Ngokomlando, idatha yedivayisi yezokwelapha iye yahlukaniswa, yavaleleka eziseleni, ngayinye inezimiso zokuxhumana ezihlukile, ukuxhumana ngokomzimba, amanani okubuyekeza, namagama, kodwa inqubekelaphambili ebalulekile ibeke imishini yezokwelapha esikhungweni sokuthuthuka kokusuka eshadini nasekubhalweni kuye ekuqashweni kwesiguli okusebenzayo. kanye nokungenelela.
Ngokulandelelwa ngolwazi oluhlukahlukene, oluthrendayo lwesikhashana, odokotela bangasebenzisa idatha yomlando neyesikhathi sangempela ukuze kube lula ukuthathwa kwezinqumo zomtholampilo zesikhathi sangempela ezisekelwe ekushintsheni nasekuguqukeni kwezitayela.
Imboni yokunakekelwa kwezempilo ikude kakhulu nokuqonda ukusebenzisana kwendawo yonke kwemishini yezokwelapha.Nakuba imihlahlandlela yenhlangano nezinguquko, intuthuko yezobuchwepheshe, izinhlangano zezimboni, nezinhlangano zamazinga, kanye nezimfuneko ezihlukahlukene zezimboni nezamabhizinisi ziye zagqugquzela abanye abakhiqizi ukuba bakhe izixhumanisi, izinsiza eziningi zezokwelapha zisadinga ukuthi izakhiwo zabo zobunikazi zihunyushelwe kokuthile okulinganiselwe futhi okujwayelekile isistimu ye-IT yezempilo, kokubili ngefomethi ye-semantics kanye nemiyalezo.
I-middleware yesistimu yedatha yedivayisi yezokwelapha (MDDS) izoqhubeka idingeka ukuze idonse idatha kusuka ezigabeni ezithile zemishini yezokwelapha kusetshenziswa imininingwane yomthengisi, bese iyihumusha futhi iyidlulisele kurekhodi lezempilo lika-elekthronikhi (EHR), inqolobane yedatha, noma olunye uhlelo lolwazi ukuze lusekele. sebenzisa izimo ezifana ne-clinical charting, ukusekelwa kwezinqumo zomtholampilo, kanye nocwaningo.Idatha evela kumishini yezokwelapha ihlanganiswa nenye idatha kurekhodi lesiguli ukuze kwakhiwe isithombe esiphelele nesiphelele sesimo sesiguli.
Ububanzi nobubanzi bamakhono e-MDDS middleware busiza izindlela izibhedlela, izinhlelo zezempilo kanye nezinye izinhlangano zabahlinzeki ezingaveza izindlela zokusebenzisa idatha egeleza isuka kudivayisi iye ohlelweni lokurekhoda.Ukusetshenziswa kwedatha ukuze kuthuthukiswe ukuphathwa kokunakekelwa kwesiguli nokwenza izinqumo zomtholampilo kufika ngokushesha engqondweni—kodwa lokho kuklwebha kuphela lokho okungenzeka.
Amandla Okubuyisa Idatha
Kancane kancane, i-MDDS middleware idinga ukwazi ukubuyisa idatha ye-episodic kusuka kudivayisi yezokwelapha futhi iyihumushele kufomethi evamile.Ukwengeza, i-middleware kufanele ikwazi ukubuyisa idatha ngesivinini esiguquguqukayo ukuze ihlangabezane nezimfuneko zezilungiselelo ezihlukahlukene zokusebenza zomtholampilo (isb., amagumbi okuhlinza aqhathaniswa namayunithi okunakekela kakhulu ngokumelene namayunithi okwelashwa nokuhlinzwa).
Izikhathi zokushadi zasemtholampilo ngokuvamile ziyahlukahluka kuye ngezidingo zomtholampilo ukusuka kumasekhondi angu-30 kuya emahoreni ambalwa.I-Higher-frequency, sub- second data, ifaka izilinganiso ze-waveform kusuka kuziqaphi ze-physiologic, amalophu evolumu yokucindezela asuka kuma-ventilators emishini, kanye nedatha yohlobo lwe-alamu ekhishwe kumadivayisi ezokwelapha.
Ukusetshenziswa kwedatha yokubonisa nokuhlaziya, ukuhlaziya okubikezelayo, kanye nekhono lokucubungula idatha eqoqwe endaweni yokunakekelwa ukuze kudale ulwazi olusha nakho kushayela amanani okuqoqwa kwedatha.Ikhono lokubuyisa idatha ngamanani aguquguqukayo, okuhlanganisa nezinga lamasekhondi amancane, lidinga amandla obuchwepheshe engxenyeni yomthengisi we-middleware, kodwa futhi lidinga amandla okulawula ngendlela yokuvunyelwa kwe-FDA, okubonisa ukuthi i-middleware iyakwazi ukukhombisa lokho. kuye kwanciphisa ubungozi obuhlobene nokuxhumana nedatha yemvamisa ephezulu yama-alamu nokuhlaziya—ngisho nokuqapha nokungenelela kwesiguli.
Imithelela Yokungenelela Kwesikhathi Sangempela
I-Middleware ingasetshenziswa ukuze idonse idatha emishinini yezokwelapha futhi ihlanganise nenye idatha kurekhodi lesiguli ukuze kwakhiwe isithombe esiphelele nesiphelele sesimo sesiguli samanje.Ukuhlanganisa ukuhlaziya nedatha yesikhathi sangempela endaweni yokuqoqwa kudala ithuluzi elinamandla lokubikezela nokusekelwa kwezinqumo.
Lokhu kuphakamisa imibuzo ebucayi ephathelene nokuphepha kwesiguli kanye nezinga lobungozi obuthathwa yisibhedlela.Izidingo zemibhalo yesiguli zihluke kanjani ezidingweni zesikhathi sangempela zokungenelela kwesiguli?Kuyini ukugeleza kwedatha kwesikhathi sangempela nokuthi yini engekho?
Ngoba idatha esetshenziselwa ukungenelela kwesikhathi sangempela, njengama-alamu omtholampilo, ithinta ukuphepha kwesiguli, noma yikuphi ukubambezeleka ekulethweni kwabo kubantu abalungile kungaba nemiphumela eyingozi.Ngakho-ke, kubalulekile ukuqonda imithelela yezidingo ekubambezelekeni kokulethwa kwedatha, impendulo, nobuqotho.
Amandla ezixazululo ezihlukahlukene ze-middleware ayagqagqana, kodwa kukhona ukucatshangelwa okuyisisekelo kwezakhiwo nokulawula okufanele kucatshangelwe, ngaphandle kwemininingwane yesofthiwe noma ukufinyelela ngokomzimba kudatha.
I-FDA Clearance
Esikhaleni se-IT sezempilo, imvume ye-FDA 510(k) ibusa ukuxhumana kwedivayisi yezokwelapha kanye nokuxhumana kumasistimu edatha yedivayisi yezokwelapha.Omunye umehluko phakathi kwezinhlelo zedatha yedivayisi yezokwelapha ezihloselwe ukusetshenziswa kweshadi nokuqapha okusebenzayo ukuthi lawo masistimu asuliwe ukuze aqaphe okusebenzayo abonise amandla okuxhumana ngokuthembekile idatha nama-alamu adingekayo ekuhlolweni kwesiguli nokungenelela.
Ikhono lokukhipha idatha futhi liyihumushele ohlelweni lokurekhoda liyingxenye yalokho i-FDA ekuthatha njenge-MDDS.I-FDA idinga ukuthi izixazululo ze-MDDS zithwale isimo se-FDA Class I ukuze kubhalwe phansi.Ezinye izici, njengama-alamu nokuqapha kwesiguli okusebenzayo, zingaphezu kobubanzi—ukudlulisa, ukugcinwa, ukuguqulwa nokuboniswa—kwamakhono ajwayelekile e-MDSS.Ngokomthetho, uma i-MDDS isetshenziswa ngaphezu kwalokho okuhlosiwe, lokhu kushintsha umthwalo wokugada nokuthobela izibhedlela ezizobizwa kamuva njengomkhiqizi.
Ukugunyazwa Kwesigaba II kungafinyelelwa ngumthengisi we-middleware obonisa ngombono wengozi ukuthi unciphise ngempumelelo izingozi zedatha ukuze zisetshenziswe ekungeneni okubukhoma, okungahambisana nokuxhumana kwe-alamu noma ukudalwa kwedatha entsha evela kudatha eluhlaza eqoqwe kusuka imishini yezokwelapha.
Ukuze umthengisi we-middleware afune imvume yokuqapha isiguli esisebenzayo, kufanele abe nakho konke ukuhlola kanye nebhalansi ukuze aqinisekise ukutholwa nokulethwa kwayo yonke idatha yesiguli esebenzayo ngezinjongo zokungenelela kusukela ekugcineni kuye ekugcineni-kusuka endaweni yokuqoqa (idivayisi yezokwelapha) ukuya ekulethweni. iphuzu (umtholampilo).Futhi, ikhono lokuletha ngesikhathi kanye nokutholwa kwedatha edingekayo yokungenelela nokuqapha okusebenzayo kwesiguli, kuwumehluko obalulekile.
Ukulethwa Kwedatha, Ukuxhumana, Nobuqotho
Ukuze kusekelwe ukuqapha kwesiguli okusebenzayo kanye nokulethwa kwedatha okuqinisekisiwe, indlela yokuxhumana esuka kudivayisi yezokwelapha eseceleni kombhede iye kumamukeli kufanele iqinisekise ukulethwa kwedatha phakathi nesikhathi esishiwo.Ukuze kuqinisekiswe ukulethwa, isistimu kufanele ihlale iqapha leyo ndlela yokuxhumana futhi ibike uma futhi lapho idatha ivinjelwa noma ibambezeleke ngalé komkhawulo omkhulu owamukelekayo wokubambezeleka nokuphuma kwemali.
Ukuxhumana okubili kwedatha kuqinisekisa ukuthi ukulethwa kwedatha nokuqinisekiswa akuvimbeli noma kuphazamisile ukusebenza kwedivayisi yezokwelapha.Lokhu kubaluleke kakhulu lapho uhlola ukulawula kwangaphandle kwemishini yezokwelapha noma uma kukhulunywa nge-alamu ngesiguli ngasinye.
Kuzinhlelo ze-middleware ezisulelwe ukuqapha okusebenzayo kwesiguli, ikhono lokuguqula idatha lingenzeka.Ama-algorithms okwenza izinguquko, ukubalwa kwemiphumela ephakeme, kanye nedatha yokuhumusha uma kungenjalo kufanele idlule futhi iqinisekiswe kuzo zonke izimo zokusebenza ezihlosiwe zedivayisi yezokwelapha, okuhlanganisa izindlela zokwehluleka.Ukuvikeleka kwedatha, ukuhlaselwa okunonya kwedatha, idivayisi yezokwelapha, nokunqatshelwa kwesevisi, kanye ne-ransomware konke kunamandla okuba nomthelela ekuthembekeni kwedatha futhi lezi zidingo kufanele ziqedwe ngezimo ezithile futhi ziqinisekiswe ngokuhlolwa.
Izindinganiso zemishini yezokwelapha yendawo yonke ngeke zenzeke ngokuphazima kweso, nakuba kuye kwathakazelisa ukuqaphela ukufuduka okunensa komkhiqizi endleleni esezingeni eliphezulu.Ukuhleleka nokusebenziseka kulawula usuku emhlabeni onezindleko eziphakeme zokutshalwa kwezimali, ukuthuthukiswa, ukutholwa, nokulawula.Lokhu kuqinisa isidingo sokuba nendlela ebanzi nebheke phambili ekukhetheni ukuhlanganiswa kwedivayisi yezokwelapha kanye nomhlinzeki we-middleware ongasekela izidingo zobuchwepheshe nezomtholampilo zenhlangano yakho yokunakekelwa kwezempilo.
Isikhathi sokuthumela: Jan-12-2017