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.
May 2026
May 28, 2026TCPALive
Information Collections Being Submitted for Review and Approval to Office of Management and Budget
As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal Agencies to take this opportunity to comment on the…
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Information Collection Being Reviewed by the Federal Communications Commission
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the followin…
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Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Suturing Device for Altering Gastric Anatomy for Weight Loss
The Food and Drug Administration (FDA) is classifying the endoscopic suturing device for altering gastric anatomy for weight loss 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 la…
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Department of Labor Federal Civil Penalties Inflation Adjustment Act Annual Adjustments for 2026
As required by statute, the Department of Labor annually publishes a final rule updating the civil monetary penalties it assesses. The Bureau of Labor Statistics (BLS) did not publish its October 2025 Consumer Price Index for All Urban Consumers (CPI-U) data due to a lapse in fu…
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Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Rural Communities Opioid Response Program Performance Measures, OMB No. 0906-XXXX-New
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB…
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Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Syntest D.S. and Syntest H.S. Tablets; Withdrawal of Hearing Requests; Final Resolution of Drug Efficacy Study Implementation 7661
The Food and Drug Administration (FDA or Agency) is announcing that all outstanding hearing requests for estrogen-androgen fixed- combination drug products under Docket FDA-1998-P-0083 (formerly 76N- 0377) (DESI 7661) have been withdrawn. Therefore, as proposed in the April 14,…
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Town Hall Meetings To Provide Input on Cyber Incident Reporting for Critical Infrastructure Act (CIRCIA) Rulemaking
This notice announces a revised town hall meeting schedule to allow external stakeholders a limited additional opportunity to provide input on refining the scope and burden of the CIRCIA Notice of Proposed Rulemaking (NPRM) issued in the Federal Register on April 4, 2024. The pr…
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Schedules of Controlled Substances; Removal of Exemption Status for Inactive Butalbital Products
The Drug Enforcement Administration (DEA) proposes to revoke the exempted status for certain nonnarcotic prescription products that are currently on DEA's Table of Exempted Prescription Products list but whose National Drug Code (NDC) is inactive because they are no longer avail…
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Schedules of Controlled Substances: Placement of Diphenidine in Schedule I
The Drug Enforcement Administration proposes placing diphenidine (1-(1,2-diphenylethyl)piperidine), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule I of the Controlled Substances Act.…
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Agency Information Collection Activities: Proposed Request
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In this document, the Federal Communications Commission (Commission) proposes actions to provide additional clarity to fill the gap between its current Know Your Customer (KYC) requirement and the types of rigorous KYC steps necessary to protect consumers. Specifically, the Comm…
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Agency Forms Submitted for OMB Review, Request for Comments
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Agency Information Collection Activities: Comment Request
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To Implement Certain Provisions in the Consolidated Appropriations Act, 2026, and for Other Purposes
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Schedules of Controlled Substances: Temporary Placement of 2-Fluorodeschloroketamine in Schedule I
The Drug Enforcement Administration (DEA) issues this temporary order to schedule 2-(2-fluorophenyl)-2- (methylamino)cyclohexan-1-one (commonly known as 2- fluorodeschloroketamine or 2-FDCK), including its salts, isomers, and salts of isomers whenever the existence of such salts…
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Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the followin…
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42 CFR Part 2 Aligns with HIPAA — Substance Use Disorder Records
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 Finalizes 2026 MIPS Performance Thresholds and MVPs
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.
OIG Releases 2025 Work Plan: Healthcare Fraud Priorities
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.
HIPAA Privacy Rule Update: Reproductive Health Information Protections
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.