Ngokwembali, idatha yesixhobo sonyango ibibekwe yodwa, ivaleleke kwii-silos, nganye inemigaqo yonxibelelwano eyodwa, uqhagamshelo lomzimba, amazinga okuhlaziya, kunye nesigama, kodwa inkqubela phambili ephambili ibeke izixhobo zonyango kwinqanaba lokutsiba lokuvela kwitshathi kunye namaxwebhu ukuya kuhlolo olusebenzayo lwesigulana. kunye nokungenelela.
Ukulandelwa ngeendlela ezininzi, ulwazi lwexeshana, oogqirha banokusebenzisa idatha yembali kunye nexesha langempela ukuququzelela ukuthathwa kwezigqibo zeklinikhi ngexesha langempela elisekelwe ekutshintsheni nasekuphuhliseni iindlela.
Ishishini lokhathalelo lwempilo lide ukusuka ekuqondeni ukusebenzisana kwehlabathi jikelele kwezixhobo zonyango.Nangona izikhokelo zomdibaniso kunye nohlaziyo, inkqubela phambili yetekhnoloji, imibutho yamashishini, kunye nemibutho yemigangatho, kunye neemfuno ezahlukeneyo zeshishini kunye neemfuno zeshishini zikhuthaze abanye abavelisi ukuba baphuhlise unxibelelwano, izixhobo ezininzi zonyango zisafuna ukuba iifomathi zabo zobunini ziguqulelwe kwinto esemgangathweni kwaye eqhelekileyo Inkqubo ye-IT yezempilo, zombini kwi-semantics kunye nefomathi yokuthumela imiyalezo.
Inkqubo yedatha yesixhobo sezonyango (MDDS) i-middleware iya kuqhubeka iyimfuneko ukutsala idatha kwiindidi ezithile zezixhobo zonyango usebenzisa inkcazo yomthengisi, emva koko iguqulelwe kwaye inxibelelane nerekhodi yezempilo ye-elektroniki (EHR), indawo yokugcina idatha, okanye enye inkqubo yolwazi ukuxhasa. sebenzisa iimeko ezifana ne-clinic charting, inkxaso yesigqibo seklinikhi, kunye nophando.Idatha evela kwizixhobo zonyango idibaniswe kunye nezinye iinkcukacha kwirekhodi yesigulane ukwenza umfanekiso ogcweleyo kunye opheleleyo wemeko yesigulane.
Ububanzi kunye nobubanzi bezakhono ze-MDDS ze-middleware ziququzelela iindlela apho izibhedlele, iinkqubo zempilo kunye neminye imibutho yababoneleli inokutyhila iindlela zokunyusa idatha ephuma kwisixhobo ukuya kwinkqubo yokurekhoda.Ukusetyenziswa kwedatha yokuphucula ulawulo lokhathalelo lwesigulane kunye nokwenza izigqibo zeklinikhi kuza ngokukhawuleza engqondweni-kodwa oko kukrwela kuphela umphezulu wento enokwenzeka.
Ulwazi lokuFumana iDatha
Kancinci, i-MDDS middleware kufuneka ikwazi ukubuyisela idatha ye-episodic kwisixhobo sonyango kwaye iguqulelwe kwifomathi eqhelekileyo.Ukongeza, i-middleware kufuneka ikwazi ukubuyisela idatha ngesantya esiguquguqukayo ukuhlangabezana neemfuno zezicwangciso ezahlukeneyo zokusebenza kwekliniki (umz., amagumbi otyando kunye neeyunithi zokhathalelo olunzima ngokuchasene neeyunithi zonyango-utyando).
Amaxesha okutshaja eklinikhi aqhele ukuhluka ngokweemfuno zeklinikhi ukusuka kwimizuzwana engama-30 ukuya kwiiyure ezininzi.I-higher-frequency, i-sub-second data, ibandakanya imilinganiselo ye-waveform evela kubahloli be-physiologic, i-loops ye-volume-volume loops evela kwii-ventilators zomatshini, kunye nedatha yohlobo lwe-alarm ekhutshwe kwizixhobo zonyango.
Ukusetyenziswa kwedatha yokubonisa kunye nokuhlalutya, ukuhlalutya kwangaphambili, kunye nokukwazi ukucubungula idatha eqokelelwe kwindawo yokunyamekela ukudala ulwazi olutsha kwakhona kuqhuba amazinga okuqokelela idatha.Ukukwazi ukubuyisela idatha kwimilinganiselo eguquguqukayo, kubandakanywa kwinqanaba le-sub-second, kufuna ubuchule bobugcisa kwicala lomthengisi we-middleware, kodwa kwakhona kufuna amandla okulawula ngendlela yokukhutshwa kwe-FDA, ebonisa ukuba i-middleware iyakwazi ukubonisa ukuba iye yanciphisa umngcipheko ohambelana nokunxibelelana kwedatha yefrikhwensi ephezulu yee-alamu kunye nohlalutyo-nokuba ukubeka iliso kwesigulane kunye nokungenelela.
Iimpembelelo zoNgenelelo lwexesha lokwenyani
I-Middleware inokuxhaswa ukutsala idatha kwizixhobo zonyango kwaye idibanise kunye nezinye iinkcukacha kwirekhodi yesigulane ukwenza umfanekiso ogcweleyo kunye opheleleyo wemeko yesigulane yangoku.Ukudibanisa uhlalutyo kunye nedatha yexesha langempela kwindawo yokuqokelela kudala isixhobo esinamandla sokuxela kwangaphambili kunye nenkxaso yesigqibo.
Oku kuphakamisa imibuzo ebalulekileyo ephathelele kukhuseleko lwesigulane kunye nenqanaba lomngcipheko othathwa sisibhedlele.Iimfuno zamaxwebhu esigulane zahluke njani kwiimfuno zongenelelo lwexesha lokwenyani?Yintoni ukuhamba kwedatha ngexesha lokwenyani kwaye yintoni engeyiyo?
Kuba idatha esetyenziselwa ungenelelo lwexesha lokwenyani, njengeealam zeklinikhi, zinefuthe kukhuseleko lwesigulana, nakuphi na ukulibaziseka ekuhanjisweni kwabo kubantu abachanekileyo kunokuba neziphumo ezibi.Ke ngoko, kubalulekile ukuqonda iimpembelelo zeemfuno kwi-latency yokuhanjiswa kwedatha, impendulo, kunye nokuthembeka.
Ubunakho bezisombululo ezahlukeneyo ze-middleware ziyadibana, kodwa kukho imiba esisiseko yoyilo kunye nolawulo ekufuneka ithathelwe ingqalelo, ngaphandle kweenkcukacha zesoftware okanye ukufikelela ngokwasemzimbeni kwidatha.
Usulelo lwe-FDA
Kwindawo ye-IT yezempilo, i-FDA 510 (k) imvume ilawula uqhagamshelwano lwesixhobo sonyango kunye nonxibelelwano kwiinkqubo zedatha yesixhobo sonyango.Olunye ulwahlulo phakathi kweenkqubo zedatha yezixhobo zonyango ezijoliswe ekusetyenzisweni kwetshathi kunye nokubeka iliso elisebenzayo kukuba ezo nkqubo zicinyiweyo ukuze zibekwe iliso elisebenzayo zibonise ukukwazi ukunxibelelana ngokuthembekileyo idatha kunye nee-alamu ezifunekayo kuvavanyo lwesigulane kunye nokungenelela.
Ikhono lokukhupha idatha kunye nokuguqulela kwinkqubo yokurekhoda inxalenye yento i-FDA icinga ukuba yi-MDDS.I-FDA idinga ukuba izisombululo ze-MDDS zithwale isimo se-FDA soDidi lwe-I kumaxwebhu jikelele.Eminye imiba, njengee-alamu kunye nokubeka iliso kwisigulane esisebenzayo, zingaphaya kwendawo-ukudluliselwa, ukugcinwa, ukuguqulwa kunye nokuboniswa-kwezakhono eziqhelekileyo ze-MDSS.Ngokomgaqo, ukuba i-MDDS isetyenziswe ngaphaya kokusetyenziswa kwayo, oku kutshintsha umthwalo wokongamela kunye nokuthotyelwa kwizibhedlele eziya kuthi emva koko zichazwe njengomvelisi.
Ukukhutshwa kweClass II kunokufezekiswa ngumthengisi we-middleware obonisa kwimbono yomngcipheko ukuba uye wanciphisa ngempumelelo iingozi zedatha yokusetyenziswa kungenelelo oluphilayo, oluya kuhambelana nokunxibelelana kwe-alamu okanye ukudala idatha entsha evela kwidatha eluhlaza eqokelelwe izixhobo zonyango.
Umthengisi we-middleware ukuba afune imvume yokubeka iliso kwisigulane esisebenzayo, kufuneka abe nazo zonke iitshekhi kunye nokulinganisa kwindawo yokuqinisekisa ukufumana kunye nokuhanjiswa kwazo zonke iinkcukacha zesigulane esisebenzayo ngenjongo yokungenelela ukusuka ekupheleni ukuya ekupheleni-ukusuka kwindawo yokuqokelela (isixhobo sonyango) ukuya ekuhanjisweni. iphuzu (ugqirha).Kwakhona, ukukwazi ukuhambisa ngexesha kunye nokufunyanwa kwedatha eyimfuneko yokungenelela kunye nokubeka iliso kwisigulane esisebenzayo, luluhlu olubalulekileyo.
Ukuhanjiswa kweeNkcukacha, uNxibelelwano, kunye neMfezeko
Ukuxhasa ukubeka iliso kwesigulane esisebenzayo kunye nokuhanjiswa kwedatha okuqinisekisiweyo, indlela yokunxibelelana ukusuka kwisixhobo sonyango esisecaleni kwebhedi ukuya kummkeli kufuneka aqinisekise ukuhanjiswa kwedatha ngexesha elibekiweyo.Ukwenzela ukuqinisekisa ukuhanjiswa kweenkonzo, isistim mayisoloko iliso elibukhali le ndlela yonxibelelwano kwaye inike ingxelo ukuba kwaye xa idatha ithintelwe okanye ilibazisekile ngaphaya kowona mda uphezulu owamkelekileyo wokubambezeleka nokugqiba.
Unxibelelwano olubini lwedatha luqinisekisa ukuba ukuhanjiswa kwedatha kunye nokuqinisekiswa akuthinteli okanye kuphazamisana nokusebenza kwesixhobo sonyango.Oku kubaluleke kakhulu xa kuhlolwa ulawulo lwangaphandle lwezixhobo zonyango okanye xa idatha ye-alarm ichazwa ngesigulane esisebenzayo.
Kwiinkqubo ze-middleware ezihlanjululweyo zokujongwa kwesigulane esisebenzayo, ukukwazi ukuguqula idatha kunokwenzeka.Ii-algorithms zokwenza iinguqu, ukubalwa kweziphumo eziphakamileyo, kunye nokunye ukutolika idatha kufuneka kudlule kwaye kuqinisekiswe kuzo zonke iimeko ezijoliswe kuzo zokusebenza kwisixhobo sonyango, kubandakanywa neendlela zokungaphumeleli.Ukhuseleko lwedatha, uhlaselo olukhohlakeleyo lwedatha, isixhobo sonyango, kunye nokwaliwa kwenkonzo, kunye ne-ransomware zonke zinokuchaphazela ingqibelelo yedatha kwaye ezi mfuno kufuneka zigqitywe ngeemeko ezithile kwaye ziqinisekiswe ngovavanyo.
Imigangatho yezixhobo zonyango jikelele ayizukwenzeka ngobusuku, nangona ibinomdla ukuqaphela ukufuduka okucothayo komenzi kwindlela esemgangathweni.Ulungiselelo kunye nokusebenza kulawula usuku kwihlabathi elineendleko eziphakamileyo kutyalo-mali, uphuhliso, ukufumana kunye nolawulo.Oku kuqinisa imfuno yokuba nendlela ebanzi kunye neyokukhangela phambili ekukhetheni ukudityaniswa kwesixhobo sonyango kunye nomboneleli we-middleware onokuxhasa iimfuno zobugcisa kunye neekliniki zombutho wakho wezempilo.
Ixesha lokuthumela: Jan-12-2017