When Software Stopped Being a Lab Test: How the CY2027 OPPS Rule’s Software as a Medical Service Category, the O1 Status Indicator, and Pulling Lab AI Off the CLFS Reshape Health Tech Investing

Beyond Installation, Operational, and Performance Qualifications: A Risk-Based Validation Framework for AI-Driven Software in GxP Environments

The new era of SaMD: Why cloud infrastructure is the foundation for digital health in 2026

AI-Assisted Development Demands a Rethink of Testing Strategy, Not Just Test Automation

The article explores the strategic decision teams face after merging AI-assisted code: whether to add traditional browser tests, use AI tool

MIT researchers call for FDA oversight of unregulated AI tools used in US hospitals

MIT researchers published a viewpoint in The Lancet Digital Health highlighting that many AI tools used in clinical decision-making across U

A Deterministic Classification Core with an Agentic Interpretation Layer: An Architecture for Auditable, Human-Gated Clinical Variant Analysis

Is AI ruining our skills? Early results are in — and they’re not good

Is AI ruining our skills? Early results are in — and they’re not good

Is AI ruining our skills? Early results are in — and they’re not good

Is AI ruining our skills? Early results are in — and they’re not good

Is AI ruining our skills? Early results are in — and they’re not good