News & Analysis as of

Medical Devices New Legislation

McDermott+

CMS Releases Final TCET Notice – Implications and Next Steps

McDermott+ on

Last week, the Centers for Medicare & Medicaid Services (CMS) issued a final procedural notice for the new Transitional Coverage for Emerging Technologies (TCET) pathway for certain US Food & Drug Administration (FDA)...more

Akin Gump Strauss Hauer & Feld LLP

EU Ratifies Pioneering Artificial Intelligence Legislation

On May 21, 2024, the European Union finalized the adoption of the groundbreaking EU Artificial Intelligence Act, a comprehensive and sector-agnostic legislation that extends globally. This 420-page Act aims to regulate the...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 1, January 2024

The Current Status of Privacy Laws Across the United States - Unlike the General Data Protection Regulation (GDPR) in the European Union (EU), the United States does not have a nationwide comprehensive data privacy law....more

Goldberg Segalla

Impact of Cannabis Legislation on Maryland Workers’ Compensation Claims: What Changed in Maryland?

Goldberg Segalla on

Key Takeaways - As of July 1, Maryland’s Cannabis Reform Act allows adults 21 years of age and older to legally possess up to 1.5 ounces of cannabis flower. However, the state remains without detailed legislation and/or...more

Mintz - Health Care Viewpoints

Connecticut Law Imposes New Requirements on Pharmaceutical Manufacturers, Defined to Include Device and Cosmetic Manufacturers,...

Public Act No. 23-171: An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs (Act) took effect in Connecticut on October 1, 2023. Under the Act, a pharmaceutical manufacturer (PM) that employs...more

American Conference Institute (ACI)

[Event] 21st Annual Life Sciences IP Summit - September 27th - 28th, Munich, Germany

Hosted by C5 Group, the 21st Annual Life Sciences IP Summit returns for another exciting year with curated programming with speakers from the pharma, biotech and medical device industries that will provide practical insights...more

A&O Shearman

EU legislative proposals to impose additional obligations on medical device companies

A&O Shearman on

Connected medical devices are used to assist with diagnosing, monitoring or treating a medical condition and thereby facilitate the remote management of a medical condition by healthcare professionals. Such medical devices...more

Bradley Arant Boult Cummings LLP

Alabama CON Report - February 2023

I. Certificate of Need Program - A. AL2022-033, North Alabama Specialty Hospital, LLC, Huntsville, AL: Proposes to add sixteen (16) long term acute care (LTAC) beds to its existing thirty-one (31) bed LTAC hospital in...more

McDermott Will & Emery

Special Report - 2022 FDA Year in Review

As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

Skadden, Arps, Slate, Meagher & Flom LLP

Trend Toward Broader Communication Continues as Congress Codifies Life Sciences Companies’ Ability To Share Product Information...

Embedded in the thousands of pages of the Consolidated Appropriations Act of 2023 (the omnibus legislation) that President Joe Biden signed into law on December 29, 2022, is a section that amends the Food, Drug and Cosmetic...more

Goodwin

Congress Expands Pathway for Drug & Device Manufacturers’ Pre-Approval Communication of Health Care Economic Information to...

Goodwin on

The legislation previously introduced as the Pre-Approval Information Exchange Act of 2022 ( “PIE Act”) was passed as part of Congress’s December 23, 2022 omnibus spending bill. Once signed into law, this legislation will...more

Mintz - Health Care Viewpoints

California Passes New Law Requiring Physicians and their Employers to Notify Patients about the Open Payments Database

A new California law (AB 1278) will require physicians and their employers to provide patients with several forms of notices about the Open Payments database, starting January 1, 2023. The law is intended to increase...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

Akerman LLP - Health Law Rx

New Help for the Florida Healthcare Transaction Attorney- Temporary Drug, Device, and Cosmetic Permits

Whoever authored this new legislation (Chapter 2021-135, Laws of Florida) deserves a pat on the back for an idea whose time has come. When an applicant files for a change of ownership (“CHOW”) or change of location for one of...more

Faegre Drinker Biddle & Reath LLP

Summary of HB1125: Deceptive Lead Generation

Lawsuit advertisements—specifically ones that target prescription drugs and medical devices—can be dangerous. Nationwide, dramatized and exaggerated legal ads have flooded both televisions and the internet, often masquerading...more

Jackson Lewis P.C.

Indiana Enacts COVID-19 Liability Shield For Hoosier Businesses

Jackson Lewis P.C. on

In an effort to stimulate safe reopening of the economy and protect companies acting in good faith, Indiana has enacted a COVID-19 immunity shield. Governor Eric Holcomb signed Indiana Senate Bill 1, “Immunity Related to...more

Mintz - ML Strategies

What You Need to Know: State and Federal Updates Related to COVID-19

Mintz - ML Strategies on

...On Monday, House Speaker Nancy Pelosi, Majority Whip James Clyburn, Transportation & Infrastructure Committee Chairman Peter DeFazio, and Energy & Commerce Committee Chairman Frank Pallone held a press conference on a...more

Robins Kaplan LLP

Financial Daily Dose 3.19.2020 | Top Story: Second COVID-19 Relief Package Now Law But Market Chaos Remains

Robins Kaplan LLP on

Late action by the Senate to pass a second COVID-19 relief package (that the White House soon signed) may [key word may] help markets yo-yo back upward today after a dismal Wednesday driven by crazy-low oil prices (West Texas...more

Hogan Lovells

Congress passes FY 2020 funding bill with tax benefits for energy, health care, and retirement plans

Hogan Lovells on

In a rare display of bipartisanship, after intense last minute negotiations between congressional leadership and the Executive Branch, President Donald Trump signed into law legislation passed last week by Congress to...more

Franczek P.C.

Marijuana, Medication, and Minors, Oh My! New Medication Laws For Schools

Franczek P.C. on

You would be forgiven if you can’t keep up with the many changes in the Illinois laws governing education at back-to-school time this year. As if Illinois special educators and administrators don’t have enough to do already,...more

Robinson+Cole Health Law Diagnosis

New Connecticut Legislation Affecting Healthcare Providers and Entities Effective October 1, 2019

Multiple public acts from Connecticut’s 2019 legislative session go into effect on October 1, 2019. Below is a list of public health legislation effective October 1, with links to our previous posts summarizing the acts...more

Robinson+Cole Health Law Diagnosis

Connecticut Legislature Extends Immunity for Emergency Assistance by Health Care Professionals to Cover Malfunctioning Automatic...

On July 1, 2019, Connecticut Governor Ned Lamont signed into law Public Act No. 19-113 “An Act Concerning the Use of Automatic External Defibrillators” (PA 19-113). This law takes effect October 1, 2019....more

Robinson+Cole Health Law Diagnosis

Connecticut Enacts Law to Increase Access to Epinephrine Auto Injectors

On June 13, 2019, Connecticut Governor Ned Lamont signed into law Public Act No. 19-19 “An Act Concerning Epinephrine Auto Injectors” (PA 19-19). PA 19-19 went into effect on the same date....more

Burns & Levinson LLP

California Enacts First U.S. Law Requiring IoT Cybersecurity

Burns & Levinson LLP on

“Smart” devices have become common, if not pervasive, experiences of daily life. Parents may monitor a baby’s heart rate and oxygen levels through sensor enabled baby socks. Businesses may equip fleet drivers with smart...more

Hogan Lovells

New Belgian legislation on the distribution of medical devices

Hogan Lovells on

Today, the Belgian Minister of Health published the new Royal Decree of 19 December 2018 on the liberalisation of the distribution circuit for medical devices....more

42 Results
 / 
View per page
Page: of 2

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide