The HIPAA Security Rule: implications for biomedical devices

The HIPAA Security Rule, with which hospitals must become compliant by April 2005, is broad in scope. Some aspect of this rule will affect virtually every function and department within a healthcare organization. The functions and departments that deal with biomedical technologies face special challenges due to the great diversity of technologies, the variety of data maintained and transmitted, and the risks associated with compromises to data security--combined with the presence of older technology and the absence of integrated expertise. It is essential that hospitals recognize this challenge and initiate steps now to implement appropriate information security management.