Tag: about
The FDA Proposes New Rule on Unique Medical Device Identification and Marking Requirements
The United States Food and Drug Administration (FDA) has proposed a rule establishing a unique device identification system for medical devices and requiring a unique device identifier (UDI) to be placed on medical devices and device packages. See 77 FR 40736 (July 10, 2012). The FDA intends the unique device identification system to reduce medical errors, create greater accuracy in adverse event reporting and post-marketing surveillance, and facilitate recalls. The proposed rule, which was promulgated in accordance with the Food and Drug Amendments Act of 2007, is the result of pilot testing and public input. The UDI requirements, process, and implementation schedule are of particular interest to medical device and instrument manufacturers, and will have an impact on manufacturing and supply chain operations. Comments on the proposed rule may be submitted to the FDA by November 7, 2012.
Goals of the … Read More »
Social Medicine?
It isn’t difficult to see that the main impact of social media penetration in our culture is an epidemic of oversharing. Americans under the age of 25 have a very different approach to privacy than, say, your average 30 year-old, and feel weirdly comfortable sharing details of their private lives. E-mail is considered to be outlandishly formal, large scale sharing over social networks and texting is commonplace, and the barriers between personal and institutional communication are nearly non-existent.
This has led, predictably, to mass sharing of medical information online — even two years ago, news organizations were reporting on the rise of “e-patients” who talk to medical experts and amongst themselves in order to obtain treatment, piece of mind and/or the thrill of exposure.
Suddenly, there is widespread information about adverse outcomes and side effects, in every search that someone does for … Read More »
The FTC Finally Issues its Report on Consumer Privacy
Interactive marketing is everywhere, and the Federal Trade Commission has struggled mightily over the past several years to deal with complex privacy issues that grow out of sophisticated, data-intensive marketing practices. On March 26, the FTC released its long-promised final report on consumer privacy. Critically, we now have a sense of the FTC staff position on future legislation, best practices and the secondary market in customer data.
The FTC was clear that it wants additional legislation to address general privacy concerns, data security and breach notifications. This is a change from the staff’s prior position that self-regulation would be sufficient, and lends weight to current efforts before congress to do exactly that (although the fact that we are currently in a highly partisan election year does diminish the likelihood of immediate action).
The rest of the report flowed logically from the principles … Read More »