Resources
for You and Your Team
CMS Proposes 2026 Changes to RPM, APCM, DMHT, and More: What Digital Health Companies Need to Know
CMS’ 2026 MPFS rule proposes major changes to RPM, APCM, and DMHT codes. See how digital health innovators can prepare and weigh in on key policies.
Digital Health Stakeholders: Weigh In on CMS 2026 Chronic Disease and Virtual Care RFIs
CMS is exploring major shifts in Medicare reimbursement policy for virtual care and chronic disease management. This article breaks down the 2026 RFIs and what policymakers, providers, and digital health innovators need to know before the September 12, 2025 comment deadline.
FDA’s New Playbook for AI in Medical Devices: What Developers Need to Know
Operating at Scale: Legal Considerations for Growth-Stage Health AI Companies
Scaling a healthcare AI company? Learn the top legal strategies for growth-stage digital health companies—from FDA SaMD analysis and HIPAA compliance to state AI laws and AI governance.
DEA Delays Implementation of Final Teleprescribing Rules—What’s Next for Telehealth Prescribing?
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.
State Health Privacy Laws Expand Beyond HIPAA: What Healthcare Businesses Need to Know About NYHIPA
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 Remote Patient Monitoring Audits Are Here: What You Need to Know
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.
FDA Resolves Semaglutide Shortage: What This Means for GLP-1 Compounding Pharmacies and Telehealth Weight Loss Companies
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.
Navigating Uncertainty: How Healthcare Innovators can Lead in Times of Change
Now is the time for action. Those who embrace uncertainty, focus on enduring industry needs, and leverage technology to enhance the system will lead this next era of healthcare innovation.
Navigating the Future of AI in Healthcare: 3 State Law Trends to Watch
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 multi-jurisdictional landscape.
Venture Debt: Considerations for Healthcare Innovation Companies
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.
Safeguarding Healthcare: Navigating Cybersecurity, Reproductive Privacy, & Data Access Challenges
Fundraising at Every Stage: Top Tips for Digital Health Startups
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.
Point Solution Fatigue, Meet M&A: How Strategic Transactions Can Transform Digital Health
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.
Navigating Reimbursement Strategies in the Food as Medicine Space
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.