Evidence Vault

The Crisis of Clinical Knowledge Medicine is entering an age of paradox. Data volume has exploded, yet decision confidence is eroding. Clinicians are overwhelmed by digital noise — billions of disconnected points in electronic health records, research databases, and claims repositories that rarely align. Every algorithm promises insight, but few can guarantee truth. The result is what the New England Journal of Medicine (2024) termed a “crisis of verifiable knowledge”: massive informational abundance, minimal evidential reliability. The underlying problem is not technology but epistemology — how we know what we think we know. 2. What Real-World Evidence Was Supposed to Solve The real-world evidence (RWE) movement emerged to complement randomized controlled trials (RCTs) with insights drawn from routine clinical practice. Regulators, payers, and clinicians hoped RWE would fill the gap between efficacy and effectiveness, providing broader, faster, and more inclusive understanding of how therapies perform in reality. But first-generation RWE largely failed to deliver. Most datasets are opportunistic EHR extractions — incomplete, inconsistently coded, and unverified. They describe events but cannot establish causality; they record encounters but cannot trace outcomes. In short, they are big data without deep truth. As Nature Medicine summarized in 2023: “Real-world evidence can accelerate discovery only if it becomes real-world science.” 3. The Core Problem: Low Signal, High Noise Uncurated EHRs and billing records were never designed for inference. They reflect administrative workflows, not scientific ones. Measurements vary by device, terminology, and context; diagnoses are inferred from billing codes; outcomes are rarely standardized. AI trained on such inputs amplifies inconsistency at scale. Signal-to-noise ratios in unstructured clinical data are so poor that even advanced models produce statistically impressive but clinically unreliable results. Without validated context, a million data points can mislead as easily as they inform. 4. The Next Step: Protocol-Driven Evidence Generation RegenMed’s answer is the Circle Dataset — a new class of structured, longitudinal, high-quality RWE built through the Circles Platform, implemented via the inCytes™ (clinician-facing) and Benchmarc™ (patient-facing) systems. Unlike EHR dumps, Circle Datasets are:  Structured — defined by observational protocols, not opportunistic charting.  Validated — each data element carries provenance and audit trails.  Longitudinal — following patients, conditions, and interventions over time.  Interoperable — mapped to FHIR-compatible standards (ICD, CPT, LOINC, SNOMED). Every data point exists within context, verified by the clinician who generated it and confirmed by the system’s validation layer. This transforms documentation into research — care into evidence. 5. Why Structure Matters Structure is the difference between observation and understanding. When data follow a defined protocol, they become comparable across patients, time, and institutions. That comparability enables real statistics, reproducibility, and learning. As the FDA’s Real-World Evidence Framework (2023) emphasized: “Fitness for regulatory purpose depends on demonstrable provenance, completeness, and traceability.” Circle Datasets institutionalize those qualities, ensuring that every metric is clinically meaningful and computationally verifiable. 6. Validation as a Continuous Process Traditional datasets treat validation as an event — a one-time audit or publication checkpoint. In Circles, validation is continuous. Each new record triggers automated quality checks, coding reconciliation, and peer-level review. Anomalies are flagged in real time; provenance is immutable. This “always-on” validation loop not only guarantees data quality but produces an evolving evidence stream — a living database that learns as care unfolds. 7. The Longitudinal Advantage Healthcare is temporal. Disease evolves, treatment responses fluctuate, and patient behavior changes. Only longitudinal data can capture those trajectories. Circles follow patients across visits, interventions, and outcomes, enabling precise time-series analyses and real-world cohort tracking. Longitudinality turns snapshots into stories — and stories into scientific signal. 8. Interoperability and FHIR Compatibility Circles will adhere to the Fast Healthcare Interoperability Resources (FHIR) standard, ensuring data compatibility across systems and geographies. Every data element maps to international vocabularies — ICD for diagnoses, CPT for procedures, LOINC for labs, SNOMED CT for concepts. This standardization makes Circle Datasets exportable, verifiable, and integrable into AI training pipelines without loss of meaning 9. The High-Signal Alternative By combining structure, validation, longitudinal tracking, and interoperability, Circles achieve an unprecedented signal-to-noise ratio. This precision enables machine learning models to generalize safely, clinicians to compare outcomes reliably, and regulators to trust conclusions confidently. It is the difference between having data and having evidence. 10. Conclusion — The New Ground Truth Real-world evidence was meant to democratize discovery. To fulfill that promise, it must mature from opportunistic collection to deliberate observation. Circle Datasets represent that maturation: a rigorous, transparent, and continuously validated foundation for medical intelligence. They are, in effect, the ground truth of modern medicine -- a living infrastructure of verified care, built to power both AI and human judgment. Selected Sources • New England Journal of Medicine. The Crisis of Verifiable Knowledge (2024). • Nature Medicine. Real-World Evidence as Real-World Science (2023). • U.S. Food and Drug Administration. Real-World Evidence Framework (2023). • RegenMed Foundation. Circle Datasets and Observational Protocols White Paper (Draft 2025).

Circles Physician Promotion Program

IntroductionIn today’s digital age, physicians no longer operate solely within clinic walls. Their voices extend across social media, webinars, professional forums, and public platforms — shaping patient trust, influencing health behavior, and defining professional reputation. As digital engagement becomes central to healthcare’s future, physicians face both unprecedented opportunities and heightened risks. Effective public communication is now not only a professional differentiator but also a regulatory responsibility requiring adherence to evidence-based standards. To navigate this evolving landscape, physicians must adopt structured, compliant, and strategically guided communication programs. RegenMed’s Circles Physician Promotion Program is designed to empower clinicians with the tools, platforms, and safeguards needed to share their expertise confidently and credibly.The Strategic Value of Public CommunicationThe digital transformation of healthcare has democratized information, making expert medical voices more visible — and more necessary — than ever before. Accurate, relatable, and evidence-based messaging combats misinformation, fosters patient understanding, and strengthens population health initiatives. For physicians, public communication also creates: Professional differentiation, highlighting data-driven outcomes and thought leadership.Patient engagement, by translating complex insights into accessible narratives.Peer recognition, through collaboration on shared observational protocols and dissemination of findings.Career advancement, as health systems increasingly value digital credibility and outreach capabilities. Yet, the same visibility that builds reputation also invites scrutiny. Physicians must balance influence with integrity, ensuring every public statement aligns with the ethical rigor expected in clinical practice.Regulatory and Ethical ConsiderationsPublic communication is not exempt from professional standards. According to the American Medical Association (AMA) and Federation of State Medical Boards (FSMB), physicians carry identical ethical responsibilities in digital spaces as in direct patient care. Key regulatory domains include:Federal Trade Commission (FTC) oversight of advertising and promotional claims, requiring Competent and Reliable Scientific Evidence (CRSE) to substantiate any statements about treatment efficacy.State Medical Board jurisdiction, addressing misinformation and “unprofessional conduct,” which can trigger licensure investigations or sanctions.HIPAA/HITECH compliance, demanding strict de-identification of any shared clinical data, whether by Safe Harbor (removal of 18 identifiers) or Expert Determination (statistical certification).Professional liability exposure, including malpractice and informed consent claims arising from inaccurate or exaggerated public claims.Conflict of interest transparency, to ensure independence and avoid perceptions of self-dealing. In this environment, structured governance is essential. Communications must be accurate, documented, de-identified, and fully transparent about financial or professional interests.Best Practices for Responsible Physician CommunicationTo safeguard both physicians and their institutions, communications should reflect five essential principles: Evidence-Based Claims: All public statements must be anchored in verified clinical data and peer-reviewed outcomes. Privacy Protection: No identifiable patient information should ever be disclosed without explicit consent and proper de-identification. Professional Boundaries: Maintain separation between personal and professional social media; avoid forming unintended patient relationships online.Transparency: Clearly disclose any financial relationships or research affiliations relevant to the content shared. Documentation: Retain records of all communications involving clinical claims or patient data in secure, auditable systems. These standards elevate public communication from marketing to a form of evidence-based public health education — reinforcing both trust and compliance.The Circles Physician Promotion Program: A Compliant Pathway to InfluenceRegenMed’s Circles platform already enables participating physicians to collect high-quality, longitudinal real-world evidence (RWE). The Circles Physician Promotion Program extends that value by transforming validated data into credible, impactful communication assets — all at no additional cost.Program ComponentsCircle Hours: Moderated, secure Zoom sessions presenting clinical hypotheses, real-world outcomes, and best practices — with full video editing and highlight vignettes for reuse.Website and Newsletter Content: Professionally produced short-form videos and articles showcasing data insights, thought-leader collaborations, and upcoming conference activities.Social Media Campaigns: Evidence-based posts aligned with regulatory guidance, promoting physician expertise while preserving compliance.Conference Support: Assistance with slide decks, brochures, and post-event communications for Circle investigators and co-investigators.Co-Investigator Recruitment: Guidance and outreach to bring aligned clinicians into similar observational protocols, strengthening professional networks. Each element is built on RegenMed’s rigorous compliance framework, ensuring that physician communications remain factually grounded, legally sound, and professionally advantageous.ConclusionIn the modern healthcare ecosystem, communication is clinical practice. Physicians who articulate their expertise — responsibly, transparently, and evidence-first — amplify their impact beyond the exam room. Yet, the legal and ethical complexities of public engagement demand structured, expert support. The Circles Physician Promotion Program bridges this gap. By merging real-world data, compliant messaging, and professional-grade media, it transforms physician communications into strategic assets — enhancing clinical reputation, supporting patient education, and driving professional growth, all while safeguarding regulatory compliance. It is your data — and with the right platform, it can serve your clinical, professional, and financial interests responsibly.‍

Physicians Welcome

How RegenMed Circles Enable Clinically and Statistically Significant PNS ProtocolsPeripheral Nerve Stimulation (PNS) is transforming the landscape of pain management. Once seen as a last resort for intractable neuropathic pain, it now stands at the forefront of non-opioid, precision-based interventions. Yet, despite its promise, PNS has long been held back by one fundamental gap: the inability to reliably predict which patients will benefit, and under which stimulation parameters. Clinical success has often relied on trial-and-error rather than science. RegenMed Circles changes that paradigm.Closing the Evidence Gap with Circles RegenMed Circles is a real-world evidence (RWE) platform designed to bring scientific rigor and statistical power to PNS therapy. By standardizing observational protocols, integrating validated Patient-Reported Outcome Measures (PROMs), and aligning with payer-recognized ICD-10 indications, Circles enables a new generation of PNS research — one that is clinically meaningful, reproducible, and regulatory-grade.Circles moves beyond empirical feedback to structured, data-driven insights. It systematically collects pain intensity, functional outcomes, psychological metrics, and opioid utilization data across diverse populations, allowing clinicians and manufacturers to identify what truly drives long-term success.Implementing Clinically and Statistically Significant PNS ProtocolsOur recently published White paper proposes three important Observational Protocols (OPs) for PNS therapy — each designed to address high-impact clinical challenges and generate evidence suitable for coverage expansion:Post-Amputation Pain: Validates early PNS intervention as a prophylactic, opioid-sparing therapy to prevent phantom limb pain.Genicular Nerve Stimulation: Measures pain relief and functional restoration in chronic knee pain, linking PROMs such as WOMAC and KOS-ADL to payer-relevant outcomes.Postherpetic Neuralgia**: Evaluates durable efficacy of permanent PNS implants in severe neuropathic pain, with a focus on quality of life and sleep interference metrics.Each OP leverages Circles’ architecture to achieve clinically and statistically significant results. By standardizing inputs and outputs across multi-center sites, Circles delivers the statistical power necessary to draw credible conclusions — transforming individual case studies into population-level insight.From Empirical Practice to Predictive PrecisionThe future of PNS lies not just in better devices, but in better data. Circles integrates anatomical, psychological, and outcome data to inform predictive models for stimulation optimization. This shift from reactive to predictive programming aligns PNS therapy with modern precision medicine standards.By embedding computational modeling, validated PROMs, and longitudinal tracking, Circles enables clinicians to personalize therapy while giving payers and regulators the reproducible evidence they demand. The result: safer, more effective, and financially sustainable PNS care.A Platform for Clinical, Regulatory, and Market SuccessIn a market projected to more than double by 2033, RegenMed Circles positions stakeholders to lead. It provides manufacturers with evidence for FDA and CMS alignment, clinicians with actionable insights, and payers with proof of value. By uniting clinical outcomes with compliance integrity, Circles builds a foundation for scalable, non-opioid pain care.ConclusionRegenMed Circles turns the promise of PNS into predictive precision. By designing and executing clinically valid, statistically robust observational protocols, it bridges the gap between innovation and validation — unlocking the full therapeutic and commercial potential of peripheral nerve stimulation.

Circle Datasets_Principal Characteristics