Our FDA comment on AI in early-phase trials

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Analysis

Everyone is racing toward the patient and stopping in the same place

Two announcements in one week, from opposite ends of the industry, both advancing on the patient and both halting at the same line. The line is not an accident, and it is exactly where the evidence says outcomes are decided.

Aug 2026
Analysis

What a new preprint does and does not establish about agentic triage

The strongest evidence yet that software can hold the response loop in remote monitoring. It is also a preprint, a retrospective component test rather than an outcomes trial, and its most quotable number is the one that deserves the most scrutiny.

Aug 2026
Analysis

Our read on the CY2027 Medicare Physician Fee Schedule proposed rule

The proposed rule tightens the screws on fee-for-service remote monitoring in the same season CMS opens an outcomes-paid lane beside it. Read together, the two moves point in one direction: away from billing for monitoring, toward being paid for prevention.

Jul 2026
Analysis

What the CMS ACCESS Model means for outcome-based care

Outcome-aligned payment changes the question a provider's data has to answer — from "did we deliver the service?" to "can we prove the result?" That is a harder question, and most monitoring data cannot yet answer it.

Jul 2026
Perspective

The case for continuous over periodic monitoring in value-based care

This is an argument we are working to prove, not a settled claim. The honest state of the evidence is that continuous monitoring has beaten periodic in exactly one domain. Whether it generalizes is the question, and value-based care is where it will be answered.

Jul 2026
Perspective

The governance line between wellness and clinical AI

The line between a wellness product and a regulated medical device is real, it is enforced, and as the past year proved, it moves. That is exactly why it cannot be hard-coded into a product. It has to be a policy the product enforces and can change.

Jul 2026
Perspective

Why neutral infrastructure keeps getting acquired

A neutral data layer is worth most to the party that would end its neutrality. That is the pattern's engine, and it explains both why these layers keep getting bought and what is lost each time one is.

Jul 2026
Podcast

Building the Clinical Compliance Layer

On Paradigm Shock, AnyBio CEO Stephen Saine sat down with host Anjon Roy to talk through the real obstacle to AI in clinical care: not the intelligence, but whether a hospital can trust it near a patient.

May 2026
Analysis

Healthcare built a safety regime for the people doing this work. There is no equivalent for the software.

Medicare's proposed 2027 rule pushes remote-monitoring labor no one can hire into software, putting a language model closer to the patient than it has ever been. For the person who did that work there is a mature accountability regime. For the software, almost none of it exists yet.

Aug 2026
Filing

The FDA RFI comment on AI in early-phase trials

Our public position on continuous device endpoints in next-generation trials, filed with the FDA.

2026
OUR THESIS

The bottleneck isn't intelligence anymore. It's the trusted path to the patient.

In healthcare, the hard part is no longer the intelligence. Models, algorithms, and devices keep getting better. The hard part is the trusted path to the patient: the neutral, governed layer that lets any validated device, algorithm, or model reach real clinical care with provenance, audit, and compliance intact. AnyBio is that layer. You stay a device, IP, or care company; we are the compliant business associate under BAA, the regulated path into care. The model keeps improving; the governed path it runs on is the part that lasts.

Talk through where this is going.

We'll walk through your program and where the regulatory and market shifts leave it.

Moving forward together