“Sen. Charles Grassley (R-Iowa), who is investigating the safety of health information technology, appears to be interested in exploring whether the Food and Drug Administration should regulate such products.
Grassley has sent letters to Health and Human Services Secretary Kathleen Sebelius, and H. Stephen Lieber, CEO at the Healthcare Information Management and Systems Society, asking for the organizations’ views on a position paper that called for regulation of clinical software. The paper was published in the Journal of the American Medical Informatics Association in 1997. That paper spurred lengthy consideration within the FDA, which ultimately declined to regulate clinical systems amid strong industry opposition.”
Article
Joseph Goedert, HDM Breaking News, 25 February 2010
