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Attorney: Proposed Data Privacy Law Would Ultimately Reduce Regulatory Burden

 
• By Hannah Daniel

Data privacy lawyer says the comprehensive, bipartisan law is “catching a lot of people’s ears.”

• Source: Shutterstock

The American Privacy Rights Act (APRA) of 2024 could be the first federal data privacy law passed in the US.

Jennifer Hennessy, data privacy and cybersecurity attorney at Foley & Lardner LLP,told Medtech Insight that she’s more interested in this...

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More from Compliance

NHS Orders Halt On Unapproved AI Scribes, Vendors Rush To Self-Certify

 
• By Natasha Barrow

The NHS England chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.

FDA ‘Regulatory Accelerator’ Aims To Speed Digital Health Development

 
• By Elizabeth Orr

The US FDA has launched the Regulatory Accelerator to expedite digital health product development. This includes resources like a Resource Index for Innovators, a Medical Device Software Guidance Navigator, and best practices for early meetings.

Device Sterilization Plants Get Extra 2 Years To Comply On EtO Phase-Out

 
• By Elizabeth Orr

The exemption, which President Donald Trump announced on July 17, is intended to cut the risk of critical device shortages. Stakeholders say the technology needed to cut emissions to required levels is not yet widely available.

Numerous Injuries Prompt Class I Recall Of Dexcom CGM Receivers

 
• By Brian Bossetta

Dexcom has recalled several models of its glucose monitoring receivers due to a speaker glitch that may suppress vital blood sugar alerts. The FDA designated the recall, which affects thousands of devices, as class I.

More from Policy & Regulation

From ‘Work Harder’ to ‘Phenomenal People’: Makary’s FDA About-Face

 
• By Michael McCaughan

In his first 100 days as FDA commissioner, Martin Makary has gone from vocal critic to vocal supporter of the agency’s staff, calling them “phenomenal” and praising their dedication—even as morale remains shaken by recent layoffs and restructuring.

Time For Medtech To Have Its Say On Critical Changes In EU Framework Legislation

 
• By Amanda Maxwell

In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.

HHS Suggests Drastic Reductions To Skin Substitute Payments

 
• By Elizabeth Orr

The US Department of Health and Human Services has proposed cutting Medicare reimbursement for skin substitutes used in chronic wound care by up to 90%. The change aims to address rising costs but could harm patient access and treatment quality, prompting concerns from industry stakeholders.