kwi-cyberattack. Oku kuquka nayiphi na ifowuni yezokwelapha, eyonke kufuneka ixhumane ngaphandle kwentambo kunye nehlabathi langaphandle (oko kukuthi, umhlaba ngaphandle komzimba).

Ubunokwenzeka ukuba abantu okanye amaqela abambelele ebubini basenokungena kwiidivaysi zonyango, kwiminyaka embalwa edlulileyo, ibonakala ngathi yingozi enkulu. Kulo mboniso, ukuvakaliswa kweentlekele ezisezantsi kweYudan kunokuba nefuthe elihle. Kucacile ukuba zombini iicandelo lezonyango zecandelo kunye ne-FDA ngoku zibucayi kakhulu ngale ngxaki, kwaye ngoku zisebenza ngamandla amakhulu ukuze zihlangane nazo.

Yintoni i-FDA eyenza malunga neNgxaki?

Ingqwalasela ye-FDA isanda kugxininiswa kulo mbandela, mhlawumbi inxalenye enkulu ngenxa yenkqubela kwiSt Jude idivayisi. NgoDisemba, ngo-2016 i-FDA ikhuphe ixwebhu le-"-guidance" yephepha le-30 kubaqulunqi bezoxhobo zonyango, ukubeka isethi emitsha yemigaqo yokujongana nokukhuselekiswa kwe-cyber kwizixhobo zonyango ezisele kwiimarike. (Imigaqo efanayo yemveliso yezobugqirha esaphantsi kokuphuhliswa yanyatheliswa ngo-2014.) Imithetho emitsha ichaza indlela abavelisi kufuneka bahambe ngayo ngokuchonga nokulungelelanisa ukukhuseleka kwe-cybersecurity kwimveliso ethengiswayo, nendlela yokuseka iinkqubo zokuchonga nokunika iingxaki zokhuseleko ezintsha.

Ngaphantsi

Ngenxa yokuba iingozi ze-cyber zihambelana naso nasiphi na inkqubo yoqhagamshelwano olungenazintambo, inqanaba elithile lobungozi be-cyber alinakugwenywa ngokusetyenziswa kwezixhobo zonyango. Kodwa kubalulekile ukwazi ukuba ukhuseleko lwakhiwe kule miveliso ukwenza ukukhwabanisa nje kuphela, nokuba uMnu. Block uyavuma ukuba ezininzi iinkampani zenzekile. Ukuba uSt. UJude uye waphila ngokukodwa malunga nale ngxaki, inkampani ibonakala iyaphiliswa yintengiso engafumanangayo ngo-2016, eyathi yatshitshisa kakhulu ishishini labo. Phakathi kwezinye izinto, uSt. UJude uye wayithumela iBhodi yeNgcebiso yezoNyango yezoKhuseleko ezizimeleyo ukujongana nemigudu yayo eya phambili. Ezinye iinkampani zedivayisi yezokwelapha ziyakulandela ukulandela. Ngaloo ndlela, zombini i-FDA kunye nabenzi bezixhobo zonyango bajongene nombandela ngokunyuka kwamandla.

Abantu abafake izixhobo ze-pacemakers, ii-ICD okanye i-CRT zixhobo kufuneka ziqwalasele umba we-cyber ubungozi, njengoko sikwazi ukuva malunga nalo njengoko ixesha lihamba. Kodwa ngoku, ubuncinci, umngcipheko ubonakala ubancinci, kwaye ngokuqinisekileyo ungaphaya kweenzuzo zokujonga iliso olude.

> Imithombo:

> FDA. Ukuxhatshazwa kwezinto ezikhuselekileyo Ukuchithwa kweziphumo kwiSt Jude Judy's Implantable Devices Cardiac Devices kunye ne-Merlin @ I-Transmitter yasekhaya: I-FDA yoNxibelelwano loKhuseleko. NgoJanuwari 9, 2017.

> Muddy Waters. INkcazelo ye-STJ / ABT Ukwamkelwa kwee-Cyber ​​Vulnerability. Inkcazelo yokushicilelwa ngoJanuwari 9, 2017.

> St Jude Medical. ISt Jude Yonyango ivakalisa ukukhutshwa kweeNkcazo zoKhuseleko ngokutsha. NgoJanuwari 9, 2017.