Sound Physicians

APRIL 28, 2025

Still, we know that sometimes the final decision comes down to a single factor: cost. While we’ve earned our reputation over the decades for our clinical excellence in hospital medicine , we’ve also earned — somewhat unfairly — a reputation for being more expensive than our competitors. percent and 5.7 percent annually. percent and 5.7

IT 52

IT Hospital Telemedicine Clinic 52

FDA Law Blog

JANUARY 5, 2023

In mid-November, FDA collaborated with the MITRE Corporation to publish an update to the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook. Combination products are sharing the digital moment with those classified solely as medical devices. FDA has shown a willingness to intervene in this space.

Manufacturing 59

Manufacturing Patient-Centered Provider Telehealth 59

FDA Law Blog

OCTOBER 10, 2022

The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains to Clinical Decision Support (CDS) software functions. The CDS Guidance interprets the Cures Act’s definition of “medical software” that is excluded from the statutory “device” definition, as it relates to CDS software.

Clinic 52

Clinic Medical Provider Patients 52

FDA Law Blog

APRIL 8, 2024

Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response. By Kalie E.

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59