Digital health applications are becoming increasingly important to health care and greater clarity and greater innovation in regulatory thinking is required to ensure safety and performance without stifling innovation 💡 🔍 Real-world performance monitoring is important to gather real-time high-quality data on the performance of digital health applications and, particularly, important for adaptive tools. 🔍 Real-world data deliver information from wider patient populations, which can enable the extension of the application’s intended purpose 🔍 Proactive postmarket surveillance is an important source of real-world data but may vary in quality and can be subject to uncontrolled bias 🔍 Patient-reported and clinician-reported outcomes and high-quality surveys are important approaches for real-world data gathering for digital health applications. https://lnkd.in/eJwRJRtE
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More Relevant Posts
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Please see our latest blog on adaptive #HTA with Ursula Giedion and Pamela Góngora Salazar (DPhil). The Fast and Furious Journey of Adaptive Health Technology Assessment in Low- and Middle-Income Countries Perspective matters (policymakers have different needs and risk tolerances compared to academics) and there is no free lunch (adaptive approaches might lead to inaccuracies, particularly on costs) #priority setting, #UHC
The Fast and Furious Journey of Adaptive Health Technology Assessment in Low- and Middle-Income Countries
cgdev.org
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Patients are willing to share their data. But it matters who asks. In a new survey about patient willingness to share health data, two things are clear: Most patients are willing to consent to sharing health data. However, that willingness goes down depending on whom the recipient is. Patients were the most willing to share health data with clinicians and family, and the least willing to share with government organizations and tech companies. A clear message to digital health founders: you won't get patients' data easily. Source: Rock Health and MedTech Pulse.
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The newly applied EU Health Technology Assessment (#HTA) Regulation and the upcoming European Health Data Space (#EHDS) Regulation are poised to revolutionise health policy in Europe. Together, they will streamline the assessment of health technologies, enhance access to data, and improve decision-making across Member States. The #EDiHTA project plays a crucial role in this landscape, bridging the gap by establishing a framework for assessing Digital Health Technologies (#DHTs), ensuring the involvement of all stakeholders, including patients. 🔍 Curious about how the EU's policy changes will impact digital health and HTA practices? Read the full article 👉 https://lnkd.in/eNgS9Pfa European Patients' Forum
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Sync fast and solve things—best practices for responsible digital health - npj Digital Medicine Title: Sync fast and solve things—best practices for responsible digital health #Introduction: The blog post discusses best practices for responsible digital health implementation, emphasizing the importance of syncing quickly to solve healthcare challenges. #Understanding the digital health landscape: Exploring the current digital health landscape and the need for responsible implementation to ensure positive outcomes for patients and healthcare providers. #Challenges in digital health implementation: Identifying common challenges in digital health implementation, such as interoperability issues, data security concerns, and regulatory compliance. #Best practices for responsible digital health: Providing recommendations for responsible digital health implementation, including prioritizing interoperability, ensuring data security, and complying with regulations. #Syncing fast to solve things: Highlighting the importance of syncing quickly to ai.mediformatica.com #health #digital #digitalhealth #innovation #regulation #digitalhealthinnovation #healthinnovation #bestpractices #governance #privacy #medicine #study #healthit #healthtech #healthcaretechnology @MediFormatica (https://buff.ly/3wsfB4A)
Sync fast and solve things—best practices for responsible digital health
nature.com
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Our CEO shares valuable insights on a critical challenge in digital health: Digital health leaders in pharma face an overwhelming array of technology choices. See more for expert perspective on making informed choices in digital health technology. #DigitalHealth #Pharma #HealthTech #Innovation #SibelHealth
CEO @ Sibel Health | Ruth K. Freinkel MD Professor @ Northwestern University | Physician Engineer | Digital Health Leader | Board Certified Dermatologist | Head of the Medical Advisory Board - Geologie
Digital health leaders in pharma are overwhelmed with choices in digital health technology. Validation and trust in the technology are key to making the right decision.
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CEO @ Sibel Health | Ruth K. Freinkel MD Professor @ Northwestern University | Physician Engineer | Digital Health Leader | Board Certified Dermatologist | Head of the Medical Advisory Board - Geologie
Digital health leaders in pharma are overwhelmed with choices in digital health technology. Validation and trust in the technology are key to making the right decision.
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In 2024, the CMS Innovation Center launched a new initiative to strengthen the focus on quality in our models. Since its launch, the Quality Pathway Initiative has refined new approaches to model design, emphasized person-centered care in models, and bolstered evaluation approaches. Read more about implementation of the Quality Pathway and how it helps to improve care through rapid dissemination and expansion of successful model tests in today’s Health Affairs Forefront blog: go.cms.gov/quality-pathway.
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New guidance for using real-world data from EHRs in health technology assessments. https://lnkd.in/dkfQWyug #healthcare #HTA #realworlddata #EHR #ISPOR
Assessing Real-World Data From Electronic Health Records for Health Technology Assessment: The SUITABILITY Checklist: A Good Practices Report of an ISPOR Task Force [Editor's Choice]
ispor.org
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𝐒𝐡𝐨𝐮𝐥𝐝 𝐨𝐮𝐫 𝐡𝐞𝐚𝐥𝐭𝐡 𝐬𝐲𝐬𝐭𝐞𝐦 𝐢𝐧𝐯𝐞𝐬𝐭 𝐢𝐧 𝐝𝐞𝐯𝐢𝐜𝐞-𝐛𝐚𝐬𝐞𝐝 𝐑𝐞𝐦𝐨𝐭𝐞-𝐏𝐚𝐭𝐢𝐞𝐧𝐭 𝐌𝐨𝐧𝐢𝐭𝐨𝐫𝐢𝐧𝐠 (𝐑𝐏𝐌) 𝐨𝐫 𝐃𝐢𝐠𝐢𝐭𝐚𝐥 𝐂𝐚𝐫𝐞 𝐉𝐨𝐮𝐫𝐧𝐞𝐲𝐬 (𝐚.𝐤.𝐚. 𝐃𝐞𝐯𝐢𝐜𝐞𝐥𝐞𝐬𝐬 𝐑𝐏𝐌)? The short answer is you don’t have to invest in one or the other. Many health systems leverage device-based RPM to reach the 5% of patients most at-risk for chronic care management and then use Digital Care Journeys to reach the other 95% of patients in a scalable way. Although some health systems only use Digital Care Journeys to have a consolidated approach. The attached diagram provides a high-level overview of the differences between the two approaches. It's a nuanced discussion and the long answer is probably not what you think. Link to the full article in the comments.
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The Digital-In-Health Flagship Program by the World Bank Group presents the Implementation Know-How Brief, a comprehensive guide for stakeholders involved in Digital-in-Health initiatives. This brief focuses on the essential aspect of interoperability in health, providing practical discussions, key terms, and guidance. Key Takeaways: 📚 Foundational Knowledge: Understand key terms and interoperability layers. 🏥 Standards and Layers: Learn how standards ensure seamless integration. 📊 Assessment Techniques: Discover methods to evaluate current interoperability. 🏛️ Policy Guidance: Promote interoperability in projects and the health sector. ⚠️ Challenges and Pitfalls: Navigate common challenges in achieving interoperability. Interoperability is not just a technical necessity; it's a transformative approach to reshaping healthcare.
