News & Analysis as of

Federal Trade Commission (FTC) Medical Devices Department of Health and Human Services (HHS)

Sheppard Mullin Richter & Hampton LLP

2025 Top-of-Mind Issues for Life Sciences Companies

DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - January 2025 #3

News Briefs - Federal Judge Rejects Attempt to Stop Nursing Home Staffing Rule - A federal judge has rejected a bid by 20 Republican state attorneys general to block enforcement of a new rule adopted by the outgoing Biden...more

Holland & Knight LLP

Safeguarding Health Information: Takeaways from HHS and NIST 2024 HIPAA Security Conference

Holland & Knight LLP on

President Ronald Reagan famously quipped, "I think you all know that I've always felt that the nine most terrifying words in the English language are: I'm from the Government, and I'm here to help."1 At an Oct. 23-24, 2024,...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | April 2024 Recap

McDermott Will & Emery on

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

Fenwick & West LLP

Increased Regulatory Scrutiny on Health Technology Companies’ Use of Advertising Technologies

Fenwick & West LLP on

The proliferation of health apps and connected devices that allow individuals to track their health conditions, treatment, medications, fitness, fertility, sleep, mental health, diet and other vital areas has led to increased...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, Volume 3, Issue 13

AHA Expresses Member Support for PATCH Act, Medical Device Security "In a letter addressed to Senators Bill Cassidy (R-LA) and Tammy Baldwin (D-WI), who first introduced the PATCH Act, the AHA said that the association and...more

Benesch

Warning from FTC Regarding Scope of Health Breach Notification Rule

Benesch on

As the collection and use of health data drastically expands, the agency issued a recent guidance to officially put health apps and connected medical devices “on notice.” On September 15, the Federal Trade Commission...more

Cozen O'Connor

AG Elections Roundup | FTC Requires Medical Device Divestiture | Aetna Data Breach Settlement

Cozen O'Connor on

2020 AG Elections- Ten AG elections were held on November 3, 2020. As of this writing, six incumbent AGs won their elections, and Republicans held the open-seats in Indiana and Montana. In the two undecided races, Democratic...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Strives to Adapt Regulatory Approach to Rapidly Evolving Digital Health Space

Just two months after taking office, in July 2017, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced the agency’s Digital Health Innovation Action Plan, which recognized that “digital technology has...more

Jones Day

New York Attorney General Announces Settlements with Three Mobile Health Application Developers

Jones Day on

New York has made a mark on the regulatory and enforcement landscape for mobile health applications ("mobile health app") with the New York Attorney General's ("NY AG") March 23, 2017, announcement of settlements with three...more

Arnall Golden Gregory LLP

Six Ways for Data-Driven Medical Device Companies to Implement Effective Privacy and Security Measures

The increasing amounts of health information being generated, stored and collected have heightened the special risks medical device manufacturers have long faced. In addition to the nexus to patient health and safety, if a...more

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