Spotlight
Healthcare Insights

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[/av_content_slide] [av_content_slide title='vitadio' heading_tag='' heading_class='' link='' linktarget='' av_uid='av-2cvl8e1' sc_version='1.0' element_template='' one_element_template='']

[/av_content_slide] [av_content_slide title='Vitolus' heading_tag='' heading_class='' link='' linktarget='' av_uid='av-26ggrcp' sc_version='1.0' element_template='' one_element_template='']

[/av_content_slide] [av_content_slide title='White Label Advisory' heading_tag='' heading_class='' link='' linktarget='' av_uid='av-1r241zt' sc_version='1.0' element_template='' one_element_template='']

[/av_content_slide] [av_content_slide title='Ypsomed' heading_tag='' heading_class='' link='' linktarget='' av_uid='av-14oqzzt' sc_version='1.0' element_template='' one_element_template='']

[/av_content_slide] [av_content_slide title='ZOLL Itamar' heading_tag='' heading_class='' link='' linktarget='' av_uid='av-t6yqk9' sc_version='1.0' element_template='' one_element_template='']

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Der Beitrag Digital Oxygen im Inno Bytes Podcast erschien zuerst auf Digital Oxygen.

]]> https://digital-oxygen.com/de/diga-und-zukunft/ Wed, 25 Oct 2023 08:10:26 +0000 https://digital-oxygen.com/?p=23440 Vincent Erdmann und Alexander Voigt klären im neuen PM-Report Podcast über aktuelle Entwicklungen und Zukunftsperspektiven von DiGA auf.

Der Beitrag Digital Oxygen im PM-Report Podcast erschien zuerst auf Digital Oxygen.

]]>

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PM-Report Spotify Apple Podcast

Die Zukunft der digitalen Gesundheitsanwendungen (DiGA)

Erfahren Sie in der neuesten Folge des PM-Report Podcast mit Vincent Erdmann und Alexander Voigt die aktuellen Entwicklungen und Zukunftsperspektiven von digitalen Gesundheitsanwendungen (DiGA). Das Bundesgesundheitsministerium hat ein wegweisendes Digitalgesetz auf den Weg gebracht, das den DiGA-Markt verändern wird. Es werden die positiven Veränderungen für DiGAs beleuchtet sowie die Herausforderungen besprochen, denen sich DiGA-Hersteller stellen müssen.

Themen der Folge:

• Neue Gesetzesentwicklungen: Welche Chancen bietet das Digitalgesetz für DiGA-Hersteller?
• Trends: Welche Trends wie PECAN zeichnen sich international für DiGAs ab?
• Ausblick: Wie wird sich der DiGA-Markt in Zukunft entwickeln?

Dieser Podcast bietet wertvolle Einblicke für Fachpersonen im Gesundheitswesen sowie für alle, die sich für die Rolle der Digitalisierung in der modernen Gesundheitsversorgung interessieren.

Für den ganzen Podcast hier klicken.

Anfrage senden

Spotlight
Healthcare Insights

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Der Beitrag Digital Oxygen im PM-Report Podcast erschien zuerst auf Digital Oxygen.

]]> https://digital-oxygen.com/de/diga-vertrieb/ Wed, 18 Oct 2023 08:00:00 +0000 https://digital-oxygen.com/?p=23435 Torsten Christann klärt im neuen PM-Report Podcast über die Erfolgsfaktoren beim DiGA Vertrieb auf und gibt Einblicke in Fallbeispiele aus der Praxis.

Der Beitrag Digital Oxygen im PM-Report Podcast erschien zuerst auf Digital Oxygen.

]]>

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PM-Report Spotify Apple Podcast

Erfolgsfaktoren im DiGA-Vertrieb

DiGA Vertrieb – ein strategischer Spagat zwischen Ärzt:innen und Patient:innen. Wir freuen uns, über eine weitere Podcast-Episode des PM-Reports mit Torsten Christann, der tiefe Einblicke in die Dynamik des DiGA-Vertriebs gibt. Diese Folge konzentriert sich auf die Herausforderung, eine effektive Balance im DiGA-Vertrieb zu finden, indem sowohl die Bedürfnisse der Gesundheitsdienstleister als auch der Patient:innen berücksichtigt werden.

Themen der Folge:

• Dualer Ansatz im DiGA-Vertrieb: Entdecken Sie, warum eine ausgewogene Strategie, die sich sowohl auf Ärzte als auch auf Patienten konzentriert, entscheidend für den Erfolg ist.
• HCP-Kommunikation: Erfahren Sie, wie persönliche Beziehungen und kontinuierlicher Support den Unterschied in der Akzeptanz und Verordnung von DiGAs ausmachen.
• Patientenaktivierung: Verstehen Sie die Hürden, die Patienten von der aktiven Nutzung einer DiGA abhalten und wie Hersteller durch proaktive Maßnahmen die Conversion-Rate verbessern können.
• Synergien mit Pharma: Erkunden Sie die vielfältigen Möglichkeiten, wie Pharmaunternehmen den DiGA-Herstellern Unterstützung bieten können, von Vertriebspartnerschaften bis hin zu strategischen Allianzen.
• DiGA als Innovationsbrücke für Pharmaunternehmen: Verstehen Sie, warum DiGAs für Pharmaunternehmen von strategischem Interesse sind, jenseits der direkten finanziellen Aspekte.

Dieser Podcast bietet essentielle Einblicke für DiGA-Hersteller, Pharmaunternehmen und Gesundheitsprofessionals, die sich für die erfolgreiche Integration von DiGAs in das Gesundheitssystem interessieren und verstehen möchten, wie eine effektive Vertriebsstrategie gestaltet sein sollte.

Für den ganzen Podcast hier klicken.

Anfrage senden

Spotlight
Healthcare Insights

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Der Beitrag Digital Oxygen im PM-Report Podcast erschien zuerst auf Digital Oxygen.

]]> https://digital-oxygen.com/de/diga-im-versorgungsalltag/ Tue, 10 Oct 2023 08:16:57 +0000 https://digital-oxygen.com/?p=23427 Torsten Christann klärt im neuen PM-Report Podcast über den Stand von DiGA im Versorgungsalltag auf und welche Herausforderungen weiterhin bestehen.

Der Beitrag Digital Oxygen im PM-Report Podcast erschien zuerst auf Digital Oxygen.

]]>

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PM-Report Spotify Apple Podcast

DiGA im Versorgungsalltag

Wir sind stolz darauf, dass unser Managing Partner Torsten Christann im aktuellen Podcast des PM-Reports über die Integration von Digitalen Gesundheitsanwendungen (DiGA) im Versorgungsalltag spricht. In dieser Folge wird die Frage beleuchtet, inwieweit DiGA bereits im Versorgungsalltag etabliert sind und welche Herausforderungen weiterhin bestehen

Themen der Folge:

• DiGA im Alltag: Wie haben sich DiGA in der Versorgung etabliert?
• Verschreibungsprozess: Welche Herausforderungen gibt es beim Verschreibungsprozess von DiGA und wie können DiGA-Hersteller diesen Prozess unterstützen?
• Verordnungszahlen: Ein Blick auf die Verordnungszahlen von DiGA in den letzten Jahren und Prognosen für die Zukunft.
• Top DiGA: Welche DiGA sind am beliebtesten und warum?
• Pharma und DiGA: Wie können Pharmaunternehmen von DiGA profitieren und wie können sie sich in diesem Bereich engagieren?

Dieser Podcast bietet wertvolle Einblicke für Gesundheitsexperten, DiGA-Hersteller und alle, die sich für die Rolle von DiGAs in der modernen Gesundheitsversorgung interessieren.

Für den ganzen Podcast hier klicken.

Anfrage senden

Spotlight
Healthcare Insights

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[/av_content_slide] [av_content_slide title='Vitolus' heading_tag='' heading_class='' link='' linktarget='' av_uid='av-26ggrcp' sc_version='1.0' element_template='' one_element_template='']

[/av_content_slide] [av_content_slide title='White Label Advisory' heading_tag='' heading_class='' link='' linktarget='' av_uid='av-1r241zt' sc_version='1.0' element_template='' one_element_template='']

[/av_content_slide] [av_content_slide title='Ypsomed' heading_tag='' heading_class='' link='' linktarget='' av_uid='av-14oqzzt' sc_version='1.0' element_template='' one_element_template='']

[/av_content_slide] [av_content_slide title='ZOLL Itamar' heading_tag='' heading_class='' link='' linktarget='' av_uid='av-t6yqk9' sc_version='1.0' element_template='' one_element_template='']

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Der Beitrag Digital Oxygen im PM-Report Podcast erschien zuerst auf Digital Oxygen.

]]> https://digital-oxygen.com/de/diga-challenges-im-zulassungsprozess/ Wed, 04 Oct 2023 09:32:06 +0000 https://digital-oxygen.com/?p=23414 Alexander Voigt klärt im neuen PM-Report Podcast über Herausforderungen im Zulassungsprozess für digitale Gesundheitsanwendungen (DiGA) auf.

Der Beitrag Digital Oxygen im PM-Report Podcast erschien zuerst auf Digital Oxygen.

]]>

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PM-Report Spotify Apple Podcast

Herausforderungen im Zulassungsprozess

Wir sind stolz darauf, dass unser Principal Alexander Voigt als Experte im aktuellen Podcast des PM-Reports zum Thema „Herausforderungen im Zulassungsprozess“ zu Gast war. In einer fünfteiligen Reihe wird das komplexe und oft missverstandene Thema DiGA und der Zulassungsprozess gründlich beleuchtet.

Themen der Folge:

• DiGA Zulassungsprozess entschlüsselt: Alexander Voigt erklärt, wie der Zulassungsprozess funktioniert und welche Behörde zuständig ist.
• Hürden und Herausforderungen: Wo liegen die häufigsten Stolpersteine und warum scheitern manche Anträge?
• Erfolgsfaktoren für den Antrag: Was sind die Schlüsselkomponenten eines erfolgreichen DiGA-Antrags?
• Start-ups und Pharma: Sollten sich Start-ups frühzeitig an Pharmaunternehmen wenden und warum?

Dieser Podcast bietet wertvolle Einblicke für Start-ups, die den Weg der Zulassung beschreiten möchten, sowie für alle, die sich für den DiGA-Zulassungsprozess und die Rolle des BfArM interessieren.

Für den ganzen Podcast hier klicken.

Anfrage senden

Spotlight
Healthcare Insights

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Der Beitrag Digital Oxygen im PM-Report Podcast erschien zuerst auf Digital Oxygen.

]]> https://digital-oxygen.com/de/diga-mythen-und-grundlagen/ Tue, 26 Sep 2023 07:22:51 +0000 https://digital-oxygen.com/?p=23349 Vincent Erdmann klärt im neuen PM-Report Podcast über Grundlagen und Mythen bei digitalen Gesundheitsanwendungen (DiGA) auf.

Der Beitrag Digital Oxygen im PM-Report Podcast erschien zuerst auf Digital Oxygen.

]]>

Kostenfrei anhören bei

PM-Report Spotify Apple Podcast

Grundlagen und Mythen von DiGA

Wir sind stolz darauf, dass unser Project Manager Vincent Erdmann als Experte im neuesten Podcast des PM-Reports zum Thema Digitale Gesundheitsanwendungen (DiGA) zu Gast war. In einer fünfteiligen Reihe wird das komplexe und oft missverstandene Thema DiGA gründlich beleuchtet.

Themen der Folge:

• Mythen entlarven: Vincent Erdmann klärt auf, was DiGAs wirklich sind und wie sie sich von herkömmlichen Lifestyle-Apps unterscheiden.
• HCPs und DiGAs: Wie steht die Ärzteschaft zu diesen Anwendungen und wie hat sich die Meinung der Verordnerinnen und Verordner im Laufe der Zeit verändert?
• Regulatorische Herausforderungen: Wie viel Aufwand steckt hinter einem DiGA-Antrag und wie wirkt sich dies auf die DiGA-Preise aus?
• DiGA und Pharma: Wie sieht die Zusammenarbeit zwischen DiGA- und Pharma-Herstellern bereits aus und warum sind DiGAs für Pharma überhaupt interessant?

Dieser Podcast bietet wertvolle Einblicke für Fachpersonen im Gesundheitswesen sowie für alle, die sich für die Rolle der Digitalisierung in der modernen Gesundheitsversorgung interessieren.

Für den ganzen Podcast hier klicken.

Anfrage senden

Spotlight
Healthcare Insights

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Der Beitrag Digital Oxygen im PM-Report Podcast erschien zuerst auf Digital Oxygen.

]]> https://digital-oxygen.com/de/pecan-insights/ Thu, 14 Sep 2023 08:00:00 +0000 https://digital-oxygen.com/?p=22938 "In "6 Insights zu PECAN" gibt unser PECAN-Experte Vincent Erdmann Antworten auf die relevantesten Fragen rund um den PECAN-Prozess in Frankreich."

Der Beitrag 6 Insights zu „PECAN“ von Vincent Erdmann erschien zuerst auf Digital Oxygen.

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6 Insights zum Thema „PECAN“ von Vincent Erdmann

01: Was genau ist PECAN und warum sollten sich DiGA-Hersteller damit befassen?

Vincent Erdmann: PECAN, was übersetzt so viel wie „Früher Zugang zur Erstattung für digitale Medizinprodukte“ bedeutet, ist Frankreichs Initiative zur Förderung des digitalen Gesundheitssektors. Im Wesentlichen handelt es sich um das französische Äquivalent zum deutschen DiGA-Fast-Track-Verfahren. PECAN ermöglicht es, digitale Therapeutika (DTx) und Telemonitoring-Lösungen von den französischen gesetzlichen Krankenkassen erstattet zu bekommen, noch während die endgültige klinische Evidenz vorbereitet wird. Für DiGA-Hersteller ist dies eine große Chance, ihre Präsenz auf den französischen Markt auszuweiten. Dies ist insbesondere der Fall, da es nicht zwingend in Frankreich generierter Evidenz bedarf, um PECAN-tauglich zu sein.

02: Bedeutet dies, dass alle DiGA-Hersteller, die ihre Evidenzgenerierung bereits abgeschlossen haben, unmittelbar eine PECAN-Listung in Frankreich beantragen können?

Vincent Erdmann: So einfach ist es leider nicht. Aber fangen wir mit der guten Nachricht an: Gerade bei dauerhaft gelisteten DiGAs ist es in der Regel möglich, mit moderatem Aufwand die PECAN-Tauglichkeit zu erreichen.

Während die DiGA-Kernfunktionalität in der Regel beibehalten werden kann, sind dennoch Anpassungen am Produkt notwendig, da sich die technischen Anforderungen für PECAN in einigen Teilen von denen für DiGA unterscheiden. Personenbezogene Gesundheitsdaten französischer Patienten können beispielsweise nur von Cloud-Anbietern gehostet werden, die über das französische Health Data Hosting (HDS)-Zertifikat verfügen.

Auch auf der Evidenzseite müssen DiGA-Hersteller Aufwand investieren, bevor sie ihren PECAN-Antrag einreichen können. Wenn die klinische Evidenz außerhalb Frankreichs erhoben wurden, müssen die Hersteller begründen, warum der positive Versorgungseffekt auch auf das französische Gesundheitssystem übertragen werden kann. Darüber hinaus kann ein PECAN-Antrag nur eingereicht werden, wenn der Hersteller noch an einer laufenden Studie arbeitet. Andernfalls wäre die einzige Option ein Antrag auf dauerhafte Listung über die Liste erstattungsfähiger Produkte und Dienstleistungen (LPPR). Dies ist jedoch nicht attraktiv, da das LPPR-Zulassungsverfahren deutlich länger dauert als der PECAN-Prozess. Daher müssen DiGA-Hersteller, die ihre randomisierte kontrollierte Studie (RCT) bereits abgeschlossen haben, eine zusätzliche Studie durchführen, um PECAN-fähig zu sein. Die gute Nachricht ist wiederum, dass es sich nicht um ein weiteres groß angelegtes RCT handeln muss – auch eine kleinere Beobachtungsstudie kann hier ausreichen.

03: Es gibt also einige Unterschiede in Bezug auf die technischen Anforderungen und die Evidenzanforderungen. Wo gibt es sonst noch Unterschiede zwischen PECAN und DiGA?

Vincent Erdmann: PECAN ist offen für Medizinprodukte aller Risikoklassen und ermöglicht so eine Vielzahl unterschiedlicher Anwendungsfälle. Hierzulande können nur Medizinprodukte der unteren Risikoklassen I und IIa eine DiGA-Listung beantragen. Das DigiG, das jüngste Digitalisierungsgesetz des Bundesgesundheitsministeriums, soll das ändern und den DiGA-Anwendungsbereich auf die Risikoklasse IIb ausweiten. Der Gesetzentwurf muss jedoch noch durch den Bundestag und wird wahrscheinlich nicht vor Anfang 2024 in Kraft treten.

Durch die Aufnahme der Risikoklasse IIb könnten auch verstärkt Telemonitoring-Lösungen zu DiGAs werden. Bisher lag der Fokus von DiGA rein auf DTx-Lösungen. Dies ist ein weiterer wesentlicher Unterschied zu PECAN. PECAN wurde von Anfang an mit einem starken Schwerpunkt auf Telemonitoring entwickelt. Frankreich verfügt bereits über ein etabliertes Telemonitoring-Erstattungssystem, sodass die meisten der bisherigen PECAN-Anträge von Herstellern von Telemonitoring-Lösungen eingereicht wurden.

Ein weiterer wahrscheinlicher Unterschied zwischen PECAN und DiGA wird das Preisschema sein. Während DiGA-Hersteller innerhalb gewisser Grenzen ihren Preis für das erste Jahr der Listung frei bestimmen können, wird PECAN wahrscheinlich ein festes Preisschema verwenden. Stand jetzt (Mitte September ’23) wird jedoch noch über das Preisdekret für PECAN verhandelt.

04: Wenn die PECAN-Preisgestaltung noch unklar ist, sollten DiGA-Hersteller dann nicht auf den entsprechenden Erlass und weitere Erfahrungen mit dem Verfahren warten, bevor sie sich mit PECAN beschäftigen?

Vincent Erdmann: Das denke ich nicht. Zum einen, weil das Preisdekret demnächst veröffentlicht wird. Darüber hinaus werden die PECAN-Preise voraussichtlich nicht wesentlich unter den verhandelten DiGA-Preisen liegen. Auf der anderen Seite müssen selbst etablierte DiGA-Hersteller, wie bereits erwähnt, einige Anstrengungen unternehmen, um PECAN-fähig zu werden. Daher kann es sehr sinnvoll sein, bereits heute mit der Arbeit an PECAN zu beginnen.

Wir sehen sogar einen First-Mover-Vorteil für Hersteller, die sich frühzeitig bewerben. Die aktuelle Situation in Frankreich ist ähnlich zu der in Deutschland vor drei Jahren, als das DiGA-Verzeichnis startete. DiGA-Kandidaten, die sich damals beworben haben, hatten es deutlich leichter als heutige DiGA-Kandidaten. Die Gründe sind vielfältig: Die formalen Anforderungen waren damals niedriger als heute, aber auch der BfArM-Prüfprozess war weniger streng und es bestand politisches Interesse daran, erste DiGAs gelistet zu haben, um das neu geschaffene Konzept als Erfolg darstellen zu können.

Ein First Mover zu sein, bringt natürlich auch Herausforderungen mit sich. Genau wie in Deutschland vor drei Jahren werden die Hersteller der ersten PECAN-Anwendungen Anstrengungen in die Marktaufklärung investieren müssen.

05: Gibt es denn zumindest erste Erfahrungen mit dem Prozess, die Early Mover berücksichtigen können?

Vincent Erdmann: Ja, die gibt es. Die Onkologie-Anwendung Cureety ist das erste digitale Medizinprodukt, das sowohl von der Haute Autorité de Santé (HAS) als auch von der Agence du Numérique en Santé (ANS) positives Feedback zu seinem PECAN-Antrag erhalten hat. Die Entscheidungen wurden von der HAS und der ANS bereits Anfang August getroffen.

Die Erstellung des PECAN-Dossiers von Cureety wurde von unserer französischen Partnerberatung MedConsult unterstützt. MedConsult hat auch den intensiven Prüfprozess begleitet, in dem die HAS viele Rückfragen zum Dossier gestellt hat.

Mehr Einblicke aus erster Hand zu dieser Erfahrung kann MedConsult in unserem gemeinsamen „PECAN Bootcamp“ teilen. Wir haben das Bootcamp zusammen mit MedConsult und unserem anderen französischen Partnerunternehmen MD101 entwickelt, um DiGA-Herstellern die Entscheidung zu erleichtern, ob PECAN eine Chance für sie ist und zu erklären, was sie beim Eintritt in den französischen Markt erwartet. Im Bootcamp erläutern wir, wie der PECAN-Prozess funktioniert und wo die Herausforderungen und bestehenden Unklarheiten liegen. Wir decken auch den LPPR-Prozess ab, der für jeden DTx-Hersteller sechs Monate nach der PECAN-Listung beginnt.

Sobald alle ein gutes Verständnis des zugrundeliegenden Prozesses haben, bewerten wir gemeinsam die digitale Gesundheitsanwendung und die vorhandene Evidenz, um Lücken zu identifizieren, die vor dem PECAN-Antrag geschlossen werden müssen. Die Ergebnisse bilden somit die perfekte Grundlage, um zu entscheiden, ob und wie der PECAN-Prozess angegangen werden soll.

06: Wie siehst Du die Zukunft von PECAN und Digital Health in Frankreich?

Vincent Erdmann: Ich bin sehr optimistisch. Frankreich investiert derzeit 2 Milliarden Euro in die Digitalisierung seines Gesundheitssystems. PECAN ist ein klares Signal, dass die französische Regierung es ernst meint. Wie ich bereits sagte, sind noch nicht alle Details zu PECAN geklärt, aber das ist nur eine Frage der Zeit. Cureety wird nur das erste von vielen digitalen Medizinprodukten sein, die im Rahmen von PECAN erstattet werden. Und ich bin mir sicher, dass wir bald die ersten DiGAs sehen werden, die in Frankreich über den PECAN-Pfad starten.

Mehr Informationen zu PECAN finden Sie hier.

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Der Beitrag 6 Insights zu „PECAN“ von Vincent Erdmann erschien zuerst auf Digital Oxygen.

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