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The Risks and Rewards of Connected Medical Devices

Technology is rapidly developing to the point where medical products like inhalers may soon be connected to the Internet. The “connectivity” would allow both doctors and patients to monitor key health data.

As highlighted in a recentLos Angeles Times article, two device makers are working to develop an Internet-connected inhaler to treat chronic obstructive pulmonary disease (COPD). Another company is working on a connected coagulation meter that monitors the viscosity of blood in stroke patients once they leave the hospital.

These are just a few of the medical Internet of Things devices currently in development. The term “Internet of Things” (IoT) refers to the ability of everyday objects, from thermostats to pacemakers, to use an Internet connection to send and receive data. According to the Federal Trade Commission, there will be 50 billion connected devices by the end of 2020.

As the technology becomes more prevalent in the healthcare industry, so do the concerns for patients. Potential risks include unauthorized access, misuse of personal information, and personal safety concerns.

Last fall, the U.S. Federal Bureau of Investigation (FBI) issued a cybersecurity alert regarding IoT devices and specifically highlighted medical devices. The FBI warned that hackers can gain access to unprotected devices used in home health care, such as those used to collect and transmit personal monitoring data or time-dispense medicines. “Once criminals have breached such devices, they have access to any personal or medical information stored on the devices and can possibly change the coding controlling the dispensing of medicines or health data collection,” the FBI cautioned.

As we have previously discussed on this San Diego Injury Blog, the U.S. Food and Drug Administration (FDA) recently published draft guidance regarding the cybersecurity of medical devices. The agency advised that medical device manufacturers should have comprehensive cybersecurity risk management programs in place.

The FDA specifically recommends that medical device makers address cybersecurity as part of the design and development of a product and submit documentation to the agency about the risks identified and controls in place to address them. The FDA also proposes that manufacturers have procedures in place to respond in a timely fashion to vulnerabilities that are identified after devices enter the market.

If you or someone you love has suffered serious harm due to a recalled or otherwise defective medical device, you may be entitled to compensation. To discuss your legal rights, contact a San Diego medical product liability lawyer at the Law Offices of Robert Vaage for a free consultation.