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Regulating Healthcare Robots: Maximizing Opportunities While Minimizing Risks, Drew Simshaw, Nicolas Terry, Kris Hauser, M.L. Cummings
Regulating Healthcare Robots: Maximizing Opportunities While Minimizing Risks, Drew Simshaw, Nicolas Terry, Kris Hauser, M.L. Cummings
Richmond Journal of Law & Technology
Some of the most dynamic areas of robotics research and development today are healthcare applications. Robot-assisted surgery, robotic nurses, in-home rehabilitation, and eldercare robots' are all demonstrating rapidly iterating innovation. Rising healthcare labor costs and an aging population will increase demand for these human surrogates and enhancements. However, like many emerging technologies, robots are difficult to place within existing regulatory frameworks. For example, the federal Food, Drug, and Cosmetic Act (FD&C Act) seeks to ensure that medical devices (few of which are consumer devices) are safe, the HIPAA Privacy and Security Rules apply to data collected by health care providers …
A Vaccine Approach To The Reverse Payment Illness, Scott Bergeson
A Vaccine Approach To The Reverse Payment Illness, Scott Bergeson
Richmond Journal of Law & Technology
Big Brand Name develops and files a patent for a drug that kills bacteria in an innovative way. The drug is groundbreaking and potentially marketable, so Big Brand Name incurs the enormous cost (estimated at $868 million) and time of drug discovery research and safety determinations of clinical trials to bring the drug to market. Small Generic Company wants to sell the same drug but must wait until Big Brand Name’s patent expires or, in the alternative, Small Generic Company can file an Abbreviated New Drug Application (“ANDA”) with the FDA and allege Big Brand Name’s patent is invalid or …
“Medical” Monitoring For Non-Medical Harms: Evaluating The Reasonable Necessity Of Measures To Avoid Identity Fraud After A Data Breach, James Graves
Richmond Journal of Law & Technology
In July 2005, “reformed” hacker Albert Gonzalez noticed an insecure wireless network at a Marshalls department store in Miami. After exploiting the vulnerability, Gonzalez and his accomplices installed programs that captured credit card numbers. They stored the credit card numbers on servers in Latvia and Ukraine, created ATM cards using some of the numbers, and used those cards to withdraw hundreds of thousands of dollars in cash. Fifteen months later, Marshalls’ parent company, TJX, announced that forty-five million of its customers’ credit card numbers had been exposed to the thieves.