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Healthcare AI at a Crossroads: How OSTP and FDA’s New Calls for Comment Could Shape Regulation
Federal agencies are reshaping how AI is regulated in healthcare. The White House OSTP and FDA are seeking stakeholder input on the impact of legacy regulations and real-world AI oversight. Learn what these calls for comment mean for innovators, investors, and providers—and how your input can shape the future of healthcare AI.
Government Shutdown Looms: How the Medicare Telehealth Cliff Impacts Providers and Patients Starting October 1
Unless Congress acts by midnight, Medicare’s temporary telehealth flexibilities will expire on September 30, 2025. Starting October 1, many non-behavioral telehealth services face new limits, while behavioral health coverage and Medicare Advantage plans remain more flexible. Here’s what patients and providers need to know now.
FDA Cracks Down on Wearable Devices: Lessons from WHOOP and Dexcom Enforcement Actions
Recent FDA actions against WHOOP and Dexcom reveal how wearables and SaMD are being regulated more aggressively. Here’s what digital health founders must know.
OIG’s 2025 Report on Remote Patient Monitoring: Growth, Compliance Red Flags, and Medicare Billing Clarifications
The Office of Inspector General (OIG) has released August 2025 Data Snapshot on Remote Patient Monitoring (RPM) in Medicare. The findings highlight both the explosive growth of RPM adoption and the compliance red flags that providers, digital health vendors, and investors need to proactively address.
Telehealth Compliance Alert: Oregon CPOM Changes and Federal OIG Insights
Learn how Oregon’s new CPOM law and a recent OIG opinion impact MSO-PC models, and how telemedicine providers can stay compliant and scale responsibly.
CMS Proposes Expanded Coverage for Digital Mental Health Devices—And Seeks Input on Broader Digital Therapeutics Use Cases
CMS proposes expanded reimbursement for digital mental health devices and seeks public input on broader digital therapeutics coverage. Comments due Sept. 12.
Remote Monitoring in the 2026 MPFS: New Codes, Old Concerns, and a Call to Action for Stakeholders
The 2026 Medicare Physician Fee Schedule proposes key changes to remote monitoring reimbursement—including new codes and a shift in data requirements. Learn what’s at stake and why stakeholders should act before the September 12, 2025 comment deadline.
Reshaping Food as Medicine: New Insights from Federal and State Policymakers
Explore how the 2026 Medicare Physician Fee Schedule and the Big Beautiful Bill are shaping the future of Food as Medicine (FaM). Learn about proposed changes to MNT reimbursement, new federal and state laws, and key compliance issues for FaM and virtual food care innovators.
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.