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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

Self-driving car concept

Imagine you are driving down a two-lane mountain road.  As you round a bend, you see five pedestrians in your lane.  You do not have enough space to stop before hitting them, but in the other lane there is only one pedestrian.  Do you stay in your lane, killing five? Do you swerve into the other lane, killing one?  Or do you steer off the road and down the mountain, avoiding the pedestrian fatality but likely killing yourself?  Can you make that decision better than an autonomous car?…
Continue Reading Why Autonomous Cars Aren’t Hit by the Trolley Problem

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On December 8, 2015, researchers at Harvard University announced that they had examined a small sample of flavored e-cigarette products and found that some contained diacetyl, a chemical suspected of causing respiratory illness. In the wake of this announcement, some news organizations reported that the Harvard paper established a “link” between e-cigarettes and bronchiolitis obliterans, a disease associated with diacetyl exposure.

But the Harvard study did not discuss any connection between diacetyl in e-cigarettes and respiratory illness. The researchers merely noted the presence of diacetyl in e-cigarettes and that diacetyl has been associated with respiratory disease in the industrial context. The study drew no conclusions about the possible health risks that vaping poses to consumers. Instead, the study’s authors recommended that this new potential source of exposure to diacetyl be further evaluated.…
Continue Reading Researchers Turn Their Attention to Diacetyl in E-Cigarettes

Male hacker with mask stealing information

Millions of Americans rely on implantable medical devices to stay alive. These battery-operated devices communicate through wireless transmissions — and can be hacked like any other wireless device. For example, a wireless pacemaker regulates a person’s heartbeat and records the heart’s activity, and then transmits this information to doctors who can reprogram the pacemaker. The interconnectivity between medical devices and clinical systems leaves wireless medical devices vulnerable to security breaches.…
Continue Reading Hacking Health Care: When Cybersecurity Can Mean Life or Death