🏥New Rule for Veterans
The Department of Veterans Affairs (VA) is issuing this interim final rule (IFR) to amend its adjudication regulations to establish presumptive service connection for acute leukemias, chronic leukemias, multiple myelomas, myelodysplastic syndromes (MDS), and myelofibrosis due to exposure to Particulate Matter 2.5 (PM<INF>2.5</INF>). The new presumptions would apply to veterans who served on active military, naval, air, or space service in the Southwest Asia theater of operations or Somalia during the Persian Gulf War (hereafter Gulf War) on or after August 2, 1990, and in Afghanistan, Syria, Djibouti, Uzbekistan, Egypt, Jordan, Lebanon, and Yemen during the Gulf War on or after September 11, 2001.
Learn More🏥FDA Guidance on Unapproved Medical Product Communications
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers." This guidance describes FDA's enforcement policy regarding certain firm-initiated communications of scientific information on unapproved use(s) of the firm's approved/ cleared medical products to health care providers (HCPs) engaged in prescribing or administering medical products to individual patients. This guidance finalizes the revised draft guidance of the same title issued in October 2023. The October 2023 revised draft guidance revised and replaced the draft guidance entitled "Distributing Scientific and Medical Publications on Unapproved New Uses--Recommended Practices," issued in March 2014, which itself revised the final guidance entitled "Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices," issued in January 2009. This guidance is not for current implementation, pending the Office of Management and Budget's (OMB's) decision on the collection of information.
Learn More🔐Proposed HIPAA Security Rule Enhancements for Cybersecurity Compliance
The Department of Health and Human Services (HHS or "Department") is issuing this notice of proposed rulemaking (NPRM) to solicit comment on its proposal to modify the Security Standards for the Protection of Electronic Protected Health Information ("Security 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 proposed modifications would revise existing standards to better protect the confidentiality, integrity, and availability of electronic protected health information (ePHI). The proposals in this NPRM would increase the cybersecurity for ePHI by revising the Security Rule to address: changes in the environment in which health care is provided; significant increases in breaches and cyberattacks; common deficiencies the Office for Civil Rights has observed in investigations into Security Rule compliance by covered entities and their business associates (collectively, "regulated entities"); other cybersecurity guidelines, best practices, methodologies, procedures, and processes; and court decisions that affect enforcement of the Security Rule.
Learn More⚖️New VA Rule on Cancer Presumptions for Veterans
The Department of Veterans Affairs (VA) is issuing this interim final rule (IFR) to amend its adjudication regulations to establish presumptive service connection for urinary bladder, ureter, and related genitourinary (GU) cancers due to exposure to Particulate Matter 2.5 (PM<INF>2.5</INF>) and to implement certain provisions of the Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics Act of 2022 (PACT Act). The new presumptions would apply to Veterans who served on active military, naval, air, or space service in Southwest Asia theater of operations or Somalia during the Persian Gulf War (hereafter Gulf War) on or after August 2, 1990, and in Afghanistan, Syria, Djibouti, Uzbekistan, Egypt, Jordan, Lebanon, and Yemen during the Gulf War on or after September 11, 2001. This amendment is necessary to provide expeditious health care, services, and benefits to these veterans. This IFR addresses the needs and concerns of Gulf War veterans and Service members who have served and continue to serve in these locations and have been diagnosed with bladder, ureter, and related GU cancers. Neither Congress nor the President has established an end date for the Gulf War. Therefore, to expedite the provision of health care, services, and benefits to current and future Gulf War veterans who may be affected by PM<INF>2.5</INF> due to their military service, VA is establishing presumptive service connection for urinary bladder, ureter, and related GU cancers. This IFR will ease the evidentiary burden of Gulf War Veterans who file claims with VA for these conditions.
Learn More🏥Copayment Exemption for Whole Health Services Proposed by VA
The Department of Veterans Affairs (VA) proposes to revise its medical regulations to exempt Whole Health well-being services from the copayment requirements for inpatient hospital care and outpatient medical care. These Whole Health well-being services, which consist of Whole Health education and skill-building programs and complementary and integrative health well-being services, are provided to Veterans within the VA Whole Health System of Care to improve Veterans' overall health and well-being.
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