Decentralized Trials & Research Alliance (DTRA)’s Post

🎉 Exciting news from Day 1 at HLTH Europe! John Mulcahy our VP of Product at S3 Connected Health, joined a distinguished panel of experts from DiMe’s International Digital Health Regulatory Pathways initiative. They delved into the "Opportunities and Realities of Developing a Multi-Market DHT Evidence and Commercial Approach in Europe.” HLTH Europe has been a tremendous success, and we're eager to share the valuable insights gained from this session. #HLTHEurope #DigitalHealth

All patients should have access to health information they understand. That's why as a Patient Information Forum Trusted Information Creator, we're updating our patient-facing materials to be simpler to understand. Learn more. ⤵️ #PfizerUK

Empower people to research their health conditions or diagnoses before and after physician appointments. Knowing more about potential health issues, treatment options, and what you don’t know, will go a long way towards true patient-physician partnership. These are some easy to navigate websites that give patients reliable disease-specific information. ·     Webmd.com ·     Mayoclinic.org ·     Clevelandclinic.org ·     Healthline.com ·     Medlineplus.gov ·     Clinicaltrials.gov ·     Check the websites of the academic medical centers (AMCs) in your area To go deeper, there are disease-specific websites that have extensive educational and clinical resources, including upcoming developments in the field. Some also have a strong patient community component. In a future post, I will highlight some of these.

With ICH M11 expected to be adopted by the end of the year, this Clinical Leader Live will discuss the advantages of improving and simplifying the dataflow of clinical trials but also the challenges associated with creating a connected digital dataflow, including digital health channels, that spans from protocol to data collection to CSR. https://lnkd.in/e_afNAf5

🏥💫 Noklus is an indispensable UniHealth EU partner, as Dr. Sverre Sandberg team will perform a pre-market performance evaluation of the instruments and assays for #Influenza and #Covid among healthcare workers in this project.💊 ⚕ 🤒 Evaluation performance will also be conducted among lay persons and will include evaluation of the #diagnostic performance and user-friendliness of the instruments and assays. 🏥 Noklus will also perform a cross-reactivity study in a hospital laboratory and develop a methodology for establishing and implementing external quality assurance for the instruments during a pandemic. 🎯 Noklus goal is to ensure good quality of instruments used for point-of-care testing that can be used in the potential next #pandemic. This to secure that the devices, such as #Pebble give reliable test results. 🔬🌎 #UniHealth #POCdiagnostics #ivdr #globalpartnership #HorizonEU #ResearchImpactEU

From a regional and community Health Information Exchange (HIE) perspective, it is notable that many health systems are moving from local exchanges to large Electronic Health Record (EHR) interoperability solutions through national exchanges. This trend is observed across various regions and communities. This may be due to decision-makers in these health systems not fully recognizing the value of their local exchanges and often having a 'check the box' approach towards interoperability. Centralis Health, along with other local exchanges, have been working closely with their communities to provide meaningful data exchange and customized solutions tailored to community needs. The national exchanges were designed to complement these models rather than replace them. It is crucial for non-national HIEs to continue educating stakeholders and equipping super users with the necessary tools to advocate for local exchanges when health systems evaluate their HIE strategies. Additionally, it is important to inform decision-makers about the contributions of local exchanges to the community. Highlighting the potential impact of the absence of local exchanges on large health systems, independent providers, rural and Critical Access Hospitals (CAH), and patient populations is essential. Thank you Lisa B. and the whole Civitas Networks for Health teams for putting on such a engaging and educational event, this is one I continue to look forward to annually. Thank you to the Centralis Health for always asking the "What if we..." questions that drive the technology that continues to support our community's in finding efficiencies they didn't even realize were possible.

The Government of New Brunswick / Gouvernement du Nouveau-Brunswick announced today that MyHealthNB, the province’s health information app, will now allow residents to create a summary of their own medications, immunizations and recent laboratory and medical imaging tests, and share it with health professionals who don’t have access to the provincial electronic health records system. The Atlantic province is the first of several planned jurisdictions in Canada to implement this patient-generated approach to the pan-Canadian and International Patient Summary standards, aligned to the Shared pan-Canadian Interoperability Roadmap, developed in partnership with Infoway and VeroSource, a HEALWELL AI Company, and supported by the Government of Canada. Read the announcement to learn more: https://bit.ly/4dguWFa

The World Health Organization webinar on best practices in clinical trials has been enjoyable to sit in. The focus on respect and appreciation for communities and people with lived experience, emphasis on minimizing the bureaucracies that slow down clinical trial implementation, and working towards resource-efficient trials is welcome. The Guidance developed can be accessed through https://lnkd.in/di6csSSi

NEW JOURNAL ARTICLE: This Practice Resource addresses the scope of FDA jurisdiction and the enforcement process; how an institution may find itself on FDA’s radar; requirements associated with various types of activities conducted at AMCs, health systems and research institutions; and best practices that can keep such institutions in FDA’s good graces. Read the full article:https://lnkd.in/gpMq6FSQ