Digitale Gesundheitsanwendung (DiGA): „App auf Rezept” bei spezifischem Knieschmerz

* Folgende Anforderungen müssen von Herstellern mindestens erfüllt sein:

Alle DiGAs sind Medizinprodukte der Klasse I oder IIa und daher mit den strengen Qualitäts- und Sicherheitsanforderungen des Medizinproduktegesetzes konform. Die Hauptfunktion einer DiGA muss auf digitalen Technologien beruhen. Diese Hauptfunktion muss die Erkennung, Überwachung, Linderung, Behandlung oder Kompensierung von Krankheiten, Verletzungen oder Behinderungen unterstützen. Die Nutzung einer DiGA erfolgt eigenständig durch die Patient:innen oder von Leistungserbringendem und Patient:innen gemeinsam. Der Hersteller muss Nachweise zur Sicherheits- und Funktionstauglichkeit, Gewährleistung des Datenschutzes und Datensicherheit, Interoperabiltät, sowie zu positiven Versorgungseffekten erbringen.

Die digitale Gesundheitsanwendung companion patella ist ein therapeutisches Trainingsprogramm. Die Nutzung ist für Anwender:innen mit diagnostiziertem „Vorderen Knieschmerz“ vorgesehen.

Dabei werden den Nutzer:innen individualisierte Therapieinhalte evidenzbasiert und leitliniengerecht für die ärztlich diagnostizierten Indikationen „Patellofemorales Schmerzsyndrom (PFSS)“ „Patellaspitzensyndrom (PSS)“ und „Patellaerstluxation“ zum Eigentraining bereitgestellt.

Basierend auf persönlichen Angaben der Anwender:innen zu Schmerz- und Belastungsempfinden, wird der bewegungstherapeutische Trainingsplan im Verlauf der Therapie kontinuierlich an die individuellen Bedürfnisse der Nutzer:innen angepasst. Zusätzlich bereitet die digitale Gesundheitsanwendung Daten zu Krankheitsverlauf und Trainingsaktivität für die Nutzer:innen grafisch auf.

Neben der Bewegungstherapie bietet ein edukativer Bereich innerhalb der digitalen Gesundheitsanwendung sowohl krankheitsspezifische als auch allgemeine medizinische Wissensartikel.
 

Erläuterung zur medizinischen Zweckbestimmung

Companion patella ist nicht dafür bestimmt, Informationen zu liefern, die für diagnostische oder therapeutische Entscheidungen herangezogen werden.

Wichtige Informationen zur companion patella App:

Gebrauchsanweisung companion patella

companion patella verwendet den Standard FHIR® von HL7® in der Version 4.0.1. JSON Exporte erfolgen stets als DiagnosticReport Objekte, die alle für die Therapie relevanten Daten enthalten. Die für eine Implementierung erforderlichen Informationen können Sie der offiziellen Dokumentation des Standards entnehmen.

Es wird Gebrauch von folgenden Ressourcen gemacht:
DiagnosticReport (https://www.hl7.org/fhir/diagnosticreport.html)
Patient (https://hl7.org/fhir/patient.html)
Observation (https://www.hl7.org/fhir/observation.html)

Implementierungsleitfaden:
https://simplifier.net/guide/implementierungsleitfadencompanionpatella/home

Für die Nutzung von companion patella werden ein internetfähiges Endgerät (zum Beispiel Smartphone, Tablet- Desktop-PC/Laptop oder Ähnliches - minimale Auflösung von 360 x 640) sowie ein Internetzugang benötigt.

Minimale Betriebssystem-Versionen:
Android ab Version 6.0
iOS ab Version 11
Windows ab Version 7
MacOS ab Version 10.10
ChromeOS ab Version 67

Damit companion patella installiert werden kann, müssen zusätzlich folgende Bedingungen erfüllt sein:

Android:
Google Chrome Browser ab Version 73

iOS:
iOS Version 13 oder höher und Apple Safari Browser ab Version 13.4

Windows:
Google Chrome oder Microsoft Edge Browser ab Version 73

MacOS und Linux:
Google Chrome oder Microsoft Edge Browser ab Version 73

Browser-Empfehlungen - für den vollen Funktionsumfang wird einer der folgenden Browser vorausgesetzt:
Google Chrome ab Version 88
Microsoft Edge ab Version 88
Apple Safari ab Version 14
Mozilla Firefox ab Version 85

¹ Online veröffentlicht unter DiGA-Verzeichnis (BfArM): https://diga.bfarm.de/de/verzeichnis/00998 (Letzter Zugriff 09.01.2024).

² NPRS (Numeric Pain Rating Scale): 10-stufige Skala zur subjektiven Beurteilung des Schmerzes

³ Kujala-Score: Fragebogen zur Evaluation des vorderen Knieschmerzes und der Funktionseinschränkung

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⁷⁸ Wolf Petersen, Andree Ellermann, Ingo Volker Rembitzki, Sven Scheffler, Mirco Herbort, Gert Peter Brüggemann, Raymond Best, Thore Zantop, Christian Liebau. Evaluating the potential synergistic benefit of a realignment brace on patients receiving exercise therapy for patellofemoral pain syndrome: a randomized clinical trial. Archives of orthopaedic and trauma surgery. 2016;136(7):975–82. doi:10.1007/s00402-016-2464-2

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