HHS

Our in-brief roundup of notable stories from the last week.

HHS announced an FDA guidance and expanded CMS payment model to help patients with rare genetic diseases.

New federal health IT regulation reduces certification requirements, with HHS estimating more than $1.5 billion in savings for developers.

An executive order directs new NIH women’s health division and White House task force to accelerate research, care, and clinical adoption.

FDA aims to accelerate treatments while maintaining safety standards.

CLIA looks to expand virtual access, update lab staffing rules, and modernize oversight as CMS and CDC review regulations.

AZ argues CMS exceeded authority under the Inflation Reduction Act by grouping separate medicines under a single drug definition.

New CMS rules require hospitals to disclose more accurate pricing data, aiming to improve price comparisons and patient decision-making.