A FDA (Chidimbu cheChirungu che Zvokudya uye Drug istration), United States Food and Drug istration, iri muhurukuro ne OpenAI kushandiswa kwehungwaru hwekugadzira kukurumidza hurongwa hwekuongorora mishonga mitsva. Pfungwa ndeyekushandisa mhando dzemitauro dzinoshanda se Chat GPT, asi chinangwa chekugadzirisa zvikamu zvekuongorora zvinyorwa uye data ine chokuita nekuongorora zvinodhaka, kuderedza nguva inodiwa mune mamwe matanho ekupedzisira ekuongorora. Nzwisisa: 3d2l6u
Nhaurirano pakati peOpenAI neFDA 1k2d6i
Mumavhiki achangopfuura, vamiriri ve OpenAI uye kubva FDA vakapinda mumisangano yakati wandei yekukurukura nezvekushandiswa kwehungwaru hwekugadzira (AI) mukuita kwemukati mesangano, sekureva portal. Wired.
Chimwe chakanyanya kutariswa nemisangano iyi ichirongwa chinodaidzwa kuti cderGPT, izvo zvinoreva Center for Drug Evaluation and Research (CDER), ine basa rekubvumidza mishonga inonyorerwa nemishonga munyika. Chikumbiro ichi chinosanganisira mukana wekushandisa AI kukwirisa uye nekumhanyisa kuongororwa kwedata uye zvinyorwa zvine chekuita nekuvandudzwa uye kubvumidzwa kwemishonga mitsva.
Kuwedzera kune tekinoroji timu ye OpenAI, vamiririri vakabatana kune vanonzi vakapinda muhurukuro Dhipatimendi reHurumende Kubudirira, chirongwa chakabatana ne Elon musk, e Jeremy Walsh, achangogadzwa wekutanga Chief AI Officer pa FDA. Kunyange hazvo pasina chibvumirano chiri pamutemo chakasainwa, nhaurirano idzi dzinoratidza kufamba FDA yekuvandudza maitiro ayo ekutonga, kunyanya maererano nekuongorora kwesainzi uye kutonga kwemavhoriyamu makuru edata, musoro wakambokurukurwa kare na. Marty Makary, ipapo FDA:
Isu kuFDA zvino tinofanira kubvunza mibvunzo mikuru yatisati tambobvunza. Sei zvichitora makore anopfuura gumi kuti mushonga mutsva usvike kumusika? Nei tisingagadzirise neAI nemamwe matekinoroji? Isu tangopedza yedu yekutanga AI-yakabatsirwa ongororo yesainzi yechigadzirwa, uye ichi chingori mavambo.
FDA Commissioner Marty Makary pane yake X mbiri.
Uku kufarira muAI-based mhinduro kunotevera matanho apfuura OpenAI, sekutanga kwe ChatGPT Gov, vhezheni yakagadziridzwa yechatbot yayo kuti ishandiswe nehurumende, ine tarisiro yekusangana chengetedzo yedata uye zvakavanzika zvinodiwa. Kushandiswa kwemidziyo yakadai se Tsvakurudzo yeGPT, iyo yakanziwo yakataurwa munhaurirano, inogona kutsigira nekukurumidza uye kwakaringana kuongororwa kwekiriniki yekutsvagisa uye zvinyorwa zvesainzi.
Pamusoro pe OpenAI inoshandawo pakuwana zvitupa zvechirongwa FedRAMP (acronym in English for Federal Risk Management and Authorization Programme, mukuturikira mahara), iyo inodzora kushandiswa kwemasevhisi emakore nemasangano emubatanidzwa. Kuwana zvitupa zvine mwero uye nepamusoro mazinga zvinobvumidza iyo OpenAI chengetedza uye gadzira ruzivo rwehurumende rwakachengeteka zvakachengeteka, kuwedzera mikana yekubatana nemasangano ehurumende akadai FDA.
cderGPT Project 6l6nm
Chirongwa cderGPT, parizvino iri kukurukurwa pakati pe OpenAI and the FDA, ine chinangwa chekuongorora kuti hungwaru hwekugadzira hunogona sei kuita kuti nzira yakaoma yekuongorora uye kubvumidza zvinodhaka zvakanyanya kushanda. Iri zita rinoreva CDER, bazi reiyo agency inodzora pamusoro-the-the-counter nemishonga yemishonga. Chikumbiro ndechekuti cderGPT ita sechishandiso chekutsigira vaongorori vevanhu, kukurumidza kutungamira uye kuongorora mabasa, pasina kukanganisa kuchengetedzeka kwakasimba uye maitiro ekuita anodiwa mubazi rezvehutano.
Mukuita, the cderGPT inogona kuita otomatiki zviitiko zvakaita sekutarisa kukwana kwemagwaro anotumirwa nemakambani emishonga, kutanga kutariswa kwedata rekiriniki uye kunyange tsigiro mukuongorora kwekuenzanisa kushanda pakati pekurapa. Izvi hazvireve kutsiva vashandi vebazi, asi kupa rubatsiro rwehunyanzvi kuitira kuti vanoongorora vatarise pane zvine hungwaru uye zvakaomarara sarudzo. Nenzira iyi, zvinotarisirwa kuderedza zvakanyanya nguva yekupindura mune mamwe matanho ekugadzirisa, kunyanya munyaya dzemishonga inotarisana nemamiriro ezvinhu akakomba kana nemaitiro mashomanana ekurapa anowanikwa pamusika.
A FDA inotoziva kugona kwehungwaru hwekugadzira uye, kubva muna Zvita 2023, yakabhadhara mari yekutsvagisa pamusoro penyaya. Sangano rakapa rubatsiro rwekusimudzira mhando dzemitauro mikuru (LLMs) yakagadzirirwa kushandiswa mukati. Muongorori ari muchirongwa ichi anonyanya kutarisisa mashandisirwo emhando idzi munzvimbo dzakaita semushonga chaiwo, kuvandudzwa kwezvinodhaka uye sainzi yekudzora. Zvidzidzo izvi zvinotsvaga kugadzirira iyo agency kuti ibatanidze AI zvakachengeteka uye nemazvo mumaitiro ayo, kusanganisira isati yaendesa mishonga kuti iongororwe zviri pamutemo.
Pasinei nekufarira, zvakakodzera kuyeuka kuti AI yaizongoita muchikamu chekupedzisira chekuongorora. Vazhinji vanotora zvinodhaka vachiri kutadza muzvikamu zvekiriniki zvekutanga, vasati vasvika kuFDA. Kunyange zvakadaro, zvishandiso zvakafanana cderGPT inogona kukwirisa iyo documentary uye yekuongorora chikamu chemaitiro, ichizadzisa iripo nzira dzekumhanyisa.
Basa reFDA muDrug Control 2t2v62
MuUnited States, the Chikafu uye Dhaka istration (FDA) isangano remubatanidzwa rinotarisira kudzora nekudzora mishonga, chikafu, zvizorwa, zvigadzirwa zvebiological uye zvigadzirwa zvekurapa. Munyaya chaiyo yemishonga, iyo FDA Inoshanda kubva pachikamu chepre-kiriniki, kuongorora marabhoritari uye bvunzo dzemhuka, kusvika kumatanho ekiriniki muvanhu, anoitika muzvikamu zvitatu zvikuru. Chete mushure mekubudirira kupedza matanho aya makambani anogona kuendesa chikumbiro chemvumo yepamutemo (NDA - New Drug Application) Kubva ipapo, maitiro ekuongorora ne FDA Zvinogona kutora mwedzi kana kunyange kupfuura gore, zvichienderana nekuoma kwechigadzirwa uye chikamu chekutonga icho chinowira.
Kuita kwe FDA Inosanganisirawo kuongorora fekitori, post-market kuchengetedza yekutarisa (pharmacovigilance) uye nekupa zviziviso kana kutombobvisa zvigadzirwa pamusika, kana zvichidikanwa. Iyo agency inozivikanwa nekuomarara kwayo kwehunyanzvi uye kudiwa kwayo kwehumbowo hwakasimba hwekuita uye kuchengetedzeka, izvo zvinobatsira kuve nechokwadi chekuvimbwa kwevashandi vehutano uye huwandu hweAmerica muzvigadzirwa zvakabvumidzwa.
Sangano iri ratova nezvirongwa zvekukurumidza kupihwa kwemishonga yakanangana nezvirwere zvakakomba kana avo vasina nzira dzekurapa, senge. nekukurumidza track, iyo inofambisa kutaurirana pakati peFDA nemakambani kuti akurumidze kugadzirwa kwezvinodhaka; kurapa kwekubudirira, kwakanangana nekurapa kunoratidza mhedzisiro inovimbisa mumatanho ekutanga; uye kuongororwa kwekutanga kunoderedza nguva yekuongorora kwekupedzisira kubva kumwedzi gumi kusvika kumitanhatu mumatambudziko anoonekwa seanonyanya kukosha.
MuBrazil, munhu anoita basa rakafanana ndiye Agência Nacional de Vigilância Sanitária (ANVISA). Sezvakangoita iyo FDA, mumwe ANVISA ine basa rekubvumidza mishonga mitsva, ongororo yemakiriniki dossiers, kuongororwa kwehutano uye mushure mekushambadzira kwekutarisa.
Iwe unofungei nezvekufambira mberi uku mukushandiswa kweAI mukuongororwa kwezvinodhaka? Tiudze nezvazvo mashoko!
Onawo:
Source: TechCrunch e Wired.
Mavara akaongororwa na Felipe Faustino musi wa 08/05/2025
