Regulatory

Feb. 26, 2025

On February 25, 2025, President Trump signed an executive order on price transparency for healthcare services. During his first term, President Trump tried to force the industry...

Price transparency executive order: What to know

How small, high-complexity testing labs can adapt to FDA LDT regulatory shifts

Dear API Abby

AABB launches toolkit to support members in midst of new FDA guidance

Communications to be halted by HHS

Updates to laboratory special procedures guidance

OCR to update HIPAA rule after more than a decade

Revisions to State Operations Manual, Appendix C

REVISED: Revisions to Appendix Q, guidance on immediate jeopardy

Guidance for time-share and leased space arrangements in CAHs

Important information about the CLIA proficiency testing final rule

New policies to reduce maternal mortality, increase access to care, and advance health equity

GlobalData concerned about new LDT rule’s impact on personalized medicine

Updates to the Condition of Participation (CoP) requirements for hospitals and critical access hospitals (CAHs) to report acute respiratory illnesses

Issue of CLIA SAPR FY 2024

Reorganization of the Office of Laboratory Science and Safety

Regulatory

Meeting of the Clinical Laboratory Improvement Advisory Committee

ADLM survey finds that FDA’s final laboratory developed tests rule will hinder patient care for underserved communities

A2LA announces first clinical laboratory in U.S. accredited to new version of ISO 15189 as part of platinum choice program

Association for Molecular Pathology files lawsuit against FDA to challenge final rule on regulation for laboratory developed testing procedures

Updated Model Signage for the Emergency Medical Treatment and Labor Act

Medicare Program; Transitional Coverage for Emerging Technologies

REVISED: Final Rule - Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing - Analytes and Acceptable Performance Final Rule (CMS-3355-F)