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🚀 Navigating the DiGA Application Process: Key Insights for Digital Health Reimbursement Success 🚀 Digital Health Applications (DiGA) are transforming patient care by offering innovative solutions that improve health outcomes and disease management. In Germany, DiGA can be reimbursed by statutory health insurance, even during their one-year test period, if they meet the rigorous criteria set by BfArM. However, the path to securing reimbursement isn’t without its challenges. Common pitfalls can lead to rejection before a DiGA is even admitted to the reimbursed test phase. 🔍 Key Pitfalls to Watch Out For: 1️⃣ Insufficient evidence of positive healthcare effects and non-compliance with data protection regulations—these are the most frequent and critical issues that can derail an application. 2️⃣ Challenges with interoperability, application completeness, and QMS documentation are also significant and can lead to delays or rejections if not properly addressed. 3️⃣ Unclear medical purpose and regulatory compliance issues—while less frequent, these remain crucial for a successful application. For developers looking to enter the DiGA directory, understanding and addressing these common pitfalls is essential for a smooth application process and successful reimbursement. #DigitalHealth #DiGA #HealthTech #Reimbursement #HealthcareInnovation #HealthIT #MedTech #GDPR #Interoperability #HealthcareCompliance #BfArM #Pharma

✨ Tuve el honor de ser invitado como speaker y apoyar la organización del evento “The European Experience of Investing on Healthtech Startups” en Montevideo, donde compartí escenario con el Dr. Andreas Keck y el especialista en Salud Digital, Jefferson G Fernandes. Fue una excelente oportunidad para debatir sobre los desafíos y oportunidades que enfrentan las health techs en LATAM, comparado con los modelos de financiación europeos. 🌎💡 El Dr. Keck nos brindó una exposición brillante sobre las claves del éxito para las startups de salud en Europa y lo que buscan los inversores al momento de apostar por estas empresas. 💼💰 Sin duda, las health techs en nuestra región tienen mucho que aprender y adaptar de estas experiencias. 🙏 Quiero expresar mi más profundo agradecimiento al Dr. Keck y al Dr. Fernandes por invitarme a participar en esta valiosa sesión. Fue un placer compartir ideas y perspectivas con profesionales tan destacados en el área y espero que hayan disfrutado mucho de su estadía en Uruguay 🤝 También quiero agradecer al Uruguay Innovation Hub y Mawdy Uruguay por el apoyo para la realización del evento. Ojalá que sea el primero de muchos más! ✨ 🇬🇧 ✨ I had the honor of being invited as a speaker and supporting the organization of the event “The European Experience of Investing on Healthtech Startups” in Montevideo, where I shared the stage with Dr. Andreas Keck and Digital Health specialist, Jefferson G. Fernandes. It was a fantastic opportunity to discuss the challenges and opportunities that health techs face in LATAM compared to European funding models. 🌎💡 Dr. Keck delivered a brilliant presentation on the keys to success for health startups in Europe and what investors look for when deciding to support these companies. 💼💰 Without a doubt, health techs in our region have much to learn and adapt from these experiences. 🙏 I want to express my deepest gratitude to Dr. Keck and Dr. Fernandes for inviting me to participate in this valuable session. It was a pleasure to share ideas and perspectives with such esteemed professionals in the field and I hope you enjoyed your time in Uruguay 🤝 I also want to thank the Uruguay Innovation Hub and Mawdy Uruguay for their support in making this event possible. Hopefully, this will be the first of many more to come! ✨ Doctari Latam | Lapsi Health | Sabrina Sauksteliskis | Ines Bonicelli | Amílcar Perea | Flavio Vasques de Oliveira | Mariela Alberto | susadi | Marcia Dellepiane

Had some amazing meetings in Singapore this week with the government, hospitals as well as industry and can't wait to be back very soon (maybe even for the AI conferences in November). Next stop tonight: Dubai. Speaking at the Annual Congress of the Emirates Health Economics Society (EHES)