Sen. Charles Grassley (R-Iowa): “[is it] is time to revisit FDA’s responsibilities in regulating HIT products?”

Senator Charles Grassley (R-Iowa)

Sen. Charles Grassley (R-Iowa), is interested in exploring whether the FDA should regulate Health IT products.

Senator Grassley sent letters to HHS Secretary Kathleen Sebelius and H. Stephen Lieber, CEO of the Healthcare Information Management and Systems Society (HIMSS), last week asking for their views on a 1997 position paper that called for voluntary industry oversight of Health IT as opposed to regulation.  The paper was printed in the journal of the American Medical Informatics Association, and the FDA has so far declined to regulate healthcare informatics in response to industry opposition.  Senator Grassley requested a response “No later than March 10, 2010.”

Grassley asks of Sebelius, in a letter dated Feb. 24: “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?”

He asks 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?”

Last October, he sent letters to 10 health I.T. vendors asking how they handle complaints of faulty software.  He asked whether nondisclosure clauses in their contracts prohibit care providers from reporting flaws to third parties, or shield vendors from liability for harm that arises from faulty I.T. Grassley sent a similar letter in January to 31 hospitals or delivery systems.

Senator Grassley expressed concern that, when he asked vendors and primary care providers how their concerns about equipment were handled, “In most cases, they tried raising their concerns to hospital administrators and/or to the HIT vendors, but they told me that their concerns were often ignored or dismissed.”

He noted in his most recent letter to HHS Secretary Sebelius “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.  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.”

Posted by Jack Mann on Monday, March 1st, 2010. Filed under Healthcare IT. You can follow any responses to this entry through the RSS 2.0. You can leave a response or trackback to this entry