Evidence Vault

The PremiseMetrics were born as tools of accountability. They promised to render the invisible work of science visible — to measure contribution, efficiency, and impact in a fair and standardized way. But as in all systems where measurement becomes identity, the instrument has consumed the intent. What began as an aid to judgment has become its replacement. In modern research, to be good is to be measurable, and what cannot be counted ceases to count. This transformation is not merely administrative; it is moral. It converts the pursuit of truth into the pursuit of indicators — citation counts, h-indexes, impact factors, altmetrics. Each of these, originally designed to illuminate influence, now distorts it. Metrics have become moral proxies, absolving institutions of the need for discernment. The Distortion Once metrics become ends rather than means, corruption is no longer an aberration — it is compliance. Scientists learn to optimize the visible signals of productivity: fragmented publications (“salami slicing”), reciprocal citations, and strategic authorship. The logic of the market invades the logic of inquiry. In such an environment, genuine discovery is penalized if it cannot be quickly or widely measured. The long, uncertain pursuit of fundamental understanding — the kind of work that often changes the world decades later — is devalued. Systems designed for fairness end up rewarding conformity, creating a moral inversion: the metrics of virtue replace the virtues themselves. The Consequence The ethical consequence of this metricization is alienation. Researchers begin to experience their own work not as calling, but as calibration. The joy of discovery yields to the anxiety of performance. Academic communities fracture into citation cartels and metric-driven tribes, each vying for algorithmic visibility. The result is epistemic inflation: a glut of measurable output with diminishing intellectual value. Metrics, which once promised to democratize recognition, now amplify inequality. Elite institutions, already advantaged, dominate the statistical landscape, their prestige self-perpetuating through the very indicators meant to neutralize it. The Way ForwardMetrics must return to their moral context — as instruments of stewardship, not judgment. Institutions can reclaim ethical balance by reintroducing qualitative assessment: peer evaluation that values originality and contribution over volume and reach. Funding agencies can weight integrity disclosures and replication efforts equally with publication counts. Above all, the research community must remember that measurement without meaning is not accountability; it is abdication. To measure science ethically is to measure its service to understanding, not its reflection in the mirror of itself. Selected References RegenMed (2025). Genuine Medical Research Has Lost Its Way. White Paper, 2025.Hicks, D., et al. (2015). The Leiden Manifesto for Research Metrics. Nature, 520(7548), 429–431. Biagioli, M., & Lippman, A. (Eds.). (2020). Gaming the Metrics: Misconduct and Manipulation in Academic Research. MIT Press. Muller, J. Z. (2018). The Tyranny of Metrics. Princeton University Press. Moher, D., et al. (2018). Assessing Scientists for Hiring, Promotion, and Tenure. eLife, 7:e33638. Wilsdon, J. (2015). The Metric Tide: Report of the Independent Review of the Role of Metrics in Research Assessment and Management. HEFCE. Get involved or learn more — contact us today!If you are interested in contributing to this important initiative or learning more about how you can be involved, please contact us.‍‍

IntroductionMany physicians are interested in becoming Circle Members, but are unsure how to do so in the context of hospital system or other provider group (medical institution) affiliations. RegenMed stands ready to assist.Decision-MakingIn view of the substantial financial and clinical benefits accruing for a medical institution, multiple decision-makers are likely to be involved in the development of a Circle Dataset program. These can include department chairs, research heads, and/or C-suite officers. Relevant MSO and/or private equity personnel may also wish to be involved. BAAs, DUTAsRegenMed and the medical institution will typically execute a Business Associate Agreement covering compliance with HIPAA and other regulatory requirements. They will also execute a Data Use and Transfer Agreement. This will reflect, among other things, the terms desired by the medical institution with respect to federated Circle Dataset participation, discussed below.Federated Control and ParticipationThe patented Circle Platform is an integrated, turnkey and closed system. It enables unambiguous ownership of and control over resulting Circle Datasets. This, coupled with the high-quality of those Datasets is the foundation of their substantial clinical and financial value, and therefore intellectual property rights. See here and here.A medical institution can license the Circle Platform for use within its firewalls, or access it as a cloud-based solution. In either scenario, the medical institution maintains control over the use of its local data. As and when it wishes to benefit from the combination of its own Circle Datasets with external Circle Datasets, it can choose to do so.The generation of Circle Datasets is not intended to involve human subjects research as defined under 45 CFR 46.102. See here. However, RegenMed can work with commercial or academic IRBs to obtain an exemption or NHSR designation. Similarly, if the medical institution wishes to use the Circle Platform for a research study, RegenMed can work with the investigators and assigned IRB to support the project.IRBsThe clinical and financial benefits of Circle Datasets are substantial for virtually any medical institution. Analogous initiatives by Duke Health and Mayo Clinic are instructive. So to is the recent discussion by the FDA Commissioner regarding the importance of fit-for-purpose and high quality real world evidence developed in medical institutions regardless of type or size.Clinician Buy-InThe Circles Platform tracks real world data contributions on the basis of individual clinicians, and individual Observational Protocols. This gives a medical institution a high degree of flexibility in allocating Circle Dataset royalties to participating physicians. Together with its excellent clinician and patient UX, the Circle Platform is designed to maximize clinician buy-in for real-world initiatives in any therapeutic area. Phased Roll-OutThe low-cost and turnkey nature of the Circle Platform allows a small controlled pilot, to be scaled only after meeting pre-agreed KPI’s.System InteroperabilityRegenMed strongly recommends the maintenance of all Circle-based data within its closed system. This ensures unambiguous ownership and resulting high-value intellectual property rights. However, the Circle Platform incorporates FHIR-mapping, and can work efficiently with a medical institution to support interoperability with other healthcare data systems.

The Myth of Ownership Modern data law pretends that information can be owned like property. Yet ownership implies exclusion — the right to deny access — while medical truth gains power only through sharing. This paradox defines medicine’s moral tension: knowledge demands openness, but ethics demands control.Circle resolves this not by redefining ownership, but by redefining consent as the true source of value. Every tokenized record within Circle exists only by virtue of an unbroken chain of permission.Possession may confer control, but consent confers legitimacy.Consent as the First Currency In primitive societies, trade required mutual recognition — a handshake, an oath, a gesture of trust. In digital societies, that gesture must be cryptographic: consent recorded, validated, and traceable. Circle’s architecture encodes each act of permission as metadata inseparable from the data it authorizes. This design transforms consent from formality to currency — a transactional unit of moral energy that powers the entire system. Without consent, data cannot circulate; with it, it accrues integrity. The Fragility of Forgetting Healthcare systems today treat consent as disposable: a checkbox, a signature, a line on a clipboard. Once recorded, it vanishes — lost in institutional memory, untraceable to the patient. Circle makes consent immortal. Each act of permission lives as an immutable record, visible to all authorized participants. Its persistence gives moral gravity to every data transaction — the knowledge that the individual remains present in the system that uses their truth. Consent becomes the patient’s enduring voice. The Economics of Permission In conventional data markets, value accrues to collectors, not contributors. But if consent itself is a measurable input, then the individual regains a share of the market they sustain. Each verified act of permission becomes a form of participatory equity. The more one’s data is ethically reused, the greater the return — financial, reputational, or clinical. Circle rebalances the moral economy: those who enable truth finally share in its yield. Consent as Continuous Relationship Permission is not a one-time transaction; it is an ongoing dialogue between person and system. Circle’s federated consent model honors that dialogue: patients may adjust, revoke, or refine their permissions without breaking the data’s lineage. This transforms consent from contract to relationship — dynamic, living, and mutual. Ethics evolves at the same pace as knowledge. The Moral Outcome Consent is the moral weight that prevents truth from drifting into exploitation. It ensures that transparency does not become exposure, and that participation remains dignity, not data extraction. In the Circle economy, consent is both gravity and guarantee — the invisible force that holds value in moral orbit. Without consent, data is weightless. With it, it becomes human truth with mass.

General NoteCircle Datasets address fundamental deficiencies in current real-world evidence implementations. Below are thematically organized descriptions of and citations to underlying concepts and responsible entities. Regulatory and Federal Frameworks21st Century Cures Act: Enacted in 2016, this legislation is the foundational authority for current federal mandates requiring health data interoperability and the prohibition of information blocking. It was designed to accelerate medical product development and bring innovation to patients faster. FDA - 21st Century Cures ActASTP (Assistant Secretary for Technology Policy): The office within the U.S. Department of Health and Human Services (HHS)—formerly known as the ONC—responsible for the nation’s health IT strategy. It sets the standards for certified health technology and enforces policies related to data access, exchange, and use. HHS - ASTP/ONCHIPAA (Health Insurance Portability and Accountability Act): The federal law that established national standards to protect sensitive patient health information from being disclosed without the patient's consent or knowledge. It governs the security and privacy requirements for Data Use Agreements (DUAs). HHS - HIPAA Privacy RuleHTI Deregulatory Shift (HTI-1, HTI-2, HTI-5): Health Data, Technology, and Interoperability. A strategic pivot by federal regulators to reduce prescriptive oversight while emphasizing interoperability through standardized APIs. HTI-1 introduced algorithm transparency, while the proposed HTI-5 aims to remove nearly 70% of existing certification criteria to ease compliance burdens for developers who prioritize automated data exchange. HealthIT.gov - HTI-1 Final Rule; ASTP - HTI-5 ProposalInformation Blocking: Any practice by a healthcare provider, IT developer, or health information network that is likely to interfere with, prevent, or materially discourage the access, exchange, or use of electronic health information. Federal law imposes significant financial penalties for organizations found to be blocking data. HealthIT.gov - Information BlockingTEFCA (Trusted Exchange Framework and Common Agreement): A set of legal and technical requirements established to support nationwide health information exchange across different networks. It creates a universal "floor" for interoperability, allowing secure data access regardless of the technology platform used. HealthIT.gov - TEFCAUSCDI (United States Core Data for Interoperability) v.3 and v.4: A standardized set of health data classes and constituent data elements for nationwide interoperable health information exchange. Version 3 is the mandatory baseline as of January 1, 2026, while version 4 expands requirements to include domains like social determinants of health and insurance details. HealthIT.gov - USCDIClinical Evidence and Data QualityAdministrative Proxies: Indirect indicators, such as ICD-10 billing codes or claims data, used by payers to estimate a patient's health status. These are considered insufficient under current veracity standards because they do not reflect the actual physiological or functional state of the patient.Biosimilar Switching Studies: Trials traditionally required by the FDA to demonstrate that a patient could safely switch between a brand-name biologic and its generic equivalent. Recent 2025–2026 reforms have begun removing these requirements to accelerate market competition. FDA - Biosimilar CurriculumHuman Ground Truth: The "gold standard" of clinical evidence derived directly from actual patient physiology and clinical interactions, rather than administrative guesses or billing codes. This data is the necessary foundation for proving the reversal of chronic disease and meeting the veracity mandate.Measurement Gap: The disparity between high-volume administrative data (billing and claims) and the actual medical facts required to prove long-term patient health improvements. Closing this gap involves capturing standardized clinical data at the point of care to ensure physicians are compensated for improving health outcomes.Proven Medical Accuracy: A clinical standard where clinical rules and data parameters are defined before the patient encounter. This proactive management makes billing errors and protocol mistakes technically impossible, replacing administrative proxies with verified facts.Real-World Evidence (RWE): Clinical evidence regarding the usage and potential benefits or risks of a medical product derived from the analysis of data collected outside of traditional randomized clinical trials. High-accuracy RWE can shorten or replace expensive studies, providing a competitive advantage in proving therapeutic results. FDA - Real-World EvidenceStandardized Long-Term Scores (PROMs): Validated, longitudinal assessment tools, such as Patient-Reported Outcome Measures (PROMs), used to objectively track a patient’s symptoms and physical function over time. These scores provide the evidence required to prove, for example, the actual reversal of chronic disease. CMS - Patient-Reported Outcome MeasuresVeracity Mandate: The 2026 macro-regulatory shift where the responsibility for proving a treatment's safety and effectiveness moves from the government to the clinical data itself. As agencies like the FDA accelerate approvals, they increasingly rely on high-integrity data that is accurate enough for federal audits and high-stakes licensing.Technical Infrastructure and AIAlgorithm Transparency: A regulatory requirement under the HTI-1 rule mandating that developers of certified health IT provide baseline information about predictive algorithms used in clinical settings. This allows users to evaluate the fairness and safety of these tools. HealthIT.gov - HTI-1 Decision Support InterventionsBias Mitigation: The proactive process of identifying and correcting systematic errors in data or algorithms that could lead to unfair outcomes. Federal rules prohibit the use of clinical decision tools that exhibit bias based on protected patient attributes. HHS - Civil Rights and AIData Exhaust: Technical jargon for the secondary trail of data—such as logs or metadata—generated by digital processes that is often discarded. In high-trust environments, this "noise" is transformed into structured, verified facts ready for review.FHIR (Fast Healthcare Interoperability Resources): The global standard for the electronic exchange of health information using modern web-based APIs. It allows disparate software systems to communicate discrete patient data seamlessly. HL7 - FHIRPredictive Model Disclosures: A formal requirement under 45 CFR 170.315(b)(11) to provide notice to patients and regulators regarding the use of AI in clinical diagnosis or treatment. Disclosures must include details on the training data, intent, and ongoing monitoring for fairness. eCFR - 45 CFR 170.315Strategic and Financial ValuationAudit Readiness: The organizational state of having clinical data continuously prepared for external review, ensuring that all captured data meets official standards at the point of entry.Automated Compliance: A structural solution using reliable data management to ensure that federal reporting is simple and error-free, maximizing Medicare payments while eliminating manual paperwork.Audit-Ready Logs: Immutable digital records that capture the provenance and clinical actions of every patient encounter. These logs provide the evidentiary foundation for proving clinical veracity and maintaining a liability shield.Federated Control Model: A physician or provider group recruitment mechanic allowing them to maintain total control over their clinical science and data while benefiting from the shared valuation and administrative support of a larger network.High-Trust Evidence (Insurable Integrity): Clinical data that is verified to be accurate enough to be used for underwriting risk or defending against legal claims. This allows organizations to move from industry averages to performance-based insurance premiums.Liability Shield: A risk-management pillar that uses verified medical facts to block legal claims and reduce professional liability insurance costs. It moves clinical data from a passive record to a defensive asset that allows for the calculation of risk for better insurance terms.MSO (Management Services Organization): An entity that provides administrative and business support to physician practices. By integrating high-trust data management and proven results, an MSO can transition from a basic service provider to a high-value tech-enabled asset.API-First Interoperability: A development strategy that prioritizes Application Programming Interfaces (APIs) as the primary method for system communication. This ensures real-time data access across platforms without manual intervention, facilitating faster treatment approvals. HealthIT.gov - API CertificationTech-Enabled Asset: A valuation category that redefines a healthcare organization based on its integrated technology and data integrity. This shift allows for a higher business valuation, moving from a standard 6–8x multiple to a 12–15x multiple.Site-Neutrality: A Medicare policy objective aimed at paying the same rate for a medical service regardless of whether it is provided in a hospital or an independent clinic. This supports the growth of independent MSOs by eliminating the facility fee advantage held by hospitals. CMS - Hospital Outpatient Fact SheetRoot-Cause Reversal: The clinical objective of treating the underlying cause of a chronic condition to achieve permanent health improvement, rather than merely managing symptoms.Price Transparency: A regulatory requirement for healthcare organizations to provide clear, accessible cost information for medical services. This transparency is a core component of the move toward analytical veracity and consumer-driven healthcare. CMS - Hospital Price Transparency‍

The Regulatory Catalyst: Collapsing the Two-Tier SystemThe U.S. biosimilar market, valued at approximately $7.7 billion in 2025, is entering a period of exponential acceleration. While biologics represent a high-margin innovation play, biosimilars are the volume-driven "generic" engine of the 2026 health economy, with a projected CAGR of 18% through 2034.This growth is being triggered by a profound shift in FDA policy under Commissioner Marty Makary. Historically, a biosimilar could only be substituted for a brand-name biologic at the pharmacy if the manufacturer completed expensive "switching studies." These trials required patients to alternate multiple times between the original drug and the biosimilar to prove no loss of efficacy—a process that cost between $100 million and $300 million and added five to eight years to the development timeline.In 2026, the FDA has finalized guidance that removes the requirement for these human switching studies. The agency’s new position is that modern analytical methods are now precise enough to determine equivalence without redundant clinical testing. Consequently, the FDA is moving toward a model where all biosimilars are interchangeable by default, allowing for automatic substitution at the point of sale, just like small-molecule generic pills.The Evidence Gap: The "Trust Gap" in Automatic SubstitutionWhile the regulatory "red tape" has been removed, a significant Evidence Gap remains. Brand-name manufacturers have historically used the lack of an interchangeable designation to sow doubt among physicians and patients regarding the safety of switching. Even as the FDA streamlines the process, the clinical community still demands proof that these drugs perform identically in the "real world".Legacy data systems—reliant on Administrative Proxies (Data Exhaust)—cannot bridge this trust gap. For a biosimilar to capture meaningful market share in a competitive oncology or immunology landscape, the manufacturer and the clinical network must provide Verified Clinical Veracity that goes beyond the lab and into the clinic.The Circle Solution: Engineering the Evidence for VolumeThe Circles platform provides the necessary Regulatory-Grade Governance to dominate the new biosimilar landscape. By using Observational Protocols (OPs), Circles enable clinicians to track the real-world impact of biosimilar substitution with a level of precision that traditional EHR systems cannot match.Audit-Ready "Ground Truth": Circles capture Standardized Longitudinal Scores (e.g., patient-reported outcomes and objective laboratory markers) directly at the clinical node. This provides the permanent, timestamped audit trail needed to prove clinical equivalence to skeptical physicians and payers.Insurable Risk Modeling: By monitoring the "switch" in real-time, Circles provide Insurable Integrity for the medical director and the MSO board. It provides the safety data required to defend against any claims of diminished efficacy, effectively Surgical-Delay Proofing the transition to lower-cost biosimilar protocols.Outcome Engineering: For biosimilar manufacturers, Circles offer a way to bypass the "reproducibility crisis" of the past. They create a Strategic Monopoly on high-veracity outcome data, ensuring their product is the preferred choice for Value-Based Contracting.Strategic Outcome: Valuation via Tech-Enabled ScaleIn the new 2026 biosimilar era, the clinical organization is no longer just a "purchaser" of drugs; it is a producer of Regulatory-Grade Evidence. By adopting Circles, an MSO reclassifies itself from a low-margin "Service Business" into a Tech-Enabled Asset.The value of the enterprise is driven by its ability to prove that its high-volume biosimilar utilization is delivering identical clinical outcomes to the expensive reference biologic. This Multiple Expansion (moving from 6–8x to 12–15x) is the direct result of owning the "Ground Truth" in a market where the FDA has traded pre-market trials for real-world veracity.

The Market Catalyst: The 51% Spend CrisisBy early 2026, biologics have become the primary economic driver of U.S. healthcare. While these complex, large-molecule treatments represent only 5% of all prescriptions, they now account for an staggering 51% of total drug spending as of late 2025. The U.S. biologics market is currently valued at approximately $203.6 billion, with projections indicating it will exceed $483 billion by 2034.Commissioner Marty Makary has identified this concentration of spend as a systemic inefficiency, often referring to the high cost of biologics as a barrier to patient access. In response, the FDA has initiated a pivot toward "Analytical Veracity." For new biologics—particularly monoclonal antibodies (mAbs), which account for nearly 70% of the market share — the agency is beginning to replace multi-year human trials with advanced laboratory characterization and real-time monitoring.The Evidence Gap: The High-Stakes Licensing RiskAs the FDA accelerates the approval of these molecules through the National Priority Voucher and other fast-track programs, the primary risk for manufacturers and clinicians moves from "regulatory approval" to "market sustainability". When a biologic with a six-figure annual price tag is approved on an accelerated timeline, payers — both public and private — demand more than a preliminary snapshot; they demand Verified Clinical Veracity.Legacy healthcare data systems fail this test. Most existing data consists of Administrative Proxies (Data Exhaust) captured for billing, which lacks the clinical depth to prove long-term efficacy or address the "Measurement-to-Management Gap" that stalls value-based transitions. Without Audit-Ready "Ground Truth", high-value biologics face the constant threat of "reimbursement limbo".The Circle Solution: Building the Infrastructure of EvidenceThe Circles platform provides the Regulatory-Grade Governance required to secure these high-valuation assets across any specialty, from oncology to immunology. By defining the data architecture via Observational Protocols (OPs) before the biologic is administered, Circles ensure that every patient encounter generates a high-fidelity dataset.Outcome Engineering: Circles capture Standardized Longitudinal Scores (e.g., functional assessments and metabolic markers) at the point of care, providing the permanent audit trail necessary to justify premium pricing to payers.Insurable Integrity: By providing Verified Clinical Veracity, Circles create a "shield" for the clinical node, making billing errors or protocol deviations technically impossible and ensuring the data is ready for federal scrutiny.Strategic Monopoly: High-volume, high-veracity data sets within a Circle enable the use of Synthetic Control Arms (SCAs), which can supplement or even replace traditional clinical trials, creating a strategic advantage for manufacturers and clinical networks alike.Strategic Outcome: Valuation via Tech-Enabled AssetsIn the legacy model, biologics were a "pass-through" cost for clinics. In the 2026 regulatory environment, the data generated by these treatments is the asset. By utilizing Circles to provide Insurable Integrity, a Management Services Organization (MSO) reclassifies itself as a Tech-Enabled Asset.This shift is the primary driver for Multiple Expansion, moving an organization from a standard 6–8x service multiple to a 12–15x asset multiple. The value is no longer in the administration of the drug, but in the "Ground Truth" evidence that secures its place in the market.