Electronic Health Records

FDA Testifies to Six Deaths and 44 Injuries Related to Health IT

Jeffrey Shuren, FDA: "...To date, FDA has largely refrained from enforcing our regulatory requirements with respect to HIT devices. Nevertheless, certain HIT vendors have voluntarily registered and listed their software devices with the FDA, and some have provided submissions for premarket review. Additionally, patients, clinicians, and user facilities have voluntarily reported HIT-related adverse events. In the past two years, we have received 260 reports of HIT-related malfunctions with the potential for patient harm —including 44 reported injuries and 6 reported deaths. Because these reports are purely voluntary, they may represent only the tip of the iceberg in terms of the HIT-related problems that exist...."

MN's System Reform Was Once Considered "Communism"

WALTER MCCLURE, who worked with Paul Ellwood to create the HMO, was interviewed in August 2012. Minnesota's health care system is close to where he wants health care to be with outside analysis of patients and doctors. From the Interview: "When [McClure's] team started on [cost and quality] assessment in the 1980's, the idea that someone would be looking over a physician's shoulder was considered communism. Physicians were convinced of their right to autonomy. However, by 2008 Minnesota's private and voluntary sector had accomplished a sea change in this culture with 85 percent of providers in the state participating in having their outcomes measured." [our emphasis]

U.S. Senators Cite CCHF Position in Health IT Letter to HHS

Four U.S. Senators, including Senator Tom Coburn (R-OK) sent a letter to HHS asking several questions about "the final rule fo rthe Stage 2 of Meaningful Use for the adoption of electronic health records." Doctors and hospitals can receive taxpayer funds for adopting EMRs. Penalties for failure to adopt EMRs begin in 2015. In their fourth and final bullet, the Senators cited an article, "More voices raised against EHR incentives," discussing CCHF's concerns about EHRs and MU.

Government Exchange - Control Through Data-Sharing

The government exchanges (state or federal) all follow the same regulatory structure. They are website portals through which data flows to the federal government for purposes of regulatory control and enforcement. Five federal agencies receive the data: IRS, Treasury, HHS, Homeland Security, and Social Security Administration.

EMRs Do Not Improve Care, Say 6 Out of 10 Doctors