Longwoods Publishing’s Post

There is a growing interest in #qualityimprovement collaboratives (QICs), even though less remains known about contextual factors that impact collective and local project implementation. A study was undertaken that used the Consolidated Framework for Implementation Research (CFIR) to explore the contextual factors impacting the use of this nationwide QIC in Canada. This paper provides insights into contextual factors that impact the implementation of local safety projects involved in a larger QIC, which may serve as a template or #blueprint for #healthcareleaders in their efforts to guide the co-design, implementation and evaluation of safety and QI efforts. Lianne Jeffs, Kim Kinder, Maryanne D'Arpino RN, BScN, MScN, CHE, Gina De Souza RN, MScN, CMP, LSSBB Ross Baker Healthcare Excellence Canada https://lnkd.in/g7NF4yvi

Following the final session on 5 November, we have released an updated interactive map summarizing the outputs of all ‘From Theory to Practice: Implementing the EU Health Technology Assessment Regulation’ sessions facilitated by the European Commission. As we get closer to the January 2025 for first phase implementation, it is reassuring to see EU HTAR readiness scores are increasing and local planning is well underway. While we still await detailed insight to local legislation and HTA process adaptations to effectively accommodate JCA outcomes in local decision making, EU HTA bodies are ready for JCA launch and so are we! Get in touch with our Lumanity HTA experts to see how we can help with your own readiness plans! https://buff.ly/4g9RYim #LumanityPerspectives #EUHTA Regulation #HEOR #HTA

📅 Yesterday, participants in the Swissmedic Regulatory Training engaged in a hands-on day at our lab facilities in Berne, gaining valuable insights into quality management practices. Experts from various countries joined our team to explore effective methods for ensuring the safety, efficacy, and quality of medical products and health technologies. 🧪🔍 This collaborative exchange of knowledge helps strengthen regulatory systems globally, and we are inspired by the dedication of these professionals to enhance public health. 🤝Together, we can contribute to the advancement of health systems around the world.🌐   #SwissmedicTraining #GlobalHealth #RegulatoryTrainings #RegulatorySystemsStrengthening 

It was a busy week: the Implementing Act on Joint Clinical Assessment is published! 23 Member States voted in favour, 4 Member States were not represented. A few things that stand out for manufacturers that are worth already mentioning here: "Upon request of the health technology developer, the HTA secretariat shall invite the health technology developer to an assessment scope explanation meeting with the JCA Subgroup." --- previously, this was to be decided by the JCA Subgroup. "The deadline to submit the dossier [...] shall be 100 days from the date of the notification of the first request to the health technology developer." --- previously, this was 90 days. These are 2 out of (frankly, few...) changes following the public consultation. Reflecting back to the webinar Lumanity provided together with Neil Grubert in January and our EU JCA / IRA webinar last week together with Ron Akehurst and Jonathan Kowalski, there are still some challenges to tackle. What are your thoughts? #EUHTA #JCA #EUHTAR #patientaccess

Looking for expert #JCA advice? Our brand new AI-powered tool is here to provide you with clear, actionable guidance, leveraging curated insights from reliable and up-to-date sources. ✨ Ready to experience smarter, faster support? Try it now and see the difference for yourself! 📩 Contact us at contact@remapconsulting.com to get started, and don’t forget to share your feedback—your suggestions will help us make it even better. #Innovation #AIPoweredSolutions #JCAAdvice #RemapConsulting

🚀 Promoting Excellence in European Health Technology Assessments by ensuring that the best expertise is included 🚀 The vfa fully supports the EU Regulation 2021/2282's commitment to high-quality, transparent, and independent Health Technology Assessments (HTA). However, we are concerned that the proposed strict conflict of interest rules in the European commission’s draft implementing regulation might exclude crucial experts, potentially compromising scientific quality. 🔍 Our Recommendation: Adopt a pragmatic approach that ensures the best expertise is included, with transparent documentation of declared interests, case-by-case evaluation and diverse expert panels. This way, we can uphold both integrity and quality in joint HTA work. Let’s find the right balance and achieve excellence in European Health Technology Assessment! For more information, please visit the vfa comment. https://lnkd.in/ewAmZbmy #HealthTech #Innovation #Quality #Transparency #Independence #vfa #EURegulation #HTA #Expertise #ScientificIntegrity #conflictofinterest

MPE provided detailed feedback on the second implementing act of the EU health technology assessment (HTA) regulation (EU HTAR) focusing on procedural rules for assessing and managing conflicts of interest (CoI) for representatives and individual experts (including patient experts). MPE believes that the current overly strict approach to CoI might lead to patient experts with the best available knowledge being left out of HTA assessments. Thus, MPE recommends a more flexible and pragmatic approach towards the CoI, one that balances the need to ensure transparency, impartiality and independence with the realities of patient expertise. https://lnkd.in/dqscBXhd

Do you have questions about Digital Health Technology (DHT) but never had the chance to ask? Are you wondering... 🤔 What is DHT and what are key differences from established clinical research tools? 🤷 What are the relevant regulatory terminology and pathways? 💭 What are some common DHT use cases and how have they been used in clinical trials? ✋ How do you deal with operational considerations? 📈 What do I need to know about contextual information of DHT data collection? Christine Cong Guo will cover these topics and answer your questions at our upcoming Digital Health Monthly session - DHT 101 for Clinical Research: Foundations, Regulations, and Real-World Applications - on June 25th! ⏩ Register here: https://hubs.la/Q02Bnyxz0 #DigitalHealthMonthly #DHT #ClinicalTrials #ClinicalResearch #Regulatory

Systematic literature reviews (SLRs) are typically required as part of the health technology assessment (HTA) process, but the focus and mandatory  requirements of SLRs vary by HTA body. Maverex investigated the SLR requirements of eight HTA agencies around the world. Read below to see what we found. Early strategic planning of SLR requirements, including engaging in early scientific advice with HTA agencies, can ensure SLRs fulfil the requirements for multiple HTA bodies in a timely and efficient manner. Contact us today to speak to one of our HTA and SLR experts, or if you would like further information. This research was presented at ISPOR 2024. #SLR #HTA #MarketAccess #TechnologyAppraisal

Our CEO Fiona Loughlan and GMO Karin Burroughs, MBA, MSc. Burroughs are both dedicated to this industry, and together, sit on a number of committees including the Australian Commission on Safety and Quality in Health Care - Accrediting Agency Working Group (ACSQHC). It is the national health care standards agency for all health services, general practices, pathology and medical imaging providers in Australia. It's responsible for: 🔹 Developing clinical care and quality standards 🔹 Overseeing model national accreditation schemes for healthcare services 🔹 Working with patients, consumers, clinicians, managers, policy makers, and healthcare organizations 🔹 Improving end-of-life care The ACSQHC's accreditation schemes include the Australian Health Service Safety and Quality Accreditation (AHSSQA) Scheme. The AHSSQA Scheme coordinates accreditation processes nationally and sets out the responsibilities of accrediting agencies. The ACSQHC's accreditation process involves: 🔹 Formulating rules for the accreditation scheme 🔹 Approving accrediting agencies and managing their performance 🔹 Ensuring consistent assessments across accrediting agencies 🔹 Evaluating the effectiveness of accreditation schemes It's just another way Fiona and Karin, as industry leaders, demonstrate their expertise, integrity and reputation. #IHCA #SupportingExcellence