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FDA Updates
03/27/2024

The following is a listing of recent U.S. Food and Drug Administration (FDA) updates and activities: Medline Industries Recalls Certain Kits and...

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

The U.S. Department of Health and Human Services, through its Office for Civil Rights (OCR) and the Substance Abuse and Mental Health Services Adminis...

Sources:
  • Department of Health and Human Services,
  • Health Insurance Portability and Accountability Act
Relevant To:
  • All Healthcare Organizations

The U.S. Centers for Medicare and Medicaid Services (CMS) has issued new guidance for State Survey Agencies and long-term care (LTC) facilities on the...

Sources:
  • Centers for Medicare and Medicaid Services,
  • Centers for Disease Control and Prevention
Relevant To:
  • Long Term Care

Administrative Simplification standards, part of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), govern electronic and admini...

Sources:
  • Department of Health and Human Services,
  • Centers for Medicare and Medicaid Services,
  • Health Insurance Portability and Accountability Act
Relevant To:
  • All Healthcare Organizations
FDA Updates
03/20/2024

The following is a listing of recent U.S. Food and Drug Administration (FDA) updates and activities: Latest Update on FDA’s Evaluatio...

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

The U.S. Department of Health and Human Services has issued revised guidance, “Use of Online Tracking Technologies by HIPAA Covered Entities and...

Sources:
  • Department of Health and Human Services,
  • Health Insurance Portability and Accountability Act
Relevant To:
  • All Healthcare Organizations

The U.S. Centers for Disease Control and Prevention has issued a new Health Advisory to inform clinicians and public health officials of an increase i...

Sources:
  • Centers for Disease Control and Prevention
Relevant To:
  • Rural Emergency Hospitals,
  • Urgent Care,
  • Medical Office,
  • Critical Access Hospitals,
  • Hospitals,
  • Ambulatory Care,
  • Clinical Lab,
  • Rural Health Clinics

The U.S. Centers for Medicare and Medicaid Services (CMS) has released updated interpretive guidelines and updates to Appendix B of the State Operatio...

Sources:
  • Centers for Medicare and Medicaid Services
Relevant To:
  • Home Health

The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) issued a “Dear Colleague” letter addressing the cybe...

Sources:
  • Department of Health and Human Services,
  • Office of Inspector General
Relevant To:
  • All Healthcare Organizations

DNV Healthcare has added a new requirement to their Hospital and Critical Access Hospital NIAHO accreditation standards. The addition is intended to a...

Sources:
  • National Integrated Accreditation for Healthcare Organizations (DNV)
Relevant To:
  • Critical Access Hospitals,
  • Hospitals

The U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) is alerting the public about a fraud scheme involving Durable M...

Sources:
  • Department of Health and Human Services,
  • Office of Inspector General
Relevant To:
  • Ambulatory Surgical Centers,
  • Assisted Living,
  • Medical Office,
  • Critical Access Hospitals,
  • Home Health,
  • Hospitals,
  • Ambulatory Care,
  • Rural Health Clinics

The Centers for Medicare and Medicare Services (CMS) has revised the State Operating Manual (SOM) - Community Mental Health Centers (CMHCs) to reflect...

Sources:
  • Centers for Medicare and Medicaid Services
Relevant To:
  • Behavioral Health - Outpatient,
  • Community Mental Health Centers
FDA Updates
03/08/2024

The following is a listing of recent U.S. Food and Drug Administration (FDA) updates and activities: Ventec Life Systems Recalls VOCSN Patient B...

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

The Joint Commission has announced that, effective July 1, 2024, they are revising the glossary definition of “designated equivalent source&rdqu...

Sources:
  • The Joint Commission
Relevant To:
  • Behavioral Health - Outpatient,
  • Critical Access Hospitals,
  • Hospitals,
  • Ambulatory Care,
  • Office-Based Surgery,
  • Behavioral Health - Inpatient

The U.S. Food and Drug Administration is seeking input on new draft guidance “Key Information and Facilitating Understanding in Informed Consent...

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