{"id":1,"date":"2022-04-19T12:50:17","date_gmt":"2022-04-19T10:50:17","guid":{"rendered":"https:\/\/coalalife.test\/?p=1"},"modified":"2023-01-13T13:57:02","modified_gmt":"2023-01-13T12:57:02","slug":"coala-heart-monitor-rekommenderas-av-medicintekniska-produktradet-for-inforande-i-klinisk-anvandning-i-sverige","status":"publish","type":"post","link":"https:\/\/coalasolutions.com\/se\/coala-heart-monitor-rekommenderas-av-medicintekniska-produktradet-for-inforande-i-klinisk-anvandning-i-sverige\/","title":{"rendered":"Coala Heart Monitor rekommenderas av Medicintekniska Produktr\u00e5det f\u00f6r inf\u00f6rande i klinisk anv\u00e4ndning i Sverige"},"content":{"rendered":"
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Det svenska medicintekniska produktr\u00e5det (MTP) rekommenderar anv\u00e4ndning av Coala Heart Monitor inom alla svenska sjukv\u00e5rdsregioner f\u00f6r utredning av patienter som s\u00f6ker med symtom p\u00e5 misst\u00e4nkt f\u00f6rmaksflimmer. Rekommendationen \u00e4r baserad p\u00e5 en sammantagen bed\u00f6mning av klinisk relevans, kostnadseffektivitet och datas\u00e4kerhet.<\/strong><\/p>\n<\/div>\n

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MTP-r\u00e5det utser vilka medicintekniska produkter som ing\u00e5r i nationell samverkan och ger rekommendationer om hur de b\u00f6r inf\u00f6ras och anv\u00e4ndas p\u00e5 uppdrag av Sveriges kommuner och regioner. Sedan 2020 har r\u00e5det utrett produkter f\u00f6r diagnostisering av f\u00f6rmaksflimmer genom egenregistrering.<\/p>\n

I februari i \u00e5r publicerades Tandv\u00e5rds- och l\u00e4kemedelsf\u00f6rm\u00e5nsverkets (TLV) h\u00e4lsoekonomiska bed\u00f6mning av Coala Heart Monitor Pro f\u00f6r utredning och diagnostisering av f\u00f6rmaksflimmer. Slutsatsen i bed\u00f6mningen \u00e4r att Coala Heart Monitor Pro \u00e4r kostnadsbesparande samt genererar st\u00f6rre nytta f\u00f6r patienten genom att detektera symptom i h\u00f6gre utstr\u00e4ckning och d\u00e4rigenom m\u00f6jligg\u00f6r behandling f\u00f6r att minska f\u00f6rekomsten av stroke.<\/p>\n

Som underlag f\u00f6r sin sammanv\u00e4gda bed\u00f6mning och rekommendation har MTP-r\u00e5det \u00e4ven inh\u00e4mtat en laglighetspr\u00f6vning fr\u00e5n Manolis Nymark Consulting AB avseende skyddet av personuppgifter i produkten och dess tillh\u00f6rande tj\u00e4nster.<\/p>\n

Sammantaget bed\u00f6mer MTP-r\u00e5det, med st\u00f6d av Nymarks laglighetspr\u00f6vning, att Coala Heart Monitor lever upp till kravet p\u00e5 stark autentisering i Socialstyrelsens f\u00f6reskrifter och allm\u00e4nna r\u00e5d om en v\u00e5rdgivare \u00e4r personuppgiftsansvarig f\u00f6r behandlingen av insamlade personuppgifter.<\/p>\n

\u201dDet \u00e4r sj\u00e4lvklart f\u00f6r Coala att v\u00e5r plattform och v\u00e5ra produkter inte bara ska vara kliniskt relevanta och kostnadseffektiva f\u00f6r v\u00e5rden, utan dessutom erbjuda en h\u00f6g s\u00e4kerhetsniv\u00e5 Vi \u00e4r glada \u00f6ver att MTP r\u00e5det konstaterat att s\u00e5 \u00e4r fallet. Med denna rekommendation \u00f6kar f\u00f6ruts\u00e4ttningarna f\u00f6r att hundratusentals svenskar med symptom som kan misst\u00e4nkas vara f\u00f6rmaksflimmer ska kunna anv\u00e4nda Coala Heart Monitor f\u00f6r diagnostik i vardagslivet\u201d, kommenterar Dan Pitulia, VD f\u00f6r Coala Life.<\/p>\n

MTP-r\u00e5det har vidare inh\u00e4mtat analyser avseende ink\u00f6psstrategiska fr\u00e5gest\u00e4llningar och haft dialog med flera grupper inom regionernas kunskapsstyrning samt av dessa grupper utsedda experter.<\/p>\n

MTP-r\u00e5dets laglighetspr\u00f6vning har gjorts med fokus p\u00e5 behandlingen och skyddet av personuppgifter i produkten och tillh\u00f6rande tj\u00e4nster med h\u00e4nsyn till i huvudsak Dataskyddsf\u00f6rordningen (GDPR), Lagen (2018:218) med kompletterande best\u00e4mmelser till EU:s dataskyddsf\u00f6rordning (dataskyddslagen), Offentlighets- och sekretesslagen (2009:400), Patientdatalagen (2008:355) och Socialstyrelsens kompletterande f\u00f6reskrifter och allm\u00e4nna r\u00e5d (HSLF-FS 2016:40) om journalf\u00f6ring och behandling av personuppgifter inom h\u00e4lso- och sjukv\u00e5rden.<\/p>\n<\/div>\n

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Om oss<\/strong><\/p>\n

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Coala Life \u00e4r ett svenskt medicintekniskt f\u00f6retag verksamt inom molnbaserad hj\u00e4rt- och lungdiagnostik. Bolaget har utvecklat och lanserat Coala Heart Monitor – en m\u00e5ngfaldigt prisbel\u00f6nad samt FDA- och CE-godk\u00e4nd produktplattform som m\u00f6jligg\u00f6r l\u00e5ngtids\u00f6vervakning, analys och algoritmbaserad diagnostik av hj\u00e4rta och auskultation av lungor i realtid och p\u00e5 distans. Coala Heart Monitor marknadsf\u00f6rs huvudsakligen mot v\u00e5rdgivare som f\u00f6rskriver produkt och tj\u00e4nst till patient f\u00f6r anv\u00e4ndning i vardagen och hemmilj\u00f6, utan behov att bes\u00f6ka n\u00e5gon v\u00e5rdenhet. Bolagets l\u00f6sningar bygger p\u00e5 m\u00e5ng\u00e5rig svensk forskning samt utveckling och skyddas av ett 30-tal patent. Huvudkontoret \u00e4r baserat i Uppsala och sedan 2019 \u00e4r det amerikanska dotterbolaget Coala Life Inc etablerat i Irvine, Kalifornien. Mer \u00e4n 10 000 patienter har anv\u00e4nt, diagnostiserats eller \u00e4r under l\u00e5ngtids\u00f6vervakning med Coala Heart Monitor. I Coala Care plattformen finns idag \u00f6ver 1 700 l\u00e4kare och sjuksk\u00f6terskor anslutna hos fler \u00e4n 500 v\u00e5rdgivare. F\u00f6r mer information se www.coalalife.com<\/a><\/strong><\/p>\n<\/div>\n

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F\u00f6r mer info, kontakta:<\/strong><\/p>\n

\n

Dan Pitulia, CEO Coala Life AB
\n+46 70 972 08 38,\u00a0dan.pitulia@coalasolutions.com<\/a><\/strong>
\nPhilip Siberg, Co-founder, Chief Strategy Officer and Head of IR
\n+46 70 790 67 34,\u00a0philip.siberg@coalasolutions.com<\/a><\/strong><\/p>\n

Certified Adviser
\nBolagets Certified Adviser \u00e4r Erik Penser Bank AB.
\nKontaktuppgifter: Erik Penser Bank AB, Box 7405, 103 91 Stockholm,
\ntel: +46 (0)8-463 80 00
\nemail:\u00a0certifiedadviser@penser.se<\/p>\n<\/div>\n

\n

Bifogade filer<\/strong><\/p>\n

\n

Coala Heart Monitor rekommenderas av Medicintekniska Produktr\u00e5det f\u00f6r inf\u00f6rande i klinisk anv\u00e4ndning i Sverige<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Det svenska medicintekniska produktr\u00e5det (MTP) rekommenderar anv\u00e4ndning av Coala Heart Monitor inom alla svenska sjukv\u00e5rdsregioner f\u00f6r utredning av patienter som s\u00f6ker med symtom p\u00e5 misst\u00e4nkt f\u00f6rmaksflimmer. Rekommendationen \u00e4r baserad p\u00e5 en sammantagen bed\u00f6mning av klinisk relevans, kostnadseffektivitet och datas\u00e4kerhet. 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