High
FDA
💬 Comments close in 23 days (Oct 19)
FDA issued a discussion paper seeking stakeholder input on regulatory approaches for GenAI-enabled medical devices due to concerns about unique risks like hallucinations and confabulations. The U.S.
High
TEFCA
New role-specific online training series prepares healthcare workforce for active federal information blocking enforcement beginning in 2026. The Sequoia Project, in partnership with AHIMA and HCPro, has launched a new role-specific online training series designed to help healthcare organizations...
High
HHS
NIST
Three critical flaws reported in Mirth Connect versions prior to 4.4.2 expose PHI to credential theft, arbitrary code execution, and remote system compromise. NextGen Healthcare disclosed three high-severity vulnerabilities (CVE-2024-37335, CVE-2024-37336, CVE-2024-37337) in its Mirth Connect...
High
Other
Multiple vulnerabilities in NextGen Healthcare's widely used integration engine allow authenticated attackers to exfiltrate data and disrupt healthcare operations. CISA issued an advisory detailing three critical vulnerabilities (CVE-2026-82583, CVE-2026-78224, CVE-2026-82578) affecting Mirth...
High
Other
A heap overflow vulnerability in Orthanc DICOM Server versions prior to 1.13.0 enables authenticated attackers to crash medical imaging systems via malicious image files. CISA has issued an advisory (ICSMA-26-253-02) detailing CVE-2026-87020, a critical integer overflow vulnerability in Orthanc...
Notable
CMS
HHS
Native Hawaiians must comply with new Medicaid work requirements in Trump's One Big Beautiful Bill Act, while other indigenous groups remain exempt, creating disparities in healthcare access. Native Hawaiians will be required to meet Medicaid work requirements under President Trump's One Big...
Notable
FDA
💬 Comments close in 45 days (Nov 10)
FDA requests public comment on proposed information collection requirements for medical device tracking under the Paperwork Reduction Act, with comments due November 10, 2026. The Food and Drug Administration (FDA) has announced a 60-day public comment period on proposed information collection...
Notable
ONC/ASTP
CMS
HHS
TEFCA
HL7
FHIR
Federal health IT leaders will examine AI integration, data quality improvements, and payer-provider collaboration as TEFCA expands nationwide interoperability capabilities. The eHealth Exchange 2026 Annual Meeting, held September 9, 2026, spotlighted the evolving landscape of nationwide health...
Notable
CMS
The updated system enables real-time data collection during patient assessments to support quality measurement, care coordination, and regulatory reporting. The Centers for Medicare & Medicaid Services (CMS) is modifying its existing Hospice Item Set (HIS) System of Records under the Privacy Act...
Notable
HHS
Congressional Democrats warn mandatory ER data collection violates patient privacy and could deter emergency care seeking. Senate and House Democrats are demanding the Trump administration halt its plan to collect patients' emergency room medical records, arguing the initiative violates privacy...
FYI
ONC/ASTP
Meeting rescheduled due to scheduling conflict with originally planned September 14 date The Office of the National Coordinator for Health Information Technology (ONC) has amended the notice of meeting for the Health Information Technology Advisory Committee, rescheduling the meeting from...