Florida Attorney General Investigates Chinese Medical Devices

Florida Attorney General James Usmier (R) has issued subpoenas to companies selling Chinese medical devices that reportedly have hidden features allowing patient data to be sent to entities linked to the Communist Party of China (CCP) without patient consent.

State officials are looking into potential cybersecurity threats, as well as possible breaches of Florida’s Deceptive and Unfair Trade Practices Act (FDUTPA). Contec, established in South Carolina in 1988, and Epsimed, which resells products from China and operates in Miami since 2006, are among the companies under scrutiny.

Recently, the US Food and Drug Administration (FDA) released Safety Notes concerning the CONTEC CMS8000 and MN-120 patient monitors, highlighting “cybersecurity vulnerabilities” that might jeopardize patients when connected to the internet. The FDA indicated that it had no knowledge of any incidents tied to these devices at that point, yet authorities found these monitors could be “remotely controlled by unauthorized users,” potentially leaking personal health data outside designated networks.

According to Uthmeier’s office, the “backdoor” in these monitors may allow unauthorized manipulation of displayed data, as well as automatic transmission of patient information to IP addresses owned by Chinese universities.

The Attorney General suggested that CONTEC and Epsimed might have violated the FDUTPA, citing several points:

• CONTEC claims FDA approval for its monitor, even though it hasn’t received FDA approval.
• Although the monitor purports to meet international standards—like FDA, CE, and ISO—it apparently does not, given its significant security vulnerabilities.
• The product fails to meet expected safety and reliability standards and contains backdoors that send patient data to China, contradicting its advertised quality assurance.
• Epsimed presents itself as a “large OEM manufacturer,” while actually selling Contec monitors under its own brand.
• Both companies are accused of withholding critical information about security vulnerabilities in the monitors.
• The devices in question engage in unfair practices detrimental to consumers, notably by transmitting patient information to foreign entities.

Usmier emphasized that medical devices handling patient data must prioritize safety and should not share this information with CCP entities. “It is crucial to protect sensitive personal data from Americans against foreign threats, and my office aims to uncover this deception,” he stated.

Michael Lucci, founder and CEO of the Anti-CCP Policy Firm State Armor, commended Uthmeier for his efforts in the investigation, while also criticizing the Chinese government’s disregard for American regulations. He remarked that these companies often embed private backdoors in their products, facilitating information extraction that could threaten national security.

Experts warn that if Contec and Epsimed are found culpable for selling medical devices that covertly transmit patient data to the CCP, serious legal action may be necessary. The implications of Chinese companies creating security risks for Americans are alarming, and it’s crucial that American companies do not assist in these activities.