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The Regulatory Catalyst: Research at The FrontlinesIn late 2025 and early 2026, the National Institutes of Health (NIH) accelerated the deployment of the Communities Advancing Research Equity (CARE) for Health initiative. This program represents a fundamental departure from the traditional "ivory tower" research model. Instead of requiring patients to travel to major academic medical centers, the NIH is investing in a national network that integrates clinical research directly into routine primary care, with an immediate focus on rural and historically underserved communities.Under the 2026 federal budget, the NIH has prioritized this "Learning Health System" where research informs physician work in real-time and clinical data informs national research priorities. This decentralization is designed to address the "reproducibility crisis" by capturing evidence from the actual populations who will use the treatments, rather than idealized study cohorts.The Evidence Gap: The "Primary Care Friction"While the vision of CARE for Health is expansive, it faces a significant structural barrier: The Primary Care Friction. Most community clinics are optimized for high-volume patient throughput and billing — not for the rigorous documentation required by the NIH or FDA.When these clinics attempt to participate in research, they often generate "Data Exhaust" — fragmented notes and inconsistent billing codes that lack the integrity needed for federal validation. Without a standardized way to capture outcomes without slowing down the clinic, the NIH’s goal of "research-integrated care" remains a theoretical ambition rather than a clinical reality.The Circle Solution: Regulatory-Grade Governance for The Local ClinicThe Circles platform provides the "plug-and-play" infrastructure that allows a local clinic to function as a high-veracity research node without the administrative overhead of a traditional clinical trial site.Observational Protocols (OPs): Circles define the data architecture before the patient visit, creating "guardrails" that make protocol deviations technically impossible. This ensures that a rural primary care site produces the same Verified Clinical Veracity as a top-tier research university.Audit-Ready "Ground Truth": By capturing Standardized Longitudinal Scores at the point of care, Circles provide the permanent, timestamped audit trail that federal agencies now demand for community-based evidence.Minimizing Burden: Circles solve the "Measurement-to-Management Gap" by automating the collection of high-fidelity data during the routine clinical encounter, fulfilling the NIH’s mandate to "minimize the burden of research on providers and patients".Strategic Outcome: The Valuation of The NetworkFor Management Services Organizations (MSOs) and clinical networks, the NIH’s shift to decentralized research is a valuation catalyst. Traditionally, these clinics were valued as low-margin service businesses (6–8x multiples). However, by adopting Circles and becoming part of the national "human-relevant" data infrastructure, these entities reclassify as Tech-Enabled Assets.‍The value of the network is no longer just in the number of primary care visits, but in the Insurable Integrity of the data it generates for the NIH and the pharmaceutical industry. This transition drives Multiple Expansion to 12–15x, as the clinic becomes a critical node in the new federal research architecture.

The Regulatory Catalyst: The Administration for A Healthy America (AHA)In 2025, the federal government initiated a dramatic restructuring of its health apparatus, consolidating 28 disparate divisions into 15 streamlined units. At the center of this reorganization is the Administration for a Healthy America (AHA). This new agency absorbs functions from the CDC, HRSA, and SAMHSA with a singular, high-stakes objective: reversing the chronic disease epidemic by addressing its "root causes".Under the leadership of Secretary Robert F. Kennedy Jr. and Commissioner Marty Makary, the AHA is moving away from the "medical dogma" of the last half-century. The agency’s focus has shifted toward metabolic health, environmental exposures, and nutrition. For the first time, federal policy is not just aimed at "treating" conditions like Type 2 diabetes or hypertension, but at providing the regulatory and financial incentives necessary to "reverse" them.The Evidence Gap: The Failure of Administrative ProxiesThis shift creates a fundamental problem for the current healthcare infrastructure. For decades, the industry has relied on Administrative Proxies — billing codes and claims data — to measure success. However, a billing code for "diabetes management" only proves that a service was rendered; it does not prove that the disease was reversed or that the "root cause" was addressed.As the AHA and CMS move toward Value-Based Contracting that rewards actual disease reversal, the lack of clinical depth in legacy systems has become a "Measurement-toManagement Gap. "To secure reimbursement in this new era, providers must move beyond "Data Exhaust" and provide Verified Clinical Veracity.The Circle Solution: Engineering Outcomes at The NodeThe Circles platform provides the Regulatory-Grade Governance required to meet the AHA’s mandate. By defining clinical protocols before the patient encounter, Circles ensure that every data point captured is a reflection of actual clinical change rather than administrative convenience.Standardized Longitudinal Scores (SLS): Circles capture objective markers — such as metabolic panels, functional movement scores, and patient-reported outcomes — over time. This allows a clinical node to prove "reversal" with an Audit-Ready "Ground Truth" that federal reviewers can verify.Outcome Engineering: By moving the focus from "sick care" to "root-cause reversal, "Circles enable clinicians to track the efficacy of interventions like the new 2026 dietary guidelines. This transforms a standard clinic into a high-veracity research node capable of proving that "food as medicine" actually works.Surgical-Delay Proof: For surgeons and specialists, this data provides the "Insurable Integrity" needed to justify procedures in an environment where payers are increasingly focused on conservative, root-cause alternatives.Strategic Outcome: Reclassifying The EnterpriseThe AHA reorganization has turned "outcome data" into the most valuable currency in healthcare. Clinical organizations that continue to rely on fragmented EHR notes will face increasing downward pressure on reimbursement and valuation.In contrast, organizations that utilize Circles to provide Verified Clinical Veracity are reclassified as Tech-Enabled Assets. This shift is the primary driver of Multiple Expansion, moving an entity from a 6–8x service multiple to a 12–15x asset multiple. The valuation of the MSO is no longer tied to the number of patients seen, but to the Insurable Integrity of the reversals it can prove.

The Regulatory Catalyst: The 60-day ReviewIn 2025, FDA Commissioner Marty Makary introduced the Commissioner’s National Priority Voucher (CNPV), a pilot program that reduces the standard 10–12 month review clock to a mere 30–60 days. Designed to fast-track treatments that align with "U.S. National Interests"— such as onshoring manufacturing, increasing affordability, or tackling the chronic disease crisis — the NPV replaces the traditional, sequential review process with a multidisciplinary, "tumor board style" evaluation.By January 2026, the first wave of approvals has proven that the "red tape" of the past century can be bypassed. However, this acceleration has created a "Scientific Reputational Risk". Career scientists and outside experts have expressed concerns that ultracompressed windows may sacrifice the rigor required to identify long-term safety signals. For the manufacturer, the prize of early market entry now comes with a significant tail of legal and clinical liability.The Evidence Gap: The "Speed-to-Payer" BarrierThe true bottleneck is no longer the FDA; it is the payer. Public and private insurers have historically been skeptical of products that bypass traditional evaluation pathways, often delaying coverage until "sufficient" real-world safety and efficacy data emerges.This creates a "Measurement-to-Management Gap. " A drug or device may be legally approved in 60 days, but if the manufacturer cannot provide Verified Clinical Veracity of its performance in the real world, it will languish in "reimbursement limbo". Legacy "Data Exhaust"— static snapshots from billing and claims — is too slow and too imprecise to satisfy insurers who are now assessing the adequacy of the FDA’s truncated review.The Circle Solution: Insurable Risk ModelingThe Circles platform provides the infrastructure to bridge this gap through Insurable Risk Modeling. By establishing Regulatory-Grade Governance at the clinical node, Circles allow manufacturers and providers to monitor performance in real-time, effectively extending the "clinical trial" into the "real-world" without loss of data integrity.Verified Clinical Veracity: Circles capture Standardized Longitudinal Scores directly from the patient and provider, creating an Audit-Ready "Ground Truth" that can be shared with payers to accelerate coverage decisions.Safety-in-Motion: Because Circles operate with pre-structured Observational Protocols (OPs), it can identify safety or efficacy signals months faster than traditional post-market surveillance. This "Safety-in-Motion" is the only viable defense against the liability risks inherent in accelerated approvals.Surgical-Delay Proof: For clinical organizations, this data architecture ensures that ValueBased Care transitions are not stalled by insurer skepticism. You aren't just performing a procedure; you are generating the Insurable Integrity that justifies the payment.Strategic Outcome: Capturing The "Integrity Premium"In a 60-day review environment, the "Insurable Integrity Premium" becomes the primary driver of enterprise value. Organizations that rely on administrative proxies will be seen as high-risk liabilities. Organizations that utilize Circles to provide transparent, verifiable outcomes will be viewed as Tech-Enabled Assets.For the healthcare executive, this is the path to Multiple Expansion. By owning the veracity of the data, the clinical entity moves from a 6–8x service multiple to a 12–15x asset multiple, fundamentally decoupled from the volatility of the new regulatory speed.

The Regulatory Catalyst: The Rise of ORIVAIn 2025 and early 2026, the National Institutes of Health (NIH) fundamentally reorganized its research priorities by establishing the Office of Research Innovation, Validation, and Application (ORIVA). This office was created with a singular, high-stakes directive: to transition the U.S. biomedical research portfolio away from traditional animal models and toward "human-based research technologies".This is not merely an ethical shift; it is a response to a persistent "translational failure" in medicine. For decades, approximately 90% of drugs that appeared safe and effective in animal trials failed when reached human subjects, often due to fundamental physiological differences that animal models simply cannot replicate. Under Commissioner Marty Makary, the FDA has synchronized with this NIH shift, releasing a "Roadmap to Reducing Animal Testing" that prioritizes New Approach Methodologies (NAMs) — specifically AI-driven computational models and high-veracity Real-World Data (RWD).The Evidence Gap: The "Translational Trap"The "Translation Trap" occurs when researchers rely on animal data that is "internally valid" (consistent within the lab) but "externally invalid" (fails in the human population). As the FDA Modernization Act 2.0 and 3.0 take full effect in 2026, the agency is now authorized to accept human biology-based evidence in place of animal studies for Investigational New Drug (IND) applications.However, this transition creates a new "Measurement-to-Management Gap." Computational models and AI simulations are only as reliable as the data used to train and validate them. Most existing human data is "Data Exhaust" — static snapshots from insurance claims or electronic health records (EHRs) that lack the longitudinal depth and clinical precision required to replace a controlled animal study. To satisfy the new "human-relevant" standard, the industry requires Verified Clinical Veracity captured in real-time.The Circle Solution: Engineering Human OutcomesThe Circles platform provides the infrastructure required to bridge this gap. By utilizing Observational Protocols (OPs), Circles enable clinicians across any specialty — from neurology to metabolic health — to capture a "Human Ground Truth" that is both longitudinal and audit-ready.Longitudinal Precision: Circles do not capture a single point in time; they track Standardized Longitudinal Scores (e.g., functional assessments, patient-reported outcomes, and metabolic markers) over months and years.Regulatory-Grade Governance: Unlike unstructured EHR notes, data within a Circle is governed by predefined clinical guardrails. This ensures the data is "Audit-Ready" for federal agencies that are now scrutinizing human-based evidence as a replacement for preclinical animal models.Validating the "In Silico" World: As the NIH and FDA move toward "in silico" (computersimulated) trials, Circles provide the high-fidelity human outcomes necessary to validate those models, ensuring they reflect actual clinical reality rather than statistical projections.Strategic Outcome: Valuation Via Insurable IntegrityIn the legacy research model, clinical documentation was a sunk cost of the procedure. In the new 2026 regulatory environment, Verified Clinical Veracity is a strategic asset. By generating data that meets the FDA’s "human-relevant" mandate, a clinical organization moves from a low-margin service provider to a Tech-Enabled Asset.The value of the organization is now tied to its Insurable Integrity — the ability to provide a data set that is robust enough to bypass or supplement traditional, expensive research phases. This transition is the primary driver for Multiple Expansion, allowing healthcare entities to capture the "Insurable Integrity Premium" that the current administration is making essential for medical innovation.

The Regulatory Catalyst: Removing The Identity BarrierIn December 2025, the FDA issued a final guidance that fundamentally changed how it evaluates Real-World Evidence (RWE). For years, the agency largely required "identifiable" patient-level data — specific names or social security numbers — to verify the accuracy of medical studies. Because privacy laws (HIPAA) and security protocols often require data to be de-identified, this created a structural barrier that disqualified vast amounts of highvalue clinical information from being used for drug or device approvals.The new mandate removes this requirement. Commissioner Marty Makary has characterized this as a shift toward "radical transparency," where the agency no longer asks "Who is the patient?" but rather "Is the data true?". The FDA will now accept de-identified datasets, provided the source can prove the information is accurate, reliable, and scientifically sound.The Evidence Gap: Administrative Proxies VS. Ground TruthWhile this "unlocks" massive amounts of data, it also exposes a significant flaw in current healthcare systems. Most medical data today consists of "administrative proxies"— billing codes, insurance claims, and fragmented notes captured for the purpose of payment. These proxies are often inaccurate and lack the clinical depth required for federal audits or highstakes licensing.To take advantage of this new regulatory path, organizations must move toward Regulatory-Grade Governance. This means defining the data architecture and clinical guardrails before the patient encounter begins. By using Circles’ Observational Protocols (OPs), providers create an Audit-Ready "Ground Truth" that makes billing errors or protocol deviations technically impossible.The Economic Model: From Service To AssetThis shift transforms the clinical record. Historically, documentation has been a regulatory burden — a cost center. In the new FDA environment, verified data becomes a high-margin, licensable asset.The Circles platform provides the infrastructure for this transformation across any medical specialty — from oncology to neurology. By capturing Standardized Longitudinal Scores and objective outcomes at the point of care, Circles ensure that every patient encounter generates Verified Clinical Veracity. This data does not just meet the new FDA standard; it exceeds it, providing the Insurable Integrity that allows for faster approvals and lower liability risks.Strategic Outcome: Valuation ExpansionFor Management Services Organizations (MSOs) and healthcare boards, the objective is Multiple Expansion. By transitioning from a "Service Business" focused on volume to a "Tech-Enabled Asset" focused on high-veracity data, organizations can significantly increase their valuation multiples. The value of the enterprise is no longer just in the procedure performed, but in the Insurable Integrity of the evidence created.