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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 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 - Health Law Insights, Issue 2, June 2024

Spilman Thomas & Battle, PLLC on

Welcome to our second issue of The Health Record - our healthcare law insights e-newsletter! SCOTUS Agrees to Review Medicare DSH Payments Case - “The suit, Advocate Christ Medical Center v. Becerra, was originally filed in...more

Hogan Lovells

Reduction of EU regulatory data protection, but not as short as the European Commission proposed - European Parliament’s position...

Hogan Lovells on

On 10 April 2024 the European Parliament adopted its position on the draft text on the revision of the European Union’s (EU) general pharmaceutical legislation, also referred to as the (proposed) “EU Pharmaceutical Law...more

Skadden, Arps, Slate, Meagher & Flom LLP

EU and Germany Lay Groundwork for the Use of Medical Data for Research and AI Training

Skadden, Arps, Slate, Meagher & Flom LLP on

Both the EU and Germany are taking significant steps to accelerate digitalization in the health sector and facilitate the exchange and use of health data for research and innovation purposes. They aim to improve...more

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter - December 2024

Morrison & Foerster LLP on

Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more

Health Care Compliance Association (HCCA)

Privacy Briefs: December 2023

Health Care Compliance Association (HCCA) on

Report on Patient Privacy 23, no. 12  (December, 2023) Northwell Health in New York and Cook County Health in Chicago each experienced impacts from a breach at Nevada-based transcription company Perry Johnson & Associates...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Nucleus: Life Sciences Enforcement and Regulatory Updates

Skadden, Arps, Slate, Meagher & Flom LLP on

In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead to new theories of False Claims Act...more

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter - October 2023

Morrison & Foerster LLP on

Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more

Foley & Lardner LLP

Recommendations for Managing Cybersecurity Threats in the Manufacturing Sector

Foley & Lardner LLP on

In the hyper-connected era of smart manufacturing, accelerated by “Industry 4.0,” the manufacturing sector is undergoing a digital revolution. By leveraging technologies such as advanced automation, artificial intelligence,...more

ArentFox Schiff

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

ArentFox Schiff on

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

Burr & Forman

Hot Topics in Health Care July 2023  

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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

Knobbe Martens

AI & the FDA

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The use of artificial intelligence (AI) in healthcare has been growing rapidly in recent years, and AI-enabled medical devices are playing a larger role in patient care. Such devices may use machine learning algorithms to...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 98

Jones Day on

This regular update (no. 98 | 1 March 2023) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal Protective...more

Wyrick Robbins Yates & Ponton LLP

Not What the Doctor Ordered: GoodRx to Pay $1.5 Million in FTC’s First Enforcement of the Health Breach Notification Rule

Wyrick Robbins Yates & Ponton LLP on

The Federal Trade Commission earlier this month undertook an enforcement action against online pharmacy and telehealth provider GoodRx, in the latest example of the agency seriously pursuing its role as the nation’s de facto...more

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter

Morrison & Foerster LLP on

Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more

Gardner Law

FDA’s New Draft Guidance on Cybersecurity

Gardner Law on

The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more

Proskauer on Privacy

“A Full Plate”: FTC’s Open Meeting on PBMs, AI, Privacy and Online Harms

Proskauer on Privacy on

During a much anticipated Open Commission Meeting announced by Commission Chair Lina M. Khan, the Federal Trade Commission (“FTC”) voted in favor of issuing one new policy statement and one new report to Congress. First,...more

King & Spalding

And So It Begins: House Energy and Commerce Leaders Unveil FDA User Fees Legislative Package

King & Spalding on

On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more

Knobbe Martens

FDA Publishes Draft Medical Device Cybersecurity Guidance Amidst Continued Cybersecurity Concerns

Knobbe Martens on

On April 08, 2022, the Food and Drug Administration (FDA) published a draft cybersecurity guidance document for medical devices, titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket...more

Morgan Lewis

Digital Health Trends to Watch in 2022

Morgan Lewis on

In the digital health market, new trends reveal future opportunities for innovators and shape healthcare investors’ strategies. Trends for 2022 include regulatory developments regarding digital health, telehealth expansion,...more

PilieroMazza PLLC

Weekly Update for Government Contractors and Commercial Businesses – February 2022

PilieroMazza PLLC on

DOJ Recovers Over $5.6 Billion From Fraud and False Claims Act Matters in FY 2021: 6 Key Takeaways - On February 1, 2022, the U.S. Department of Justice (DOJ) announced that it had recovered more than $5.6 billion in Fiscal...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No.69

Jones Day on

COMPETITION & STATE AID - State Aid - European Commission publishes revised Communication on State aid rules for Important Projects of Common European Interest (IPCEI). On 25 November 2021, the Commission published a...more

Morgan Lewis

Asia Life Sciences – Navigating US-China Relations

Morgan Lewis on

Life sciences companies are increasingly global, with the nationalities of individuals in management teams and offices often spanning the major life sciences centers across the United States, in China, and around the world....more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - July 2021

Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

King & Spalding

Congressional Investigations in the 117th Congress: U.S. Senate Oversight Activities Ramp Up

King & Spalding on

Six months into the 117th Congress, the U.S. Senate has recently increased its oversight activities following a slow start. Since April, newly empowered Democratic Members have launched or requested more than 20 inquiries...more

Foley Hoag LLP - White Collar Law &...

False Claims Act Enforcement in 2021: A Look Ahead

Foley Hoag LLP - White Collar Law &... on

This is the sixth in our First 100 Days series examining important trends in white collar law and investigations in the early days of the Biden administration. Our previous entry discussed ESG initiatives by the SEC. Up next...more

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