The lawsuit — filed by the plaintiff “A.H.” in U.S. District Court in Central California — levels allegations against Medtronic and its MiniMed and InPen devices. It addresses MiniMed’s transmission and disclosure of personally identifiable information and protected health information to Google and other third parties.
Per the lawsuit, the data was transmitted via tracking and authentication technology, including Google Analytics, Crashlytics, Firebase Authentication and related tools. A.H. says these technologies, installed on the website and/or mobile applications, include the InPen iOS and Android applications.
“Information about a person’s health is among the most confidential and sensitive information in society, and its mishandling can have serious consequences, including embarrassment, discrimination, and denial of insurance coverage,” the lawsuit reads.
According to the allegations, MiniMed promotes its digital platforms and corresponding medical devices as an integrated system. It combines insulin pumps and continuous glucose monitoring for those with diabetes. A.H. says MiniMed encourages patients to sign up for its app, promoting it with the use of the Medtronic InPen system insulin delivery system.
More on the allegations against Medtronic
The lawsuit says MiniMed represents it will only use or disclose protected health information without a patients’ written authorization in limited circumstances. It adds that none apply here, and it fails to mention tracking technologies with information shared with Google.
A.H. cites the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) as binding MiniMed/Medtronic to keep the information confidential. However, the suit alleges that it “made the conscious decision” to use tracking tools to acquire sensitive, personal information and data. That data on medical conditions and communications was then disseminated to third parties, like Google, the lawsuit alleges.
The lawsuit says that the full scope of the data monetization and sharing practices remains unknown. It adds that the data can aid in the creation of highly detailed user profiles for marketing and commercial purposes with no benefit to InPen users.
“MiniMed’s disclosures of PII and PHI to Google is particularly problematic because Google provides webservices—such as YouTube and Gmail—that give it access to InPen users’ real identity and device identifiers,” the lawsuit says. “Plaintiff used his mobile device to access the app, and he also uses it to access his Gmail account. As a result, his PII and PHI was automatically linked to his real identity. Even if Plaintiff did not possess a Gmail account, Google would have nonetheless received information that allows it to individually identify him.”
Medtronic’s response
A Medtronic spokesperson issued the following statement via email:
“Medtronic has not been served and will review the complaint once we receive it. It’s important to note that protecting patient information is critically important to Medtronic. We have strong processes, technologies, and people in place to safeguard and protect our information and systems, the information of our business partners, and most importantly, the privacy and safety of the patients and healthcare providers that use our products.”
A possible setback for the medtech giant’s Diabetes unit after a strong recent run?
In what has otherwise been an impressive 2023 for Medtronic Diabetes, this marks the first negative faced by the company in a while.
In April, Medtronic received FDA approval for its next-generation MiniMed 780G automated insulin delivery system. Shortly after, the company fully resolved a warning letter issue with the FDA.
Medtronic kicked off the first quarter of its fiscal 2024 with its Diabetes unit helping to drive the company’s overall growth. Highlights included the U.S. launches for the MiniMed 780G automated insulin delivery system, which led to led to 6.8% revenue growth year-over-year for Medtronic Diabetes.
This year also brought news of a planned $738 million acquisition of insulin delivery technology developer EOFlow.
“The turnaround in Diabetes is real and underway, and I am pleased with the progress the team is making,” CEO Geoff Martha said. “And we’re just at the beginning of this inflection point for the business.”
