Government officials who "get it"

I heard Department of Health and Human Services Secretary Michael Leavitt speak at the AHRQ Annual Patient Safety and Health Information Technology conference this week. The linked article summarizes his plans for spearheading standardization on electronic medical records data.

It is with great pleasure that I can report this government official seems to know the issues, challenges and benefits of such an initiative quite well.

US moves to spur digital health records nationwide
By Lisa Richwine
Mon Jun 6, 5:11 PM ET

The U.S. government is taking steps to help spawn a nationwide network of electronic medical records that are easily accessible but protect patient privacy, Health and Human Services Secretary Michael Leavitt said on Monday.

A new advisory panel will make recommendations aimed at prodding the private sector to establish standards so medical records can be shared throughout the health-care system, Leavitt said.

"In order for health IT (information technology) to move forward, we have to have interoperable standards ... creating a system where information is digital, privacy protected and interchangeable," Leavitt said in an interview ... the new panel, announced by Leavitt at a health IT meeting in New York, will have 17 government and private sector members, plus Leavitt as chairman. The group will give recommendations on how to make health records compatible among varying computer systems while keeping patient information secure. The panel will exist for at least two years and possibly as long as five years ... President Bush has set a goal for most Americans to have electronic health records by 2014.

The last paragraph was particularly interesting:

Leavitt said the technology also would be a boost to the Food and Drug Administration's efforts to monitor drug side effects because reports from throughout the country could be gathered quickly for analysis.

Then there's this from the New York Times:

Drug Safety System Is Broken, a Top F.D.A. Official Says
By Gardiner Harris

WASHINGTON, June 8 - A top federal drug official told a medical advisory board on Wednesday that the nation's drug safety system had "pretty much broken down" and that there was room for "a lot of improvement" in the government's approach to uncovering dangers in drugs already on the market.

The official, Dr. Janet Woodcock, deputy commissioner of operations at the Food and Drug Administration, made her remarks before a committee of experts at the Institute of Medicine, who had been asked by the agency to suggest safety improvements after a year of well-publicized troubles, including the withdrawal of two big-selling painkillers.

... She said the drug agency had long known that it needed to improve systems for learning about problems with drugs on the market. One way to do that, she said, is to take advantage of electronic health records from managed-care organizations.

As I wrote here, I agree with these assessments. Unfortunately, based on my experiences in pharma (where my experience in EMR and views on its use for drug safety surveillance were quite completely ignored, or perhaps I should say discarded), I predict there will be significant initial opposition by pharma to use of data collected on adverse drug events from EMR's. It is not data from a RCT, after all, and will invariably cause major headaches after the rollout of new drugs.

-- SS

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