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.
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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.
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On Monday, August 3rd, the Food and Drug Administration (FDA) approved the first 3D printed pill, signaling a new opportunity for drug makers and 3D printing technology.

Spritam, a medication for epilepsy, is manufactured by Ohio-based pharmaceutical company, Aprecia Pharmaceuticals.  This particular drug has already been on the market, but the new, 3D printed version, is designed to dissolve more rapidly than any other seizure medication.  This new design also allows for a high drug load to be delivered in a single dose, limiting the number of pills necessary.  The 3D printed design may be particularly helpful for children or other patients who have difficulty swallowing large pills.  By layering medication, 3D printing allows the creation of a more porous pill that can dissolve more quickly into liquid.  The pill should be available commercially early in 2016. 
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The Food and Drug Administration recently issued a “safety communication” warning that a common medical device used to perform procedures that over 500,000 Americans undergo annually, may put patients at risk for developing “super bug” infections.   The FDA communication, Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication, was issued on February 19, 2015 and updated on February 23rd.  The communication includes a summary and scope of the problem, as well as recommendations for facilities and staff that reprocess ERCP duodenoscopes.  While the intended audience of the safety communication is health care providers (gastroenterologists, surgeons, nurses, health care facility staff) and patients, the alert underscores the importance of the design, warnings and instruction manuals for these devices.
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The Food and Drug Administration (FDA) wants to know your opinion.  More specifically, it wants to know how it can better regulate drugs and medical devices.  The Agency is creating a public forum for commentary on its activities under the Food and Drug Administration Safety and Innovation Act (FDASIA), Patient Participation in Medical Product Discussions.  With this public docket FDA intends to gather input from stakeholders, and the public at large, on how it can more effectively (1) obtain the views of patients during the medical product development process, and (2) consider patient perspectives during regulatory discussions.   
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