News & Analysis as of June 2, 2025

Data Protection

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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 Learned Concierge - March 2025, Vol. 17

Clark Hill PLC on 3/17/2025

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

Security Requirements and Compliance Obligations in DOJ's Final Rule on Data Transactions

Akin Gump Strauss Hauer & Feld LLP on 2/24/2025

The Department of Justice’s (DOJ) final rule implements President Biden’s Executive Order 14117 of February 28, 2024, on “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data...more

CISA and FDA Sound Alarm on Backdoor Cybersecurity Threat with Patient Monitoring Devices

Polsinelli on 2/13/2025

Last week, the U.S. Cybersecurity and Infrastructure Security Agency (“CISA”) and the U.S. Food and Drug Administration (“FDA”) released warnings about an embedded function they found in the firmware of the Contec CMS8000,...more

Generative Artificial Intelligence Leveraged to Deliver Healthcare - Legal Risks and Issues

Polsinelli on 2/6/2025

With daily media reports citing to the explosion of interest in Artificial Intelligence (“AI”), AI start-ups have attracted a huge capital influx. During the last fiscal quarter of 2024 ending on December 31st, investors...more

FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions

King & Spalding on 1/13/2025

On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more

The Health Record - Healthcare Law Insights, Issue 7, November 2024

Spilman Thomas & Battle, PLLC on 11/19/2024

Welcome to our seventh issue of The Health Record - our healthcare law insights e-newsletter. This will be our final issue of 2024. When we started this publication earlier this year, our goal was to provide our clients,...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

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

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

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

Cybersecurity Awareness Month: FDA Guidance on Cybersecurity in Medical Devices

Jackson Lewis P.C. on 10/23/2023

Cyber incidents are on the rise with no signs of slowing down, particularly in the healthcare industry. To combat this trend, on September 27, 2023, the U.S. Food and Drug Administration (FDA) released guidance on...more

FDA Updates Cybersecurity Guidance

Knobbe Martens on 6/2/2023

(May 30, 2023) Going forward, medical device approval will require the device maker to provide cybersecurity information to the FDA. Congress made this change by adding Section 524B to the Federal Food, Drug, and Cosmetic...more

Privacy & Cybersecurity Update - April 2023

Skadden, Arps, Slate, Meagher & Flom LLP on 5/2/2023

In this month’s Privacy & Cybersecurity Update, we look at Washington state’s passage of the first-ever state-level health data privacy law and the finalized California Consumer Privacy Act regulations. We also examine a...more

Heightened Cybersecurity Requirements for Medical Devices Passed Into Law

Ballard Spahr LLP on 1/25/2023

Many privacy professional may have missed it, but In the run-up to the New Year — while many U.S. companies were focused on complying with the California Privacy Rights Act (CPRA) — Congress passed an appropriations bill that...more

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

Gardner Law on 12/2/2022

US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

Global Authorities Ramp Up Medical Device Cybersecurity Expectations: What Medical Device Companies Need to Know

Orrick, Herrington & Sutcliffe LLP on 10/26/2022

The last year has seen a multijurisdictional regulatory push for increased cybersecurity standards for medical devices. The new approaches, issued by regulatory authorities in the United States (U.S.), the United Kingdom (UK)...more

Decoded - Technology Law Insights, Volume 3, Issue 16

Spilman Thomas & Battle, PLLC on 8/19/2022

CHIPS and Science Act Will Lower Costs, Create Jobs, Strengthen Supply Chains, and Counter China "Spurred by the passage of the CHIPS and Science Act of 2022, companies have announced nearly $50 billion in additional...more

Decoded - Technology Law Insights, Issue 15, 2022

Spilman Thomas & Battle, PLLC on 8/5/2022

Data Privacy, Abortion Limits Set to Collide Post-Roe "Even before the June 24 ruling in Dobbs v. Jackson Women’s Health Organization, privacy advocates, concerned that data on women seeking abortions could be used to target...more

Decoded - Technology Law Insights, Volume 3, Issue 14

Spilman Thomas & Battle, PLLC on 7/21/2022

Is the U.S. Finally Getting a Comprehensive Cybersecurity and Data Protection Law? What You Need to Know About the Proposed American Data Privacy and Protection Act - In the beginning of the 2000s, as a result of the...more

Privacy & Cybersecurity Update - April 2022

Skadden, Arps, Slate, Meagher & Flom LLP on 5/4/2022

In this month’s Privacy & Cybersecurity Update, we examine the FTC chair’s comments suggesting a potential shift in its approach to data privacy regulation, the European Data Protection Board’s request for comment on its...more

FDA updates “cybersecurity in medical devices” guidance, seeks industry input - Draft guidance addresses quality system...

Hogan Lovells on 4/15/2022

The U.S. Food and Drug Administration (FDA) issued updated draft guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” which aims to help industry take a more...more

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Cybersecurity › Food and Drug Administration (FDA) › Data Protection

The Learned Concierge - March 2025, Vol. 17

Security Requirements and Compliance Obligations in DOJ's Final Rule on Data Transactions

CISA and FDA Sound Alarm on Backdoor Cybersecurity Threat with Patient Monitoring Devices

Generative Artificial Intelligence Leveraged to Deliver Healthcare - Legal Risks and Issues

FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions

The Health Record - Healthcare Law Insights, Issue 7, November 2024

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

Vital Signs: Digital Health Law Update | Spring 2024

The Learned Concierge - July 2024, Vol. 10

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

Cybersecurity Awareness Month: FDA Guidance on Cybersecurity in Medical Devices

FDA Updates Cybersecurity Guidance

Privacy & Cybersecurity Update - April 2023

Heightened Cybersecurity Requirements for Medical Devices Passed Into Law

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

Global Authorities Ramp Up Medical Device Cybersecurity Expectations: What Medical Device Companies Need to Know

Decoded - Technology Law Insights, Volume 3, Issue 16

Decoded - Technology Law Insights, Issue 15, 2022

Decoded - Technology Law Insights, Volume 3, Issue 14

Privacy & Cybersecurity Update - April 2022

FDA updates “cybersecurity in medical devices” guidance, seeks industry input - Draft guidance addresses quality system...

Decoded - Technology Law Insights, Volume 3, Issue 6

Decoded: Technology Law Insights, Volume 3, Issue 5

Digital Health Trends to Watch in 2022

Decoded: Technology Law Insights, Volume 3, Issue 1

Cybersecurity › Food and Drug Administration (FDA) › Data Protection

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