Marion Lepmets, Dr.

'Pride' is the first word that comes to mind. ❤️ Seeing the EU prescription go live made all the long days and complex integrations worthwhile. It paid off! Cross-border healthcare is finally digital and interoperable — for real people in real situations. Thank you to the entire team. We have built something lasting. 🙏 #EHDS #DigitalHealth #eHealth #SVC

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Dear Lava Kafle, I hope you are doing well. We are pleased to invite you to participate in Round 2 of the Delphi Study titled: “Developing a Consensus Framework for Real-Time Cybersecurity Monitoring in Internet of Medical Things (IoMT).” Based on the qualitative insights collected in Round 1, we have synthesized 53 structured statements reflecting the key themes, risks, and responsibilities identified by the expert panel. In this round, you are asked to rate the importance of each statement using a 7-point Likert scale to help establish expert consensus. Your continued participation is highly valuable for advancing a robust, consensus-based governance framework in this field.  Estimated time: 20–25 minutes  Round 2 Survey Link:  https://lnkd.in/ghUhsNsb  Deadline: Friday, 6 March 2026 Please note that responses will be analyzed in an aggregated and anonymized form. Statements that do not reach consensus may be reconsidered in a potential third round. Thank you very much for your time and expertise. If you have any questions, please do not hesitate to contact me. Kind regards, Ebrar ________________________________ Ebrar Akdeniz Research Associate Medical Device Regulatory Science Group Else Kröner Fresenius Center for Digital Health Faculty of Medicine Carl Gustav Carus Technische Universität Dresden E-Mail: [email protected] Web: https://lnkd.in/gVxa4RXj

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When health IT systems speak the same language, we enable safer, more efficient care - but without clear specifications, interoperability becomes fragmented and unreliable. That’s why Germany created ISiK (Informationsaustausch im Gesundheitswesen): a national specification developed by gematik to define how healthcare systems must exchange data using HL7 FHIR. ISiK ensures secure, standardized, and consistent communication across all players in the German healthcare ecosystem. If you’re looking for a healthcare IT solution that’s secure, truly interoperable, and ready for the future, Kodjin FHIR Server is now gematik-certified for ISiK profiles - so you know you’re covered. Read more about ISiK compliance: https://lnkd.in/er-Hbszq #hl7 #FHIR #healthIT #interoperability

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First paper published 🎉 Thank you, Prof. Martina Huemann, for your co-authorship and support. What it is about? Rather than treating autonomy as a fixed trait or ideal, we outline that experienced autonomy is a dynamic concept and full of tensions. The research identifies three dimensions of autonomy: autonomy to create, autonomy to share, and autonomy to learn. For leaders of agile project teams and organizations, this is a good reminder: granting autonomy isn’t just about giving people freedom. Recognising autonomy as a nuanced experience helps design work settings that balance freedom with guidance. If we want resilient, motivated teams, we have to move beyond the idea of autonomy as a uniform, universal good — and toward designing environments that balance freedom with clarity, connection, and support. Read the paper here: https://lnkd.in/eU_K5vaC

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I am pleased to share our latest article, co-authored with Harald Stummer, which has just been published in Digital Business and is now freely accessible to all: 📝 Title: The socio-technical adoption and diffusion of digital health innovations: The development of the STAD-HC model based on telemedicine in Germany 🔗 Read the full article here: https://lnkd.in/eYsgHYFQ 📚 About the article: Digital and telemedicine innovations play an increasingly critical role in healthcare transformation. However, their adoption is shaped not only by technological capabilities but also by institutional, cultural, and political contexts. In this study, we integrate the Diffusion of Innovations (DOI) theory with the Social Shaping of Technology (SST) approach to analyze the adoption of telemedicine in the German healthcare system. Using a secondary analysis of 12 expert interviews, we develop the Socio-Technical Adoption and Diffusion Model for Healthcare (STAD-HC) — a multi-level framework that captures the dynamic interplay between innovation processes and structural forces. 🔍 Our findings highlight how cultural skepticism, fragmented governance, and organizational inertia act as barriers, while demonstrating the value of theory integration for managing complex digital health technologies such as AI and blockchain. We hope this work provides a useful conceptual tool for researchers, policymakers, and innovation leaders in healthcare. I look forward to engaging discussions and welcome your thoughts.

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Germany’s healthcare system is under pressure: rising costs, shortage of skilled medical professionals, and a growing demand for quality emergency services. With modular setups, cloud-based solutions, and real-time integration of emergency physician expertise, the Telenotarzt system is not only driving efficiency and reducing costs but also addressing the sector’s most pressing challenges head-on. Discover how #digitalization and #connectivity can transform traditional industries like #healthcare and boost Germany’s competitive edge: https://accntu.re/40VqCrm

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"Big Tech’s new bet is healthcare.” This observation, now echoed by the Handelsblatt, reflects a broader shift that is becoming increasingly visible: 𝐡𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐢𝐬 𝐞𝐧𝐭𝐞𝐫𝐢𝐧𝐠 𝐚 𝐩𝐡𝐚𝐬𝐞 𝐰𝐡𝐞𝐫𝐞 𝐀𝐈 𝐜𝐚𝐧 𝐠𝐞𝐧𝐮𝐢𝐧𝐞𝐥𝐲 𝐞𝐱𝐩𝐚𝐧𝐝 𝐰𝐡𝐚𝐭’𝐬 𝐩𝐨𝐬𝐬𝐢𝐛𝐥𝐞. Healthcare is moving into the strategic focus of Big Tech. What’s driving this momentum is clear: rising costs, aging populations, overloaded systems, and an enormous amount of data that has not always been used. It’s no longer a simple story of AI startups versus established big players. Frontier labs and large tech players are bringing platforms, models, and infrastructure that can lift the entire field. AI is already changing parts of the system in very practical ways: - Medical scans can be analyzed faster, anomalies flagged earlier, and diagnoses supported with additional context. - In oncology and chronic care, therapies are becoming more individualized, moving closer to the specific patient instead of the average case. - Documentation, billing, scheduling, and coding consume a significant share of clinical time. This shift deserves attention, but also care. - Capacity to care for more people. - Capacity to personalize treatment. - Capacity to focus human expertise where it matters most. Technology here must earn legitimacy through transparency, reliability, and clear human oversight. If healthcare systems, regulators, clinicians, and technology providers move forward together, these new capabilities can strengthen resilience rather than concentrate dependency. The future of healthcare AI can be collaborative, responsible, and deeply human — supported by powerful technology, but guided by shared values. Source: Handelsblatt Picture and logo: Handelsblatt

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I spent two wonderful days at the MedTech Summit in Berlin - filled with thought-provoking conversations, inspiring sessions, and the chance to reconnect with familiar faces and meet many new ones. It was a great opportunity to see where the industry stands today and reflect on the challenges ahead. Thank you to everyone who made it such a rewarding experience - I’m already looking forward to next year! 🙌 📣 Summary of my presentation:  1. Start Implementing AI lifecycle for your medical devices based on the current state-of-the-art 2. Instead of focusing on checklists and requirements, look at the ML process end-to-end and integrate it into your existing QMS.  3. Make sure to address such aspects as bias, representativeness, cybersecurity, oversight and transparency throughout the lifecycle, not as an afterthought.  4. Use checklists from regulators and notified bodies as a final quality control step, not the foundation. 💡 Insights from the event:  1. AI technology is evolving far faster than regulations. It is our responsibility as industry representatives, consultants, notified bodies and regulators to collaborate on closing this gap.  2. The AI Act raises more questions than it answers. The timeline is ambitious, and clear implementation path is not in place yet.  3. GenAI is a thing, and many companies are already using it not just for internal process optimisation, but also in the products.  4. Industry continues to struggle with ML-based lifecycle and controls. We are in a big need to close the gap between technological knowledge and regulatory science. 

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Germany’s updated Digitalisation Strategy for Health sets the right focus: interoperable infrastructures, meaningful use of health data, and digital tools that genuinely improve care. https://lnkd.in/dZGtsUh6 This is a clear call for action and a necessary element of an agenda where health system is increasingly under pressure, and pressure will increase further. The challenge however is not technology alone. Tons of applications which in themselves all make somewhat sense. But. It is clinical integration, regulatory robustness, data sovereignty, and measurable benefit in real-world settings. Digital health must move from pilot projects to validated, scalable standards. Herein a new class of products, explainable regulated CE-compliant clinical AI, will play a highly relevant and needed role. In this context, CE-certified Class IIb medical software plays clearly and expectedly a distinct role. And this is why Prof. Valmed® - validated medical information GmbH is positioned as a CE-regulated medical intelligence layer — designed to support clinical decision-making within compliant IT ecosystems, with documented intended use, risk management, and post-market obligations. Digital transformation in healthcare will succeed only if innovation is evidence-based, interoperable, and aligned with regulatory and clinical reality. Dr. Vera Roedel Heinz Wiendl

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Today at the Agile Testing Days, Fabian Streitel and Florian Wartenberg (Vestas) are tackling one of the biggest challenges in our industry: The Quality Dilemma. Catch their talk: "How Much Money is Our Test Improvement Initiative Worth?" The Challenge: Cost vs. Value We all know the struggle: quantifying the cost of testing is easy, but proving its monetary value - the language decision-makers speak - is tough. How do you put a price tag on a bug that was successfully prevented? Our Solution at Vestas At Vestas, the wind turbines run on complex software, and downtime due to bugs has clear, quantifiable consequences: penalties for lost energy production. This direct link allows us to trace costs back to specific components, including software issues. By attaching a real price to potential bugs, we can accurately estimate the monetary benefit of investing in better testing processes. What the talk covers: Vestas’ test process for wind turbine control software. The Test Gap analysis initiative we launched a year ago. Our detailed cost-benefit analysis of this initiative. A comparison of our estimates vs. real-world data after implementation. Even if your domain doesn't have a direct bug-to-penalty link, our approach offers a crucial template for quantifying the financial benefits of testing. https://tmscl.me/4rjKJuG Let's change the conversation from "Testing is a cost" to "Testing is a high-value investment." #AgileTestingDays #Testing #QualityAssurance #TestManagement #ValueStream #Vestas #SoftwareTesting

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Digital health regulations and requirements in Germany are changing in 2026. 🇩🇪 Here’s a couple of changes to be aware of: 🔎 Germany’s BfARM streamlined the DiGA rules around security. Now you just need the obligatory BSI TR-03161 if you want to be listed in the DiGA directory. This is a significant change in security requirements and will definitely make it harder for apps to get listed. 🔎New standard BSI TR-03185 is in the pipeline. This is a German-specific secure software lifecycle standard similar to IEC 62304. It’s still early days but we will watch this one with interest. On the one hand, it will increase the regulatory burden. On the other, it removes some ambiguity. Meanwhile, BfARM (Bundesinstitut für Arzneimittel und Medizinprodukte) is still insisting that DiGAs need to have a GDPR certificate. But at the same time they admit there is no such certificate in existence! When a suitable certification finally comes out, they will allow a transition period for companies to get certified. My advice? Make sure you are complying with the long list of data protection criteria from BfARM. That way you should be ready if we finally see movement on GDPR certification. #dtx #compliance #dataprotection #diga #bsi #chinoio #business

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More Than Just a Tool: How AI Will Reshape IT Architectures, Security, and Value Creation in 2026 Artificial intelligence is set to fundamentally shift how organizations design systems, manage security, and create business value. Credits: All About Security #CyberSecurity #CyberResilience #DataProtection #SwissStartUp #InfoSec #CyberCrime #DigitalTransformation #CyberResilienz #Datenschutz #Cybersécurité #RésilienceCyber #Innovation #Switzerland #CyberSicurezza #AI #ITArchitecture #FutureOfSecurity https://lnkd.in/e4hXfZWe

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Human-AI Teams Deliver the Most Accurate Medical Diagnoses – New Research Shows A new international study led by the Max Planck Institute for Human Development confirms what many in the AI and healthcare communities have long suspected: the best diagnostic outcomes are achieved when humans and AI work together. The research found that mixed teams—consisting of both medical professionals and AI systems—consistently outperformed purely human or purely AI groups when diagnosing complex medical cases. Why? Because AI and humans tend to make different types of errors. These differences, rather than being a weakness, actually complement one another and lead to more accurate collective decisions. Key findings include: Hybrid teams outperform soloists: When doctors combine their medical expertise with the reasoning capabilities of large language models (LLMs), diagnostic accuracy increases significantly—especially in cases with many possible outcomes. Even one AI helps: Adding a single AI model to a group of doctors—or a single doctor to a group of AI models—improved diagnostic performance. But the best results came from teams combining several humans with several AI systems. AI ≠ infallible: While AI-only teams ranked above 85% of human diagnosticians on average, humans still outperformed AI in situations where models "hallucinated" or generated incorrect facts. The takeaway? AI should not be seen as a replacement for human intelligence but as a powerful complement. When thoughtfully integrated into clinical workflows, it enhances accuracy, reduces bias, and supports better decision-making. As we shape the future of AI in medicine and beyond, this study is a timely reminder: collaboration—not competition—is where AI shows its greatest promise. https://lnkd.in/ePwKG2-M #AI #GenAI #Cloud #CloudFirst

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𝗜𝗡𝗞𝗔 𝗵𝗮𝘀 𝗼𝗳𝗳𝗶𝗰𝗶𝗮𝗹𝗹𝘆 𝗯𝗲𝗲𝗻 𝗹𝗶𝘀𝘁𝗲𝗱 𝗶𝗻 𝘁𝗵𝗲 𝗗𝗶𝗚𝗔 𝗱𝗶𝗿𝗲𝗰𝘁𝗼𝗿𝘆 – 𝗰𝗼𝗻𝗴𝗿𝗮𝘁𝘂𝗹𝗮𝘁𝗶𝗼𝗻𝘀 𝘁𝗼 𝘁𝗵𝗲 𝗲𝗻𝘁𝗶𝗿𝗲 Dr. Pfleger Arzneimittel GmbH 𝘁𝗲𝗮𝗺! INKA is a reimbursable digital health application designed to support people undergoing treatment for incontinence. It marks Dr. Pfleger’s huge step into the digital therapeutics space and moving toward creating value beyond traditional medication. Achieving DiGA listing requires clinical evidence, regulatory rigor, and persistence. It is thus a remarkable accomplishment by everyone involved. Link to DiGA: https://lnkd.in/djQD3M7d Learn more about the project: https://lnkd.in/dZA-f9iN

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🗨️ „Health Data Reimagined – Interoperability, Structure, and Smart Use” – our CEO Dr. Florian Fuhrmann discussed this topic with Diana Meskendahl (née Fischbach) and Julian Springer at Dänische Botschaft in Deutschland on today's Life Science Days 2025. 🎤 On interoperability as a key for the future use of health data, Dr. Florian Furhmann explained: "Connecting over 130 outpatient and dozens of inpatient information systems requires common data exchange and standards. We have all agreed on FHIR, and the electronic medication list has been made mandatory. Through our KIG (Competence Center for Interoperability in the German Healthcare System), we facilitate consensus within the IT provider. We see this as a way to create positive momentum for improving data quality and interoperability. For example, FHIR structured eRx data and the ePA module in outpatient information systems have been required since October 1st. Interoperability is also the key to a successful EHDS - common semantic and technical standards are the make-or-break point." 🎤 Regarding the use of AI on health data in Germany, Fuhrmann emphasized: "AI adoption is picking up in Germany as well as in other countries but integration is more challenging compared to other countries. At gematik we want to enable integration and data flow." ➡️ As conclusion: interoperability is the foundation for the use of health data. Our focus on care processes and good data quality creates real added value for the healthcare system.

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Germany’s healthcare system is under pressure: rising costs, shortage of skilled medical professionals, and a growing demand for quality emergency services. With modular setups, cloud-based solutions, and real-time integration of emergency physician expertise, the Telenotarzt system is not only driving efficiency and reducing costs but also addressing the sector’s most pressing challenges head-on. Discover how #digitalization and #connectivity can transform traditional industries like #healthcare and boost Germany’s competitive edge: https://accntu.re/40VqCrm

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What does cloud readiness look like in healthcare? Let’s find out together in Leipzig! At the Gesundheitsforen Symposium 2025 🏥 on October 29, experts will discuss how cloud technologies are reshaping public health insurance; making data management, analytics and collaboration more efficient while keeping patient trust intact. 11:15 AM: Wolfgang Brücker will share how European cloud infrastructure can bring performance and compliance together. • GDPR-secure and healthcare-ready • Scalable and transparent by design • Built to keep data where it belongs: in Europe 🇪🇺 Learn more and join the conversation: https://lnkd.in/ekbgV4_R . . . #exoscale #sovereigncloud #healthtech #publicsector #cloudsecurity #gdprcompliance #europeancloud #cloudinnovation

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📢 How digital is Germany's healthcare system—and where is it headed? The new Future of Health & New Work special edition with Handelsblatt explores how data, AI, and smart tech are shaping a more efficient, human, and resilient healthcare future. 🔍 Insights across healthcare, pharma, and MedTech 💡 A vision for work that centers meaning, autonomy, and innovation 📄 Read more here! Note: Publication is in German #DigitalHealth #Digitalisierung #FutureOfHealth #Gesundheitswesen #Handelsblatt #HealthcareInnovation #KI #MedTech

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