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Cybersecurity Medical Devices

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 -
Spilman Thomas & Battle, PLLC

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

Spilman Thomas & Battle, PLLC

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

Jones Day

EU Emergency Response Update – Key Policy & Regulatory Developments No. 115

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This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2024

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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

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - July 2024 #1

News Briefs - Texas Federal Court Ruling Puts Noncompete Ban on Hold - A Texas federal court issued a preliminary injunction against the Federal Trade Commission's noncompete ban, which if implemented would allow existing...more

Jones Day

EU Emergency Response Update – Key Policy & Regulatory Developments No. 114

Jones Day on

This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more

Jones Day

EU Emergency Response Update – Key Policy & Regulatory Developments No. 113

Jones Day on

This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more

King & Spalding

Congressional Insight into Strategy to Combat Cyberattacks on the Healthcare Industry

King & Spalding on

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

Jones Day

FDA Proposes Updated Guidance Concerning Cybersecurity of Medical Devices

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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

McDermott Will & Emery

The Impact of the New EU AI Act on the Medtech and Life Sciences Sector

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As technology continues to advance almost every aspect of healthcare, so the use of AI has become an increasing focus for developers and the regulators who are racing to keep pace with rapid advancements in technology. ...more

Troutman Pepper

New FDA Guidance on AI and Medical Products

Troutman Pepper on

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

Jones Day

EU Emergency Response Update – Key Policy & Regulatory Developments No. 112

Jones Day on

This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more

Goodwin

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

Goodwin on

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

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - May 9th - 10th, New York, NY

Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...more

Mintz - Health Care Viewpoints

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

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

Jones Day

EU Emergency Response Update – Key Policy & Regulatory Developments No. 111

Jones Day on

This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more

McGuireWoods LLP

Key Takeaways From McGuireWoods’ Webinar on HIPAA and Cybersecurity for Medical Device Companies

McGuireWoods LLP on

On Jan. 17, 2024, McGuireWoods partners Kimberly Kannensohn and Sam Bernstein conducted a webinar regarding how the Health Insurance Portability and Accountability Act (HIPAA) applies to medical device companies and certain...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

Jones Day

EU Emergency Response Update – Key Policy & Regulatory Developments No. 110

Jones Day on

This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more

Morrison & Foerster LLP

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

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

McDermott+

McDermottPlus Check-Up: January 5, 2024

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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

Jones Day

EU Emergency Response Update – Key Policy & Regulatory Developments No. 109

Jones Day on

This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more

King & Spalding

HHS Releases Cybersecurity Strategy for the Healthcare Sector

King & Spalding on

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

Gardner Law

Med-Tech Meets High-tech: Privacy, Cybersecurity and Ai in Connected Devices

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...Innovation in connected medical devices is critical to advances in health care outcomes, user experience, and reducing costs. These exciting technologies also can be challenging when it comes to navigating the complex...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - November 2023 #3

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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