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When California enacted SB 327 last year, it became the first state to regulate Internet of Things (IoT) devices, which refer to physical devices that are connected to the internet. Beginning next January, the new law will require manufacturers of IoT devices sold in California to implement reasonable security features that protect the software, data, and information contained within them. While the law regulates only the minimum security standards for IoT devices, its definition of a “connected device” (i.e., an IoT device) may impact product liability claims because “connected devices” are physical objects and not technology. SB 327’s definition suggests that manufacturers of the software in IoT devices may not be held strictly liable for software defects, because the law aligns with and reinforces the view of most courts that software is not a product, but a service.…
Continue Reading Product Liability in the Internet of Things

woman hand touh smartphone

It’s a typical marketing story: Not too long ago, manufacturers marketed coconut oil as a heat-tolerant alternative to other cooking oils. They further promoted it by noting that it was more sustainably harvested than palm oil and could replace butter for people avoiding dairy.

But then coconut oil marketing took a turn. People—not the manufacturers but social media influencers—started to talk about coconut oil in a different way. Influencers claimed that coconut oil was a “miracle cure” for a variety of health and other problems.…
Continue Reading How Manufacturers Can Work With Social Media Influencers

Suitcase or luggage with conveyor belt in the airport

“Smart luggage” is truly smart. Companies have created sleek, stylish bags that also contain practical, convenient accessories. Although smart luggage solves all sorts of problems, it has grabbed the attention of airlines and authorities due to the use of lithium batteries.

When companies develop new products, they can often turn to existing regulations to inform the plan and design, ensuring that it complies with the regulations when it is released. But sometimes innovation can make things a bit more complicated. Incorporating new features like an internal scale, GPS tracking, TSA-approved locks, and USB ports to charge electronics, smart luggage perfectly illustrates this tricky situation.…
Continue Reading Speed and Flexibility: A Smart Approach to Developing Policies

Molecular Structure

Under the recently enacted FDA Reauthorization Act of 2017, drug and device manufacturers will have more time to report device malfunctions to the U.S. Food and Drug Administration (FDA).

Current standards require medical device malfunction reports to the FDA within 30 days. The 2017 Act maintains the 30-day deadline for reporting events that have already resulted in serious medical consequences to users—“adverse events.” But the Act expands the quarterly reporting function, allowing 90 days to report issues that may cause harm in the future but have not yet resulted in patient complications, injuries, or deaths—“malfunctions.” The Act also allows companies to submit summary malfunction reports when the incident reported is already known and understood by the FDA, rather than reporting incidents individually.…
Continue Reading New Legislation Gives More Time for Medical Device Reporting

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Consider the world today: Smartphone manufacturers have already introduced vehicle infotainment systems in automobiles. Vehicle safety technology may be next.

A recent safety proposal by the National Highway Traffic Safety Agency (NHTSA) raises intriguing questions about how our smartphones and automobiles may interface. The proposal may encourage smartphone manufacturers to add vehicle safety technology to their infotainment system applications. That may start to blur the lines between your vehicle and your smartphone.

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Continue Reading Where Does Your Smartphone End and Your Car Begin?

Tesla Roadster

When the fatal car crash involving a Tesla Model S sedan made headlines last fall, we posted about the accident and predicted that government authorities would classify the crash as being caused by driver error rather than an issue with the “Autopilot” system.

Our prediction turned out to be correct.  The National Highway Traffic Safety Administration (NHTSA) was still investigating the incident when we first posted about it, but on January 19, NHTSA closed its preliminary evaluation, which found that driver error was responsible.

Still, the performance of Automated Driver Assistance Systems, or ADAS, is an area of intense regulatory interest, and it was therefore not surprising to see NHTSA’s Office of Defect Investigation deploy a special crash investigations team to reconstruct the accident.

Several news reports have characterized NHTSA as having “exonerated” or “cleared” Tesla of any wrongdoing in connection with the crash. Officially, NHTSA merely closed the investigation, noting that it reached no conclusion about whether a defect existed and retained its right to reopen the investigation later.

That said, NHTSA was clearly satisfied with the performance of Tesla’s ADAS system during the crash, which allowed the agency to close its investigation.…
Continue Reading Truly Exonerated? NHTSA’s Tesla Autopilot Investigation

EKG monitor

Medical device manufacturers are now facing a new challenge: managing the cybersecurity of their products.

On January 9, the FDA issued a Safety Communication setting out potential risks that could be caused by a cybersecurity vulnerability in certain St. Jude Medical cardiac devices. A growing number of devices – including St. Jude Medical’s implantable cardiac devices and corresponding Merlin@home Transmitter – transmit data directly to physicians to allow direct patient and device monitoring.…
Continue Reading Medical Device Manufacturers Face A Cybersecurity “Heartache”

EKG monitor

Medical device manufacturers are now facing a new challenge: managing the cybersecurity of their products.

On January 9, the FDA issued a Safety Communication setting out potential risks that could be caused by a cybersecurity vulnerability in certain St. Jude Medical cardiac devices. A growing number of devices – including St. Jude Medical’s implantable cardiac devices and corresponding Merlin@home Transmitter – transmit data directly to physicians to allow direct patient and device monitoring.…
Continue Reading Medical Device Manufacturers Face A Cybersecurity “Heartache”

Self-driving car concept

After 130 million miles driven without a fatality, Tesla Autopilot’s perfect track record ended tragically on May 7 with the first fatal crash of a car using Autopilot. Given the infrequency of fatal crashes involving autonomous vehicles, why are commentators suggesting that the auto industry “put the brakes” on this technology?

That’s unclear, especially with the facts here. Autopilot has a better safety record than human drivers. Overall, drivers in the United States cause one fatality roughly every 93 million miles. This was Autopilot’s first fatal accident in over 130 million miles driven.…
Continue Reading Tesla Crash: Don’t Slam the Brakes on Autopilot