What You Need To Know

The DEA has delayed implementation of two major teleprescribing rules until December 31, 2025, citing stakeholder concerns about patient access and pharmacy burden. While current pandemic-era flexibilities remain in place, the future of telehealth prescribing, especially for opioid use disorder treatment, remains uncertain as regulators weigh next steps.

New York is the latest state to introduce its own health privacy law, the NY Health Information Privacy Act (NYHIPA), signaling a growing trend of state-level regulations extending beyond HIPAA. If enacted, NYHIPA will impose strict requirements on how businesses—both inside and outside the healthcare industry—collect, process, and share consumer health data, making compliance a priority for many organizations.

OIG’s increased oversight of Remote Patient Monitoring (RPM) and Chronic Care Management (CCM) has led to a surge in Medicare audits, with a focus on documentation, medical necessity, and compliance with billing requirements. To stay compliant, organizations should ensure clear documentation, conduct proactive compliance assessments, and seek legal guidance when responding to audits.

The removal of semaglutide from the Drug Shortage List will have a significant impact on the way telehealth practices and compounding pharmacies handle this medication. With the normal FDA restrictions on compounding set to take effect once again, practices and pharmacies need to be aware of the deadlines and regulatory requirements that come with this change.

Explore how state laws are shaping the future of AI in healthcare, focusing on transparency, consumer rights, and algorithmic fairness. As regulations evolve, healthcare AI innovators must adapt to ensure compliance and equitable outcomes in a multijurisdictional landscape.

Discover how AI is transforming healthcare in 2025, driving advancements in clinical care and value-based models while navigating a rapidly evolving regulatory landscape.

Discover the top trends and opportunities for digital health innovators in 2025, from AI adoption and value-based care to regulatory shifts and cybersecurity challenges. These insights from Nixon Law Group will help you navigate the year ahead.

Explore how venture debt can offer healthcare innovation companies non-dilutive capital to fuel growth, bridge equity rounds, and scale operations, while navigating key legal and financial considerations to maximize value.

CMS has finalized the APCM codes for 2025. See what this means for primary care and digital health companies.

See what the final Medicare Physician Fee Schedule for 2025 has to say about Digital Mental Health Treatment

Learn about the Office of Inspector General’s new report around remote patient monitoring and the key areas where it misses the mark.

Learn how to make the fundraising process go as smoothly – and as quickly – as possible as a digital health startup — whether you're raising for the first time or you're a Series C company preparing for exit.

Explore how strategic mergers and acquisitions (M&A) can reduce or even eliminate point solution fatigue by creating more comprehensive and integrated platforms that will improve patient care and reduce administrative burden.

One of the key factors in FaM’s growth is reimbursement policy across various payors and providers. This post introduces reimbursement frameworks and strategies that support the FaM space, including medical nutrition therapy (MNT), medically tailored meals (MTM), the Supplemental Nutrition Assistance Program (SNAP), and employer-sponsored benefits programs.

In the recently released 2025 Medicare Physician Fee Schedule Proposed Rule (the “Proposed Rule”), the Centers for Medicare & Medicaid Services (CMS) created a new reimbursement pathway for “Digital Mental Health Treatment” (DMHT) devices and services. 

Under the Proposed Rule, physicians and non-physician practitioners – for example, nurse practitioners (NPs) and physician assistants (PAs) – can order and bill for APCM services. Here’s what digital healthcare innovators need to know.

Below is an overview of the most important proposals and the opportunities for healthcare innovators and digital health companies from the 2025 Medicare Physician Fee Schedule Proposed Rule

At the most recent Food as Medicine (FaM) Summit, leading experts, policymakers, and healthcare innovators in FaM gathered to discuss one important goal: revolutionizing how we improve population health through food and nutritional guidance.

Here’s what we believe every healthcare and FaM innovator should know. 

The Digital Therapeutics Alliance Summit 2024, held in Washington, D.C., brought together over 500 industry leaders (including NLG’s own Carrie Nixon and Michael Schellhous), innovators, and key stakeholders to discuss the current state and future of digital therapeutics (DTx). 

The Federal Trade Commission (FTC) finalized changes to the Health Breach Notification Rule (HBNR), clarifying its applicability to health apps and similar technologies, including those that are not subject to HIPAA. In 2023, FTC began enforcing the HBNR in earnest, with an expanded interpretation of their authority under the HBNR. In the 2024 Final Rule (the 2024 Final Rule), the agency conforms the HBNR to this expanded interpretation, clarifying its breadth for industry and the public.

Healthcare delivery is changing, and digital health is revolutionizing healthcare, creating a burgeoning market opportunity for software-as-a-medical-device (SaMD) and digital therapeutic (DTx) products.

Last Friday, Colorado’s governor signed into law the Colorado AI Act (“CAIA”). For digital health companies building with artificial intelligence, CAIA sets the first comprehensive national benchmark for minimum rights and protections for users of healthcare AI, effective February 1, 2026.

The ATA Nexus 2024 Conference, one of the largest gatherings of virtual healthcare experts and thought leaders, just took place in Phoenix last week. If you weren’t able to attend…what did you miss?

No centralized framework for the regulation of artificial intelligence in the United States currently exists. That said, the flurry of regulatory policymaking and legislation, congressional hearings and inquiries, and industry stakeholder organization around the development and deployment of healthcare AI portends major developments in the coming years. Experienced entrepreneurs and executives know that the ability to peer into the future can pay dividends, and we agree.