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Data Management Healthcare

Ropes & Gray LLP

The Data Act: Six Months to Go — But What To Do?

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Our clients are at the forefront of many of the developments covered by the report. That said, I couldn’t help thinking that the report overlooked a law that takes effect in less than six months’ time and which will have...more

McGuireWoods Consulting

Health Care Executive Orders And Legal Actions: Part Six

On March 14, 2025, President Trump rescinded a number of Biden-era executive orders (EOs), two of which are health related. Executive Order 13994 (2021): The Ensuring a Data Driven Response to COVID-19 and Future...more

DLA Piper

FDA in focus: 2024 in review and 2025 outlook

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In 2024, the Food and Drug Administration (FDA) significantly invested in reorganizing its internal infrastructure and enhancing operations. These efforts aimed to address the complexities of a global supply chain, rapid...more

McDermott Will & Emery

FDA Reveals AI Development Cheat Sheet in Highly Anticipated Draft Guidances

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Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more

Troutman Pepper Locke

2025 SCOPE Conference Emphasizes AI and Better Technologies to Improve Patient Outcomes

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The 2025 SCOPE Conference (Summit for Clinical Ops Executives), held last week in Orlando, FL, brought together more than 4,500 industry leaders, innovators, and experts in the clinical operations field. ...more

Ropes & Gray LLP

The Biden Administration’s Swan Song on Digital Health: Two FDA Guidances on Artificial Intelligence and FDA’s Defense of its...

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In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, FDA published two new...more

Knobbe Martens

FDA Issues Draft Guidance for the Use of Artificial Intelligence (AI) in Medical Devices and Drug Development

Knobbe Martens on

The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more

HaystackID

Cybersecurity Breach Targets Australian Data Firm ZircoDATA, Exposing Sensitive Personal Information

HaystackID on

A recent cyber attack targeting ZircoDATA, a data firm contracted by Australia’s Department of Home Affairs, has raised significant concerns about data privacy and cybersecurity in government-linked organizations. This breach...more

Health Care Compliance Association (HCCA)

Picture this: Data visualization

As most of you who’ve heard me speak or read my columns know, I’m a strong supporter of using data analytics in compliance programs. It’s an important tool that all compliance professionals should have a working understanding...more

DLA Piper

FemTech and the use of AI

DLA Piper on

Due to an exponential growth in the investment in female health and wellbeing, Forbes and Dealroom reported that 2023 saw 1.14 billion USD raised collectively across 120 deals in ‘FemTech’. ...more

Robinson+Cole Health Law Diagnosis

Connecticut Governor Signs Bill Requiring Hospitals to Submit Reports on Policy Proposals Related to Emergency Department Crowding

On May 9, 2024, Connecticut Governor Ned Lamont signed into law Public Act No. 24-4, “An Act Concerning Emergency Department Crowding,” (The Act). The Act requires all Connecticut hospitals with an emergency department to, no...more

Burr & Forman

FDA Releases New Draft Guidance Regarding Clinical Trial Data Monitoring Committees

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The U.S. Food & Drug Administration (FDA) released a new proposed draft guidance in February that would change the FDA’s outlook on the engagement of a data monitoring committee (DMC) in clinical trials. Originally...more

Wyrick Robbins Yates & Ponton LLP

Sense and Sensitivity: Latest FTC Enforcement Actions Continue Focus on Sensitive Health Data

We’ve talked before about the FTC’s focus on consumer health privacy. In cases against BetterHelp and GoodRx, a blog post announcing rules it intends to enforce in the space, and a report summarizing its recent privacy and...more

Stinson LLP

First of its Kind Privacy Law Signals Fundamental Shift in Protection of Consumer Health Data

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As more and more states consider consumer privacy laws, the first-of-its kind My Health My Data Act (the Act) could be a harbinger of health and wellness compliance requirements to come. The ramifications of Washington...more

Troutman Pepper Locke

New California Law Imposes Significant Data Management Requirements for Sensitive Health Data

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On January 1, California's Assembly Bill No. 352 (AB 352) went into effect, introducing significant changes to the handling and sharing of sensitive health information — particularly information related to reproductive health...more

Health Care Compliance Association (HCCA)

BA Depicted by OCR as Example of Ransomware Dangers Recovered Quickly, Didn’t Expect Fine

Report on Patient Privacy 23, no. 11 (November, 2023) Tim DiBona clearly remembers Christmas Eve 2018 when the staff of his small firm—Doctors’ Management Service (DMS)—arrived at their West Bridgewater, Mass., office to...more

Health Care Compliance Association (HCCA)

Privacy Briefs: November 2023

Report on Patient Privacy 23, no. 11 (November, 2023) The American Hospital Association (AHA) is urging federal lawmakers to intervene with the HHS Office for Civil Rights (OCR) so that hospitals and health systems can...more

Health Care Compliance Association (HCCA)

Privacy Briefs: October 2023

Report on Patient Privacy 23, no. 10 (October, 2023) Kaiser Foundation Health Plan Inc. and Kaiser Foundation Hospitals will pay California $49 million to resolve allegations that they unlawfully disposed of hazardous waste,...more

Nelson Mullins Riley & Scarborough LLP

EMA Finalizes Guidance on Safeguarding PPD and CCI in Clinical Trial Filings in the European Economic Area (EEA)

The European Medicines Agency (EMA) published Version 1.1 of its “Guidance on how to approach the safeguarding of personal protected data (“PPD”) and commercially confidential information (“CCI”) while using the Clinical...more

Cornerstone Research

5 Questions with Ben Handel: The Use of Algorithms in Healthcare

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We interview Professor Ben Handel of the University of California, Berkeley to gain his insights into the benefits, concerns of bias, and potential for the use of  algorithms in healthcare. You have been studying the use of...more

Robinson+Cole Data Privacy + Security Insider

Privacy Tip #365 – Nevada Enacts Consumer Health Data Privacy Law

Nevada Governor Joe Lombardo recently signed into law a sweeping and restrictive consumer health data privacy law that requires covered entities (defined as any person who conducts business in the state or produces or...more

Wyrick Robbins Yates & Ponton LLP

My Health, My Data, My Class Action Lawsuit: Why the Washington My Health My Data Act Deserves EVERY Company’s Attention

To say there’s been a lot of new privacy law in the last decade is an understatement. For those of us who think we’ve “seen it all,” many of these new laws arrive and elicit a sense of challenge (for the optimists) or mild...more

Robinson+Cole Data Privacy + Security Insider

NYAG Issues Fine Against Law Firm for Data Breach

New York Attorney General Letitia James announced on March 27, 2023 that she had levied a fine against law firm Heidell, Pittoni, Murphy & Bach LLP for failing to secure personal and health information of clients exposing the...more

Akerman LLP - Health Law Rx

FTC Cracks Down on BetterHelp’s Sharing of Health Information for Advertising

Following its February settlement with GoodRx, the Federal Trade Commission (FTC) has fired another shot across the bow in its ongoing campaign to protect consumers’ digital health information. Earlier this month the FTC...more

Nelson Mullins Riley & Scarborough LLP

Clinical Research and Patient Data Protection are at a Complicated Intersection

The privacy landscape in the United States and much of the world is quickly evolving around the framework of the General Data Protection Regulation (GDPR) within the European Economic Alliance (EEA). Clinical trials involve...more

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