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FDA Updates
09/16/2025

The following is a listing of recent U.S. Food and Drug Administration (FDA) updates and activities: Electrical Wheelchair Component Correction:...

Sources:
  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

As of September 2025, there is a notable divergence between the U.S. Food and Drug Administration (FDA) approved indications for COVID-19 vaccines and...

Sources:
  • Food and Drug Administration,
  • Department of Health and Human Services,
  • Centers for Disease Control and Prevention
Relevant To:
  • All Healthcare Organizations
FDA Updates
09/12/2025

The following is a listing of recent U.S. Food andDrug Administration (FDA) updates and activities: Continuous Glucose Monitor Apps Correction: ...

Sources:
  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) and the Assistant Secretary for Technology Policy (ASTP) recently relea...

Sources:
  • Health Insurance Portability and Accountability Act
Relevant To:
  • All Healthcare Organizations

The U.S. Centers for Medicare and Medicaid Services (CMS) is shifting to a data-driven process to prioritize transplant program reapproval surveys. ...

Sources:
  • Centers for Medicare and Medicaid Services
Relevant To:
  • Hospitals

The U.S. Centers for Medicare and Medicaid Services (CMS) Comprehensive Error Rate Testing (CERT) Task Force continues to identify missing or incomple...

Sources:
  • Centers for Medicare and Medicaid Services
Relevant To:
  • Home Health,
  • Long Term Care,
  • Inpatient Rehabilitation Facility

The Centers for Medicare & Medicaid Services (CMS) has released revisions to Appendix A of the State Operations Manual (SOM) for Hospitals to incl...

Sources:
  • Centers for Medicare and Medicaid Services
Relevant To:
  • Critical Access Hospitals,
  • Hospitals

The Department of Health and Human Services has delegated enforcement of the Confidentiality of Substance Use Disorder (SUD) Patient Records Rule (42 ...

Sources:
  • Department of Health and Human Services
Relevant To:
  • All Healthcare Organizations

The U.S. Department of Health and Human Services (HHS) is strengthening enforcement  against information blocking, which occurs when healthcare e...

Sources:
  • Department of Health and Human Services
Relevant To:
  • All Healthcare Organizations
FDA Updates
08/29/2025

The following is a listing of recent U.S. Food and Drug Administration (FDA) updates and activities: Ventilator Correction: Hamilton Medical AG ...

Sources:
  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations
FDA Updates
08/28/2025

The following is a listing of recent U.S. Food and Drug Administration (FDA) updates and activities: Vascular Stent Recall: Boston Scientific Re...

Sources:
  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

The U.S. Food and Drug Administration (FDA) is reminding health care providers and facilities about the safe use of hyperbaric oxygen therapy (HBOT) d...

Sources:
  • Food and Drug Administration
Relevant To:
  • Critical Access Hospitals,
  • Hospitals

According to the Joint Commission (TJC), the storage of concentrated electrolytes in patient care areas outside of the pharmacy is permitted only in s...

Sources:
  • The Joint Commission
Relevant To:
  • Rural Emergency Hospitals,
  • Dialysis Facilities,
  • Critical Access Hospitals,
  • Hospitals,
  • Pharmacy

The Accreditation Association for Ambulatory Health Care (AAAHC) recently released v44 Standards, which will be effective as of December 16, 2025. ...

Sources:
  • Accreditation Association for Ambulatory Health Care (AAAHC)
Relevant To:
  • Ambulatory Care

The U.S. Centers for Medicare and Medicaid Services (CMS) recently transitioned to a cloud-based Internet Quality Improvement and Evaluation System (i...

Sources:
  • Centers for Medicare and Medicaid Services
Relevant To:
  • Long Term Care