Data Privacy, PHI, Food and Drug Administration (FDA)

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

FDA Authorized to Establish New Cybersecurity Standards for Medical Devices: What it Means for Industry

Ankura on 4/26/2023

On December 29, 2022, President Biden signed a new statute that will significantly impact medical device cybersecurity regulation. Section 3305 of the Consolidated Appropriations Act of 2023 (“Section 3305”) authorizes the...more

Roundup of FTC Consumer Protection Matters of Interest to Digital Advertisers: March 2023

Hinch Newman LLP on 3/20/2023

In March 2023, the Federal Trade Commission announced a number of consumer protection actions involving data privacy, COVID health claims, a robocall debt relief pitch scheme, and alleged harmful noncompete restrictions. The...more

Five Emerging Concerns for the Health Care Industry as AI & Telehealth Converge

Goodwin on 9/13/2021

The use of telehealth continues to grow rapidly across the U.S. Given legislative proposals and the Centers for Medicare & Medicaid Services efforts to expand access to telehealth, we can only anticipate that remotely...more

Drug Pricing Concerns Drive Continued DOJ Focus on Life Sciences Companies

Skadden, Arps, Slate, Meagher & Flom LLP on 1/24/2020

In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more

Impact of the New Health Industry Cybersecurity Practices: 2019 Outlook

Holland & Knight LLP on 1/14/2019

• 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

New York Regulators Lead the Charge to Fill Health Data Protection Gaps Left by Federal Law

Hogan Lovells on 4/28/2017

New York AG Settles Data Protection Enforcement Against Mobile Health Apps - After a year-long investigation into mobile health apps claiming to be able to measure vital signs or health indicators through smartphone...more

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