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Health Insurance Portability and Accountability Act (HIPAA) Cybersecurity Food and Drug Administration (FDA)

Gardner Law

Why Every Manufacturer Needs a Robust Information Security Program

Gardner Law on

Drug and device manufacturers are increasingly targeted by cyber threats that can compromise patient safety, intellectual property, and other critical data and systems, while also facing new regulatory demands. As regulators...more

Blank Rome LLP

[Webinar] 180 Days of the Trump Administration—Quick Hits on Executive Orders, Actions, and Policies - July 17th - August 13th,...

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Blank Rome presents a new summer webinar series where our interdisciplinary team will unpack the most pressing legal, regulatory, and policy developments from the Trump Administration’s first 180 days. Each session offers...more

Spilman Thomas & Battle, PLLC

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

Polsinelli

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

Polsinelli on

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

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - January 2025 #1

News Briefs - Number of Official Physician Union Drives Soared Over Two Years - While fewer than 10 percent of U.S. physicians are unionized, the number of official union drives among private-sector doctors have skyrocketed...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - December 2024 #1

News Briefs - FDA Guidelines Require TV Drug Ads to Be Simpler, More Direct - Those ever-present TV drug ads showing patients hiking, biking, or enjoying a day at the beach could soon have a different look: New rules require...more

Spilman Thomas & Battle, PLLC

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

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

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

Akin Gump Strauss Hauer & Feld LLP

President Biden's AI EO: Key Takeaways for Health Care & Life Sciences

Key Points - President Biden’s eagerly-awaited executive order (EO) on artificial intelligence (AI) tasks the Department of Health & Human Services (HHS) with promoting responsible AI innovation, development and use,...more

Burr & Forman

Hot Topics in Health Care July 2023  

Burr & Forman on

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

Health Care Compliance Association (HCCA)

Privacy Briefs: June 2023

Privacy Briefs: June 2023 - Long-term care pharmacy network PharMerica disclosed a breach involving more than 5.8 million patients, making it the largest breach reported to the HHS Office for Civil Rights (OCR) in the last...more

Knobbe Martens

FDA Updates Cybersecurity Guidance

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(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

Skadden, Arps, Slate, Meagher & Flom LLP

Privacy & Cybersecurity Update - April 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

Sheppard Mullin Richter & Hampton LLP

HHS Releases Cybersecurity Guide

The US Department of Health and Human Services recently updated its guide to help the private and public healthcare sectors develop cybersecurity protocols that address NIST’s Framework for Improving Critical Infrastructure...more

Gardner Law

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

Gardner Law on

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

MoFo Life Sciences

Prevent A Clinical Trial From Turning Into A Criminal Trial

MoFo Life Sciences on

On November 2, 2022, Stacy Cline Amin, former Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS), moderated the panel “Compliance and...more

Morgan Lewis - Tech & Sourcing

Metaverse Health: A Chance to Respawn Data Interoperability, Privacy, and Security

As we all try to keep up with the Metaverse and as the healthcare system wilts under a data deluge, the convergence of realities in a shared online space is not merely a chance for practitioners and patients to find each...more

Sheppard Mullin Richter & Hampton LLP

Top 5 Legal Issues in Digital Health to Watch for in 2022

The use of digital health to deliver healthcare has seen unprecedented growth over the past few years, with significant acceleration due to the COVID-19 Public Health Emergency (PHE). As patients seek ways to empower...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights, Volume 3, Issue 1

EHR Vendor Breach Lawsuit Seeks Security Improvements - "Patient portal hacking incident last summer affected nearly 320,000." Why this is important: On October 22, 2021, QRS Inc., a medical practice management system...more

Sheppard Mullin Richter & Hampton LLP

Eye On Privacy: 2021 Year in Review

Just as we thought 2022 was going to be significantly different than 2021, December 2021 and January 2022 events have thrown us for another (pandemic) loop. We anticipate that some of the privacy and cybersecurity...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights. Volume 2, Issue 23

Athletic Fashion Dispute in Race to Courthouse - Lululemon and Peloton are suing each other over clothing design patents and trade dress. Specifically, the case involves designs for athletic bras and leggings. Peloton won...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - July 2021

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

Proskauer - The Patent Playbook

Synthetic Data Gets Real

As we mentioned in the early days of the pandemic, COVID-19 has been accompanied by a rise in cyberattacks worldwide. At the same time, the global response to the pandemic has accelerated interest in the collection, analysis,...more

Wilson Sonsini Goodrich & Rosati

Digital Health Report - Q2 2021

In this issue, we discuss U.S. Food and Drug Administration (FDA) regulation of wellness devices. We also look at good commercial contracting hygiene for digital health start-ups. Other articles include recent enforcement...more

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