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J.S. Held

Beyond Safety & Effectiveness: Business Reasons to Prioritize Human Factors in Medical Device Design

J.S. Held on

To err is human. We have short attention spans and get distracted easily. We have unreliable memories and forget. We have a limited ability to process information, and we overgeneralize rules-of-thumb to the wrong situations....more

Wyrick Robbins Yates & Ponton LLP

ConnectiCut to the Chase: Lessons from the Connecticut AG's Latest CTDPA Enforcement Report

On April 17, 2025, the Connecticut Office of the Attorney General (“OAG”) released an Updated Enforcement Report Pursuant to the Connecticut Data Privacy Act (“Report”). The Report, the second issued by OAG (read our...more

Holland & Knight LLP

Ministerio del Trabajo de Colombia emitió lineamientos ante emergencia sanitaria

Holland & Knight LLP on

El Ministerio de Salud y Protección Social de Colombia expidió la Resolución 691 de 2025, mediante la cual declaró la emergencia sanitaria en todo el territorio nacional debido al brote activo del virus de la fiebre amarilla....more

Venable LLP

BiologicsHQ Monthly Injection - March 2025

Venable LLP on

On March 17, 2025, Senators Chuck Grassley (R-IA), John Cornyn (R-TX), Richard Blumenthal (D-CT), and Richard Durbin (D-IL) re-introduced the “Affordable Prescriptions for Patients Act” (“APPA”), which previously passed the...more

Marshall Dennehey

Commonwealth Court Clarifies Scope of IREs, Orders Remand in Light of Duffey Decision

Marshall Dennehey on

Del Val Home Improvements v. Gaw; No. 1117 C.D. 2022; filed March 19, 2025; Judge Wojcik - In a case hinging on the interpretation of impairment rating evaluations (IREs) under the Act, the Commonwealth Court has ordered a...more

McDonnell Boehnen Hulbert & Berghoff LLP

AI News Roundup – OpenAI and FDA discussing AI for drug approval, AI chatbots fuel wave of cheating at U.S. colleges, AI bots...

To help you stay on top of the latest news, our AI practice group has compiled a roundup of the developments we are following....more

Benesch

Dialysis & Nephrology Digest - May 2025

Benesch on

DOJ scores first victory in criminal antitrust labor market trial - A federal jury convicted a former home healthcare staffing executive in Las Vegas for orchestrating a three-year wage-fixing conspiracy targeting...more

Paul Hastings LLP

Potential Antitrust Scrutiny for Healthcare Provider Tools Like Strata Decision Technology

Paul Hastings LLP on

As the presence of algorithms offering customized pricing recommendations has grown throughout the economy, so too has the scrutiny from U.S. antitrust regulators and private litigants over their potential to facilitate...more

BakerHostetler

The Weekly Hill Update - May 2025 #2

BakerHostetler on

Below is this week’s congressional update by BakerHostetler’s Federal Policy team. We’ll continue to post in weeks when both chambers of Congress are in session....more

Sheppard Mullin Richter & Hampton LLP

Onshoring Pharma Ops: Reading Recent EO and Policy Tea Leaves

Recently, underscoring a commitment to national security, the White House and the Food and Drug Administration (FDA) issued separate communications that aim to bolster domestic drug manufacturing while tightening oversight of...more

Clark Hill PLC

Colorado Court of Appeals rules that claims under the Health Care Worker Protection Act are subject to the Colorado Governmental...

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On May 8, the Colorado Court of Appeals concluded that any claim that might be asserted under the Health Care Worker Protection Act (“HCWPA”), C.R.S § 8-2-123, is subject to the notice requirement in the Colorado Governmental...more

McDermott+

Trump Administration Executive Order Tracker

McDermott+ on

Below is a tracker of healthcare-related executive orders (EOs) issued by the Trump administration, including overviews of each EO and the date each EO was signed. We will regularly update this tracker as additional EOs are...more

McDermott+

McDermott+ Check-Up: May 9, 2025

McDermott+ on

THIS WEEK’S DOSE - - Republicans Advance Reconciliation Debate. Work continued behind the scenes among Republicans to reach consensus on Medicaid policies, with a House Energy and Commerce Committee markup announced for May...more

Troutman Pepper Locke

Federal Court Pumps the Brakes on Iowa Vape Directory

Troutman Pepper Locke on

We previously wrote about this case last January, when Iowans for Alternatives to Smoking & Tobacco, Inc., Global Source Distribution, LLC, and others filed a complaint and motion for a preliminary injunction in federal...more

Conn Maciel Carey LLP

Illinois’ Proposed Workplace Extreme Temperature Safety Act: Key Provisions and Status Update

Conn Maciel Carey LLP on

The trend of states proposing or adopting heat illness prevention standards continues, with Illinois attempting to become the first Fed/OSHA state (for private employers) with a general industry standard. The proposed...more

Health Care Compliance Association (HCCA)

Former OCR Director Fontes Rainer Reflects On ‘Imperfect’ RSP Law, Urges Final Security Reg

In October, the HHS Office for Civil Rights (OCR) fined Providence Medical Institute (PMI) $240,000, an amount that reflected a 20% discount for having “recognized security practices” (RSPs) in place. But many more covered...more

Pullman & Comley - Connecticut Health Law

Head of Connecticut OHS to Resign

Late last week, Governor Lamont announced that the Commissioner of the Office of Health Strategy (OHS), Deidre Gifford, plans to retire from state service in June. No successor was named. ...more

Carlton Fields

Tenth Circuit Interprets Excess Policy’s Definition of “Medical Incident” as Applying to the Injuries of One Single Person

Carlton Fields on

On May 2, 2025, the Tenth Circuit Court of Appeals issued an opinion in AdHealth Limited v. PorterCare Adventist Health Systems affirming the lower court’s summary judgment ruling that a hospital’s excess liability insurance...more

Hogan Lovells

New ministerial guidance letter: a vague framework that contradicts three of the CEPS's positions while leaving it alone in charge...

Hogan Lovells on

The new ministerial guidance letter (‘LOM’) intended to guide the Economic Committee for Health Products (‘CEPS’) on the pricing strategy for pharmaceutical products and medical devices has been signed and published on 5 May...more

Faegre Drinker Biddle & Reath LLP

FDA Identifies Data Quality and Study Conduct Concerns With Raptim Research and Requires Sponsors to Submit Replacement Study Data

The Food and Drug Administration (FDA) recently announced that it had identified “significant data integrity and study conduct concerns” with bioequivalence studies conducted by the India-based contract research organization...more

Morris James LLP

Recent Developments in Depo-Provera Litigation: Formation and Progress of Multidistrict Litigation (MDL)

Morris James LLP on

The legal landscape surrounding Depo-Provera, a long-acting injectable birth control, has entered a pivotal phase. With the growing number of lawsuits alleging that the drug caused serious brain tumors known as meningiomas,...more

Osano

A Guide to Data Privacy in Healthcare: Compliance and Best Practices

Osano on

Healthcare is a very personal experience. In order to receive the best care, individuals must share the most intimate details about themselves. For this reason, trust between patients and healthcare providers is crucial. Data...more

Orrick, Herrington & Sutcliffe LLP

Virginia enacts law protecting consumers from medical debt abuse

On May 2, the governor of the Commonwealth of Virginia approved HB 1725, which establishes the Medical Debt Protection Act to regulate billing and collection practices for medical debts. Effective July 1, 2026, the Act...more

Maynard Nexsen

Alabama Legislative Update: Regular Session - Week Twelve

Maynard Nexsen on

Local Bill Shutdown With the session nearing its end, tensions between the House and Senate have stalled numerous local bills. Senate Minority Leader Bobby Singleton filibustered local legislation in protest over the House’s...more

Orrick, Herrington & Sutcliffe LLP

Virginia Enacts Amendment to Protect Reproductive and Sexual Health Privacy

Virginia recently enacted an amendment to its state Consumer Protection Act to regulate the processing of Virginia consumers’ reproductive and sexual health information. Specifically, SB 754 prohibits businesses from...more

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