Auto-fed daily from GuardWell's regulatory intelligence engine — Federal Register agency feeds, OCR enforcement, CMS rules, OSHA, DEA, FDA, and more. Below: the most recent items the engine flagged as relevant to small medical practices.
This is notice of an Administrative declaration of a disaster for the state of Texas dated May 7, 2026. Incident: Severe Storms and Tornadoes.
Summary unavailable — click through to read the source.
The Food and Drug Administration (FDA) is classifying the device to detect and identify microorganism nucleic acids and resistance markers from patients with suspected orthopedic infection into class II (special controls). The special controls that apply to the device type are i…
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Reg…
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the public and other federal agencies to comment on a continuing information collection, as required by the…
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of the Agency's annual compilation of notices of updates to the Agency's Susceptibility Test Interpretive Criteria web page. The Agency established the Susceptibility Test Interpretive Crite…
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collect…
The Centers for Medicare & Medicaid Services (CMS) is reopening the comment period for a limited time for a collection of information notice that published in the Federal Register on April 22, 2026. The notice is entitled "Medicaid and Children's Health Insurance Program (CHIP)…
By this interim final rule ("IFR"), the Department of Health and Human Services ("Department") is revising the Department's regulations implementing section 504 of the Rehabilitation Act ("section 504") to extend the compliance dates for the requirements for web content and mobi…
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Reg…
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Reg…
The Food and Drug Administration (FDA) is classifying the device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples into class II (special controls). The special controls that apply to the device type are identified in this order and wil…
The Food and Drug Administration (FDA) is classifying the circulating tumor cell enrichment device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of th…
The Agency for Toxic Substances and Disease Registry (ATSDR), within the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comments on a draft of the updated Toxicological Profile for Xylene. This action is necessary as this is an opportu…
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Reg…
The Food and Drug Administration (FDA, the Agency, or we) is evaluating substances that have been nominated for inclusion on a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need for outsourcing facilities to use in compounding (th…
The Food and Drug Administration (FDA) is classifying the phototherapy device for reducing the appearance of acute post-surgical incisions into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the co…
The Department of Health and Human Services (HHS) provides notice of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines) usin…
This notice announces a public meeting to receive comments and recommendations (including data on which recommendations are based) on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System codes being con…
This notice announces the rechartering of the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel), appointment of five new members to the Panel, and the next public meeting dates for the Panel on Tuesday, July 14, 2026, and Wednesday, July 15, 2026. The p…
The final rule aligning 42 CFR Part 2 with HIPAA took effect February 16, 2026. Substance use disorder (SUD) treatment records can now be disclosed under the same framework as other protected health information, reducing the separate-consent burden for providers while maintaining patient protections against use in legal proceedings.
What this means for your practice
Practices that handle SUD records should update their Notice of Privacy Practices and train staff on the streamlined disclosure rules.
CMS released the 2026 Medicare Physician Fee Schedule final rule with updated MIPS performance thresholds. The performance threshold increased to 82 points (from 75), and additional MIPS Value Pathways (MVPs) are now available for specialty-focused reporting.
What this means for your practice
Review your MIPS reporting strategy, especially if you use traditional MIPS. Consider transitioning to an MVP that aligns with your specialty.
The HHS Office of Inspector General published its 2025 Work Plan highlighting enforcement priorities for healthcare providers — telehealth billing oversight, Medicare Advantage risk adjustment audits, opioid prescribing patterns, and laboratory test utilization reviews.
What this means for your practice
Review your billing practices for telehealth services and ensure documentation supports medical necessity. Audit high-risk CPT codes flagged in the plan.
HHS published a Notice of Proposed Rulemaking to modernize the HIPAA Security Rule for the first time since 2013. Key proposals include mandatory encryption of ePHI at rest and in transit, required multi-factor authentication, annual compliance audits, and more prescriptive technical safeguard standards. The comment period has closed and a final rule is anticipated in 2026.
What this means for your practice
Start preparing now: assess current encryption practices, evaluate MFA readiness, and review your Security Risk Analysis process.
The final rule adding protections for reproductive health information under HIPAA took effect June 25, 2024. Covered entities and business associates are now prohibited from disclosing PHI related to lawful reproductive healthcare for non-healthcare purposes such as investigations or legal proceedings in states where the care was legally provided.
What this means for your practice
Update your Notice of Privacy Practices to reflect new reproductive health attestation requirements and train staff on permissible disclosures.
GuardWell automatically monitors regulatory sources, analyzes changes, and updates your compliance program — so you don't have to.
See how it worksGuardWell
Healthcare Compliance Assistant
Hi! I'm GuardWell's sales assistant.
I can answer questions about our healthcare compliance platform, pricing, and features. How can I help?
Powered by GuardWell AI
