Wednesday, September 6, 2023

Medtronic faces class-action lawsuit over diabetes data-sharing

Your health data is for sale. Even insulin pumps and CMG.



Medtronic faces class-action lawsuit over diabetes data-sharing: Mere months after Medtronic Diabetes resolved a 2021 FDA warning letter, it's in the hot seat again—now, as the subject of a class-action lawsuit.
According to the lawsuit, the affected data include those collected by the apps connected to Medtronic’s MiniMed insulin pumps and InPen “smart” insulin pens.

This information is protected by HIPAA regulations.   



The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) is responsible for enforcing the HIPAA Privacy and Security Rules. In cases of noncompliance where the covered entity does not satisfactorily resolve the matter, OCR may decide to impose civil money penalties (CMPs) on the covered entity. CMPs for HIPAA violations are determined based on a tiered civil penalty structure. The secretary of HHS has discretion in determining the amount of the penalty based on the nature and extent of the violation and the nature and extent of the harm resulting from the violation. The secretary is prohibited from imposing civil penalties (except in cases of willful neglect) if the violation is corrected within 30 days (this time period may be extended at HHS’ discretion). Penalties for civil violations range from $100 - $50,000 per violation, with an annual maximum of $25,000 for repeat violations¹³. 

In cases of willful neglect and is not corrected within required time period, the penalty range is $50,000 per violation, with an annual maximum of $1.5 million¹². 

I hope this helps!

Source: Conversation with Bing, 9/6/2023
(1) HIPAA violations & enforcement | American Medical Association. https://www.ama-assn.org/practice-management/hipaa/hipaa-violations-enforcement.
(2) The Most Common HIPAA Violations in the Workplace. https://factorialhr.com/blog/hipaa-violations-in-the-workplace/.
(3) HIPAA Violation Cases - Updated 2023 - HIPAA Journal. https://www.hipaajournal.com/hipaa-violation-cases/.
(4) HIPAA Violation Fines - Updated for 2023 - HIPAA Journal. https://www.hipaajournal.com/hipaa-violation-fines/.

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