News & Analysis as of September 23, 2024

Cybersecurity › Food and Drug Administration (FDA)

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Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk... more +

Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk management, global regulations, data protection, leaks, hacking, cyber insurance, compliance, HIPAA, and every other aspect of cybersecurity of import to corporate readers right now. less -

The Health Record - Healthcare Law Insights, Issue 5, September 2024

Spilman Thomas & Battle, PLLC on 9/19/2024

Welcome to our fourth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we take a look at the Biden administration's proposed insurance rule regarding mental health and substance use...more

Decoded - Technology Law Insights, V 5, Issue 7, August 2024

Spilman Thomas & Battle, PLLC on 9/4/2024

Welcome to our seventh 2024 issue of Decoded - our technology law insights e-newsletter. We have a few events we want to pass along to those interested in technology, but also other areas of law and business. ...more

[Hybrid Event] Due Diligence Decoded: M&A Success in FDA-Regulated Industries - September 20th, Boston, MA

Gardner Law on 8/20/2024

Join Gardner Law for a half-day CLE event in person at Loft on Two in Boston, MA or attend virtually. Industry experts will decode the intricacies of regulatory scrutiny and strategic decision-making in acquisitions. Gain...more

Decoded - Technology Law Insights, V 5, Issue 6, July 2024

Spilman Thomas & Battle, PLLC on 8/1/2024

Welcome to our seventh 2024 issue of Decoded - our technology law insights e-newsletter. We have a few events we want to pass along to those interested in technology, but also other areas of law and business....more

Vital Signs: Digital Health Law Update | Spring 2024

Jones Day on 7/22/2024

Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more

Akin Intelligence - June 2024

Akin Gump Strauss Hauer & Feld LLP on 7/15/2024

Welcome to the June edition of Akin Intelligence. This month, the General Services Administration (GSA) launched its first AI-focused cohort of Presidential Innovation Fellows (PIF), bringing together experts from across the...more

The Learned Concierge - July 2024, Vol. 10

Clark Hill PLC on 7/12/2024

The Learned Concierge - Welcome to your monthly legal insights on the trends impacting the Retail, Hospitality, and Food & Beverage Industries....more

Holland & Knight Health Dose: June 11, 2024

Holland & Knight LLP on 6/13/2024

Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include:...more

Healthcare Authority Newsletter - May 2024 #1

Arnall Golden Gregory LLP on 5/6/2024

News Briefs - Hospitals, Physicians at Odds Over FTC Noncompete Ban - The Federal Trade Commission's final rule banning noncompetes nationwide has implications for hospitals and physician practices, with representatives from...more

FDA Proposes Updated Guidance Concerning Cybersecurity of Medical Devices

Jones Day on 4/29/2024

The U.S. Food and Drug Administration ("FDA") has proposed updated guidance, intended to assist individuals in meeting the cybersecurity requirements for FDA medical device submissions....more

New FDA Guidance on AI and Medical Products

Troutman Pepper on 4/12/2024

n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more

FDA Issues Supplemental Draft Guidance for Premarket Cybersecurity

Gardner Law on 4/4/2024

The U.S. Food and Drug Administration (FDA) recently released its draft guidance with a proposal to add a Section VII. to the Premarket Cybersecurity Guidance to support obligations under Section 524B of the Food, Drug and...more

Healthcare Authority Newsletter - March 2024 #4

Arnall Golden Gregory LLP on 4/2/2024

News Briefs - Lawmaker Introduces Health Care Cybersecurity Improvement Act - Senator Mark Warner (D-VA) has introduced the Health Care Cybersecurity Improvement Act of 2024, which would allow for advance and accelerated...more

A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 and Beyond

Goodwin on 4/1/2024

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

CISA’s Proposed Cyber Incident Reporting Requirements Would Hit a Range of Industries and Sectors

Wiley Rein LLP on 4/1/2024

The U.S. Department of Homeland Security’s (DHS) Cybersecurity and Infrastructure Security Agency (CISA) is publishing a proposed rule (Proposal or NPRM) that will require broad segments of industry to meet onerous and quick...more

The Nucleus: Life Sciences Enforcement and Regulatory Updates - March 2024

Skadden, Arps, Slate, Meagher & Flom LLP on 3/25/2024

Circuit Split Widens Over AKS-Based FCA Causation Element - The Anti-Kickback Statute (AKS) continues to form the basis of hundreds of millions of dollars of annual recoveries for the government under the federal False...more

FDA Needs a New Approach to AI/ML-Enabled Medical Devices

Mintz - Health Care Viewpoints on 3/13/2024

We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital technology, such as launching the...more

Decoded - Technology Law Insights, V 5, Issue 2, March 2024

Spilman Thomas & Battle, PLLC on 3/8/2024

HHS Cybersecurity Performance Goals and the Healthcare Industry - The healthcare industry is a major target for cyberattacks because of all of the personal information collected from patients. Recognizing that the healthcare...more

The Learned Concierge - March 2024, Vol. 6

Clark Hill PLC on 3/6/2024

The Learned Concierge - Welcome to your monthly legal insights on the trends impacting the Retail, Hospitality, and Food & Beverage Industries....more

Look Ahead to the Week of March 4: The State of the Union and Government Spending

Alston & Bird on 3/5/2024

Look Ahead to the Week of March 4: The State of the Union and Government Spending - Both the Senate and House are in session. This week, Congress will attempt to pass the first tranche of government spending bills after...more

FCC Continues Push to Establish IoT Cyber Trust Mark Program

Wiley Rein LLP on 2/26/2024

On February 22, 2024, the Federal Communications Commission (FCC or “Commission”) released a Public Draft of a Report and Order that, if adopted, would establish a voluntary labeling program for Internet of Things (IoT)...more

In This Month’s E-News: February 2024

Health Care Compliance Association (HCCA) on 1/30/2024

The Food and Drug Administration (FDA) is seeking strategies from Jeffrey W. Taub, M.D., to prevent future violations of human subject regulations the agency said were documented during site visits in September and October...more

2024 Regulatory, Compliance, and Enforcement Predictions for Life Sciences Companies

Morrison & Foerster LLP on 1/10/2024

The year 2023 was a busy one for regulatory, compliance, and enforcement developments in the healthcare and life sciences industries, and 2024 promises to be even busier. We tapped MoFo’s Life Sciences + Healthcare Compliance...more

Holland & Knight Health Dose: December 12, 2023

Holland & Knight LLP on 12/15/2023

Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Healthcare Authority Newsletter - November 2023 #3

Arnall Golden Gregory LLP on 11/21/2023

News Briefs - Senate Committee Advances Bill on 'Ghost Providers,' PBMs - In a unanimous 26-0 vote, the Senate Finance Committee passed a comprehensive draft package that puts pharmacy benefit manager reform and mental health...more

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