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Food and Drug Administration (FDA) Privacy Laws

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | April 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more

Spilman Thomas & Battle, PLLC

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

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

Mintz - Health Care Viewpoints

Biden Executive Order Calls for HHS to Establish Health Care-Specific Artificial Intelligence Programs and Policies

On October 30, 2023, the Biden Administration released and signed an Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (Executive Order) that articulates White House...more

Wiley Rein LLP

Wiley Consumer Protection Download (September 11, 2023)

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Welcome to Wiley’s update on recent developments and what’s next in consumer protection at the Consumer Financial Protection Bureau (CFPB) and Federal Trade Commission (FTC). In this newsletter, we analyze recent regulatory...more

Gardner Law

FDA Regulatory, Compliance, and Privacy Due Diligence — Finding Your Goldilocks Zone

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When conducting due diligence of an FDA-regulated company, there are several important questions that should be posed. These include questions relating to regulatory, compliance, and privacy matters. For example, questions...more

Gardner Law

New WA Privacy Law ‘Turns The Beat Around’ on Drug and Device Makers

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The Washington My Health My Data Act ("MHMDA") may not have been written by Earth, Wind, & Fire, but it is certainly poised to make medical device and pharmaceutical manufacturers move to a new beat like a classic disco hit....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

Foley & Lardner LLP

FDA Encourages the Use of Decentralized Clinical Trials in New Draft Guidance

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On May 2, 2023, the U.S. Food and Drug Administration (FDA) released Draft Guidance regarding the implementation of Decentralized Clinical Trials (DCTs) for drugs, biological products, and devices. DCTs are clinical trials...more

Morrison & Foerster LLP

MoFo’s State + Local Government Enforcement Newsletter - May 2023

Morrison Foerster’s State + Local Government team is pleased to provide our bimonthly newsletter summarizing some of the most important and interesting developments from state attorneys general across the country, with links...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

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights - V 4, Issue 1, January 2023

Big Boosts to Cybersecurity and Tech Funding in $1.7T Omnibus Bill Signed by Biden - “The bipartisan fiscal 2023 omnibus spending agreement includes $2.9 billion for the Cybersecurity and Infrastructure Security Agency, a...more

Faegre Drinker Biddle & Reath LLP

5 Major Drug and Device Developments of 2022

As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702...more

Lowenstein Sandler LLP

Reproductive Rights: FAQS for People Seeking Abortions in New Jersey

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SAFE INTERNET SEARCHES AND PHONE CALLS- If I’m researching abortion online, are there ways to keep my searches private? Before you read these FAQs, you might want to educate yourself on how to keep your data more private....more

Sheppard Mullin Richter & Hampton LLP

Health Law Policy Heading Into 2022 At The ABA Health Law Summit

The ABA Washington Health Law Summit is the premier legal conference focusing on health law policy and, as a result, offers insight into current and future major policy issues. But, as always at this conference, there are...more

Sheppard Mullin Richter & Hampton LLP

FDA Joins Other Regulators in Focus on AI and Machine Learning

The Food and Drug Administration recently sought comments on the role of transparency for artificial intelligence and machine learning-enabled medical devices. The FDA invited comments in follow up to a recent workshop on the...more

Sheppard Mullin Richter & Hampton LLP

New State Genetic Privacy Law Directed at Consumer Genetic Tests

Utah recently signed into law SB 227, creating the Genetic Information Privacy Act (GIPA). The law, which is anticipated to go into effect in May 2021, is aimed at protecting genetic data collected from direct-to-consumer...more

Arnall Golden Gregory LLP

I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Data Privacy Issues Life Sciences Companies May Encounter

In this episode, AGG’s Food & Drug team leader, Alan G. Minsk, and co-chair of AGG's Data Privacy practice, Kevin L. Coy, discuss U.S. and international privacy and data security law issues life sciences companies may...more

Jones Day

JONES DAY PRESENTS® Digital Health and Clinical Research: Understanding Regulatory Regimes

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Jones Day partner Maureen Bennett talks about how advancements in digital technology and their clinical trial applications have introduced additional regulatory regimes in the United States and the European Union, and...more

McDermott Will & Emery

California Bill Proposes CCPA Exceptions for HIPAA De-identified Information, Other Health Data

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On January 6, 2020, the California State Senate’s Health Committee unanimously approved California AB 713, a bill that would amend the California Consumer Privacy Act (CCPA) to except from CCPA requirements additional...more

Verrill

More Proposed Changes to CCPA Geared to Health Care and Life Sciences Industries

Verrill on

The California Consumer Privacy Act of 2018 (“CCPA”) took effect on January 1, 2020. Days later on January 8, 2020, the California Senate Health Committee unanimously approved Senate bill A.B. 713 (the “Bill”) to establish...more

Bradley Arant Boult Cummings LLP

Lawmakers Propose CCPA Amendment to Further Except Healthcare and Research Information - Cybersecurity and Privacy Alert

A little more than a week after California’s groundbreaking California Consumer Protection and Privacy Act (CCPA) went into effect on January 1, the Senate Health Committee unanimously approved A.B. 713, introduced by...more

Akin Gump Strauss Hauer & Feld LLP

What's New In Washington - September 2018

Following a truncated August recess, the House and the Senate returned to Washington after Labor Day with a full plate of legislative items to address prior to the end of the fiscal year on September 30. That list includes...more

Cooley LLP

Alert: Key Regulatory Considerations for Digital Health Companies

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Digital health is a growing field that promises improved patient education, wellness, engagement, access to care, and outcomes, among other things. However, with these new technologies come unique regulatory concerns that...more

Robins Kaplan LLP

PATIENT PRIVACY IN AN ERA OF SOCIAL MEDIA

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The rise of social media has introduced new opportunities and new legal challenges for companies in the health care industry. Attorneys Seth Northrop and Sharon Roberg-Perez discuss the legal issues faced by care providers,...more

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