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FTC Health Breach Proposal Could Create Confusion For HIPAA Entities

 
• By Hannah Daniel

Medtech Insight followed up with Invitae’s Deven McGraw about further possible confusion that could be caused by the Federal Trade Commission’s proposed amendments to the Health Breach Notification Requirements (HBNR).

website screenshot of the FTC
• Source: Shutterstock

Entities covered by the Health Insurance Portability and Accountability Act (HIPAA) may find confusion among the Federal Trade Commission’s Health Breach Notification Requirements (HBNR) proposed amendments, data privacy expert Deven McGraw said.

The amendments modify the definition of personal health record (PHR)-identifiable health information, “health care provider,” “health care services or supplies”...

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More from United States

Serious Injuries Tied To Medtronic Bravo GERD Diagnosing System

 
• By Brian Bossetta

The US FDA has issued an early alert to notify consumers about serious risks associated with a recall from Medtronic and its subsidiary Given Imaging. The alert concerns delivery capsules for diagnosing GERD.

DME And Diagnostics In Crosshairs As DOJ ‘Follows The Money’

 
• By Elizabeth Orr

The DOJ has launched nearly 70 enforcement actions in 2025, targeting diagnostics, durable medical equipment, and telehealth fraud. Key cases involve significant fraudulent claims against Medicare, with individuals facing severe penalties.

Dxcover Launches US Operations With New Headquarters In Tennessee

 
• By Natasha Barrow

Dxcover sets up new Clinical Laboratory Improvement Amendments (CLIA) lab in Franklin, Tennessee.

FDA Blocks Some Olympus Endoscopes From Entering US

 
• By Brian Bossetta

After multiple warning letters and safety communications, the US FDA has decided to block the import of certain endoscopes from Olympus. In total, the agency’s action pertains to 58 device models manufactured by the Japanese firm used in urinary, respiratory, abdominal and pelvic procedures.

More from North America

Fallouh Healthcare Receives Grant Funding From Innovate UK

 
• By Natasha Barrow

Fallouh Healthcare has received £305,050 in grant funding from Innovate UK as part of the European Union’s Eureka Eurostars program. The company aims to detect cardiac tamponade, a condition that affects patients after heart surgery. Currently, there is no way to accurately diagnose the condition.

Mexico’s New Procurement Rules Aim To Increase Healthcare Investment, But May Face Legal Trouble

 
• By Francesca Bruce

Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.

Newborn Screening Tests Among FDA Classifications

 
• By Elizabeth Orr

The US FDA has announced classifications for five device types, including four diagnostics as well as a hand cream to protect healthcare workers exposed to radiation. Two of the products are newborn screening tests.