News & Analysis as of August 3, 2025

Cybersecurity › Medical Devices › Healthcare

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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 -

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 121

Jones Day on 6/3/2025

This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more

Healthcare Authority Newsletter - April 2025 #2

Arnall Golden Gregory LLP on 4/16/2025

News Briefs - Judge Blocks Trump from Cutting Billions in State Health Funding - A federal judge said she will grant a request from 23 states to issue an emergency block on the federal government's rescindment of billions in...more

AI Regulation and Legal Trends in the U.S and Abroad

Gardner Law on 2/28/2025

The Evolving Role of AI/ML in Healthcare - The use of artificial intelligence/machine learning (AI/ML) in healthcare is evolving rapidly and introducing new challenges. Not only are medical devices using AI for diagnostics,...more

Decoded - Technology Law Insights, V 6, Issue 2, February 2025

Spilman Thomas & Battle, PLLC on 2/27/2025

Welcome to our second issue of 2025 of Decoded - our technology law insights e-newsletter. For those of you with an interest in the Corporate Transparency Act, Brienne Marco and Joe Unger report that the recent injunction...more

Healthcare Authority Newsletter - January 2025 #4

Arnall Golden Gregory LLP on 2/3/2025

News Briefs - 80 Percent of Health Organizations Hit with Cyberattack - More than 80 percent of healthcare organizations detected a cyberattack on their technology infrastructure within the past year, according to a survey by...more

FDA Issues Draft Guidance for the Use of Artificial Intelligence (AI) in Medical Devices and Drug Development

Knobbe Martens on 1/23/2025

The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more

Healthcare Industry Team 2024 Year in Review

BakerHostetler on 1/22/2025

As we begin a year that will once again be transformative for the industry, we are excited to present our comprehensive 2024 year-in-review, highlighting all that has happened and the trends that will shape 2025. ...more

Drug Pricing and Health Care Fraud Remain Key Issues

Skadden, Arps, Slate, Meagher & Flom LLP on 1/21/2025

Key Points - - It remains to be seen what priorities Robert F. Kennedy Jr. and Marty Makary might set if confirmed as HHS secretary and FDA commissioner, respectively. - The Trump administration will likely focus on drug...more

FDA Issues Artificial Intelligence-Enabled Device Software Functions Draft Guidance

DLA Piper on 1/16/2025

The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more

Healthcare Authority Newsletter - December 2024 #2

Arnall Golden Gregory LLP on 12/20/2024

News Briefs - Congress Taking on Healthcare Policies Set to Expire - Congress has begun discussions on important healthcare policies set to expire on December 31....more

Decoded - Technology Law Insights, V 5, Issue 10, December 2024

Spilman Thomas & Battle, PLLC on 12/11/2024

Happy Holidays and welcome to our year-end issue of Decoded. We hope you enjoyed reading our technology law insights e-newsletter this year. We are already planning for 2025. ...more

Three Questions with Sedgwick’s Jeremy Schutz

Akin Gump Strauss Hauer & Feld LLP on 12/4/2024

In this edition of Three Questions, health care & life sciences partner Nate Brown spoke with Jeremy Schutz, director of business development, recall & remediation at Sedgwick, to explore key strategies that pharmaceutical...more

Decoded - Technology Law Insights, V 5, Issue 8, October 2024

Spilman Thomas & Battle, PLLC on 10/25/2024

Welcome to our eighth 2024 issue of Decoded - our technology law insights e-newsletter. Thank you for reading. EU AI Act Tightens Grip on High-Risk AI Systems: Five Critical Questions for U.S. Companies - Why this is...more

The Health Sector Cybersecurity Coordination Center’s September 19 Threat Briefing on Healthcare Technology Security

Foley Hoag LLP - Security, Privacy and the... on 9/20/2024

As healthcare technology continues to evolve, so does the need for robust compliance strategies to safeguard patient information and ensure the integrity of medical devices. In a joint September 19, 2024 presentation, the...more

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

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

Congressional Insight into Strategy to Combat Cyberattacks on the Healthcare Industry

King & Spalding on 5/3/2024

On April 16, 2024, the House Committee on Energy and Commerce held a bipartisan hearing on the issue of cyberattacks involving healthcare providers. The Committee called as witnesses cybersecurity professionals and...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 Locke 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

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

Spilman Thomas & Battle, PLLC on 1/17/2024

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

McDermottPlus Check-Up: January 5, 2024

McDermott+ on 1/8/2024

Congress Returns Next Week to Face Imminent Funding Deadlines. The Senate will return to session on January 8, and the House will return on January 9. Lawmakers face an immediate time crunch on FY 2024 appropriations, as the...more

HHS Releases Cybersecurity Strategy for the Healthcare Sector

King & Spalding on 12/18/2023

On December 6, 2023, HHS released a concept paper that outlines the Department’s cybersecurity strategy for the healthcare sector titled, “Healthcare Sector Cybersecurity Strategy.” HHS reports that cyber incidents in...more

ArentFox Schiff Issues the First Global Definitive Legal Guide for Industries Navigating AI

ArentFox Schiff on 8/29/2023

Artificial intelligence promises to transform the way we live and work and its impact will undoubtedly stretch to every business sector across the globe. This next generation of technology brings exciting possibilities and...more

Hot Topics in Health Care July 2023

Burr & Forman on 7/27/2023

Progress of Pre-Submissions for Medical Devices Now Trackable Through CDRH Portal - Medical device manufacturers must submit applications for certain classes of medical devices for approval by the Food and Drug...more

Cybersecurity: What Businesses Need to Know

Butler Snow LLP on 6/30/2023

Cybersecurity is a top concern for all industries, particularly for the pharmaceutical and medical device industries. These industries hold some of the most sensitive data and highly valuable technology, making them prime...more

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