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 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 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?"

Grassley has considerable legislative clout as the ranking member--the leading Republican--on the Finance Committee. Last October, he sent letters to 10 health I.T. vendors asking how they handle complaints of faulty software and whether clauses in their contracts prohibit providers from discussing flaws with third parties, or shield vendors from liability for harm that results from the use of I.T. Grassley sent a similar letter in January to 31 hospitals or delivery systems.

"As I stated in recent questions to you, I strongly agree that HIT has the potential to prevent medical errors and increase the efficiency and effectiveness of health care delivery, thereby improving the safety and quality of care," Grassley noted in the new letter to Secretary Sebelius. "However, I have also been surprised by the lack of discussion about patient safety concerns when, for example, HIT products are not functioning properly or when they are being used incorrectly."

Both new letters are available at Click on press releases, then Grassley's releases, then the link to the HHS letter that includes the HIMSS letter.

--Joseph Goedert

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