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Insights on Health Care

1355 total results. Page 3 of 55.

Investigations Blog
$2.3 Million Oral FCA Settlement Affirmed by Fifth Circuit
June 22, 2026
D. Jacques Smith + 7

Headlines that Matter for Companies and Executives in Regulated Industries

Press Release
Legal 500 Lists ArentFox Schiff in Top Tier Rankings for 2026
June 17, 2026

ArentFox Schiff is pleased to announce that 23 practices and 81 attorneys have been recognized by The Legal 500 United States 2026 guide.

Investigations Blog
Ahold Delhaize Settles Allegations of Inflated Drug Price Reporting for $40 Million
June 15, 2026
D. Jacques Smith + 7

Headlines that Matter for Companies and Executives in Regulated Industries

Alerts
Gene Editing for Human Therapies Just Got a Shortcut: What the FDA’s New Draft Guidance Means for Your Business
June 12, 2026
Emily M. Cowley + 1

On June 2, the US Food and Drug Administration (FDA) released a new draft guidance called “Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing.”

Longevity Lens
California Signals Support for Longevity and Healthspan With Senate Resolution
June 11, 2026
Gayland O. Hethcoat II

On June 8, the California State Senate adopted Senate Resolution (SR) 104, a measure expressing support for targeting the biological mechanisms of aging as a strategy to prevent and delay chronic disease.

Alerts
Proposed Health Care Supports in the 2027 DC Budget
June 10, 2026
David P. Grosso + 1

The 2027 DC budget proposes substantial investments in health care access, behavioral health services, and public health infrastructure across the District of Columbia. Nearly four in 10 DC residents depend on Medicaid, the Basic Health Plan, or the locally funded Alliance program for coverage.

Alerts
Supreme Court Unanimously Reverses Federal Circuit in Hikma v. Amarin
June 8, 2026
Sailesh K. Patel + 1

On June 4, the US Supreme Court issued a unanimous decision authored by Justice Ketanji Brown Jackson in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24–889, delivering a significant win for generic pharmaceutical manufacturers seeking US Food and Drug Administration (FDA) approval for drugs with multiple indications.

Investigations Blog
New DOJ Health Care Fraud Unit Secures Six Trial Convictions Totaling Over $1.1 Billion
June 8, 2026
D. Jacques Smith + 7

Headlines that Matter for Companies and Executives in Regulated Industries

Alerts
Federal Agencies Finalize Overhaul of No Surprises Act Dispute Resolution Process
June 5, 2026
Alison Lima Andersen + 1

The US Departments of Treasury, Labor, and Health and Human Services have issued a sweeping final rule (CMS-9897-F) implementing significant changes to the Federal Independent Dispute Resolution (IDR) process established under the No Surprises Act (NSA).

Press Release
Chambers USA Ranks 68 Attorneys, 25 Practice Areas for 2026
June 4, 2026

ArentFox Schiff is pleased to announce that 68 attorneys were recognized as leaders in their field and 25 practices spanning the firm’s litigation, regulatory, and transactional capabilities, as well as key industries, were ranked among the best in the country in the 2026 edition of Chambers USA: America’s Leading Lawyers for Business.

News
Brain Computer Interfaces Boot Up Multipronged Legal Issues
June 3, 2026
Gayland O. Hethcoat II + 2

Forget science fiction — the race to connect computers directly to the human brain is already underway, and it is accelerating. In recent months, neurotechnology companies have expanded human clinical trials and attracted substantial investment.

Trade Secrets Case Watch
Federal Circuit Reverses $59 Million Jury Verdict in Omnipod® Trade Secret Case as Time Barred Under the ‘Knew or Should Have Known’ Standard
June 3, 2026
Linda M. Jackson + 8

In a 2-1 decision authored by Judge Timothy B. Dyk, the Federal Circuit reversed a jury verdict awarding Insulet Corporation over $59 million in compensatory and exemplary damages for trade secret misappropriation under the Defend Trade Secrets Act (DTSA).

News
Beyond the Algorithm: How Lifecycle Regulation Is Building Entry Barriers and Concentrating the Healthcare AI Market
June 1, 2026
Douglas A. Grimm

The U.S. Food and Drug Administration is building a new regulatory framework for artificial intelligence and machine learning in medical software. This article argues that the FDA’s evolving approach extends beyond a compliance issue for technology developers; it is a market-shaping force that will change how healthcare providers buy, deploy, and govern AI-enabled tools.

Investigations Blog
HHS Using AI to Address Ongoing Audit Noncompliance
June 1, 2026
D. Jacques Smith + 7

Headlines that Matter for Companies and Executives in Regulated Industries

Longevity Lens
The Wearables Tightrope
May 28, 2026
Gayland O. Hethcoat II

ArentFox Schiff’s Gayland Hethcoat on navigating the line between wellness and medical devices in the longevity era.

Alerts
AI Do: Why the FDA Wants Your Input on AI in Clinical Trials (and Why You Should Give It)
May 26, 2026
Abha Kundi + 1

On April 29, the US Food and Drug Administration (FDA) published a Request for Information (RFI) seeking public comment on a proposed pilot program to test the use of artificial intelligence (AI) in early-stage clinical trials for drugs and biologics. Comments are due June 29.

Investigations Blog
DOJ Warns That AI and Algorithmic Pricing Tools Can Trigger Criminal Antitrust Liability
May 26, 2026
D. Jacques Smith + 7

Headlines that Matter for Companies and Executives in Regulated Industries

Investigations Blog
Perfectus Aluminum Agrees to Pay $549.5 Million to Settle False Claims Act Allegations Relating to Evaded Customs Duties
May 18, 2026
D. Jacques Smith + 7

Headlines that Matter for Companies and Executives in Regulated Industries

Health Care Counsel Blog
CMS Nationwide Enrollment Moratorium on Hospice and Home Health Agencies
May 18, 2026
Douglas A. Grimm + 3

On May 13, the Centers for Medicare & Medicaid Services (CMS) implemented two separate nationwide moratoria that halt the Medicare enrollment of new home health agencies (HHAs) and hospice providers. The moratoria took effect immediately.

Alerts
US Supreme Court Restores Access to Mifepristone — For Now*
May 14, 2026
Jill A. Steinberg + 3

Mail and telemedicine access to mifepristone — used together with misoprostol to end an early pregnancy — is in flux following a Fifth Circuit Court of Appeals ruling that restricts mail-order distribution of the medication nationwide, and the US Supreme Court’s subsequent administrative stay restoring the status quo ante on a temporary basis.

Longevity Lens
The Shot Heard ‘Round the Pharmacy’: FDA Takes Aim at GLP-1 Compounders
May 13, 2026
Abha Kundi + 4

On May 1, the US Food and Drug Administration (FDA) announced that it is proposing to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List. If finalized, this proposal would close the last remaining regulatory pathway for large-scale compounding of these popular GLP-1 receptor agonists by 503B outsourcing facilities.

Investigations Blog
Cybersecurity Failures and Liability for Health Care Organizations: A New Enforcement Frontier
May 11, 2026
D. Jacques Smith + 7

Headlines that Matter for Companies and Executives in Regulated Industries

Events
Health Care Fraud Enforcement: Examining the Current Era
May 7, 2026
Michelle J. Shapiro

Michelle J. Shapiro will speak on the “Health Care Fraud Enforcement: Examining the Current Era” panel at the Boston Bar Association’s (BBA) 2026 White-Collar Crime Conference.

Investigations Blog
Cybersecurity Failures and Liability for Health Care Organizations: A New Enforcement Frontier
May 5, 2026
D. Jacques Smith + 1

False Claims Act Investigations & Litigation attorneys Jacques Smith, Pat Naples, and John Keblish authored a piece for Chief Healthcare Executive on the key regulatory developments and emerging areas of risk in cybersecurity-specific False Claims Act (FCA) settlements.

Investigations Blog
DOJ Civil Division Launches FOCUS Initiative to Vet Data-Mining Whistleblowers
May 4, 2026
D. Jacques Smith + 7

Headlines that Matter for Companies and Executives in Regulated Industries

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