Why Regulated AI Needs a Different Approach
Precoh exists because clinical AI governance is broken — not for lack of trying, but for lack of infrastructure. We built RegOS to fix that.
"Healthcare AI has produced impressive research. What it has not produced, at scale, is clinical governance. The gap between a capable model and an approved, deployed, monitored model is not a technology problem — it's an infrastructure problem."
Three things we know to be true about clinical AI
Regulation is an asset, not a barrier
The organizations that build structured regulatory infrastructure early move faster in the long run. Governance isn't what slows clinical AI down — ad hoc governance is. A reproducible evaluation pipeline is a competitive advantage.
Defensibility is non-negotiable in healthcare
Clinical decisions affect lives. The tools that inform those decisions need to be evaluated against a standard that holds up in court, in front of regulators, and in front of patients. "It worked in the study" is not a governance framework.
Approval is only the beginning
A cleared model that degrades silently in production is more dangerous than a model that never deployed. Post-market surveillance, drift monitoring, and re-validation are not optional follow-ons — they are core to responsible AI deployment.
The regulatory environment shifted. The infrastructure didn't keep pace.
The FDA's Software as a Medical Device framework, the EU AI Act, and the proliferation of national AI sandbox programs have created a new regulatory reality for clinical AI developers. These frameworks demand structured evidence, reproducible evaluation, and ongoing monitoring — but they don't provide the operational tools to execute them.
Precoh RegOS was built to close that gap — not by adding another layer of documentation, but by replacing ad hoc compliance with a structured operating system that produces defensible, auditable outputs by design.
FDA SaMD framework matures
FDA's Predetermined Change Control Plans and Total Product Lifecycle approach set new expectations for AI model governance that most developers had no tools to meet.
EU AI Act classifies medical AI as high-risk
High-risk AI classification creates mandatory conformity assessment obligations across the EU — with no standardized evaluation tooling to meet them.
National health AI sandboxes proliferate
Regulatory sandbox programs launch globally — each needing structured evaluation pipelines and auditable decision records for hundreds of AI submissions.
RegOS launches
Precoh RegOS provides the structured operating system the regulatory landscape required but didn't have — from intake through tamper-evident audit trail.
Expert advisory. Regulatory platform. Both, by design.
Precoh is two things at once — a consultancy that builds clinical AI readiness, and a platform company that operationalizes it. The two sides are inseparable.
Together, Precoh's advisory work and RegOS platform create a complete system: the expertise to understand your clinical AI needs, and the infrastructure to execute evaluation, approval, and scale — with full auditability and regulatory defensibility built in.