Center for European Health Policies Ltd

🚀 HealthData Box is your ultimate solution for managing data on medical devices (MDs) and in vitro diagnostic devices (IVDs). With eight powerful modules, it serves the entire healthcare ecosystem, ensuring 🌟 process optimization, 🔍 transparency, and ✅ compliance with EU Regulations 2017/745 and 2017/746. 🔑 Key Benefits: 📋 Comprehensive coverage: Supports manufacturers, suppliers, health insurance funds, medical institutions, NHIF, and regulatory authorities. ⚙️ Modular design: Flexible tools for managing data, monitoring effectiveness, and analyzing results. 🛡️ Regulatory compliance: Ensures high-quality, secure data management. 🔗 Transparency: Enables seamless data exchange across stakeholders. 📊 Real-world data: Tracks health, social, and economic impacts of MDs and IVDs. 🌍 Impact: 👩⚕️ Patients: Access to innovative, effective devices. 🏥 Healthcare institutions: Simplified management and reimbursement processes. 📊 NHIF: Data-driven decisions on financing. 🏭 Manufacturers & distributors: Better product management and proof of effectiveness. 🎯 Module 6 Highlights: ✅ Effectiveness monitoring: Tracks performance, health outcomes, social impact, and cost-effectiveness over three years. ⚡ Automation: Simplifies compliance and reporting, saving time and resources. 📈 Analysis: Real-time data access, trend analysis, and comparative evaluations. 💡 HealthData Box optimizes processes, drives sustainable healthcare, and ensures access to high-quality medical devices while meeting all regulatory standards. 🌟

На 31 декември 2024 г. влязоха в сила изменения в НАРЕДБА № 7 ОТ 31 МАРТ 2021 Г. ЗА УСЛОВИЯТА И РЕДА ЗА СЪСТАВЯНЕ НА СПИСЪК НА МЕДИЦИНСКИТЕ ИЗДЕЛИЯ ПО ЧЛ. 30А ОТ ЗАКОНА ЗА МЕДИЦИНСКИТЕ ИЗДЕЛИЯ И ЗА ОПРЕДЕЛЯНЕ НА СТОЙНОСТТА, ДО КОЯТО ТЕ СЕ ЗАПЛАЩАТ. Промените въвеждат редица нововъведения, които целят подобряване на административната ефективност и осигуряване на по-добър достъп на пациентите до качествени и икономически ефективни медицински изделия. Основните изменения включват: 1. Намаляване на административната тежест както за НЗОК, така и за заявителите. 2. Въвеждане на възможност медицинските специалисти да участват като заявители, с акцент върху медицинската целесъобразност при включването и актуализацията на спецификациите за медицински изделия. 3. Премахване на изискването за доказателство за заплащане на медицински изделия, произведени в България, от здравноосигурителни фондове в държави членки на ЕС, което насърчава българските производители и повишава конкурентоспособността им. 4. Проследяване на ефекта на медицинските изделия: Заявителите ще бъдат задължени да събират данни за здравните, социалните и икономическите резултати от прилагането на изделията за срок от три години, считано от момента на включването на нова група, подгрупа или технически изисквания за заплащане от НЗОК, както и при промени в съществуващи групи. В случаи на незадоволителни резултати съответните изделия ще бъдат изключвани от спецификацията. Макар че подобно изискване досега беше заложено в Правилата на НЗОК по съответната процедура, сега то е разписано като част от самата Наредба. Тези изменения ще позволят събиране на реални данни за ефективността на медицински изделия и медицински изделия за инвитро диагностика. Така ще се осигури достъп на пациентите до продукти с добавена стойност, а НЗОК ще може да взема обосновани решения за продължаващо реимбурсиране, в съответствие с високите изисквания на Регламент (ЕС) 2017/745 и Регламент (ЕС) 2017/746, гарантиращи качество и безопасност. #CEHP #HEALTHDATABOX #HealthTechnologyAssessment #Legislation #EmpoweredByData

🎄 Merry Christmas from CEHP! 🎄 As the year comes to a close, we at CEHP reflect on the importance of health, compassion, and collaboration. This holiday season, we want to express our deepest gratitude to our partners, colleagues, and clients who have been part of our journey in advancing healthcare solutions. 🎁 Thank you for inspiring us to make meaningful changes in the healthcare landscape. Together, we’ve achieved milestones that reflect our shared commitment to a healthier, brighter future for all.🎁 From our team to yours, we wish you a joyous holiday season filled with warmth, love, and laughter. May the new year bring you peace, prosperity, and continued success. ✨ Happy Holidays and a Prosperous New Year! ✨ Warm regards, The CEHP Team #CEHP #MerryChristmas #HappyNewYear #HealthTechnologyAssessment #EmpoweredByData

🎉 We are excited to introduce the newest members of our team through our Internship Program at CEHP! 🚀 After a thorough selection process, we are thrilled to welcome Tsvetomira and Tsvetan as our interns. They bring enthusiasm, fresh perspectives, and a passion for learning to our dynamic environment. 💡 Our program is all about empowering young talents by providing: • Real-World Experience 🎨: Tsvetomira and Tsvetan will be working on impactful projects that contribute to our mission. • Mentorship: They will receive guidance from our experienced professionals to support their growth. • Skill Development: This journey will help them sharpen their skills and prepare for exciting career opportunities. • Networking Opportunities 📚: They will connect with industry professionals and peers within our network. ✨ We are always eager to connect with ambitious individuals who share our passion. Feel free to reach out and let us know about your interests—we’d love to keep in touch for future opportunities. Stay tuned for updates on our upcoming programs! ⏳ 📢 Have questions? Feel free to reach out to us at info@cehp.eu Let’s shape the future together. Welcome, Tsvetomira and Tsvetan, to CEHP! 🙌✨ #WelcomeInterns 🌟 #CareerGrowth 🏋️♂️ #Teamwork #MedicalDevices #EmpoweredByData #CEHP #HealthTechnologyAssessment #MedicalTechnologies #HTA #Medtech

🎉 CEHP Internship Program – Series 1 Success 🚀 At CEHP, we are driven by the belief that empowering people through learning and growth leads to excellence. Today, we are thrilled to celebrate an incredible milestone achieved by two of our talented interns, Anelia Zasheva and Elina Bacheva! After months of dedication, hard work, and a steadfast commitment to their personal and professional development, both have successfully completed their mid-term internship programs. 🌟 ✨ Meet Our Rising Stars: Anelia Zasheva: A passionate young medical doctor and PhD candidate with a keen interest in advancing healthcare. Elina Bacheva: A motivated master pharmacist with a Master’s degree in Clinical Trials Management, showcasing a clear dedication to excellence in her field. Reflecting on their experience, they shared: "This proved to be a valuable journey, and we learned so much about medical devices, health technology assessment, and European regulations." Their determination, adaptability, and eagerness to learn embody CEHP’s core values, and we couldn’t be more proud. This achievement highlights not only their resilience but also the incredible support from our mentors and team, who foster an environment of collaboration, encouragement, and growth. We can’t wait to see how Anelia and Elina apply their newfound knowledge and skills as full members of CEHP, contributing to meaningful advancements in healthcare. 🙌 #HealthTechnologyAssessment #CEHP #EmpoweredbyData #MedicalDevices #ClinicalTrials

Center for European Health Policies Responds to the EC’s Public Consultation on Implementing Regulation for Joint Scientific Consultations on Medical Devices and In Vitro Diagnostic Medical Devices at the Union Level. CEHP’s mission is to promote evidence-based health strategies, projects, and activities that address the greatest health challenges. We believe that everyone has the right to good health and are committed to creating policies that advance health equity and social justice. Our work focuses on improving the health of young people through policy advocacy, research and analysis, and collaboration with healthcare stakeholders. As such, CEHP strongly supports the Health Technology Assessment (HTA) Regulation, which serves as a cornerstone for advancing medical devices and in vitro diagnostic medical devices within the European Union. This new legislation aims to facilitate access to innovative, high-value health technologies, provide a harmonized and balanced approach to strengthening healthcare systems, and ensure timely access to effective treatments. As the EU continues to implement its HTA frameworks, prioritizing patient-centered outcomes and enhancing transparency will be crucial to building public confidence that health technologies will address the diverse needs of populations across Europe.

📢 The survey closes in 1 month! The European Commission is conducting a survey on electronic instructions for use (eIFU) of medical devices for healthcare professionals and professionals working in healthcare institutions. 📄 Take the survey here: https://bit.ly/4duAZ9d 💬 Share it within your networks This survey runs until 11 October 2024 and represents an important step towards a wider use of eIFU for medical devices, and your participation as a healthcare professional is invaluable. Are you curious about eIFUs? Check out MedTech Europe's factsheet: https://bit.ly/4eljGsE

🔬 Конференция: „Медицински технологии и онкология“ 🌟   С удоволствие анонсираме конференцията „Медицински технологии и онкология“, организирана по инициатива на Center for European Health Policies Ltd (ЦЕЗП), пълноправен член на Establishing of Cancer Mission Hubs: Networks and Synergies (ECHoS) и под патронажа на Националната здравноосигурителна каса (НЗОК).   📅 Дата: Предстои обявяване на датата на провеждане 📍 Място: Зала Моцарт, Гранд Хотел Милениум, гр. София   Научните лекции и дискусиите ще се фокусират върху подобряване на достъпа до медицински изделия, медицински изделия за инвитро диагностика и дигитални решения за диагностика, лечение и проследяване на ефекта на медицинските изделия в онкологията.   Тази конференция цели и създаване на синергия между всички заинтересовани страни и разработване на обща стратегия за подобряване на осведомеността относно профилактиката, диагностиката и лечението на онкологичните заболявания в контекста на медицинските изделия, медицински изделия за инвитро диагностика и дигитални решения. Детайлите предстоят!    #CEHP #MedicalDevices #WorldHealthOrganization #MedTech #Innovation #HealthDataBox #DigitalHealthSolutions #EmpoweredByData   🔬 Conference: “Medical Technologies and Oncology” 🌟 We are thrilled to announce the conference “Medical Technologies and Oncology,” organized under the initiative of the Center for European Health Policies Ltd (CEHP), an official member of Establishing of Cancer Mission Hubs: Networks and Synergies (ECHoS) and under the patronage of the National Health Insurance Fund (NHIF).   📅 Date: Upcoming 📍 Venue: Mozart Hall, Grand Hotel Millennium, Sofia   The scientific lectures and discussions will focus on improving access to medical devices, invitro diagnostic medical devices, and digital solutions for the diagnosis, treatment, and monitoring of the effects of medical devices in oncology.   This conference also aims to create synergy among all stakeholders and develop a common strategy to raise awareness about prevention, diagnosis, and treatment of oncological diseases in the context of medical devices, in vitro diagnostic devices, and digital solutions.   Stay tuned!    #CEHP #MedicalDevices #WorldHealthOrganization #MedTech #Innovation #HealthDataBox #DigitalHealthSolutions #EmpoweredByData

📯 We are thrilled to announce the second event in our "Medical Technologies and...." series, this time focusing on “Medical Technologies and Oncology”. Building on the outstanding success of our inaugural "Medical Technology and Legislation" event, we are confident that, alongside our partners and stakeholders, we are moving in the right direction. Our goal is to foster dialogue among institutions, healthcare professionals, patients, manufacturers, and distributors to enhance access to medical devices and in vitro diagnostic medical devices, ultimately improving the diagnosis and treatment of patients in Bulgaria. Stay tuned!   #CEHP #Medicaldevices #IVDmedicaldevices #HealthDataBox #Medicaltechnologiesandoncology

Днес, на светлия празник Успение Богородично, излезе от печат очакваното второ издание на Компендиум за Имунотерапия при злокачествени солидни тумори. Книгата е издание на Българското Научно дружество по имуноонкология и е под редакцията на Професор Nikolay Conev Компендиумът е единственото учебно помагало на български език, което на едно място събира данни за дизайна на регистрационните клинични изпитвания, ключовите резултати и индикациите за приложение на имунотерапия при солидни злокачествени тумори при възрастни пациенти в България към настоящата година. Научното дружество по имуноонкология благодари на авторския състав: д-р Tanya Zlatanova , Д-р Petya Balikova , д-р Иван Тонев, д-р Драгомир Стоянов и д-р Ростислав Манев за положения труд и разбира се специални благодарности към Професор Цонев за отличната редакция! Компендиума се разпространява напълно безплатно и ще достигне до всички, прилагащи имунотерапия в практиката си специалисти, както и до обучаващите се медицински и радиационни онколози в помощ на тяхната подготовка за изпита за специалност. Приятно и ползотворно четене!