frontiers.health
German Digital Healthcare Act
%5Bvc_row+equal_height%3D%22yes%22%5D%5Bvc_column%5D%5Bvc_single_image+image%3D%225169%22+img_size%3D%22full%22+alignment%3D%22center%22%5D%5Bultimate_spacer+height%3D%2230%22+height_on_tabs%3D%2215%22+height_on_tabs_portrait%3D%2215%22+height_on_mob_landscape%3D%2215%22+height_on_mob%3D%2215%22%5D%5B%2Fvc_column%5D%5B%2Fvc_row%5D%5Bvc_row+css%3D%22.vc_custom_1561037856751%7Bpadding-top%3A+20px+%21important%3Bpadding-bottom%3A+20px+%21important%3B%7D%22%5D%5Bvc_column%5D%5Bvc_column_text+el_class%3D%22post-text%22%5DThe+article+has+been+writtend+by+%3Cstrong%3EUte+Mercker%3C%2Fstrong%3E+and+%3Cstrong%3EDaniel+Steffen%3C%2Fstrong%3E+from+IBB+Beteiligungsgesellschaft+in+Berlin+.+They+shared+some+very+exciting+news+with+you%3A%C2%A0+yesterday+evening+the+German+Parliament+%2F+Bundestag+decided+to+pave+the+way+for+a+broad+usage+and+reimbursement+of+digital+health+applications+and+to+improve+the+digitization+of+the+German+healthcare+market.%0D%0A%0D%0AUntil+now%2C+apps+or+other+medical+software+offerings+for+patients+could+only+be+reimbursed+by+an+insurance+company+on+a+case-by-case+basis+or+under+special+selective+agreements.+The+first-mentioned+was+a+very+complex+process+for+the+patient+and+did+not+open+up+a+sustainable+business+model+for+the+provider+of+the+app+or+software.+A+selective+agreement+was+and+is+a+way+of+having+the+product+reimbursed+by+statutory+health+insurers%2C+but+these+agreements+were+limited+in+time+and+did+not+allow+for+comprehensive+market+coverage+in+Germany.+Once+the+contract+expired%2C+there+was+no+direct+route+to+transition+into+the+regulated+reimbursement+by+all+statutory+health+insurers+in+Germany.+The+new+Digital+Healthcare+Act+%28DVG%29+now+opens+up+a+structured+path+to+have+digital+health+applications+reimbursed+by+statutory+health+insurance+funds%2C+thus+make+them+accessible+to+patients+on+a+broad+basis.%0D%0A%0D%0ABut+what+does+the+Digital+Healthcare+Act+actually+mean+for+stakeholders+in+the+healthcare+market%3F%0D%0A%0D%0A%3Cstrong%3EWhat+are+the+key+implications+for+patients+and+providers%3F%3C%2Fstrong%3E%0D%0A%0D%0AAll+such+health+apps%2C+which+can+help+patients+to+manage+a+diagnosed+medical+condition%2C+can+from+January+2020+onwards+be+prescribed+by+their+doctors.+The+costs+are+borne+by+the+statutory+health+insurances%2C+hence+those+insurances+73+million+people+in+Germany+are+members+of.+To+receive+market+clearance%2C+apps+have+to+undergo+an+assessment+on+data+security+and+functionality+by+the+Federal+Institute+for+Drugs+and+Medical+Devices+%28BfArM%29.+It+is+important+to+know%2C+however%2C+that+statutory+health+insurances+will+reimburse+the+costs+provisionally+for+one+year+only.+In+order+to+qualify+for+cost+reimbursement%2C+providers+of+health+apps+have+to+generate+proof+for+positive+effects+on+care+for+their+respective+apps+within+these+first+twelve+months.+This+process+is+referred+to+as+the+%E2%80%9CFast+Track%E2%80%9D+into+standard+care+in+Germany.+Such+positive+effects+could+be+related+directly+to+medical+outcomes+for+patients+or+to+process+and+structural+improvements.+Providers+of+health+apps+which+already+generated+proof+for+these+positive+effects+can+now+apply+at+the+BfArM+to+become+component+of+German+reimbursed+standard+care+directly.%0D%0A%0D%0A%3Cstrong%3EWhat+does+the+act+mean+for+telemedicine+and+digitization%3F%3C%2Fstrong%3E%0D%0A%0D%0AIn+2018+the+before+then+highly+restrictive+regulation+on+distant+treatments+had+been+opened+towards+remote%2Fvideo+consultations.+Now%2C+doctors+are+allowed+to+better+inform+patients+about+their+video+offerings%2C+and+video+consultations+will+be+reimbursable.+In+addition%2C+there+will+be+stronger+incentives+and+regulations+in+place+to+further+improve+digitization+of+traditionally+paper-bound+documents%2C+e.g.+certificates+for+sick+leaves%2C+medical+reports%2C+and+prescriptions.+To+allow+for+a+more+efficient+exchange+of+data+amongst+all+stakeholders+in+the+healthcare+sector%2C+doctors%2C+hospitals%2C+and+pharmacies+are+now+obliged+to+connect+to+the+German+telematics+infrastructure.+Midwives%2C+physiotherapists+as+well+as+rehabilitation+and+nursing+facilities+can+voluntarily+join+the+telematics+infrastructure+and+will+be+reimbursed+for+that+voluntary+connection.+As+a+consequence%2C+the+relevant+preconditions+for+an+electronic+patient+file+will+highly+improve+as+well.%0D%0A%0D%0A%3Cstrong%3EDoes+it+have+an+effect+on+funding+options+for+start-ups%3F%3C%2Fstrong%3E%0D%0A%0D%0AYes%2C+it+does%21+Statutory+health+insurances+are+now+allowed+to+support+start-ups+not+only+know+how-+and+market-related%2C+but+also+financially+%E2%80%93+by+investing+directly+into+VC+funds+with+focus+on+digital+solutions+in+the+healthcare+space.+Up+to+approximately+400+million+EUR+out+of+the+financial+reserves+of+the+German+statutory+health+insurances+could+be+potentially+invested.%0D%0A%0D%0AThe+euphoria+and+excitement+in+Berlin%27s+digital+health+ecosystem+is+enormous.+And+the+speed+at+which+the+Federal+Ministry+of+Health+has+designed+the+new+law+is+worthy+of+a+start-up%3A+in+18+months+from+the+idea+to+the+passing+of+the+law.+%E2%80%9EAs+a+former+co-founder+of+a+digital-health+startup%2C+I+am+relieved+and+impressed.+Relieved%2C+as+the+%23DVG+is+a+key+milestone+in+Germany%E2%80%99s+strategy+to+leapfrog+its+health+system+into+the+21st+century.+And+impressed%2C+as+the+very+robust+but+also+rigid+German+system+is+now+taking+a+pioneering+role+to+open+up+for+digital+health+innovations.%E2%80%9D%2C+says+Dr.+Henrik+Matthies%2C+managing+director+of+Berlin+based+health+innovation+hub+%28%3Ca+href%3D%22http%3A%2F%2Fwww.hih-2025.de%2Fen%22%3Ehealth+innovation+hub%3C%2Fa%3E%29+%C2%A0%E2%80%93+think+tank+and+digital+transformation+partner+of+the+German+Ministry+of+Health.+Digital+health+start-ups+can+now+prepare+their+market+entry+in+a+clearly+defined+regulatory+environment.+Patients+can+look+forward+to+easy+and+fast+access+to+their+physician%2C+pharmacy+and+digital+healthcare+applications%2C+as+well+as+improved+medical+care.+And+we+healthcare+investors+can+better+assess+the+opportunities+for+our+portfolio+companies+to+enter+the+market.+But+let%27s+write+about+it+in+the+next+blog+post.%5B%2Fvc_column_text%5D%5B%2Fvc_column%5D%5B%2Fvc_row%5D%5Bvc_row+css%3D%22.vc_custom_1561037874898%7Bpadding-bottom%3A+20px+%21important%3B%7D%22%5D%5Bvc_column%5D%5Bvc_empty_space+height%3D%2245px%22%5D%5Bvc_custom_heading+text%3D%22MORE+STORIES%22+font_container%3D%22tag%3Ah1%7Ctext_align%3Acenter%7Ccolor%3A%2523de3014%22+use_theme_fonts%3D%22yes%22%5D%5Bcarousel_slide+id%3D%224048%22%5D%5Bvc_empty_space+height%3D%2245px%22%5D%5B%2Fvc_column%5D%5B%2Fvc_row%5D%5Bvc_row+full_width%3D%22stretch_row%22+bg_type%3D%22image%22+parallax_style%3D%22vcpb-default%22+bg_image_new%3D%22id%5E1916%7Curl%5Ehttp%3A%2F%2Ffh2019.stage.healthwareinternational.com%2Fwp-content%2Fuploads%2F2019%2F03%2Fbktg-frontiers-health-01.png%7Ccaption%5Enull%7Calt%5Enull%7Ctitle%5Ebktg+frontiers+health-01%7Cdescription%5Enull%22+bg_image_repeat%3D%22no-repeat%22+css%3D%22.vc_custom_1561456131965%7Bbackground-color%3A+%23000000+%21important%3B%7D%22%5D%5Bvc_column+width%3D%221%2F6%22%5D%5Bvc_empty_space+height%3D%2210px%22%5D%5B%2Fvc_column%5D%5Bvc_column+width%3D%222%2F3%22%5D%5Bvc_empty_space+height%3D%2245px%22%5D%5Bvc_single_image+image%3D%221120%22+img_size%3D%22medium%22+alignment%3D%22center%22%5D%5Bvc_empty_space+height%3D%2210px%22%5D%5Bvc_separator+color%3D%22white%22+border_width%3D%222%22+el_width%3D%2250%22%5D%5Bvc_empty_space+height%3D%2210px%22%5D%5Bvc_column_text+css%3D%22.vc_custom_1553793983115%7Bmargin-top%3A+15px+%21important%3Bmargin-right%3A+15px+%21important%3B%7D%22%5D%0D%0A%3Cp+style%3D%22text-align%3A+center%3B%22%3E%3Cspan+style%3D%22color%3A+%23fff%3B%22%3EIF+YOU+WOULD+LIKE+TO+TAKE+PART+IN+THE+EVENT%2C%0D%0AOR+BE+THE+FIRST+TO+FIND+OUT+ABOUT+OUR+2019+EDITION%0D%0A%3C%2Fspan%3E%5B%2Fvc_column_text%5D%5Bvc_btn+title%3D%22CONTACT+US%22+style%3D%22custom%22+custom_background%3D%22%23de3014%22+custom_text%3D%22%23ffffff%22+align%3D%22center%22+link%3D%22url%3Ahttps%253A%252F%252F2019.frontiershealth.co%252Fpage%252F1403926%252Fcontact-us%7C%7Ctarget%3A%2520_blank%7C%22+css%3D%22.vc_custom_1556782241429%7Bmargin-right%3A+15px+%21important%3Bborder-radius%3A+20px+%21important%3B%7D%22%5D%5Bvc_empty_space+height%3D%2245px%22%5D%5B%2Fvc_column%5D%5Bvc_column+width%3D%221%2F6%22%5D%5B%2Fvc_column%5D%5B%2Fvc_row%5D%3C%2Fp%3E