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Jones Day

Vital Signs: Digital Health Law Update | Fall-Winter 2024

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We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we present a timely discussion about increasing litigation and...more

Foley & Lardner LLP

FDA Clinical Investigations: New Guidance on Electronic Systems

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On October 2, 2024, the U.S. Food and Drug Administration (FDA) released guidance in a question and answer format regarding the use of electronic systems, electronic records, and electronic signatures in clinical...more

ArentFox Schiff

As the (Customs and Trade) World Turns: November 2024

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Welcome to the November 2024 issue of “As the (Customs and Trade) World Turns,” our monthly newsletter where we compile essential updates from the customs and trade world over the past month. We bring you the most recent and...more

Gardner Law

Responding to CIDs and Other Government Information Requests: A Practical Guide for FDA-Regulated Companies

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Understanding Your Obligations and Protecting Your Rights - Government investigations are a reality for businesses operating in FDA-regulated industries. While the previous webinar focused on general preparedness, this...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FDA Releases New Draft Guidance Regarding Clinical Trial Data Monitoring Committees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The U.S. Food & Drug Administration (FDA) released a new proposed draft guidance in February that would change the FDA’s outlook on the engagement of a data monitoring committee (DMC) in clinical trials.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

Wiley Rein LLP

CISA’s Proposed Cyber Incident Reporting Requirements Would Hit a Range of Industries and Sectors

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The U.S. Department of Homeland Security’s (DHS) Cybersecurity and Infrastructure Security Agency (CISA) is publishing a proposed rule (Proposal or NPRM) that will require broad segments of industry to meet onerous and quick...more

Saul Ewing LLP

2024 Health Care Predictions

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Happy 2024!  The entire Saul Ewing Health Law Practice Group wishes you and yours a healthy and prosperous new year and successful (and compliant) activities in the health care delivery system this year and beyond....more

Nelson Mullins Riley & Scarborough LLP

FDA Revamps Guidance Concerning Use of Electronic Systems, Records, and Signatures in Clinical Investigations

The U.S. Food and Drug Administration (FDA) has published updated draft guidance for industry, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers (Draft...more

MoFo Life Sciences

FDA Publishes Digital Health Technology Framework

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On Thursday, March 23, 2023, the Food and Drug Administration (FDA) announced the publication of the “Framework for the Use of Digital Health Technologies in Drug and Biological Product Development” (Framework) by the Center...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

Foley & Lardner LLP

CPSC Takes First Step to Expand Enforcement

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On March 1, 2021, the Consumer Product Safety Commission (CPSC) signaled its intent to increase enforcement of its product safety regimen by seeking to more than double its current $135 million budget via a public letter from...more

Fox Rothschild LLP

Medical Devices Are Double-edged Swords For Hospitals: Vital For Patient Care But Vulnerable To Cyberattacks

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On October 28th, the Federal Bureau of Investigation, the Department of Health and Human Services, and the Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency alerted hospital administrators and...more

Stinson - Government Contracting Matters

GAO Reminds Offerors that It’s Important to Substantiate Key Personnel’s Experience

Putting your best foot, or best personnel, forward seems like “Winning the Contract Award 101.” But a refresher course never hurts. Recently, the Government Accountability Office (GAO) decision in Deloitte Consulting, LLC...more

Holland & Knight LLP

Impact of the New Health Industry Cybersecurity Practices: 2019 Outlook

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• The U.S. Department of Health and Human Services on Dec. 28, 2018, announced the release of the "Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients" that provides a "Call to Action" to make...more

Foley & Lardner LLP

This Week in Health Care Policy

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Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to introduce “This Week in Health Care Policy,” a new weekly publication providing a compilation of the latest health care policy news and legislation....more

Sheppard Mullin Richter & Hampton LLP

House committee questions authority of a DHHS staff division to regulate health IT

Is the Office of the National Coordinator for Health Information Technology (ONC) overstepping its statutory authority in pursuing enhanced regulatory activity? A June 3, 2014 letter from the House Committee on Energy and...more

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