Law, Regulation and the Medical Use of Nanotechnology

While protection of society and individuals is essential, it is also impor tant that legal and regulatory measures applied to nanotechnologies in medicine are rational and do not unnecessarily blunt the proliferation of valuable modalities. In most respects the existing U.S. legal and regulatory structure is flexible and suffi ciently adaptive to accommodate the challenges posed by the use nanotechnology in medicine. In product liability and medical malpractice in particular, currently existing theories and approaches should apply to this revolutionary technology without fundamental revision. The regulatory and approval structure, too, should be mostly serviceable as well. However, the p?tential of biomedical nanotechnologies to have a wide range of post-approval, unintended and un-discoverable conse quences pose a special challenge. As a result, an integrated, national post-approval registry tracking the use of nanotechnologies should be created. Because different nanosubstances used for different purposes may have similar ill-effects, it is impor tant that the registry utilize a centralized repository in which all medical uses of nanotechnologies can be analyzed across uses and technologies and uncover p?tfalls and limitations in the shortest possible period.