OpenLoop Health|12/31/2025|4 min read

Recent Digital Health Trends, Insight and News - January 2026

AI neurotech advances, federal AI strategy, and new FDA payment pilots

The latest digital health trends and news from december

Between hot chocolate and holiday cheer, digital health still continued its momentum in the final month of the year. From the FDA’s new device pathway and CranioSense’s grant-funded intracranial pressure monitors to HHS’s AI strategy, the industry experienced rapid evolution. 

Below, get a recap of the latest digital health trends and news from last month!  

Technology, News and Insights

Mayo Clinic Scientist Uses AI, Wearables and Implants to Decode Brain Rhythms and Forecast Seizures

Mayo Clinic researcher Gregory Worrell, M.D., Ph.D., and his team use AI, wearables, and brain implants to manage seizures better. The brain implant, specifically, sits under the skin behind the ear and records people’s brain activities to observe seizure patterns. Then there’s the AI-enabled smartwatch, which tracks skin temperature, heart rate, movement, and more to predict epileptic seizures before they occur. 

Both tools allow clinicians to adjust treatment and spot patterns that might otherwise go unnoticed. 

Read the full Mayo Clinic News Network article >> 

Study: Responsible Adoption of Multimodal Artificial Intelligence in Health Care

A new study in The Lancet Digital Health explored multimodal AI systems in healthcare that combine diverse data types, such as medical imaging, lab results, and patient records, to improve diagnosis and treatment. Researchers found these systems showed promise across applications such as sepsis detection and cardiology.

However, implementation challenges also exist, including fairness issues affecting demographics, inconsistent formats across healthcare systems, and more. 

Read the Lancet article here >> 

Policy and Regulatory

HHS Releases AI Strategy for Agency Efforts

The Department of Health and Human Services (HHS) shared a strategy for integrating AI across internal operations, research, and public health efforts. It supports the Trump administration's AI action plan that focuses on five pillars, including:

  • Ensuring governance and risk management for public trust

  • Designing infrastructure and platforms for user needs

HHS explained that the strategy doesn’t cover all efforts surrounding the delivery of AI services, but is a first step toward efficiency and proper federal use. 

Read the full AHA news article here >> 

FDA Pilots Allowing Digital Health Devices Access to CMS Payment Program

A pathway for allowing unauthorized digital health devices to access a Medicare payment option has been developed by the Food and Drug Administration (FDA).  

It’ll take place through the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot, which allows companies to request waivers of premarket authorization and investigational device requirements. This allows them to collect real-world data through CMS’s ACCESS program, which provides recurring payments to healthcare sites that manage chronic conditions. 

They’ll accept up to 10 U.S. manufacturers for each of the four categories, with applications opening January 2.

Read the full Healthcare Dive article here >>

  

Industry Conversations

Physicians' Telehealth Use Varies Across Specialties, Practice Type

Physicians' use of telehealth varies by specialty and practice ownership. In 2024, over 50% of physicians used telehealth to manage patients with chronic diseases, and almost 50% used the tool to diagnose and treat them. Furthermore, 25% worked in practices that used telehealth for preventive care. 

The article explained that based on their survey, psychiatrists relied the most on telehealth, and among medical specialists, cardiologists appeared to use it the least. The majority of those who didn’t use it shared that it was “not relevant to the work of the specialties in my practice.”

Read the TechTarget article here >> 

Urgent Specialist Care? It's Possible with Telehealth

According to this article, telehealth has decreased specialist wait times from the usual 3 to 6 months to under 48 hours. Additionally, it’s allowed specialist visits to be more cost-effective due to the lack of brick-and-mortar overhead costs. 

Dr. Anne Allen, a dermatologist who provides virtual care, suggests that health systems integrate telehealth into triage processes. This would allow specialists to promptly identify which patients need immediate in-person evaluation and which can be treated virtually. 

Read the full Healthcare IT News article here >> 

Growth, Funding and Innovation

CranioSense Lands $5.5M NIH, DoD Funding for Intracranial Pressure Monitoring

The Boston-based neurotechnology company, CranioSense, received nearly $5.5 million in non-dilutive funding. The NIH Blueprint MedTech Program and the U.S. Department of Defense’s Joint Warfighter Medical Research Program provided the grants to help fund device development, particularly for their defense-driven initiative. 

CranioSense’s system utilizes a forehead patch, two clip-on sensors, and a handheld device to measure intracranial pressure. Their proprietary algorithms make it possible for patients with traumatic brain injury to be tested for elevated pressure without drilling into the skull or inserting brain sensors.

Read the full MobiHealthNews article here >> 

ARCH-backed Paradigm Snaps Up Flatiron’s Clinical Research

BusinessParadigm Health acquired Roche-owned Flatiron Health’s clinical research division and closed a $78 million Series B funding round. The acquisition includes Flatiron’s AI-powered clinical research infrastructure, including its OncoEMR electronic health record system and Clinical Pipe data streamlining service. They also gained access to Flatiron’s over 25 academic medical centers and nearly 100 community oncology practices nationwide. 

This investment round was crucial for improving accessibility, as many patients are underrepresented in clinical research data, particularly those in community and rural settings. 

Read the full Clinical Trials Arena here >>  

OpenLoop Resources & News 

How to Start Your Own Supplements Brand

The global supplements market is growing, and is an especially promising venture for influencers. However, what does it take to launch your very own supplement company?

This article shares two business models (private label and custom formulation) and offers key steps on defining your niche, designing compliant packaging, and more.   

Read the full OpenLoop article here >>

Top 12 Healthcare AI Companies in the U.S in 2026

AI is transforming healthcare from administrative workflows to life-saving diagnostics. But with hundreds of companies offering AI solutions, which ones are leading the charge?

This article showcases the top healthcare companies based on scale of deployment, economic impact, technological innovation, and healthcare system integration. Featured companies include HeyRevia, Aidoc, and Livongo. 

Read the full OpenLoop article here >>

What High-Cost Specialty Drugs Will Affect Premiums in 2026?

In 2026, specialty drug costs are expected to increase health plan costs by almost 12%, even though they account for only a small fraction of prescriptions. But what exactly is driving this increase? In this article, we reveal the five categories driving this growth, including GLP-1 medications, and what employers can do to combat these rising premiums. 

Employee wellness programs could be just the solution to keeping costs contained, as they help decrease risk factors and identify chronic conditions sooner. 

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.