Recent Digital Health Trends, Insight and News - December 2025

November ushered in holiday preparations alongside digital health trends, including regulatory clarity, new FDA clearances, and record-breaking AI investments. From CMS issuing post-shutdown telehealth guidance to conversations on what consumers really want from AI-based products, the month showcased both innovation and increased scrutiny across the industry. 

Below, dive into the digital health trends, regulatory updates, and industry shifts that defined November. 

Technology, News and Insights

RapidAI Earns FDA Clearance for Rapid Aortic Product

RapidAI, a leader in AI-driven medical imaging analysis and coordination, recently received FDA clearance for its Rapid Aortic product. This device uses deep clinical AI to improve how clinicians assess and manage aortic disease by going beyond basic detection. Instead, it automatically measures key dimensions, creates 3D reconstructions of the entire aorta, and tracks changes over time by analyzing CT scans that include the aorta. 

This will help radiologists work faster with less mental strain while giving surgeons better tools to monitor patients long-term.

Read the full DAIC article here >> 

Zimmer Biomet Receives U.S. FDA Clearance for Enhanced Version of ROSA® Knee Robotic Technology

The global medical technology company Zimmer Biomet received FDA clearance for its enhanced robotic system for knee replacement surgery, which uses AI algorithms to personalize surgical planning. The system, called ROSA, creates customized profiles based on each surgeon’s preferences and the patient's anatomy. From there, it generates surgical plans that can cut planning time by nearly half. 

The article goes on to discuss its other features, including motion-sensitive tracking, its simplified interface, and more. 

Read the full PR Newswire article here >> 

Policy and Regulatory

CMS Clarifies Telehealth Rules Following the Government Shutdown

Following the 43-day government shutdown, CMS confirmed that providers will be reimbursed for virtual care visits that occurred from October 1 through November 13. The guidance also clarifies address reporting requirements, explaining that providers with physical practice locations don’t need to report their home address when delivering telehealth from home. However, virtual-only practitioners must still enroll their home address as a practice location. 

Medicare telehealth flexibilities have been extended through January 30, 2026, but major rollbacks could take effect after that date if Congress doesn’t act. 

Read the full Healthcare IT News article here >>

Democrats Introduce Bill to Repeal Medicare Prior Authorization Pilot

House Democrats introduced legislation to repeal a CMS pilot program that would implement AI-based prior authorization for certain Medicare services, such as skin substitutes and nerve stimulator implants. The Wasteful and Inappropriate Service Reduction (WISeR) model, launching in January across six states, would be administered by private health tech companies and would receive a percentage of savings from denied care. 

Democrats argue the model could delay necessary care for seniors and create dangerous incentives by financially rewarding companies for denying treatment. 

Read the full Healthcare Dive article here >> 

Senate Bill Aims to Close HIPAA Gap for Wearable Health Data

Senator Bill Cassidy introduced the Health Information Privacy Reform Act to address privacy gaps in health data collected by wearable devices and mobile health apps. HIPAA currently doesn’t cover data from consumer devices, so this bill would require developers to notify users that HIPAA protections don’t apply to their data. Additionally, they’d need to offer an option to block data sharing. 

Read the full Becker’s Health IT article here >>

Industry Conversations

HIMSS Forum: The Challenge of Advancing Secure AI in Healthcare

During the HIMSS AI and Cybersecurity Virtual Forum, Dr. Xiaoqian Jiang from UTHealth Houston explored the growing complexity of healthcare data sharing. As institutions move towards consortium collaborations, privacy risks are growing, and removing patient names alone isn’t enough as it can still reveal identities. 

Dr. Jiang explains that an AI approach, known as federated learning, may be the best solution, as it trains models across multiple datasets without pooling raw data. 

Read the full MobiHealthNews article here >> 

Why ‘Time-to-Value’ Is the #1 Metric Healthcare AI Customers Care About

According to Rock Health, AI-focused startups captured 62% of digital health venture funding in the first half of 2025. However, investors and health systems are increasing scrutiny, prioritizing time-to-value as the top evaluation metric. 

Health systems now demand tangible ROI, such as reduced staffing costs or increased revenue, within six to nine months post-deployment, which is a shift from earlier tolerance for multi-year ROI timelines. 

Read the full MedCity News article here >> 

Growth, Funding and Innovation

Hippocratic AI Lands $126M Series C to Expand Patient-Facing AI Agents, Fuel Acquisition Deals

Hippocratic AI, a healthcare technology company founded in 2023, raised $126 million in Series C funding at a $3.5 billion valuation, bringing total funding to $404 million. The company has partnered with over 50 health systems, payers, and pharma clients across six countries and built 1000 use cases for its patient-facing agents. 

They plan to use this next phase of funding to deepen their customer deployments worldwide, pursue strategic mergers and acquisitions to reach more patients, and invest in their safety framework. 

Read the full Fierce Healthcare article here >>

WellTheory and Instacart Partner to Expand Access to Food-as-Medicine for Autoimmune Patients

WellTheory, a whole-person care platform for autoimmune disease, partnered with Instacart to expand access to nutrition-based care for approximately 300,000 individuals in its network. Through Instacart Health Fresh Funds, members will receive grocery stipends to purchase clinically recommended anti-inflammatory foods from local grocers. 

Instacart’s reach extends to more than 98% of U.S. households, including 95% in food deserts. The partnership integrates grocery delivery into WellTheory’s root-cause care model, which combines nutrition guidance, lifestyle modification, and one-on-one support from registered dieticians and health coaches.

Read the full HIT Consultant article here >> 

OpenLoop Resources & News 

An Executive’s Guide to AI in Healthcare: Cost, Access, and Outcomes

Executives recognize that AI in healthcare is quickly moving from pilot programs to full scale platforms, but what else should they know if they plan to implement this innovation at their organization? 

This comprehensive guide reveals real-world ROI examples like $40 million contribution margins from AI-driven OR scheduling, how AI impacts the healthcare “Iron Triangle”, along with common implementation challenges. 

Read the full OpenLoop article here >> 

How to Start a Women’s Health Company (Step-by-Step Guide)

Curious about what it takes to launch a women’s health business? Doing so requires careful planning across compliance, technology, staffing, and patient experience. 

In this guide, founders learn essential steps, from defining your niche audience (midlife transitions, metabolic health, telehealth birth control) to designing evidence-based care journeys with clear intake protocols, follow-up schedules, and adverse-event handling.

Read the full OpenLoop article here >> 

The Cost of Starting a Longevity Clinic (and How to Save)

There’s a growing market of individuals seeking services that help them live longer and healthier lives. However, there’s just one question: how much does running a longevity clinic actually cost? 

Truthfully, start-up costs vary widely based on your delivery model (telehealth, hybrid, or in-person), treatment scope (lifestyle coaching vs. prescription peptides and HRT), and compliance strategy. The article shares key cost categories and how to avoid common areas of overspend so companies can scale appropriately. 

Read the full OpenLoop article here >>

How to Implement AI Into Your Patient Scheduling

Companies are losing thousands of dollars due to scheduling inefficiencies, no-shows, and administrative burden. This article explores practical use cases for AI-powered scheduling, including intelligent no-show prevention, dynamic rescheduling, and follow-up coordination. Plus, it dives into a six-step implementation roadmap to help healthcare leaders integrate AI scheduling tools into their existing infrastructure.

Read the full OpenLoop article here >>

*This content is intended for general informational purposes only and should not be construed as legal advice. For guidance on your specific situation, please consult a licensed attorney.