Clinical Ventures Blog

Evidence-based insights on healthcare investing, physician advisory work, and startup due diligence — for physician investors and the startups they fund.

Medicare Skin Substitute Payment Reset in 2026: A Physician Investor Due Diligence Guide

Medicare's 2026 payment reset sharply changes the economics of skin-substitute products and wound-care companies. Physic…

Hospital Price Transparency Startups in 2026: A Physician Investor Due Diligence Guide

The 2026 CMS requirements make hospital pricing data more structured and more useful, but they do not make every price c…

Laboratory-Developed Test Startups After the FDA Rule Vacatur: A Physician Investor Due Diligence Guide

The 2025 court decision removed FDA's laboratory-developed-test phaseout rule, but it did not remove validation, state a…

FDA Cybersecurity for Connected Medical Devices: A Physician Investor Due Diligence Guide

For a connected medical-device startup, cybersecurity is a product-lifecycle capability rather than a premarket attachme…

Medicare Digital Mental Health Treatment Devices: A Physician Investor Due Diligence Guide

Medicare now pays for a narrow digital mental health treatment-device pathway, not for mental health apps in general. Th…

42 CFR Part 2 for SUD Data Startups: A Physician Investor Due Diligence Guide

The 2026 Part 2 transition changed how substance use disorder records can move for treatment, payment, and health care o…

CMS Prior Authorization APIs for Digital Health Startups: A Physician Investor Due Diligence Guide

CMS prior authorization reform creates a near-term market for payer, provider, and workflow technology, but a FHIR endpo…

TEFCA for Digital Health Startups: A Physician Investor Due Diligence Guide

TEFCA can widen a digital health startup's path to nationwide clinical data, but participation does not guarantee comple…

CMS TEAM Model for Healthcare Startups: A Physician Investor Due Diligence Guide

CMS TEAM creates a defined 2026 market for tools that help participating hospitals manage surgical episodes, but mandato…

ONC HTI-1 Algorithm Transparency for Clinical AI: A Physician Investor Due Diligence Guide

ONC HTI-1 creates a transparency and risk-management layer for predictive decision support in certified health IT, but i…

FTC Health Breach Notification Rule for Health Apps: A Physician Investor Diligence Guide

The FTC Health Breach Notification Rule can apply to many consumer health apps outside HIPAA, including unauthorized dat…

FDA Predetermined Change Control Plans for AI Medical Devices: A Physician Investor Due Diligence Guide

An FDA-authorized predetermined change control plan can reduce regulatory friction for specified AI medical device updat…

CMS-FDA RAPID Coverage Pathway: A Physician Investor Diligence Guide

The new CMS-FDA RAPID pathway could shorten the distance between FDA authorization and Medicare coverage for eligible Br…

Healthcare Startup Due Diligence: A Physician Investor Framework

Healthcare diligence requires an integrated review of clinical evidence, regulation, reimbursement, workflow, compliance…