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Regulatory Requirements New Regulations Healthcare

Gardner Law

The EU Data Act Has Arrived

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The EU AI Act has arrived, and the countdown to compliance is on. As of August 2, 2025, penalties, including administrative fines, are in force. ...more

Dentons

Ep. 77 – Keeping Up to Date on New Developments

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One of the biggest challenges for any busy compliance professional is staying abreast of all the changes in healthcare regulations, enforcement trends and risks. Yet doing so is critically important so that you have enough...more

Quarles & Brady LLP

Alabama Board of Pharmacy Issues Non-Disciplinary Fine Schedule

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On August 20, 2025, the Alabama Board of Pharmacy (the “Board”) issued its long-awaited non-disciplinary penalty schedule via emergency rulemaking. The rule went into effect immediately and will expire on December 18, 2025....more

Stevens & Lee

New York Adopts Certificate of Need Amendments to Streamline Reviews of Health Facility Projects

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The New York State Department of Health (the Department) adopted amendments to its Certificate of Need (CON) regulations at Part 710 of Title 10 of the New York Codes, Rules and Regulations (NYCRR) to update, modernize and...more

Sheppard Mullin Richter & Hampton LLP

New York Adopts Major Certificate of Need Amendments Effective August 6, 2025

On August 6, 2025, the New York State Department of Health (DOH) finalized amendments to its Certificate of Need (CON) regulations in 10 N.Y.C.R.R. Part 710, raising the financial thresholds for full review, expanding...more

McNees Wallace & Nurick LLC

Navigating Pa.’s unique IBHS licensing requirement for ABA therapy providers

Per Autism Speaks’ “Autism by the Numbers: 2025 Annual Report” (see autismspeaks.org/ABN, last visited July 20, 2025), currently one in 35 children in the United States has autism....more

Polsinelli

HCBS Update: Indiana Implements Home-Grown 70/30 Direct Caregiver Compensation Requirement

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Executive Summary: On July 10, 2025, Indiana Medicaid issued guidance to providers of attendant care and structured family caregiver services requiring providers to pass through a specific percentage of their Medicaid...more

Polsinelli

Needle Little Regulation: What Texas’s New IV Therapy Law Really Says

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Key Takeaways - House Bill 3749, also known as Jenifer’s Law, goes into effect on September 1, 2025, and applies only to elective IV therapy provided outside physician offices or licensed health facilities....more

Quarles & Brady LLP

Puerto Rico Repeals Special Authorization Requirement for Nonresident Manufacturers and Distributors

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In July 2022, the agency formerly known as the Puerto Rico Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS), now the Auxiliary Secretariat for the Regulation of Public Health (SARSP),...more

Bass, Berry & Sims PLC

Texas Caps Physician Non-Compete Buyouts and Adds New Limits Under SB 1318

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On June 20, Texas Governor Greg Abbott signed Senate Bill 1318 (Amendment) into law, amending Texas Business & Commerce Code Section 15.50(b), which is commonly thought of as the “Texas physician non-compete buyout statute.”...more

McDermott+

Health Plans’ Commitment to Prior Authorization Improvements: What’s New Versus What’s Already Required

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Health plan members of AHIP and the Blue Cross and Blue Shield Association made news earlier this week when they announced a series of steps that a broad swath of health insurers will take to improve the prior authorization...more

Jackson Lewis P.C.

Texas SB 1318 Tightens Physician Non-Compete Rules, Extends Restrictions to Other Healthcare Practitioners

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Texas Governor Greg Abbott has signed a bill that imposes more limitations on employers’ covenants not to compete with physicians and extends similar restrictions to agreements with other healthcare practitioners, including...more

Keating Muething & Klekamp PLL

OSHA’s Updated Inspection Program: What Employers Should Know and Expect

On May 20, 2025, the Occupational Safety and Health Administration (OSHA) updated its Site-Specific Targeting (SST) inspection program. The SST inspection program is OSHA’s primary planned inspection initiative for...more

Bass, Berry & Sims PLC

New Tennessee Law Eases Physician Employment Restrictions for Certain Hospitals

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On May 21, Governor Bill Lee signed House Bill 979 (HB 979) into law.  Notably, provisions of this law aim to address physician shortages and improve access to specialized medical care in rural and underserved areas in...more

Rivkin Radler LLP

NYS DOH Releases New Electronic Material Transaction Form

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Just last week, we reported that the 2025/26 NYS Budget Bill did not include a provision that would have increased the requirements for seeking Department of Health (DOH) approval of a material healthcare transaction (which...more

Katten Muchin Rosenman LLP

Have You Done Your Part to Comply with Part 2 Changes?

Important changes are coming to 42 CFR Part 2 (Part 2), which deals with the confidentiality of patients’ substance use disorder (SUD) records. On April 16, 2024, the US Department of Health and Human Services (HHS) published...more

Schwabe, Williamson & Wyatt PC

Regulatory Changes Address Surge of Food-As-Health Initiatives and Shift “Healthy” ‎Standard; Plus New Labeling Requirements

Food and beverage products that promote health and well-being have proliferated. Demand has surged for foods and drinks that are loaded with nutrients and offer health benefits. Their growth is partly driven by an increased...more

McDermott Will & Schulte

Beyond Private Equity Transaction Oversight: Mass. H.5159 Includes New Licensing Requirements

H.5159, An Act Enhancing the Market Review Process, was signed into law in January 2025. The primary focus of H.5159 is to expand the Commonwealth’s healthcare oversight mechanisms, particularly with respect to private equity...more

Troutman Pepper Locke

FCC Grants Limited One-Year Extension for TCPA Robocall Revocation Rule Compliance

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The Federal Communications Commission (FCC) issued an order extending the effective date of certain parts of § 64.1200(a)(10) of its rules under the Telephone Consumer Protection Act (TCPA) to April 11, 2026....more

Bass, Berry & Sims PLC

Illinois Board of Pharmacy Adopts New Licensure Requirement for Out-of-State Pharmacists-in-Charge

Beginning January 1, 2026, the Illinois Board of Pharmacy will require “out-of-state” (non-resident) pharmacies licensed or seeking licensure in Illinois to have a pharmacist-in-charge (PIC) who is licensed in Illinois....more

Foley Hoag LLP - White Collar Law &...

New Massachusetts Healthcare Law Targets Private Equity, REITs, and MSOs; Expands State False Claims Act

On January 8, 2025, Governor Maura Healey signed House Bill 5159 into law, toughening the rules and increasing the risks for private equity (PE) companies, real estate investment trusts (REITs), and management services...more

DLA Piper

DEA and HHS Propose Telemedicine Special Registration and Finalize Buprenorphine Telemedicine Prescribing Rules

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On January 17, 2025, the US Drug Enforcement Administration (DEA) and the US Department of Health and Human Services (HHS) published two rules regarding telemedicine prescribing of controlled substances: a proposed rule...more

McDermott Will & Schulte

Section 1557 Patient Care Decision Support Tools, Anti-Discrimination Compliance: 12 Things to Consider

In April 2024, the US Department of Health and Human Services (HHS) issued a final rule reinterpreting Section 1557 of the Affordable Care Act, which prohibits discrimination on the basis of race, color, national origin, sex,...more

DLA Piper

FDA Issues ACNU Final Rule Establishing New Requirements for Nonprescription Drugs with an Additional Condition for...

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The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting requirements for a nonprescription drug product with an “additional condition for...more

Cozen O'Connor

California and New Jersey Release AI-Related Advisories and Guidance

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In a continuation of the trend of artificial intelligence becoming a regulatory focal point, California AG Rob Bonta issued legal advisories on the application of California law to AI, while New Jersey AG Matthew Platkin...more

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