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Generative AI (GAI) is considered the most important technical development since the establishment of the Internet. It has profound implications in healthcare. Research, product development, and clinical decision-making are a few major examples. At the same time, clinical-grade real-world data (RWD) is fast becoming the most important data category in healthcare. More than EMR, payer, RCT, and other types of data, RWD is essential to achieving value-based care, health equity and overall cost reduction in healthcare delivery. GAI/RWD use cases will include value-based care for payers, product development for manufacturers, scientific breakthroughs for researchers, and clinical decision support for providers. Circles represent proprietary and well-structured RWD databases which are ideal for a variety of GAI applications. They possess several important characteristics making them attractive for healthcare-related GAI applications: They are well-structured, enabling the efficient derivation of statistically significant correlations among scientific hypotheses, clinical interventions, and long-term outcomes. They are “fit-for-purpose”. Each Circle database corresponds to one or two well-defined endpoints representing clinically and statistically significant datasets. Data integrity, auditability, scalability, and regulatory compliance. Clear data ownership rights. Ease of integration with other private (e.g., EMR) or public (e.g., open access medical literature) data sources. Circles Founders and Members already capture value from their RWD through publication, study investigator fees, honoraria, and other channels. Their most important opportunity for value creation will likely come from Generative AI. For more information, see our Articles on the importance of real world data and Circles data monetization.

Type image caption here (optional)Quality medical care is the domain of the treating physician. Its fundamental elements include education, training, observational skills, and professional judgment. Those hard-won traits are then applied to the relevant data the clinician is able to assemble. Those data comprise the patient story, clinical assessments, imaging, and laboratory results. Ideally, these data are augmented by reference to evidence-based research and consultation with peers. However, the physician is often hindered in delivering quality care by administrative burdens, financial factors, information overload, time constraints, and limitations on meaningful collaboration, education, and training. Circles return the physician to the center of healthcare delivery. They provide her with the ability to diagnose, treat and monitor each patient on the basis of evidence-based standards of care. Critically, they enable him to do so in a cost-effective and minimally burdensome manner. This is the essence of value-based quality medicine, a dominant theme of 21st Century healthcare.Contact us to learn more.

Type image caption here (optional)The FDA has released draft guidance on the “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices”. The principles underlying this guidance have important – and advantageous – implications not only for device manufacturers but also for clinicians.The FDA states that real-world evidence (RWE) “may provide an efficient means of generating the necessary clinical evidence to support regulatory decisions”. However, the guidance also emphasizes that data quality, good clinical practice, proper study design, longitudinal outcomes data and other traditional methodological considerations remain critical.The FDA enumerates many potential sources of RWE. Nevertheless, it is clear from the guidance that only specific types of real-world data (RWD) surrounding a discrete category of clinical interventions, and causally correlated to longitudinal outcomes, will generate acceptable “study-specific derived dataset(s).”This means that busy clinicians and their patients are essential to developing the RWD which can be converted into RWE. It is those already over-worked clinicians who are best positioned to design, capture and analyze study-specific RWD. It is their patients who must report long-term outcomes against standardized assessment measures. The overriding question is: where is the time or incentive to do so?The technology and processes underlying each Circle is “fit-for-purpose”in the context of any RWE objective to comply with the FDA’s guidance. (Indeed, the U.S. patent underlying Circles is titled “Method and System For Processing Large Amounts of Real-World Evidence”.) Moreover, Circles eliminate administrative burden for clinicians in generating RWE, while developing accompanying ethical professional and financial incentives.Please contact us to find out more.

RegenMed’s December 2023 Newsletter may be found here. It summarizes many of the ways our clients around the world are generating clinical, scientific, and financial value through Circles. The Newsletter also covers select company developments.Value-based care, real-world evidence and health equity will remain forceful healthcare trends in 2024. Addressing and benefiting from these trends is the essence of our client partnerships. All of us at RegenMed wish a restful and joyful holiday season to the exemplary healthcare professionals with whom we have the pleasure of working. We look forward to expanding and deepening those partnerships in the New Year.

Type image caption here (optional)Institutional constraints can limit the ability of physicians and researchers to collect long-term outcomes, design and execute studies, develop value-based care models best suited to their patient panels, or publish. Obstacles include time and RVU pressures, funding, complex IRB processes, and access to laboratory time and scientific experts. ‍Circles address these challenges. They inherently support collaboration across institutional and national borders. Their patented functionality is clinical grade, but imposes virtually no administrative burden. Cost is minimal; indeed, RegenMed often sources investigator-initiated study funding for Circle Members.Circles thus represent a powerful yet efficient solution for observing, participating in, or even designing “external” real-world evidence initiatives.Moreover, simple “internal” Circles implementations – such as long-term capture of standardized outcomes measures – can provide substantial clinical value to employed physicians. At only $5 per Case, and with easy data import capability for institutional EMRs, the cost-benefit analysis is straightforward.