RWE4Decisions

🔎 In April, the EIT Health Think Tank published its report on “Implementing the European Health Data Space (EHDS) across Europe.” The piece discusses the complexities of implementing the EHDS, especially given the dense regulatory landscapes and diverse health systems of the Member States. It is divided into six chapters, covering: 🧑⚖️ 1. Data 𝗴𝗼𝘃𝗲𝗿𝗻𝗮𝗻𝗰𝗲 structures and legal provisions 📚 2. Technical capabilities and human 𝗰𝗮𝗽𝗮𝗰𝗶𝘁𝘆 𝗮𝗻𝗱 𝘀𝗸𝗶𝗹𝗹𝘀 for achieving equitable access to electronic health data collection and its secondary use 📈 3. 𝗥𝗲𝘀𝗼𝘂𝗿𝗰𝗲𝘀 𝗮𝗻𝗱 𝗳𝘂𝗻𝗱𝗶𝗻𝗴 available nationally and locally 📊 4. Sufficiency of national 𝗱𝗮𝘁𝗮 𝗾𝘂𝗮𝗹𝗶𝘁𝘆 for generating meaningful insights 🔄 5. 𝗧𝗵𝗲 𝗿𝗲𝗹𝗮𝘁𝗶𝗼𝗻𝘀𝗵𝗶𝗽 𝗯𝗲𝘁𝘄𝗲𝗲𝗻 𝗽𝗿𝗶𝗺𝗮𝗿𝘆 𝗮𝗻𝗱 𝘀𝗲𝗰𝗼𝗻𝗱𝗮𝗿𝘆 𝘂𝘀𝗲 for the flow of data and its application in research and innovation 📢 6. 𝗔𝘄𝗮𝗿𝗲𝗻𝗲𝘀𝘀, 𝗲𝗱𝘂𝗰𝗮𝘁𝗶𝗼𝗻, 𝗮𝗻𝗱 𝗰𝗼𝗺𝗺𝘂𝗻𝗶𝗰𝗮𝘁𝗶𝗼𝗻 for fostering a data-driven culture in healthcare 📋 Each chapter delves deeper into the relevant aspects of the national landscapes affecting the implementation process, as well as the challenges, enablers, and proposed solutions for the implementation. 🔜 Notably, the EHDS is yet to be published in the Official Journal and to take effect in Member States' jurisdictions. ⭐ This analysis will be important for understanding how to best implement the EHDS in a way that effectively utilises electronic data to empower all relevant stakeholders. 🔗 We invite you to read this insightful report here: https://lnkd.in/ehhesEFE #EHDS #EuropeanHealthDataSpace #RWE #RealWorldEvidence #RWD #RealWorldData

📄The report from our recent webinar is out👇 🎙️ On June 25th, we hosted an insightful webinar “Can Endpoints from Digital Technology Provide Meaningful Outcomes for HTA?". The session brought together experts to explore the potential of digital endpoints in Health Technology Assessments (HTA). 🔷 Rossella Di Bidino highlighted that hospitals are not only adopters but also collectors, co-developers, and assessors of digital health. She emphasised the importance of assessing these technologies with a flexible HTA framework, using innovative hospital initiatives like the Gemelli Generator. 🔷 Andreas Hager shared his journey in digital technology development, driven by his family's experience with cystic fibrosis. He discussed how patient-generated data can enhance stakeholder communication and improve health outcomes. 🔷 Lara J Wolfson reflected on digital technologies' potential to reduce patient burden and provide long-term insights, stressing the need to balance rapid technological advancement and validation. 🔷 Anja Schiel provided the perspective of a statistician working in regulation and HTA, reminding us that while digital tools offer refined data, the traditional rules of validation and context remain crucial. Digital endpoints show great promise in Health Technology Assessments (HTA) but require further validation to be recognized as primary outcomes. Integrating real-world data, particularly patient-reported outcomes, is needed to enhance decision-making processes. 🤝🏻 Developing effective digital health technologies hinges on a collaborative approach where all stakeholders—patients, providers, payers, and researchers—benefit from the data collected. 👉🏻 For more detailed insights from the webinar and to access the full report, visit our website: https://lnkd.in/db8AgA_9. #HealthData #RealWorldEvidence #HTA

The Spanish Ministry of Health published a draft Royal Decree, setting Spain's future framework for Health Technology Assessment (HTA) and making significant changes to governance and processes. 🇪🇸 🔝 The decree aligns Spain's HTA process with the EUnetHTA domains and prepares the country for the national uptake of the EU HTA Regulation by 2025. Notably, using real-world data (RWD) to evaluate and monitor health technologies is encouraged, and both patients and health professionals will be formally involved in the assessment process. Additionally, a reform of the pricing and reimbursement (P&R) procedures is planned for next year, which will impact Post-Launch Evidence Generation in Spain. For more details and to participate in the public consultation (open until 20 September), refer to the official Spanish government announcement: https://lnkd.in/dfEPfjXc. #HTA #EU #HealthData

Lara J Wolfson, Associate Vice-President & Head HTA Statistics, MSD; Co-Chair, PSI/EFPSI HTA Special Interest Group, discusses the transformative potential of digital technologies in healthcare. "𝗪𝗵𝗲𝗿𝗲 𝗱𝗶𝗴𝗶𝘁𝗮𝗹 𝘁𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝗶𝗲𝘀 𝗰𝗮𝗻 𝗵𝗲𝗹𝗽 𝘂𝘀 𝗴𝗲𝘁 𝗱𝗮𝘁𝗮 𝘁𝗵𝗮𝘁 𝗵𝗲𝗹𝗽𝘀 𝘂𝘀 𝗲𝘃𝗮𝗹𝘂𝗮𝘁𝗲 𝘁𝗵𝗲 𝘀𝗮𝗳𝗲𝘁𝘆 𝗮𝗻𝗱 𝗲𝗳𝗳𝗶𝗰𝗮𝗰𝘆 𝗼𝗳 𝗮 𝗽𝗿𝗼𝗱𝘂𝗰𝘁 𝗶𝗻 𝗮 𝘄𝗮𝘆 𝘁𝗵𝗮𝘁 𝗶𝘀 𝗹𝗲𝘀𝘀 𝗯𝘂𝗿𝗱𝗲𝗻𝘀𝗼𝗺𝗲 𝘁𝗼 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀 𝗮𝗻𝗱 𝗺𝗼𝗿𝗲 𝗮𝗰𝗰𝘂𝗿𝗮𝘁𝗲, 𝘁𝗵𝗮𝘁'𝘀 𝗮 𝘄𝗶𝗻 𝗳𝗼𝗿 𝗲𝘃𝗲𝗿𝘆𝗯𝗼𝗱𝘆: 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀, 𝗶𝗻𝗱𝘂𝘀𝘁𝗿𝘆, 𝘀𝗰𝗶𝗲𝗻𝘁𝗶𝘀𝘁𝘀, 𝗮𝗻𝗱 𝗲𝘃𝗲𝗻𝘁𝘂𝗮𝗹𝗹𝘆 𝗣𝗮𝘆𝗲𝗿𝘀 𝗮𝗻𝗱 𝗵𝗲𝗮𝗹𝘁𝗵𝗰𝗮𝗿𝗲 𝗽𝗿𝗼𝘃𝗶𝗱𝗲𝗿𝘀." Watch Lara's presentation in our latest public webinar: Can Endpoints from Digital Technology Provide Meaningful Outcomes to HTA? 👉 https://lnkd.in/d9tGh3gF. #RWD #RWE #DigitalTechnologies #Healthcare

Denmark, Finland, Norway, and Sweden are leading the charge in leveraging health data to ultimately improve patient outcomes. 👏🏻 🌎 Before the adoption of the regulation for a European Health Data Space (EHDS), these countries were already taking measures to collect and centralise patient data for research, treatment decisions, or policy-making. ✅ All 4 had in place a unique patient ID enabling data linkage, and Finland and Sweden had already started elaborating standards or systems to assess data quality. The implementation of the EHDS aims to facilitate the sharing and use of health data, including between Member States, with standards harmonised at the EU level. 👉🏻 Discover in further detail the approach these health systems had towards health data at the time of the EHDS proposal: https://lnkd.in/eH4stgzi. *The National Health Data Sources need to be treated as ‘living documents’, and updates will be sought on an annual basis. #RWE #Healthcare #HTA #EUROPE

While we wait for the new European Commission's work programme, what key legislation from the previous mandate will change the collection and use of Real-World Evidence in HTA? 🗓️ On 24 April, the European Parliament adopted a European Health Data Space regulation. 💡 By creating a coordinated health data ecosystem, it will enable the collection and (re)use of quality data to inform medical research and policymaking, for the benefit of patients' outcomes and access to innovative treatments. As we move towards implementing the legislation, what is the current state of play of patient data collection in European countries? Stay tuned and find out in our upcoming series spotlighting different groups of countries! 👉🏻 Find out more about the correlation between the EHDS and Real-World Evidence here: https://lnkd.in/dJbbD_KR #RealWorldEvidence #HealthData #EUHealthcare #EHDS

Real-world evidence can support the European Medicines Agency and national regulators in making more robust decisions on medicines. Using data, and the right tools to analyse it, helps us to do things smarter and improve the assessment of medicines. Read more in my latest article. All relevant links are in the comment section. #realworldevidence #realworlddata #healthdata #medicines

EMA has just published its latest report on real-world evidence studies to support medicine regulation. Some takeaways from the report: 📊 A total of 40 studies were conducted between February 2023 and February 2024. 🌐 The DARWIN EU network expanded from 10 to 20 data partners since 2023, allowing access to data from almost 130 million patients from 13 European countries - in full compliance with data protection legislation. 💉 13 studies informed vaccine safety and effectiveness, supporting the response to health crises like COVID-19 and Mpox. 🧠 One study examined the risk of suicide and self-harm in people using GLP-1 receptor agonists and helped EMA to conclude that the evidence does not support a causal association. 💊 For the first time, two studies looked at the demand and stock levels of critical human medicines, to better understand management and prevention of medicine shortages. Learn more from the infosheet below 👇 👇 👇 Link to the full report 🔗 https://lnkd.in/ddpnHFfg #RealWorldEvidence #BigData #DARWINEU

In June, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) published its “ICH reflection paper on pursuing opportunities for harmonisation in using real-world data to generate real-world evidence with a focus on the effectiveness of medicines”. This document, developed collaboratively by the European Medicines Agency, the FDA, and Health Canada | Santé Canada, identifies two overarching areas for harmonisation: ✔️RWD/RWE terminology, metadata, and assessment principles ✔️RWD/RWE protocol & report format, and study transparency Read this important reflection paper below. 👇 #RWD #RWE #ICH #EMA #RealWorldEvidence #RealWorldData 

Anja Schiel, Senior Advisor, Methodologist in Regulatory and Pharmacoeconomic Statistics, Norwegian Medical Products Agency (NOMA), talks about the complexities of assessing real-world effectiveness from digital tools and how they can be overcome. "𝗜𝗳 𝗮 𝗱𝗶𝗴𝗶𝘁𝗮𝗹 𝘁𝗼𝗼𝗹 𝗵𝗮𝘀 𝗮𝗻 𝗶𝗺𝗽𝗮𝗰𝘁 𝗼𝗻 𝘁𝗵𝗲 𝗮𝗰𝘁𝘂𝗮𝗹 𝗯𝗲𝗻𝗲𝗳𝗶𝘁 𝗿𝗶𝘀𝗸, 𝗶𝘁 𝘄𝗶𝗹𝗹 𝗮𝗹𝘀𝗼 𝗮𝘂𝘁𝗼𝗺𝗮𝘁𝗶𝗰𝗮𝗹𝗹𝘆 𝗵𝗮𝘃𝗲 𝗮𝗻 𝗶𝗺𝗽𝗮𝗰𝘁 𝗼𝗻 𝘁𝗵𝗲 𝗰𝗼𝘀𝘁 𝗲𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲𝗻𝗲𝘀𝘀, 𝗺𝗲𝗮𝗻𝗶𝗻𝗴 𝘆𝗼𝘂'𝗿𝗲 𝗺𝗼𝘃𝗶𝗻𝗴 𝗳𝗿𝗼𝗺 𝘁𝗵𝗶𝘀 𝗲𝘅𝗽𝗲𝗿𝗶𝗺𝗲𝗻𝘁𝗮𝗹 𝘀𝗮𝗳𝗲 𝗵𝗮𝗿𝗯𝗼𝘂𝗿 𝗼𝗳 𝘁𝗵𝗲 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘀𝘁𝘂𝗱𝘆 𝗶𝗻𝘁𝗼 𝘁𝗵𝗲 𝗿𝗲𝗮𝗹 𝘄𝗼𝗿𝗹𝗱, 𝘄𝗵𝗲𝗿𝗲 𝘀𝘂𝗱𝗱𝗲𝗻𝗹𝘆 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀, 𝗻𝗼𝘁 𝘁𝗵𝗲 𝗽𝗮𝗿𝘁𝗶𝗰𝗶𝗽𝗮𝗻𝘁𝘀 𝗶𝗻 𝘁𝗵𝗲 𝘁𝗿𝗶𝗮𝗹, 𝗮𝗿𝗲 𝘀𝘂𝗽𝗽𝗼𝘀𝗲𝗱 𝘁𝗼 𝗲𝘅𝗽𝗲𝗿𝗶𝗲𝗻𝗰𝗲 𝘁𝗵𝗲𝗶𝗿 𝗿𝗲𝗮𝗹-𝘄𝗼𝗿𝗹𝗱 𝗲𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲𝗻𝗲𝘀𝘀." Watch Anja’s presentation in our latest public webinar: Can Endpoints from Digital Technology Provide Meaningful Outcomes for HTA? 👉 https://lnkd.in/d9tGh3gF #HTA #RWE #Healthcare