{"id":22924,"date":"2022-06-06T12:47:13","date_gmt":"2022-06-06T12:47:13","guid":{"rendered":"https:\/\/www.esin.av.tr\/?p=22924"},"modified":"2022-06-09T13:41:37","modified_gmt":"2022-06-09T13:41:37","slug":"saglik-sektorunde-guncel-gelismeler-5","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2022\/06\/06\/saglik-sektorunde-guncel-gelismeler-5\/","title":{"rendered":"Sa\u011fl\u0131k Sekt\u00f6r\u00fcnde G\u00fcncel Geli\u015fmeler"},"content":{"rendered":"<p><strong><a href=\"https:\/\/podcast.esin.av.tr\/?lang=tr&amp;playing=PFC7667994614?updated=1654508519\" target=\"_blank\" rel=\"noopener\"><img decoding=\"async\" class=\"alignnone wp-image-18799\" src=\"https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/02\/1.png\" alt=\"\" width=\"47\" height=\"47\" srcset=\"https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/02\/1.png 186w, https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/02\/1-150x150.png 150w\" sizes=\"(max-width: 47px) 100vw, 47px\" \/><\/a>\u00a0 \u00a0 \u00a0 \u00a0 Bu b\u00fcltenimizi podcast olarak da dinleyebilirsiniz!<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p>Ge\u00e7ti\u011fimiz haftalarda T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (Kurum) taraf\u0131ndan (i) \u00d6zel T\u0131bbi Ama\u00e7l\u0131 G\u0131dalar Ruhsat Ba\u015fvurusu Hakk\u0131nda K\u0131lavuz Tasla\u011f\u0131 ile (ii) \u00d6zel T\u0131bbi Ama\u00e7l\u0131 G\u0131dalar\u0131n Stabilite \u00c7al\u0131\u015fmalar\u0131na \u0130li\u015fkin K\u0131lavuz Tasla\u011f\u0131 ve Sa\u011fl\u0131k Bilgi Sistemleri Genel M\u00fcd\u00fcrl\u00fc\u011f\u00fc (Genel M\u00fcd\u00fcrl\u00fck) taraf\u0131ndan ise (iii) Uzaktan Sa\u011fl\u0131k Bilgi Sistemleri (USBS) K\u0131lavuzu yay\u0131mland\u0131.<\/p>\n<p>G\u00fcncel geli\u015fmeler \u00f6zelindeki notlar\u0131m\u0131za a\u015fa\u011f\u0131daki linklerden ula\u015fabilirsiniz:<\/p>\n<p><strong><a href=\"#tr1\">\u00d6zel T\u0131bbi Ama\u00e7l\u0131 G\u0131dalar\u0131n Stabilite \u00c7al\u0131\u015fmalar\u0131na \u0130li\u015fkin K\u0131lavuz Tasla\u011f\u0131 ve \u00d6zel T\u0131bbi Ama\u00e7l\u0131 G\u0131dalar Ruhsat Ba\u015fvurusu Hakk\u0131nda K\u0131lavuz Tasla\u011f\u0131 Neleri D\u00fczenlemektedir?<\/a><\/strong><strong><br \/>\n<a href=\"#tr2\">Uzaktan Sa\u011fl\u0131k Bilgi Sistemleri K\u0131lavuzu Neleri D\u00fczenlemektedir? <\/a><\/strong><\/p>\n<p><strong>\u00d6zel T\u0131bbi Ama\u00e7l\u0131 G\u0131dalar\u0131n Stabilite \u00c7al\u0131\u015fmalar\u0131na \u0130li\u015fkin K\u0131lavuz Tasla\u011f\u0131 ve \u00d6zel T\u0131bbi Ama\u00e7l\u0131 G\u0131dalar Ruhsat Ba\u015fvurusu Hakk\u0131nda K\u0131lavuz Tasla\u011f\u0131 Neleri D\u00fczenlemektedir? <\/strong><\/p>\n<p>Kurum, 24 May\u0131s 2022 tarihinde \u00d6zel T\u0131bbi Ama\u00e7l\u0131 G\u0131dalar\u0131n Stabilite \u00c7al\u0131\u015fmalar\u0131na \u0130li\u015fkin K\u0131lavuz Tasla\u011f\u0131 \u00a0(Stabilite \u00c7al\u0131\u015fmalar\u0131 K\u0131lavuz Tasla\u011f\u0131) ve \u00d6zel T\u0131bbi Ama\u00e7l\u0131 G\u0131dalar Ruhsat Ba\u015fvurusu Hakk\u0131nda K\u0131lavuz Tasla\u011f\u0131&#8217;n\u0131 (Ruhsat Ba\u015fvurusu K\u0131lavuz Tasla\u011f\u0131) yay\u0131mlad\u0131. S\u00f6z konusu taslak k\u0131lavuzlar, mevzuat \u00e7al\u0131\u015fmalar\u0131 devam etmekte olan \u00f6zel t\u0131bbi ama\u00e7l\u0131 g\u0131dalar\u0131n (\u00d6TAG) stabilite \u00e7al\u0131\u015fmalar\u0131 ve ruhsatland\u0131rma s\u00fcre\u00e7lerine ili\u015fkin d\u00fczenlemeler getirmektedir. Taslak k\u0131lavuzlara <a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=a2QyNFErV1ZzY281NldZaXQ2VFZUV21IeG94RkdjMEhRWG9ZOWluMlFuMmJvYTVCSkk2d2paM2pRU29ydGFyM1BUemp6YUNHd3hiWFdBNFo5SWY4S3UreTllZDljMEoySE1LQU1TYzU4dTFtUTU0VmoyZUx6N3ZDS0JuaUt1MTQ4TXdsUDduSXkxZXF1aW5BTzNpOURKY3JkcGlKRjV3b0pZUXVCc0dnOXJMSE1IZnpwRmJaa0R0OUdNMW5QLzNldzJudmtzQTFYWTBteHdkcUFCOGdoaDYrM1pya2pVbjY5MmtJMVZSVkV6TDVDQU5JakxnVjR0VGNzM29kb0NpVXpYMmlDL2ExT1NnR2FpRzF5RGV0WHhRWXV5M3hCRkFNREVyVmpiWDRXUzQ9&amp;rh=ff00921ee5f59e74997c67d2f143808df58a5242__;!!Hj9Y_P0nvg!U7cEXEWPXzyLlY0ZYw49md-BTDWv2ojc9ZVsrvqgFfTR8qHD5jkAeONSwcHh9Kd80fSrCwl16d6r_O8mRARnEeNsww$\">buradan <\/a>ula\u015fabilirsiniz.<\/p>\n<p>Taslak k\u0131lavuzlara ili\u015fkin g\u00f6r\u00fc\u015fler 8 Haziran 2022 tarihine kadar <a href=\"mailto:t\u0131bbi.beslenme@titck.gov.tr\">t\u0131bbi.beslenme@titck.gov.tr<\/a> e-posta adresine iletilebilecektir.<\/p>\n<p><strong>Ne De\u011fi\u015fecek?<\/strong><\/p>\n<p><em>Stabilite \u00c7al\u0131\u015fmalar\u0131 K\u0131lavuz Tasla\u011f\u0131<\/em><\/p>\n<p>Stabilite \u00c7al\u0131\u015fmalar\u0131 K\u0131lavuz Tasla\u011f\u0131 \u00d6TAG izin ba\u015fvurunda yer alan ve \u00d6TAG kalitesinin, s\u0131cakl\u0131k, nem gibi \u00e7evresel fakt\u00f6rlerin etkisi alt\u0131nda zaman i\u00e7indeki de\u011fi\u015fimine ili\u015fkin verileri sunarak raf \u00f6mr\u00fc ve saklama ko\u015fullar\u0131n\u0131 belirleyen stabilite \u00e7al\u0131\u015fmalar\u0131n\u0131 d\u00fczenlemektedir.<\/p>\n<p>K\u0131lavuz uyar\u0131nca Kurum&#8217;a en az 6 ayl\u0131k bir s\u00fcreyi i\u00e7erecek \u015fekilde (i) en az iki seri ile ger\u00e7ekle\u015ftirilmi\u015f uzun s\u00fcreli ve\u00a0 (ii) bir seri ile ger\u00e7ekle\u015ftirilmi\u015f h\u0131zland\u0131r\u0131lm\u0131\u015f stabilite \u00e7al\u0131\u015fmas\u0131n\u0131n sonucu sunulmal\u0131d\u0131r. \u00c7al\u0131\u015fmalarda, saklama ko\u015fullar\u0131na ba\u011fl\u0131 olarak etkinli\u011fi, g\u00fcvenlili\u011fi ve kalitesi de\u011fi\u015fen bitmi\u015f \u00fcr\u00fcn\u00fcn \u00f6zellikleri tespit edilmelidir. \u00c7al\u0131\u015fmalar, \u00fcretici firman\u0131n laboratuvarlar\u0131nda ya da akredite analiz laboratuvarlar\u0131nda, k\u0131lavuzda \u00f6ng\u00f6r\u00fclen \u00e7al\u0131\u015fma planlar\u0131na uygun olarak ger\u00e7ekle\u015ftirilmelidir.<\/p>\n<p>\u00c7al\u0131\u015fma sonucu elde edilen veriler ihmal edilebilir d\u00fczeyde degredasyon veya de\u011fi\u015fiklik g\u00f6steriyorsa, konuyla ilgili gerek\u00e7e sunulmas\u0131 halinde talep edilen raf \u00f6mr\u00fc, rutin istatistiksel analizler aranmaks\u0131z\u0131n onaylanacakt\u0131r. Ayr\u0131ca, ger\u00e7ek s\u00fcreye ait verilerin h\u0131zland\u0131r\u0131lm\u0131\u015f ko\u015fullara ait veriler ile desteklenmesi halinde raf \u00f6mr\u00fc ger\u00e7ek zaman \u00e7al\u0131\u015fmalar\u0131na g\u00f6re uzat\u0131labilecektir.<\/p>\n<p>\u0130lgililer, stabilite \u00e7al\u0131\u015fmalar\u0131na ba\u015flamadan \u00f6nce Kurum&#8217;a, \u00e7al\u0131\u015f\u0131lacak parametreler ve primer ambalaj de\u011fi\u015fikli\u011fi sonras\u0131 yeni \u00e7al\u0131\u015fma gerekip gerekmeyece\u011fi hususlar\u0131yla s\u0131n\u0131rl\u0131 olmak \u00fczere g\u00f6r\u00fc\u015f ba\u015fvurusunda bulunabilecektir.<\/p>\n<p><em>Ruhsat Ba\u015fvurusu K\u0131lavuz Tasla\u011f\u0131<\/em><\/p>\n<p>Ruhsat Ba\u015fvurusu K\u0131lavuz Tasla\u011f\u0131, \u00d6zel T\u0131bbi Ama\u00e7l\u0131 G\u0131dalar Ruhsatland\u0131rma Y\u00f6netmeli\u011fi uyar\u0131nca \u00d6TAG ruhsat ba\u015fvurusunda sunulmas\u0131 gereken bilgi ve belgelere y\u00f6nelik d\u00fczenlemeler i\u00e7ermektedir.<\/p>\n<p>K\u0131lavuz uyar\u0131nca, her t\u00fcrl\u00fc \u00d6TAG ruhsat ba\u015fvurusu dosyas\u0131nda (i) idari bilgiler, (ii) kaliteye ili\u015fkin bilgiler ve (iii) klinik bilgiler yer almaktad\u0131r. K\u0131lavuz her bir b\u00f6l\u00fcmde yer almas\u0131 gereken unsurlar\u0131 detayl\u0131ca d\u00fczenlemektedir. Ba\u015fvuru s\u0131ras\u0131nda, tamamlanmam\u0131\u015f veya yar\u0131da kesilmi\u015f klinik ara\u015ft\u0131rma ve\/veya ba\u015fvuruda bahsedilmeyen t\u0131bbi kullan\u0131m amac\u0131 ile ilgili tamamlanm\u0131\u015f ara\u015ft\u0131rmalarla ilgili ayr\u0131nt\u0131l\u0131 bilgiler de dahil \u00d6TAG&#8217;\u0131n lehine ve aleyhine her t\u00fcrl\u00fc bilginin sunulmas\u0131 gerekmektedir.<\/p>\n<p><strong>Uzaktan Sa\u011fl\u0131k Bilgi Sistemleri K\u0131lavuzu Neleri D\u00fczenlemektedir? <\/strong><\/p>\n<p><strong>Yeni Geli\u015fme<\/strong><\/p>\n<p>Genel M\u00fcd\u00fcrl\u00fck, 13 May\u0131s 2022 tarihinde yay\u0131mlad\u0131\u011f\u0131 USBS K\u0131lavuzu&#8217;nda ,10 \u015eubat 2022 tarihinde y\u00fcr\u00fcrl\u00fc\u011fe giren Uzaktan Sa\u011fl\u0131k Hizmetlerinin Sunumu Hakk\u0131nda Y\u00f6netmelik&#8217;te yer alan USBS&#8217;lerin sahip olmas\u0131 gereken asgari \u00f6zellikleri d\u00fczenlemi\u015ftir. K\u0131lavuza <a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=a2QyNFErV1ZzY281NldZaXQ2VFZUV21IeG94RkdjMEhRWG9ZOWluMlFuMEN3VkY2RzhtSDNFRFNDWEN3d243ZEZ0UzNrUzJINnJuajFhU2hneVhteWRnWkJyb21Jb0IvdEM3ODJ2RlhJL1ppSWl5WWN2MDhHaTNKc0g5MDFDVzJSU1hISnNxSm55MWsrMDlFVTJnUTgvdGs3ZXZORE8xZ3VlblNEcWZ5S0RSa0xVb0xaSytaZExCNmZCdGYydnR0UGFwTEdLRDYyN2dndWgxQi9xU3Q2cyt2bnBsZ0Y4V2M=&amp;rh=ff00921ee5f59e74997c67d2f143808df58a5242__;!!Hj9Y_P0nvg!U7cEXEWPXzyLlY0ZYw49md-BTDWv2ojc9ZVsrvqgFfTR8qHD5jkAeONSwcHh9Kd80fSrCwl16d6r_O8mRAQcTXNHDw$\">buradan <\/a>ula\u015fabilirsiniz.<\/p>\n<p><strong>Ne De\u011fi\u015fecek?<\/strong><\/p>\n<p>K\u0131lavuz uyar\u0131nca uzaktan sa\u011fl\u0131k hizmeti verenler, USBS&#8217;lerin Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 taraf\u0131ndan belirlenen veri tan\u0131mlar\u0131na, i\u015f kurallar\u0131na, yaz\u0131l\u0131m s\u00fcr\u00fcm notlar\u0131na, sa\u011fl\u0131k bili\u015fim standartlar\u0131na, geli\u015ftirmelere ve Genel M\u00fcd\u00fcrl\u00fck taraf\u0131ndan yay\u0131mlanan veri g\u00f6nderim servislerine uyumlu olmas\u0131n\u0131 sa\u011flamakla y\u00fck\u00fcml\u00fcd\u00fcr.<\/p>\n<p>USBS&#8217;ler Sa\u011fl\u0131k Bilgi Y\u00f6netim Sistemleri (SBYS) ile entegre olarak veya entegre edilmeksizin \u00e7al\u0131\u015fabilecektir.<\/p>\n<p>K\u0131lavuz, (i) USBS&#8217;lerde bulunmas\u0131 gereken genel nitelikler, (ii) g\u00f6r\u00fcnt\u00fc ve\/veya ses kayd\u0131 yapabilen USBS&#8217;lerde bulunmas\u0131 gereken \u00f6zellikler ve (iii) SBYS ile entegre olmadan \u00e7al\u0131\u015fabilen USBS&#8217;lerde bulunmas\u0131 gereken \u00f6zellikleri detayl\u0131 \u015fekilde d\u00fczenlemi\u015ftir. Bu kapsamda, kullan\u0131c\u0131 hesaplar\u0131n\u0131n y\u00f6netimini sa\u011flayan ve yaln\u0131zca kullan\u0131c\u0131lar\u0131n \u00e7ift fakt\u00f6rl\u00fc do\u011frulama ile eri\u015febilece\u011fi ara y\u00fczler, hatal\u0131 giri\u015f halinde CAPTCHA do\u011frulamas\u0131, ba\u015far\u0131l\u0131 ve ba\u015far\u0131s\u0131z kimlik do\u011frulama giri\u015fimlerinin kaydedilmesi, parola bilgilerinin geri d\u00f6n\u00fc\u015f\u00fcms\u00fcz olarak saklanmas\u0131, T\u00fcrk\u00e7e dil deste\u011fi sa\u011flanmas\u0131, USBS \u00fczerinden ger\u00e7ekle\u015fen ileti\u015fimin \u015fifreli olmas\u0131, ilgili sa\u011fl\u0131k personeline ili\u015fkin bilgilerin sunulmas\u0131 ve taraflar\u0131n g\u00f6r\u00fc\u015fme \u00f6ncesinde hizmet sunumuna ili\u015fkin \u015fartlar hususunda bilgilendirilmesi gibi \u00f6zelliklerin t\u00fcm USBS&#8217;lerde bulunmas\u0131 gerekmektedir.\u00a0 USBS verilerinin yurt i\u00e7inde saklanmas\u0131 ve anl\u0131k mesajla\u015fma\/g\u00f6r\u00fc\u015fme imkan\u0131 tan\u0131yan USBS sunucular\u0131n\u0131n yurt i\u00e7inde bulunmas\u0131 gerekmektedir.<\/p>\n<p>Hizmet \u00f6ncesinde ses ve\/veya g\u00f6r\u00fcnt\u00fc kayd\u0131 al\u0131nmas\u0131 hususunda taraflar\u0131n bilgilendirilerek a\u00e7\u0131k r\u0131za al\u0131nmas\u0131, ses ve\/veya g\u00f6r\u00fcnt\u00fc kay\u0131tlar\u0131n\u0131n \u015fifreli olarak saklanarak yetkisiz eri\u015fimin engellenmesi ve yasal s\u00fcre sonunda kal\u0131c\u0131 olarak silinmesi gibi \u00f6zelliklerin g\u00f6r\u00fcnt\u00fc ve\/veya ses kayd\u0131 yapabilen USBS&#8217;lerde ayr\u0131ca bulunmas\u0131 gerekmektedir.<\/p>\n<p>SBYS ile entegre olmadan \u00e7al\u0131\u015fabilen USBS&#8217;lerde; randevu al\u0131nacak poliklinik veya hekim bilgilerinin listesinin bulundurulmas\u0131 ve randevu olu\u015fturulmas\u0131, hekimin USBS \u00fczerinden ba\u015fka bir SBYS&#8217;ye ba\u011flanmadan e-re\u00e7ete ve e-rapor d\u00fczenleyebilmesi ve bulgular\u0131n\u0131 USBS&#8217;ye kaydetmesi ve\u00a0 Merkezi N\u00fcfus \u0130daresi Sistemi (MERN\u0130S) entegrasyonu gibi \u00f6zellikler bulunmal\u0131d\u0131r.<\/p>\n<p><strong>Sonu\u00e7<\/strong><\/p>\n<p>Kurum ve Genel M\u00fcd\u00fcrl\u00fck sa\u011fl\u0131k sekt\u00f6r\u00fcnde faaliyet g\u00f6steren \u015firketlere rehberlik etmeye devam etmektedir. Sa\u011fl\u0131k sekt\u00f6r\u00fcnde faaliyet g\u00f6steren t\u00fcm ilgili \u015firketler, yay\u0131mlanan k\u0131lavuzlar\u0131 yak\u0131ndan takip etmeli ve mevzuatta yer alan y\u00fck\u00fcml\u00fcl\u00fcklerini Kurum&#8217;un y\u00f6nlendirmeleri do\u011frultusunda yerine getirmelidir.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u00a0 \u00a0 \u00a0 \u00a0 Bu b\u00fcltenimizi podcast olarak da dinleyebilirsiniz! &nbsp; Ge\u00e7ti\u011fimiz haftalarda T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (Kurum) [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_stopmodifiedupdate":false,"_modified_date":"","footnotes":""},"categories":[120],"tags":[92],"class_list":["post-22924","post","type-post","status-publish","format-standard","hentry","category-legal-alerts","tag-healthcare-tr"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Sa\u011fl\u0131k Sekt\u00f6r\u00fcnde G\u00fcncel Geli\u015fmeler<\/title>\n<meta name=\"description\" content=\"\u00a0 \u00a0 \u00a0 \u00a0 Bu b\u00fcltenimizi podcast olarak da dinleyebilirsiniz! 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