Federal Register Documents matching 'clia' and from Health and Human Services Department

• HIPAA Privacy Rule To Support Reproductive Health Care Privacy April 26, 2024
  The Department of Health and Human Services (HHS or "Department") is issuing this final rule to modify the Standards for Privacy of Individually Identifiable Health Information ("Privacy Rule") under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act). The […]
  Health and Human Services Department,
• Announcement of the Re-Approval of AABB (Association for the Advancement of Blood and Biotherapies) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988 April 25, 2024
  This notice announces the application of the Association for the Advancement of Blood and Biotherapies (AABB) for re-approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. This deeming authority is granted to AABB for the Blood Bank and Transfusion Service (BB/TS) program, the Immunohematology Reference Laboratory […]
  Health and Human Services Department, Centers for Medicare & Medicaid Services
• Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 Exemption of Laboratories Licensed by the State of Washington April 1, 2024
  This notice announces that laboratories located in and licensed by the State of Washington that possess a valid license under the Medical Test Site law, chapter 70.42 of the Revised Code of Washington, are exempt from the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for a period of 4 years.
  Health and Human Services Department, Centers for Medicare & Medicaid Services
• Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability March 15, 2024
  The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.'' This draft guidance document provides an overview of the mechanisms available to submitters through which they can request interactions with FDA related to medical device submissions. […]
  Health and Human Services Department, Food and Drug Administration
• Medicare Program; Announcement of the Re-Approval of COLA Under the Clinical Laboratory Improvement Amendments of 1988 March 6, 2024
  This notice announces the application of COLA for re-approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for the following specialty and subspecialty areas under CLIA: Microbiology, including Bacteriology, Mycobacteriology, Mycology, Parasitology, and Virology; Diagnostic Immunology, including Syphilis Serology, and General Immunology; Chemistry, including Routine Chemistry, […]
  Health and Human Services Department, Centers for Medicare & Medicaid Services