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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” and “PHR-related entity.” These changes could imply that HIPAA-covered entities may now fall under the scope of the amendments, while the original rule is meant only to apply to non-HIPAA entities

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FDA And Boston Scientific Face Legal Action Over Spinal Device Safety

 
• By Elizabeth Orr

A patient, Dena Lawler, is suing Boston Scientific and the US FDA over alleged harm from a spinal stimulator device. Lawler claims inadequate regulatory review allowed dangerous modifications to the device, which then caused her pain and other health issues. She is calling for reconsideration of the device approvals.

Tariff Pressures Creep Into Dexcom’s Margin Outlook Despite Domestic Manufacturing Shield

 
• By Shubham Singh

Dexcom’s relatively strong position amid tariff-related uncertainty is rooted in its long-standing investments in domestic manufacturing, but raw material inflation is driving cost concerns even in the face of operational efficiencies.

Does Makary’s Reorg Choice Mark FDA Turning Point?

 
• By Michael McCaughan

US FDA Commissioner Martin Makary’s disavowal of a proposed reorganization plan may be an important turning point in the Trump Administration. The move does not improve the situation, but may mean the administration stops actively making things worse.

Don’t Sleep On Inspections: Experts Warn FDA Maintains Enforcement Resources

 
• By Brian Bossetta

Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.

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Switzerland Investigates Private Sector Assessment of FDA-Approved Medical Devices

 
• By Amanda Maxwell

Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.

New Guidance From Canada’s HTA Agency On Submission Of AI-Driven Evidence

 
• By Neena Brizmohun

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.

Medtronic Presents Data To Boost Hugo’s Odds Of Getting FDA Nod

 
• By Brian Bossetta

Medtronic says results from a recent study on the Hugo robotic-assisted surgery system substantiate its safety and effectiveness for various urological procedures. The company also announced it has submitted the system to the FDA for approval for a urological indication.