Should FDA Regulate Health IT?

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. Sen 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 1997 position paper that called for voluntary industry oversight of the integrity of clinical systems rather than regulation. The paper was published in the Journal of the American Medical Informatics Association. The FDA, which started considering regulation in 1996, ultimately declined to do so amid industry opposition. One of the questions Grassley asks of Sec Sebelius, in a letter dated Feb. 24, is: "With over $20 billion in taxpayer money at stake and with increasing complexity in the technologies being used in our hospitals, do you believe it is time to revisit FDA's responsibilities in regulating HIT products being used in clinical care?"Among the questions to HIMSS: What is HIMSS' position on FDA's current role in the regulation of HIT products? Would you support providing FDA with more authority in this area? Is there another agency that should be given authority to regulate the safety of HIT products?"