Regulatory

April 21, 2025

But laboratories should still prepare for the future

Regulatory

Anticompetitive Regulations Task Force — Healthcare

Christina Wichmann

April 2, 2025

Regulatory

AMP celebrates U.S. District Court’s decision to vacate FDA rule on laboratory-developed test procedure regulation

LABline

March 31, 2025

Regulatory

Price transparency executive order: What to know

Christina Wichmann

Feb. 26, 2025

Regulatory

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

Dominique Dotson, PhD

Feb. 24, 2025

Regulatory

Dear API Abby

Sue Styles, MSI

Feb. 24, 2025

Regulatory

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

Erin Brady

Jan. 30, 2025

AABB regulatory update.

Regulatory

Communications to be halted by HHS

LABline

Jan. 24, 2025

Memo provides steps to take until February 1, 2025.

Regulatory

CMS guidance: Revisions to the State Operations Manual

Erin Brady

Jan. 22, 2025

The Centers for Medicare & Medicaid Services (CMS) has updated chapter 6 of the State Operations Manual (SOM), and certain guidance memos are now expired. Key updates: ·...

Regulatory

OCR to update HIPAA rule after more than a decade

Erin Brady

Jan. 6, 2025

OCR hopes to reduce cyberattacks.

Regulatory

Revisions to State Operations Manual, Appendix C

LABline

Dec. 9, 2024

Survey procedures and interpretive guidelines for laboratories and laboratory services – advance copy.

Regulatory

REVISED: Revisions to Appendix Q, guidance on immediate jeopardy

LABline

Dec. 2, 2024

Revision to QSO-19-09-ALL revised originally released on March 5, 2019.

Regulatory

Guidance for time-share and leased space arrangements in CAHs

LABline

Nov. 21, 2024

CMS memo.

Regulatory

Important information about the CLIA proficiency testing final rule

LABline

Nov. 12, 2024

CMS CLIA communications update.

Regulatory

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

LABline

Nov. 5, 2024

HHS introduces new requirements for maternal safety standards, eliminates barriers to care for underserved communities.

Regulatory

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

LABline

Nov. 4, 2024

The final rule is scheduled for May 6, 2025.

Regulatory

Regulatory

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

LABline

Oct. 28, 2024

Regulatory

Issue of CLIA SAPR FY 2024

LABline

Oct. 1, 2024

Regulatory

Reorganization of the Office of Laboratory Science and Safety

LABline

Sept. 20, 2024

Regulatory

Meeting of the Clinical Laboratory Improvement Advisory Committee

LABline

Sept. 13, 2024

Regulatory

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

LABline

Sept. 6, 2024

Regulatory

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

LABline

Aug. 28, 2024

Regulatory

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

LABline

Aug. 20, 2024

The laboratory-developed test rule is vacated

Anticompetitive Regulations Task Force — Healthcare

AMP celebrates U.S. District Court’s decision to vacate FDA rule on laboratory-developed test procedure regulation

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

CMS guidance: Revisions to the State Operations Manual

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

Regulatory

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

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