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Full-Text Articles in Law
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 …
The Regulation Of Nanomedicine: Will The Existing Regulatory Scheme Of The Fda Suffice?, Shanna Harris
The Regulation Of Nanomedicine: Will The Existing Regulatory Scheme Of The Fda Suffice?, Shanna Harris
Richmond Journal of Law & Technology
Nanotechnology is the science and technology of manipulating molecules and atoms at the molecular level to create devices with new molecular properties, organizations and functions.1 Devices such as new computers that are billions of times more powerful than any currently available2 and boxes the size of sugar cubes that can hold the entire content of the Library of Congress are examples of the power of nanotechnology.
Will The Federal Circuit’S Eli Lilly V. Teva Decision Lead To Efforts To Abuse The Modification Provision Of The Hatch-Waxman Act?, Claire K. Comfort
Will The Federal Circuit’S Eli Lilly V. Teva Decision Lead To Efforts To Abuse The Modification Provision Of The Hatch-Waxman Act?, Claire K. Comfort
Richmond Journal of Law & Technology
The Hatch-Waxman Act provides a mandatory thirty-month stay on the Food and Drug Administration’s (FDA) approval of an Abbreviated New Drug Application (ANDA) when a patent infringement suit is filed. The Act includes a provision for a district court to shorten or extend the Act’s thirty-month stay on FDA approval if “either party to the action failed to reasonably cooperate in expediting the action”
Drug Regulations And The Constitution After Western States, Margaret Gilhooley
Drug Regulations And The Constitution After Western States, Margaret Gilhooley
University of Richmond Law Review
No abstract provided.
Will A Lawsuit A Day Keep The Cyberdocs Away? Modern Theories Of Medical Malpractice As Applied To Cybermedicine, Ruth Ellen Smalley
Will A Lawsuit A Day Keep The Cyberdocs Away? Modern Theories Of Medical Malpractice As Applied To Cybermedicine, Ruth Ellen Smalley
Richmond Journal of Law & Technology
Rivaled only by lawyers, those who earn their livelihood by practicing medicine are viewed by many as America's Public Enemy No. 1. This perception is due to the rising cost of medicine, the over-scheduling of patients, and the poor bedside manner that many people associate with a trip to the doctor's office. However, the advent of the Internet and its proliferation into schools, offices, and homes has placed medical opinions only a mouse click away. Websites, such as cyberdocs.com, allow patients to type in a description of their ailments and receive diagnoses and treatment advice from an on-line medical professional …
Blood As A Biological "Drug": Scientific, Legal, And Policy Issues In The Regulation Of Placental And Umbilical Cord Stem Cell Transplantation, Jennifer Kulynych
Blood As A Biological "Drug": Scientific, Legal, And Policy Issues In The Regulation Of Placental And Umbilical Cord Stem Cell Transplantation, Jennifer Kulynych
University of Richmond Law Review
Not all blood cells are created equal. Some are born, carry out their appointed tasks-red blood cells oxygenating the blood, white blood cells fighting infection-and die. But an elusive subset have special properties: they are the progenitors of all the many types of peripheral (circulatory) blood cells, and as such, they have the potential to reconstitute an entire blood supply. Known as hematopoietic stem cells, these blood cells reproduce indefinitely. For patients with leukemia or other blood diseases, the transplantation of hematopoietic stem cells from another person's bone marrow can provide the gift of life.