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.
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recently published draft guidance regarding the cybersecurity of medical devices.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.