Evidence Vault

Physicians-Owned Circles for Longevity/Geroscience

Physicians-Owned Circles for Spinal Muscular Atrophy (SMA)

While the $60 billion healthcare data analytics industry expands rapidly, ASCs are failing to exploit their most valuable asset while others do so. This RegenMed video explains how any ASC can generate new revenue streams and asset value by capturing and monetizing real-world evidence (RWE) from routine patient care. Key sections of the video, with time codes, are:The Opportunity [0:18 – 1:14]Real-World Evidence — structured datasets generated from routine patient care — is in high demand across industry and research. The $60 billion healthcare data analytics industry is growing at a rate of over 20% annually. ASCs are not only uniquely positioned to contribute to this market, but to benefit from it financially. RWE licensors include product manufacturers, insurers, research centers, and AI models. Use cases for licenses include competitive intelligence, regulatory submissions, product innovation, legal compliance, value based care, social determinants of health, and health equity. ASCs Can Participate [1:15 – 2:26]ASCs already regularly enter EMR and other real-world data, and pay to do so. However, that data is being aggregated, manipulated, and licensed by others. However, and despite their high cost, RWE datasets synthesizing EMRs, prescription, insurance claim and other disparate sources are incomplete, unverifiable and generally clinically irrelevant. Using RegenMed’s patented Circles technology and processes, ASCs can now structure, aggregate, own and monetize that RWD themselves — without burdening staff or altering clinical workflows. Primary and well correlated datasets which are verifiably sourced from daily patient care – against a prospectively designed Observational Protocol – are far more clinically relevant and “fit-for-purpose” than current RWE offerings. They are therefore far more valuable.What Do Circles Datasets Look Like [2:27–3:40]This section shows two separate illustrative reports. One compares four different knee implant products over twelve months against KOOS Jr. scores in the context of total knee arthroplasty. The second compares two separate surgical techniques over 27 months against a VAS score in the context of total hip arthroplasty.Although these are orthopedics examples, Circles can be and are used to generate clinically and statistically significant datasets for any anatomical region, pathology, treatment protocol, and standardized or custom outcomes score – regardless of medical specialty. EBITDA and New Asset Potential For An Average ASC [3:40 – 6:04]Based on the stated assumptions, which of course will depend on the specific circumstances of each ASC, five Circles datasets generated by ten physicians can produce new annual EBITDA of $850,000 for a total cost of only $31,000 — a return on investment of 14x. Moreover, these five 6-month longitudinal Circles datasets represent asset value of $2.6 million on the stated assumptions. Finally, an ASC can continue to increase these income streams and asset value through continued outcomes capture, additional Observational Protocols relevant to its practice mix, and combining internal and external Circles datasets.ConclusionTo discuss your specific situation, please contact us. RegenMed is not a mere solutions vendor. It works with each Client as a long-term partner to develop meaningful clinical and financial returns on investment.Contact usRegenMed | www.rgnmed.comcircles@rgnmed.com

The New Role of Real-World Evidence (RWE)Real-World Evidence (RWE) has emerged as a cornerstone of modern healthcare innovation, regulatory science, and payer strategy. Once considered supplementary, RWE now informs pivotal regulatory decisions, market access strategies, and post-market evaluations. The U.S. Food and Drug Administration (FDA), through the 21st Century Cures Act and subsequent guidance, has formally embraced RWE — defined as clinical evidence derived from real-world data (RWD) such as electronic health records (EHRs), insurance claims, and patient-generated information.RWE’s legitimacy has been reinforced by landmark regulatory approvals, including Medtronic’s CRT-D device and label expansions for drugs like Ibrance and Tecentriq, all supported by high-quality RWD. Industry and payers alike are accelerating investment in RWE strategies. A 2023 Deloitte survey revealed that 92% of life sciences firms have RWE strategies, with two-thirds planning increased investments. Likewise, payers such as UnitedHealthcare and Aetna are leveraging RWE to drive value-based care.The Imperative for Primary, Validated RWDDespite the growing utility of retrospective datasets, the RegenMed’s recent White Paper argues for the superiority of purpose-collected, prospective RWD. These data sources — gathered directly from clinicians and patients — offer several compelling advantages over administrative or passively collected data:Fit-for-Purpose DesignEMR and claims data, collected primarily for billing, often lack the precision and completeness required for rigorous research. Purpose-built datasets enable the use of validated instruments, structured formats, and contextually relevant clinical endpoints.Clinical NuanceStructured physician reporting captures nuanced clinical insights, including treatment rationale, staging, and intent — data points typically obscured in EMRs.Patient-Reported OutcomesProspective data collection engages patients directly, capturing metrics like pain, functionality, and satisfaction — offering a fuller picture of treatment efficacy than retrospective proxies.Agility and TimelinessReal-time data collection enables swift adaptation to emergent clinical trends, whereas retrospective data sources lag by months or years.Data IntegrityPurpose-collected data allows immediate validation at the point of entry. Structured electronic case report forms (eCRFs) and integrated logic checks dramatically reduce error rates.Regulatory CredibilityHigh internal validity and transparent provenance make prospectively collected RWD more persuasive in regulatory and payer contexts.Circles: RegenMed’s Response to the RWE ChallengeTo meet the demand for validated RWD, RegenMed regularly publishes and executes “Circles” — an ecosystem of statistically robust, domain-specific datasets focused on discrete pathologies, anatomical regions, and standardized outcomes. These datasets are:Built from physician-generated, real-world clinical data.Structured to answer specific scientific or clinical questions.Fully de-identified and HIPAA/GDPR compliant.Designed for flexibility in observational protocol (OP) development.Circles empower clinicians to contribute cases while sharing in dataset monetization, aligning incentives and driving long-term data growth. Importantly, Circles data typically do not require IRB review, as they are gathered during routine care for quality improvement purposes rather than interventional experimentation.Real-World Application: TKA and THA DatasetsThe White Paper includes illustrative Circles reports on Total Knee Arthroplasty (TKA) and Total Hip Arthroplasty (THA), demonstrating Circles’ potential for granular, verifiable insights. These reports exemplify how customized observational protocols, rich clinical detail, and long-term patient-reported outcomes converge to support practice-changing analytics and licensing opportunities.ConclusionValidated real-world data, collected directly from clinicians and patients with rigor and intent, is no longer optional — it is essential. As regulatory bodies, payers, and innovators continue to demand more actionable, credible, and agile evidence, RegenMed’s Circles platform positions itself as a next-generation solution. By aligning clinical insight, scientific design, and economic incentives, Circles transforms real-world data into real-world impact.

BackgroundOn May 16, 2025, the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ASTP/ONC) issued a Request for Information (RFI) on the Health Technology Ecosystem. The RFI is gathering input from all healthcare stakeholders on how to modernize the digital health ecosystem for Medicare beneficiaries, focusing on improved patient empowerment, interoperability, and value-based care (VBC). CMS and ASTP/ONC are especially interested in practical ideas, evidence-based suggestions, and real-world examples to guide potential policy updates, future rulemaking, and digital health innovation that is patient-centered, cost-effective, and outcome-driven. Key CMS objectives include:Reduce provider and patient burden related to data access, reporting, and administrative workflows.Encourage development and widespread adoption of real-time, personalized, and secure digital tools.Improve access for patients and caregivers to their health data. Develop secure digital identity credentials for such access.Eliminate barriers to using digital tools in clinical workflows. Standardize and automate documentation and quality measurement. Develop strategies for supporting small/rural practices.Simplify data exchange between providers and payers.Align technology with Alternative Payment Model requirements. Promote adoption of digital tools measuring and improving outcomes. Support VBC organizations with scalable, interoperable infrastructure.This RFI marks a pivotal step in shaping how digital tools and real-world data can transform U.S. healthcare. CMS and ASTP/ONC emphasize transparency, patient empowerment, ecosystem-wide participation, and practical policy refinements to make digital health technology work better — for everyone. These are precisely the goals and capabilities of RegenMed’s technical platforms and associated processes.RegenMed Summary ResponseThe Company’s flagship solution, Circles, is a digital platform designed to collect, structure, and analyze longitudinal health data in a secure and patient-centric way. Key capabilities include:Low-cost, clinically relevant data collection with minimal burden on providers.Supports value-based care by correlating treatments with long-term patient outcomes.Allows patients to access and compare their personal outcomes with similar cohorts.Provides cloud-based, real-time access to longitudinal datasets from any device.Incorporates both conventional and Complementary and Alternative Medicine (CAM) practices, addressing gaps in traditional clinical trial data. See this Article.Empowers clinicians — especially in non-academic settings — to engage in high-quality, outcomes-driven research.Avoids shortcomings of “big data” systems such as clinical irrelevance, poor interoperability, algorithmic opacity, and data ownership disputes. See this Article.Clinically and statistically significant datasets based on verifiable physician-patient interactions, structured around specific anatomical regions, pathologies, treatment protocols, and standardized outcomes assessments.Enabling faster, lower-cost and more impactful medical innovation, especially critical today due to declining public research funding and bias concerns in peer-reviewed literature.Provide high-quality, verifiable data for training reliable AI healthcare models.Supports SODH and health equity through use by any sized provider group, any specialty, in any location.Supports deep and sustained collaboration on any clinical topic among providers and medical scientists across institutional and regional borders.Innovative patient health tokens for highly secure digital access to, and control over, individual longitudinal health records. (See this White Paper.)Ethical, clinical, reputational, and financial motivation to providers to generate clinically and statistically significant real-world evidence. (Physicians-Owned Circles.)This summary captures RegenMed’s overarching position: that real-world, patient- and provider-validated data, structured around long-term outcomes and specific clinical contexts, is the foundation for effective digital health transformation. Their Circles platform is proposed as a model framework for CMS and stakeholders to achieve these goals at scale. RegenMed’s detailed Response can be found in the Federal Register here.

Longevity medicine is redefining healthcare by shifting focus from treating disease to proactively extending healthspan — the years of life spent in good health. Grounded in geroscience, which targets the biological mechanisms of aging such as cellular senescence and mitochondrial dysfunction, this emerging field relies on personalized diagnostics and interventions including lifestyle optimization, supplements, and geroprotective drugs like metformin and rapamycin.Yet despite growing interest, longevity medicine faces critical challenges: fragmented data, unvalidated biomarkers, and a lack of large-scale human evidence. This is where real-world evidence (RWE) becomes transformative. RWE captures data from everyday clinical settings, enabling researchers to evaluate interventions across diverse populations and timeframes that randomized trials often cannot reach.RegenMed’s Physicians-Owned Circles (POCs) offer a breakthrough approach to generating validated RWE in longevity medicine. These decentralized, clinician-led data networks allow practitioners around the world to collaborate on observational studies tailored to specific conditions and interventions. Each POC adheres to regulatory standards and supports physicians in collecting actionable, clinically-relevant data with minimal burden.For clinicians, POCs offer benchmarking, professional development, and deeper patient engagement. For industry sponsors, they provide cost-effective, validated datasets that can accelerate regulatory approval and post-market surveillance. For the broader field, POCs build a scalable infrastructure to validate therapies, refine biological age clocks, and personalize treatment protocols.As the longevity industry continues to grow, the integration of validated RWE into clinical and research frameworks is essential. It is the key to moving from theory to practice, from hype to health impact. RegenMed’s model demonstrates how real-world data — when generated ethically and collaboratively — can unlock the full promise of longevity medicine for patients, providers, and society.