Segmed Blogs

In the recently released  FDA guidance on real-world evidence (RWE) from real-world datasets (RWD)   like electronic health records (EHRs) and medical claims data, which further can be extrapolated for other types of data sources (like Real-world imaging data (RWiD), genetic data, etc.). The evaluation of RWD is crucial in regulatory decision-making for drug and biological products. This involves rigorous validation of study design elements to ensure the reliability and relevance of the data used. The design and methodology of these studies are vital to generating credible evidence to support regulatory submissions. Here, we delve into the fundamental aspects of study design elements outlined in the document. FDA guidance specifies that the study questions of interest need to be established before the finalization of the data sources. And it should not be reversed since the limitations of the chosen RWD may restrict the options for study design and inferences that can be drawn...

  Alphabet, Microsoft, Amazon, and Apple have all dominated many sectors of technology. Aside from tech, these four companies have one thing in common. They have all entered additional markets vastly different from the ones from which they started. Such markets include oil, transportation, and food and beverage. Something else these four companies have in common is that they seem to prevail effortlessly time and again as leaders in these new distinct industries. Given these trends, it only seems likely that they would also be the predominant companies when it comes to AI in healthcare. However, unlike the oil, transportation, food and beverage industries, etc., the medical field requires far more prudence. In order to be successful in this sphere, a profuse amount of patient data is needed. This data can be received from places such as hospitals, urgent care, primary care, EHR/EMR companies, and nursing homes. Given how large the above mentioned tech companies already are, it will ...

  At Segmed, we are excited to announce the release of our latest review at the  Radiology Journal , exploring cutting-edge advancements in computer vision for medical imaging. This project was led by the Segmed team in collaboration with our friends from University of Washington Seattle, Harvard University, Stanford University, Microsoft, and University of San Francisco! Over the past decade, artificial intelligence (AI) has played a pivotal role in transforming healthcare, particularly in medical imaging, by enhancing techniques like image classification and segmentation. Our review highlights how the next frontier for AI, with large-scale generative models and synthetic data, is addressing key challenges in medical data sharing and accelerating innovation. In this blog article, we’ll dive into the core findings from our publication and explain why synthetic data could be the game-changer for the development of AI models in healthcare. ‍ 1. How Synthetic Data Can Fuel AI Mod...

On July 24 th , US FDA (Food and Drug Administration) finalized the guidance (initially published in September 2021) for  evaluating and using electronic health records (EHR) and medical claims data for real-world evidence (RWE) studies and for using these for regulatory approvals . In recent years, there has been a significant shift in the healthcare industry towards utilizing real-world data (RWD) to improve regulatory decision-making. This shift is driven mainly by the 21st Century Cures Act, which aims to speed up medical product development and bring innovations quickly to patients in need. The FDA’s new guidance on assessing EHRs and medical claims data underscores the importance of this movement. Real-world evidence (RWE) derived from RWD, such as EHRs, medical claims data, real-world imaging data (RWiD) and others, provides valuable insights into the effectiveness and safety of medical products. This information, collected during routine clinical practice, offers a comprehe...

  Segmed recently participated in the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting in Chicago. Taylor Duguay, Segmed’s Director of Clinical Development, attended the event at McCormick Place and shares his insightful experience below. ‍ First Impressions The American Society of Clinical Oncology Annual Meeting is a pinnacle event in the world of oncology and ASCO 2024 did not fall short. Forty-thousand oncologists, healthcare professionals, researchers, and industry leaders from across the globe gathered to exchange the latest in groundbreaking research and novel therapies. McCormick Place featured an expansive Exhibit Hall which included a dedicated Poster Session area where hundreds of researchers presented their research to what seemed to be a continuous flow of attendees. With four days of sessions, there was more to see and experience than time allowed. Research & Presentations The poster sessions showcased significant advancements in oncology, often su...

  Medical AI is often hailed as the future of medicine and will improve diagnostics, increase quality of patient care, enable further-sighted prediction of diseases, boost affordability of healthcare, and make healthcare available to many more people across the world. These are ambitious and admirable goals, and Segmed wants to enable this reality to improve the lives of millions seeking and requiring medical support. At the moment, one big impediment that companies must overcome to speed up the process of medical AI algorithm development is the lack of high quality training data sets. Readily available and free data sets are often difficult to use and lack any useful form of annotation which Medical AI companies require. As a result, most companies today spend significant resources and time to source data directly from individual partner hospitals and engage specialists to clean up the data so that it can be used in algorithm development. These relationships are difficult to manag...

Segmed today announced that their data network has now surpassed 100 million imaging studies. This was made possible by the onboarding of several national and international healthcare providers, and represents exciting progress towards the company’s mission to democratize healthcare data for ethical and privacy-preserving research and development. As research and development for real world evidence (RWE) and medical AI has advanced rapidly, the demand for real world data (RWD) to support these advancements has soared. Segmed’s Insight web platform acts as a bridge, connecting healthcare providers, researchers and technology developers with fully de-identified, standardized imaging data through its user-friendly interface. By simplifying access to RWiD, Segmed and their partners are empowering the medical research community to gather insights, advance medical research and drive meaningful progress in healthcare. A differentiating factor that separates Segmed from others in the space is ...

Segmed announced today that we’ve achieved our ISO/IEC 27001 certification. But what does that mean for us as an organization—and for you as our customer? Here at Segmed, keeping customer and stakeholder data secure is our top priority. To demonstrate that our systems and controls have been designed appropriately to achieve that goal, we sought out an independent assessment from an accredited auditing firm,  BARR Certifications . In this blog post, we’ll explain what it means to achieve ISO/IEC 27001 certification and why we chose to undergo this rigorous compliance audit. ‍ What is ISO/IEC 27001? Considered the gold standard in information security, ISO/IEC 27001 is an internationally accepted compliance standard that mandates numerous controls for the establishment, operation, monitoring, maintenance, and continual improvement of an Information Security Management System (ISMS).  The certification attests that an organization has deep-rooted methodologies for business, ...