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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

J&J MedTech Launches KINCISE 2 Surgical Automated System In US

 
• By Natasha Barrow

The KINCISE 2 Surgical Automated System aims to “reduce the physical burden on surgeons compared to manual impaction in primary and revision hip and revision knee replacement procedures,” said J&J MedTech.

Guardant’s Multi-Cancer Detection Test Granted FDA Breakthrough Device Designation

 
• By Natasha Barrow

Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.

‘Dawn Of FDA’s AI Era’ Has Arrived. Makary Announces Early Implentation Of ‘Elsa’ Platform

 
• By Brian Bossetta

US FDA Commissioner Marty Makary says the agency’s generative AI tool ‘Elsa’ will allow employees across the FDA to work more efficiently. The commissioner says Elsa’s launch comes ahead of schedule following a successful pilot program.

DeepLook AI Imaging Provides A Deeper Look At Dense Breast

 
• By Brian Bossetta

DeepLook Medical recently announced the commercial rollout of DL Precise, an AI-powered imaging platform that enhances breast cancer screening, at major healthcare institutions across the US.

More from North America

First AI Breast Cancer Prediction Platform Receives FDA Authorization

 
• By Natasha Barrow

Clairity’s "first-in-class" mammography-based AI screening tool, Clairity Breast, provides "equitable risk assessments," expanding access to lifesaving early detection for breast cancer, said company founder Connie Lehman.

SAGA Diagnostics Launches Early Breast Cancer MRD Detection Test In US

 
• By Natasha Barrow

SAGA Diagnostics has launched its breast cancer residual and recurrence detection test – Pathlight – in the US. The test’s ultrahigh sensitivity and specificity is rare to see in oncology, the company claimed.

ConcertAI Launches Generative AI-Powered Precision Suite

 
• By Natasha Barrow

Valued at over $1.9bn, ConcertAI is building on its pre-existing multi-agentic AI SaaS solution CARAai to bring life science customers the new Precision suite of applications: Precision Explorer, Precision Trials, Precision GTM and Precision360.