Originally Published MX September/October 2001

GOVERNMENTAL & LEGAL AFFAIRS

Part 1: An Overview of U.S. and International Laws

For medtech manufacturers, compliance with new laws on the privacy of patient data is key to bringing a new product to market.

Edward J. Green and Lisa J. Acevedo

Fueled by the Internet and advances in computer and electronic technology, the electronic communications age has given rise to public concern about the privacy of personally identifiable information—in
particular, health information. This public concern has translated into new laws and regulations in the United States and internationally, governing the use and disclosure of personal data.

Technology permits easy and rapid collection and disclosure of personal information, much of which can be profoundly personal—especially medical information. The public recognizes that, with literally the push of a key or click of a mouse, their most personal information could be disclosed to countless numbers of people.