Medical Device Daily Washington Editor

"Power to the people" is an expression that has a decidedly Sixties ring to it, but it seems to be morphing into a mantra for modern healthcare, and the Department of Health and Human Services is doing its best to put people power into electronic health records (EHRs).

In a conference call Tuesday, two officials at HHS gave details on an upgrade to the department's web-based family health history tool that will give healthcare providers a better look at the risks and propensities of the patient along with details of that patient's individual health history. However, the reliability of that information may be called into question, given the number of hands that will massage the data.

Acting Surgeon General Steven Galson said during the conference call, "we wanted a tool that was ready for the age of electronic health records," describing the system's characteristics as including standardized data formats. He said that HHS's ambitions for the family history health tool also includes convenience, consumer control, privacy, and that it be ready for use in physician decision support. "Today, with this new version of My Family Health Portrait, we're achieving these goals," Galson said, adding that the data could be electronically transmitted to other family members or stored and retrieved on thumb drives and conveyed that way.

The family health history tool is an open-source program based on extensible markup language (XML), which like hypertext markup language (HTML) is a subset of the electronic metalanguage known as standard generalized markup language, or SGML.

The web-based interface is housed on a server at the National Cancer Institute, but data disappear from NCI computers at the end of the session and are permanently stored on the user's computer. That user would then send the file to kin for updates on their health statuses to help build a genetic profile for each member of that genealogical line, a source of information that can help healthcare providers choose more accurately which treatment will work for that patient.

Robert Kolodner, the national coordinator for health information technology, said the family history instrument, which made its debut in 2004, is "another important step in empowering individuals in managing their personal health information" and building a national health information infrastructure. "Individuals will be able to play an active role in their health and care on a whole new level," and doctors will be able to connect "with other providers anywhere in the nation."

In response to a question about whether home computers are truly safer than the systems run by the federal government, Galson said, "in general, the impression is that [most people are] more skeptical about a centralized government database "than data safety on their own computers. Galson acknowledged that "there are large centralized databases ... that are very secure," and that such databases will eventually be needed for family history data to be effectively merged with the individual's own health history if this system is to make any impact on care.

Another issue is that of the reliability of information that may pass through several sets of hands on its way to the doctor's office. As for a physician's liability for treatment that goes wrong when based on erroneous information, Jim Harman, a partner in the law practice of Cirignani, Heller & Harman (Chicago), told Medical Device Daily that this will not be an issue for the most part.

"A physician gets a history from the patient and there's no liability for treatments based on that information," he said, and any errors provided via an electronic family history is, in legal terms, "no different from the patient verbally giving inaccurate information.

"There is an argument that could be made that this is not as good as a live history," Harman said, but he also noted that an electronic family history "would be used as an adjunct, not as a substitute."

Still, a doctor has to be careful in the case of a patient who may suffer from cognitive disorders. One possible trouble spot is when "the patient was available to take a real live history and the physician chooses to rely" on the electronic data because of suspicions regarding the patient's recall, Harman said.

He also acknowledged that in the case of a patient who suffers from an undiagnosed case of cognitive disorder, a suit could conceivably proceed on the grounds that the doctor should have known that the patient's recall was suspect. Should that doctor ignore the electronic family history in favor of the patient's information, liability could be incurred in the event of an untoward outcome.

The family health history tool can be found on the web at

OIG: FDA lax in CI oversight

The Office of Inspector General at the Department of Health and Human Services recently reviewed FDA's oversight of clinical investigators (CIs) who participate in drug and device trials, and found the agency's oversight lacking.

According to the OIG report, dated January 2009, 42% of applications for new drugs and devices lacked financial information on CIs who took part in studies. In most of those cases, sponsors "used the due diligence exemption to indicate that they were unable to provide complete financial information," OIG states, which is regulatorily permitted. The document also states that neither FDA nor the sponsor "took action for 20% of marketing applications with disclosed financial interests."

Among OIG's recommendations is that FDA obtain financial information from CIs prior to commencement with a study arm, but FDA's argument is that this is the job of the sponsor. However, OIG rebutted that FDA "has no mechanism in place to ensure that sponsors are in fact collecting" such data.