The 21st Century Cures Act Will Be Implemented Piecemeal

fdaBy Jason Liu

As technology and medicine advance, the need to streamline and regulate medicine will increase. One can visit a virtual doctor, connect medical devices to the internet, and access cutting-edge gene therapy precision medicine. However, government agencies work with laws that never considered these innovations. To update these laws, the House passed the 21st Century Cures Act in 2015. The Act currently sits in the Health, Education, Labor and Pensions Senate (HELP) committee. Congress may also break the bill into smaller pieces of legislation.

Lamar Alexander (R-Tenn.), the leader of the HELP committee, recently stated that the panel will divide the 21st Century Cures Act into smaller pieces of legislation. The Act has stalled in the Senate because Democrats and Republicans disagree on how to fund the bill. Beginning Feb. 9, the committee will vote on at least seven bipartisan bills ranging from expediting therapies for rare diseases to improving electronic health records. Continue reading

YouTube Remixers & Small Statutory Offenders in Focus

YOUTUBER_ICONBy Andrew H. Fuller

There is little doubt that YouTube content creators have been causing waves in the copyright world since its inception. For example, in 2009, YouTube started to mute the audio tracks of any videos or streams posted by users that contained unauthorized copyrighted music. Another common and popular genre of YouTube content is remixes, where YouTube artists create content by altering and sampling from existing, copyright protected content. Most YouTube content creators are unaware and unconcerned about copyright laws or infringement claims until YouTube cracks down on them. Those who are vaguely familiar often assume that their use is within the bounds of Copyright’s Fair Use exception. Given the general (mis)understanding around Fair Use and the courts’ treatment and application of this exception, the Lanham Act would seem ripe for an update. While the technological landscape of media dissemination and user consumption has radically shifted, the laws around copyright haven’t changed. Continue reading

Are Hoverboards Hovering Above the Law?

hoverboardBy Denise Kim

Hoverboard, glider, electric skateboard, or skywalker—the technology goes by many different names. But many in the public and the news use the term hoverboard. For those who are unfamiliar with the technology, a hoverboard is a self-balancing scooter or a two-wheeled motorized gadget that normally costs between $300-500. To operate a hoverboard, the owner leans forward to move ahead. The owner leans back on the two pressure sensitive footpads to brake or reverse. Hoverboards have become a new staple in the 21st Century. Hoverboards have also raised safety concerns.

One safety concern is that hoverboards can randomly catch on fire. Major airlines including American, Delta, United and Southwest banned hoverboards from being checked in or carried on the plane. Toward the end of 2015, these safety concerns caused major panic across the U.S. and the rest of the world as many bought hoverboards for loved ones for Christmas. The airline companies cited concerns over the lithium ion batteries (which the Federal Aviation Administration regulates as hazardous materials) as the reason behind this universal ban. Continue reading

Securing Dr. Robot

unnamed By Brooks Lindsay

Medical device robots present a number of cybersecurity, privacy, and safety challenges that regulation and industry standards must address in order to safely and rapidly advance innovation in the field.

The University of Washington’s Computer Science Department recently highlighted the problem. Computer Science Researchers hacked a teleoperated surgical robot called the Raven II during a mock surgery. The hack involved moving pegs on a pegboard, launching a denial-of-service attack that stopped the robot, and making it impossible for a surgeon to remotely operate. The researchers maliciously controlled a wide range of the Raven II’s functions and overrode command inputs from the surgeon. The researchers designed the test to show how a malicious attack could easily hijack the operations of a medical device robot. The researchers concluded that established and readily available security mechanisms, like encryption and authentication, could have prevented some of these attacks.  Continue reading