Software as a Medical Device (SaMD) refers to standalone software that performs medical functions (for diagnosis, treatment, monitoring, etc.) without being part of a hardware device. In recent years, such software – especially AI-driven tools – has become widespread in health care. Recognizing the unique risks and innovation potential of SaMD, the FDA (via its Digital Health Center of Excellence) has embarked on a series of new policies and guidance's.
On May 22, 2025, the Centers for Medicare & Medicaid Services
On July 4, 2025, the "One Big Beautiful Bill" was signed into law, a sweeping legislative package that combines tax cuts, spending reductions, and policy reforms. Officially titled the "One Big Beautiful Bill Act," this legislation has sparked both optimism and concern across industries, including healthcare.
The Centers for Medicare & Medicaid Services (CMS) Quality Payment Program (QPP) is a critical framework for ophthalmologists participating in Medicare, aimed at improving care quality while reducing administrative burden. For ophthalmology practices, meeting QPP deadlines is essential to avoid penalties, secure incentives, and maintain financial stability.
On April 7, 2025, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year 2026 Rate Announcement for Medicare Advantage (MA) and Medicare Part D Prescription Drug Programs....
For Ophthalmologists, Practice Managers, and Eye Practice Owners, ensuring HIPAA compliance is not just a legal obligation but a cornerstone of patient trust and operational efficiency.
Keeping up with HIPAA regulations feels like trying to hit a moving target. Just when you think you’ve got a handle on patient privacy rules, new updates roll out.
Cataract surgery audits are becoming more stringent, especially with the inclusion of Ambulatory Surgical Centers (ASCs)
The U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) has introduced a proposed rule aimed at enhancing imaging requirements for EHR.
During the recent annual conference of ASCRS in Boston, Dr. Elizabeth Yeu shared groundbreaking insights into the triple procedure, showcasing its transformative impact on patients with corneal edema.