Anna Smith’s Post

📢 The EU Health Technology Assessment Regulation has taken a significant step forward with the publication of two new guidance documents. ➡ Guidance on Outcomes: This document will aid Member States’ authorities in defining the scope of joint clinical assessments and ensure assessors report all necessary elements for national appraisal. ➡ Guidance on Reporting Requirements: It addresses how assessors should handle multiplicity issues and subgroup, sensitivity and post hoc analyses in joint clinical assessments. These documents are crucial for health technology developers as they prepare their submissions for assessment. Adopted at the 9th meeting of the Member State Coordination Group on Health Technology Assessment, these guidelines promise to streamline processes and enhance collaboration. For more details, visit the official announcement page: https://lnkd.in/d3aiK_We These guidance documents will also be covered in our upcoming webinar on 9th July: https://lnkd.in/dzW67XMr #HTA #EUJCA #StatisticalGuidelines #JCA 

I'm proud to share our latest update at RD Privacy regarding the new ICO guidance on transparency in health and social care. This guidance is a game-changer for the industry, and it's crucial for organizations that handle sensitive health information daily. As we continue to embrace new technologies and innovate in medical research, maintaining the trust of those we serve remains a top priority. This new framework from the ICO not only enhances companies compliance with data protection laws but also reinforces your commitment to ethical practices in all our operations. Implementing these standards is not just about legal compliance; it's about leading with integrity and ensuring that every participant in your clinical trials can trust you with their most personal information. Let's lead the change and set new standards for transparency and trust in healthcare. #Biopharma #HealthCare #ICO #DataProtection #Transparency #MedicalResearch

🌟 New ICO Guidance on Transparency in Health and Social Care 🌟 The Information Commissioner's Office (ICO) has released pivotal new guidance designed to ensure that health and social care organizations maintain high transparency standards regarding the use of personal information. 🔎 Key Highlights: - Regulatory Certainty: The guidance clarifies how organizations should inform individuals about the handling of their sensitive health information. - Enhanced Trust: Transparency is critical for building public trust, enabling patients to feel secure in sharing their information, crucial for accessing services and supporting medical research. - Support for New Technologies: As health technologies evolve, understanding how to manage personal information transparently ensures the efficiency and public benefit of these innovations. 🛠 Practical Implementation: 1. Understand Transparency: The guidance helps organizations grasp what transparency means in practice and assess necessary levels of openness. 2. Develop Transparency Information: It provides practical steps for crafting clear and effective communications about personal data use. 3. Stakeholder Feedback: Reflecting inputs from a public consultation with health and social care bodies across the UK, the guidance is fine-tuned to real-world needs. 📈 Impact for Biopharma For biopharma companies involved in medical research, this guidance is a cornerstone for ensuring compliance and enhancing participant trust. By implementing these standards, we can improve patient engagement and support the development of innovative healthcare solutions. ➡ Let's align our practices with this new framework and lead the way in ethical research and care delivery! ⬅ #Biopharma #HealthCare #ICO #DataProtection #Transparency #MedicalResearch #BiopharmaDataProtection #ClinicalTrialsPrivacy #GDPRCompliance #DPORole #BiopharmaGDPR #ClinicalDataSecurity #PrivacyInPharma #DataEthicsInTrials #PharmaCompliance #HealthDataProtection 

These steps towards implementation of the JCA are critical to embedding this in the way we work.... #heor #marketaccess #avalerehealth

Day three of the #PandemicAccord talks at the World Health Organization in Geneva began with news of states coming to an agreement on Research & Development (Art 9) text. Final changes included the removal of softening language on clinical trials (e.g., “as appropriate”) and text expanding product access from just trial participants to include those at-risk in their communities. The Intergovernmental Negotiating Body Co-chair said yesterday’s talks on surveillance (Art 4), however, remained stalled and that while some Member States had put forward new text, others felt it was too late and that they should focus on meeting the May '25 deadline. There appears to be a greater sense of urgency, during this INB session, as there is more noticeable state activity. The Co-chair noted that there were early morning consultations and informal discussions planned for lunch with smaller groups of countries. Given the flux in the negotiations and text, Wednesday’s negotiating schedule was revised with financing (Art 20) on tap for the morning, surveillance/One Health (Art 4/5) set for afternoon informal discussion, and Pathogen Access & Benefit Sharing (Art 12) up in the evening session. Expect more schedule changes as talks evolve. Stakeholders focused their morning interventions on tech transfer and financing. Many urged stronger sharing language keeping access and sharing linked. One noted that asking countries to share pathogens immediately, but then waiting for pharma’s goodwill to share health products does not make sense. A pharma stakeholder said states with manufacturing capacity must also commit to the export of countermeasures, but reiterated that any sharing should remain voluntary and that pharma companies would retain their IP rights. A stakeholder pushed stronger text on financing, ensuring sustained and predictable public financing. More updates tomorrow, following the opening session of Day 4.

https://lnkd.in/e4qscdQv “Being transparent is essential to building public trust in health and social care services. If people clearly understand how and why their personal information is being used, they are likely to feel empowered to share their health information to both access care and support initiatives such as medical research.  “As new technologies are developed and deployed in the health sector, our personal information is becoming more important than ever to boost the efficiency and public benefit of these systems. With this bespoke guidance, we want to support health and social care organisations by improving their understanding of effective transparency, ensuring that they are clear, open and honest with everyone whose personal information is being used.” - Anne Russell, Head of Regulatory Policy Projects

Great to attend this insightful event last week. Patient Language Summaries to support Patient Expert Input to HTA: Lessons and Guidance for Patient Organisations, HTA Bodies and Industry. The collective aim being to improve the availability of Plain Language Summary Information to support the timely, structured, and meaningful integration of patients' insights into Health Technology Assessment (HTA) evaluations. To meaningfully contribute to the HTA process, patient experts need a baseline of timely, clear & accessible information on the treatment being assessed. The quality and relevance of written & verbal submissions to HTA bodies are likely to improve if patient experts are better informed. To support this. a standard template to gather Plain Language Information has been developed based on the Summary Information for Patients (SIP) template originated by the Scottish Medicines Consortium. #HTAI:PatientAndCitizenInvolvementInterestGroup #HTAI:HealthTechnologyAssessmentInternational #SMC:ScottishMedicinesConsortium #NICE:NationalInstituteForHealthAndCareExcellence #EPF #CancerPatientsEurope #OpenedDoorConsultancy #BMSAustralia

Day 6 of #PandemicAccord talks at the World Health Organization in Geneva started with a recap of Friday’s closed talks on R&D (Art 9) & strengthening regulatory systems (Art 14). At the INB11 halfway point, the underlying point of contention remains: sharing. Who has to share what and when? And how and when are those details defined?   On R&D (Art 9), there is significant enough distance on what obligations should exist for publicly funded research that the co-chair said the Bureau will come up with new language. Also still unresolved is how to define “open science” (ie, access to research).   Regarding strengthening regulatory systems (Art 14), talks have progressed further. Questions remain over the timing of info-sharing on new health products (who gets what when).  Improving the WHO prequalification process is close to agreement, the co-chair said.   On tap for Day 6: Diversifying local production (Art 10) & tech transfer for the production of pandemic-related health products (Art 11). Language details were, again, at the top of the docket. Some stakeholders urged stronger obligations for tech & know-how transfer and replacing “voluntary” language with stronger commitments to help avoid a hierarchy of obligations. The Pharma industry groups countered that voluntary aspects were key to past successes. Many stakeholders highlighted the interconnectedness of sharing IP (Art 9), diversifying production (Art 10) and transferring tech and know-how (Art 11). A strong provision on tech transfer was considered a must until it is clear how the Pathogen Access and Benefit Sharing (PABS) language will look. The Co-chairs previewed the rest of the week’s talks, noting some details TBC. ·     Wednesday: PABS (Art 12) ·     Thursday: Surveillance & One Health (Art 4&5); PM - R&D & Regulatory Strengthening (Art 9&14) ·     Friday: Diversified Production (Art 10) & Tech Transfer (Art 11)

The Regulation (EU) 2021/2282 on health technology assessment (HTAR) contributes to improving the availability for EU patients of innovative technologies in the area of health, such as medicines and certain medical devices. It ensures an efficient use of resources and strengthens the quality of HTA across the Union. It provides a transparent and inclusive framework by establishing a Coordination Group of HTA national or regional authorities, a stakeholder network and by laying down rules on the involvement in joint clinical assessments and joint scientific consultations of patients, clinical experts and other relevant experts. The HTAR will also reduce duplication of efforts for national HTA authorities and industry, facilitate business predictability and ensure the long-term sustainability of EU HTA cooperation. Do you want to be updated regarding this new Regulation?, please, contact RegPharmaClin S.L. to be fully aware about this new regulation and how to proceed for its implementation.

The Regulation (EU) 2021/2282 on health technology assessment (HTAR) contributes to improving the availability for EU patients of innovative technologies in the area of health, such as medicines and certain medical devices. It ensures an efficient use of resources and strengthens the quality of HTA across the Union. It provides a transparent and inclusive framework by establishing a Coordination Group of HTA national or regional authorities, a stakeholder network and by laying down rules on the involvement in joint clinical assessments and joint scientific consultations of patients, clinical experts and other relevant experts. The HTAR will also reduce duplication of efforts for national HTA authorities and industry, facilitate business predictability and ensure the long-term sustainability of EU HTA cooperation. Do you want to be updated regarding this new Regulation?, please, contact RegPharmaClin S.L. to be fully aware about this new regulation and how to proceed for its implementation.