On October 11, 2005, both the Centers for Medicare and Medicaid Services ("CMS") and the Health and Human Services Office of Inspector General ("OIG") published separate, but parallel, proposed rules to advance the goal of widespread adoption of electronic health records technologies by hospitals, physicians,...
The FDA sees radio frequency identification (RFID) technology as critical for the long-term safety and integrity of the U.S. drug supply. RFID allows pharmaceutical packages to be tracked, traced and authenticated throughout the chain of distribution from manufacturer to pharmacy. ...
Food and Drug Administration (FDA) approval or authorization is critical to any new medical technology or treatment's success. But coverage and reimbursement issues can be just as determinative. ...
Businesses could lose important trademark rights by failing to meet the technical filing requirements of the U.S. Patent and Trademark Office and the Trademark Trial and Appeal Board, as demonstrated by an international case of earlier this year....
Be careful when hiring an independent computer programmer to write software for your company. A recent court case offers insight into how you should address the ownership of such programming. By leaving ownership issues open, businesses invite expensive litigation. ...
Wisconsin companies regularly and eagerly await responses from the FDA to requests for authorization of clinical trials, submissions for premarket clearance, and other submissions and applications. But a different type of FDA letter -- a warning letter -- is much less welcome....
During a week in which President Bush announced his choice for a seat on the U.S. Supreme Court, it would have been easy to overlook the storm building around the next election for a seat on the Wisconsin Supreme Court. ...
Although outsourcing has been utilized by thousands of U.S. companies since the 1970s, it has become an increasingly controversial topic. ...
Businesses that manufacture FDA-regulated products are not the only ones that can be inspected by the U.S. Food & Drug Administration at any time. The FDA also inspects clinical trial sites (studies in humans) and nonclinical laboratories that conduct animal, plant or microorganism studies...
The Supreme Court's decision against file-sharing networks affects how software companies and other technology providers will function in the future when their technology can be used to play, transmit or store copyrighted content....