Real-World Evidence Circles

06/02/2026

Discover how federated AI transforms medicine from mere prediction to trustworthy proof. Learn why verification, transparency, and accountability are essential for clinical trust—and how innovative data governance is reshaping healthcare’s future:

Healthcare AI predictions lack trust without verification. This article explains how auditability, provenance, and reproducibility turn AI outputs into clinical proof.

04/02/2026

AI in healthcare dazzles with record-breaking scores—yet 92% of top-performing models fail in real-world clinics. The problem? Benchmarks lie. Discover why trustworthy AI demands more than metrics—and how the future belongs to systems built on verifiable truth, not just impressive numbers:

High AI benchmark scores don’t ensure real-world reliability. This article explains why healthcare AI needs continuous, outcome-based validation instead of static benchmarks.

03/02/2026

We invite you to this first Circle Hour for the MOTIV™ TKA Observational Protocol. Leading the discussion will be co-investigators Doctors Andrew Wickline and John Mercuri, as well as OREF leadership.

As of today, orthopedic surgeons representing over 1600 TKAs per year, have already joined this Circle, or indicated their intention to do so. By February 12, we expect many more will have joined. More information about this initiative can be found here: https://hubs.li/Q041ts_r0

𝐓𝐡𝐞 𝐬𝐮𝐦𝐦𝐚𝐫𝐲 𝐚𝐠𝐞𝐧𝐝𝐚 𝐢𝐬:

▪️ An overview of the major regulatory, reimbursement and commercial trends driving the value of real-world data inherent in the everyday practice of orthopedic medicine. (3 𝘮𝘪𝘯𝘶𝘵𝘦𝘴.)

▪️ OREF’s objectives in the context of the MOTIV™ initiative. (3 𝘮𝘪𝘯𝘶𝘵𝘦𝘴.)

▪️ The clinical hypotheses underlying the Observational Protocol. (5 𝘮𝘪𝘯𝘶𝘵𝘦𝘴.)

▪️ Sample aggregated data reports available to Circle Members. (3 𝘮𝘪𝘯𝘶𝘵𝘦𝘴.)

▪️ Live demonstration of physician and patient user experiences. (5 𝘮𝘪𝘯𝘶𝘵𝘦𝘴.)

▪️ Q & A. (30 𝘮𝘪𝘯𝘶𝘵𝘦𝘴.)

This live-streamed event is open only to orthopedic surgeons who have pre-registered. Registration information is here: https://hubs.li/Q041tv1P0

We believe that all orthopedic surgeons will find this to be a stimulating discussion, and the first step of an ongoing valuable collaboration with peers around the world.

03/02/2026

𝐀𝐫𝐞 𝐲𝐨𝐮 𝐚 "𝐒𝐞𝐫𝐯𝐢𝐜𝐞 𝐁𝐮𝐬𝐢𝐧𝐞𝐬𝐬" 𝐨𝐫 𝐚 𝐧𝐨𝐝𝐞 𝐢𝐧 𝐭𝐡𝐞 $𝟏𝟖𝟏 𝐁𝐢𝐥𝐥𝐢𝐨𝐧 𝐕𝐞𝐫𝐚𝐜𝐢𝐭𝐲 𝐈𝐧𝐟𝐫𝐚𝐬𝐭𝐫𝐮𝐜𝐭𝐮𝐫𝐞?

Biosimilars are projected to save the U.S. healthcare system $181 billion in the next five years. But as the FDA swaps clinical trials for 𝐀𝐧𝐚𝐥𝐲𝐭𝐢𝐜𝐚𝐥 𝐕𝐞𝐫𝐚𝐜𝐢𝐭𝐲, the burden of proof shifts to the real world.

To capture this value, MSOs must transition from 𝐀𝐝𝐦𝐢𝐧𝐢𝐬𝐭𝐫𝐚𝐭𝐢𝐯𝐞 𝐏𝐫𝐨𝐱𝐢𝐞𝐬 to 𝐈𝐧𝐬𝐮𝐫𝐚𝐛𝐥𝐞 𝐈𝐧𝐭𝐞𝐠𝐫𝐢𝐭𝐲.

With the 𝐂𝐢𝐫𝐜𝐥𝐞𝐬 platform, we help you achieve 𝐌𝐮𝐥𝐭𝐢𝐩𝐥𝐞 𝐄𝐱𝐩𝐚𝐧𝐬𝐢𝐨𝐧 (12-15x) by reclassifying your enterprise as a 𝐓𝐞𝐜𝐡-𝐄𝐧𝐚𝐛𝐥𝐞𝐝 𝐀𝐬𝐬𝐞𝐭. We don't just document procedures; we engineer outcomes and provide the 𝐕𝐞𝐫𝐢𝐟𝐢𝐞𝐝 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐕𝐞𝐫𝐚𝐜𝐢𝐭𝐲 that drives the new health economy.

https://hubs.li/Q041t5WK0

Biologics now account for over half of U.S. drug spending, forcing payers to demand verified clinical evidence to sustain reimbursement after accelerated FDA approvals.

29/01/2026

𝐈𝐬 𝐲𝐨𝐮𝐫 𝐌𝐒𝐎 𝐫𝐞𝐚𝐝𝐲 𝐟𝐨𝐫 𝐭𝐡𝐞 𝐁𝐢𝐨𝐬𝐢𝐦𝐢𝐥𝐚𝐫 𝐕𝐨𝐥𝐮𝐦𝐞 𝐖𝐚𝐯𝐞?

Biologics are the margin play, but Biosimilars are the volume play. With the FDA now treating biosimilars like traditional generics, automatic substitution is about to become the new standard.

To win in this high-volume environment, you must move beyond 𝐀𝐝𝐦𝐢𝐧𝐢𝐬𝐭𝐫𝐚𝐭𝐢𝐯𝐞 𝐏𝐫𝐨𝐱𝐢𝐞𝐬. You need 𝐈𝐧𝐬𝐮𝐫𝐚𝐛𝐥𝐞 𝐈𝐧𝐭𝐞𝐠𝐫𝐢𝐭𝐲.

By utilizing 𝐎𝐛𝐬𝐞𝐫𝐯𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐏𝐫𝐨𝐭𝐨𝐜𝐨𝐥𝐬, we turn routine documentation into a high-margin, licensable asset. We help you achieve 𝐌𝐮𝐥𝐭𝐢𝐩𝐥𝐞 𝐄𝐱𝐩𝐚𝐧𝐬𝐢𝐨𝐧 by reclassifying your clinical nodes as 𝐓𝐞𝐜𝐡-𝐄𝐧𝐚𝐛𝐥𝐞𝐝 𝐀𝐬𝐬𝐞𝐭𝐬.

The data veracity is the only thing that can't be commoditized.
https://hubs.li/Q040Rz-m0

FDA removes biosimilar switching studies, enabling automatic substitution and shifting market success to real-world evidence proving clinical equivalence.

28/01/2026

𝐓𝐡𝐞 𝟖-𝐘𝐞𝐚𝐫 𝐑&𝐃 𝐁𝐚𝐫𝐫𝐢𝐞𝐫 𝐣𝐮𝐬𝐭 𝐜𝐨𝐥𝐥𝐚𝐩𝐬𝐞𝐝. 𝐈𝐬 𝐲𝐨𝐮𝐫 𝐝𝐚𝐭𝐚 𝐬𝐭𝐫𝐚𝐭𝐞𝐠𝐲 𝐬𝐭𝐢𝐥𝐥 𝐦𝐨𝐯𝐢𝐧𝐠 𝐚𝐭 𝐚 𝐬𝐧𝐚𝐢𝐥'𝐬 𝐩𝐚𝐜𝐞?

Commissioner Marty Makary has signaled the end of the "Red Tape" era for biosimilars. With the FDA halving the time and money for market entry, the 8-year development marathon is becoming a 30-month sprint.

𝐓𝐡𝐞 𝐂𝐡𝐚𝐥𝐥𝐞𝐧𝐠𝐞: Speed without Veracity is a Liability. Accelerated approvals demand a new standard of 𝐈𝐧𝐬𝐮𝐫𝐚𝐛𝐥𝐞 𝐑𝐢𝐬𝐤 𝐌𝐨𝐝𝐞𝐥𝐢𝐧𝐠.

𝐓𝐡𝐞 𝐒𝐨𝐥𝐮𝐭𝐢𝐨𝐧: You need more than "Data Exhaust." You need 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲-𝐆𝐫𝐚𝐝𝐞 𝐆𝐨𝐯𝐞𝐫𝐧𝐚𝐧𝐜𝐞. By using pre-structured 𝐎𝐛𝐬𝐞𝐫𝐯𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐏𝐫𝐨𝐭𝐨𝐜𝐨𝐥𝐬, we turn your clinical nodes into high-veracity research assets that provide the 𝐀𝐮𝐝𝐢𝐭-𝐑𝐞𝐚𝐝𝐲 "𝐆𝐫𝐨𝐮𝐧𝐝 𝐓𝐫𝐮𝐭𝐡" payers and litigators now demand: https://hubs.li/Q040Fqmj0

FDA shortens biosimilar R&D from years to 30 months, shifting approval to analytics and making real-world clinical evidence critical for payer trust.

27/01/2026

Consent is becoming the true currency of healthcare data. Discover why ethical value now depends on permission—not possession:

This article argues that ethical data value comes from continuous, traceable consent, redefining ownership, integrity, and trust in medical data systems.

21/01/2026

𝐁𝐢𝐠𝐠𝐞𝐫 𝐈𝐬𝐧’𝐭 𝐒𝐦𝐚𝐫𝐭𝐞𝐫: 𝐖𝐡𝐲 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐀𝐈 𝐍𝐞𝐞𝐝𝐬 𝐚𝐧 𝐄𝐩𝐢𝐬𝐭𝐞𝐦𝐢𝐜 𝐑𝐞𝐬𝐞𝐭

For years, the mythology of machine learning has worshipped scale — more data, more records, more parameters. In medicine, this belief became doctrine: if we gather millions of patient encounters, surely our models will become “truly intelligent.”

Discover in our article why bigger isn't always better in healthcare AI. Learn how precision, context, and responsible federation redefine "scale"—turning data volume into trustworthy insights and ethical innovation. Ready to rethink the future of medical intelligence? Read more: https://www.rgnmed.com/post/the-mirage-of-scale

13/01/2026

𝐖𝐡𝐞𝐧 𝐃𝐨𝐮𝐛𝐭 𝐁𝐞𝐜𝐨𝐦𝐞𝐬 𝐚 𝐁𝐮𝐬𝐢𝐧𝐞𝐬𝐬 𝐌𝐨𝐝𝐞𝐥: 𝐓𝐡𝐞 𝐇𝐢𝐝𝐝𝐞𝐧 𝐂𝐫𝐢𝐬𝐢𝐬 𝐢𝐧 𝐌𝐨𝐝𝐞𝐫𝐧 𝐒𝐜𝐢𝐞𝐧𝐜𝐞

Science was once the disciplined pursuit of truth. Today, doubt has been commodified—manufactured, monetized, and weaponized. In a system where ambiguity sustains funding and controversy drives attention, progress becomes an illusion. How do we reclaim science’s integrity? Discover the moral challenge and the way forward in our latest article:

Modern science monetizes doubt, eroding trust and progress. Learn how uncertainty became a business model—and what we can do to restore integrity.

12/01/2026

𝐖𝐡𝐲 𝐃𝐨𝐞𝐬 𝐚 "𝐁𝐫𝐞𝐚𝐤𝐭𝐡𝐫𝐨𝐮𝐠𝐡" 𝐃𝐞𝐯𝐢𝐜𝐞 𝐅𝐫𝐨𝐦 𝐭𝐡𝐞 𝐅𝐃𝐀 𝐆𝐞𝐭 𝐚 "𝐍𝐨" 𝐅𝐫𝐨𝐦 𝐭𝐡𝐞 𝐂𝐚𝐫𝐫𝐢𝐞𝐫?

We recently had an interesting exchange with neurosurgeon Ahilan Sivaganesan at Hospital For Special Surgery on this exact disconnect. He describes it as the "Twin Sins" of healthcare: Prior authorization acting as both a barrier to high-value care and an enabler of low-value care.

The root cause isn't just policy—it's an 𝐄𝐧𝐠𝐢𝐧𝐞𝐞𝐫𝐢𝐧𝐠 𝐏𝐫𝐨𝐛𝐥𝐞𝐦.

Most systems today are "scraping the exhaust"—attempting to find clinical meaning in billing codes and messy notes after the fact to "guess" at an outcome. This is "schema-on-read," and it creates an inference gap that insurers use to deny innovative treatments like TOPS surgery.

To build the 𝐋𝐞𝐚𝐫𝐧𝐢𝐧𝐠 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐒𝐲𝐬𝐭𝐞𝐦 Dr. Sivaganesan envisions, we need to move to 𝐒𝐭𝐫𝐮𝐜𝐭𝐮𝐫𝐢𝐧𝐠 𝐚𝐭 𝐭𝐡𝐞 𝐒𝐨𝐮𝐫𝐜𝐞. By defining the structure before the care happens (“schema-on-capture”), we:

▪️ 𝐌𝐢𝐧𝐭 𝐆𝐫𝐨𝐮𝐧𝐝 𝐓𝐫𝐮𝐭𝐡: Physicians capture high-fidelity, longitudinal evidence as a byproduct of their workflow.

▪️ 𝐎𝐯𝐞𝐫𝐫𝐢𝐝𝐞 𝐒𝐭𝐚𝐭𝐢𝐜 𝐑𝐮𝐥𝐞𝐛𝐨𝐨𝐤𝐬: We provide deterministic proof of value that carriers can no longer ignore.

▪️ 𝐑𝐞𝐬𝐭𝐨𝐫𝐞 𝐒𝐜𝐢𝐞𝐧𝐭𝐢𝐟𝐢𝐜 𝐒𝐨𝐯𝐞𝐫𝐞𝐢𝐠𝐧𝐭𝐲: The clinician—not the administrator—becomes the primary architect of the evidence.

Healthcare doesn't need more "data exhaust." It needs new rails for clinical veracity.

08/01/2026

In a world where trust is the new currency, Circle Coin revolutionizes healthcare and data markets by transforming honesty into a verifiable, liquid asset. Through decentralized proof and transparent verification, we’re building an infrastructure where integrity fuels value — empowering industries to operate with unprecedented confidence. Discover how the future of trust and morality as financial infrastructure is reshaping markets today: https://hubs.ly/Q03-0mzt0

If you are interested in contributing to this important initiative or learning more about how you can be involved, please contact us.

Circle Coin: Transforming trust into liquidity. Discover how blockchain and tokenization make honesty an asset, proof a currency, and integrity the foundation of the new healthcare economy.

07/01/2026

𝐓𝐡𝐞 𝐅𝐃𝐀 𝐡𝐚𝐬 𝐜𝐥𝐞𝐚𝐫𝐞𝐝 𝐭𝐡𝐞 𝐩𝐚𝐭𝐡. 𝐈𝐬 𝐲𝐨𝐮𝐫 𝐒𝐨𝐜𝐢𝐞𝐭𝐲 𝐫𝐞𝐚𝐝𝐲?

A major rule change at the now allows de-identified, real-world to play a central role in drug and medical device reviews. This has created an unprecedented demand for high-quality, specialty-specific information — the kind a medical society’s members can provide.

𝐂𝐢𝐫𝐜𝐥𝐞 𝐃𝐚𝐭𝐚𝐬𝐞𝐭𝐬 position those societies at the heart of this innovation.

✔️𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲-𝐆𝐫𝐚𝐝𝐞 𝐃𝐚𝐭𝐚: Capture the clinical rigor required for new product approvals.
✔️𝐀𝐈 𝐑𝐞𝐚𝐝𝐢𝐧𝐞𝐬𝐬: Provide the accurate, real-world information needed to train the next generation of medical AI.
✔️𝐌𝐞𝐦𝐛𝐞𝐫 𝐁𝐞𝐧𝐞𝐟𝐢𝐭𝐬: Give members a way to benchmark their own results against the best in their field.

Third-party “big-data” aggregators should not be the middleman for a medical society’s data. Rather, a society should build a sovereign resource that benefits its members and its members’ patients directly.

📄𝐃𝐨𝐰𝐧𝐥𝐨𝐚𝐝 𝐭𝐡𝐞 𝐎𝐯𝐞𝐫𝐯𝐢𝐞𝐰: https://hubs.li/Q03Y_4Rg0