Mike Leavitt, secretary of the Department of Health and Human Services (HHS; Washington) last month unveiled the creation of a commission that he will chair to develop standards to ensure that most Americans have electronic health records (EHRs) in this decade, a mission handed down from President George Bush. Speaking at a meeting in New York sponsored by the Healthcare Information and Management Systems Society (HIMSS; Chicago), Leavitt said that in the coming weeks he would be filing the charter of the American Health Information Community (AHIC). He also said that he would issue four requests for proposals. David Brailer, national coordinator of Health Information Technology, was scheduled to address RFPs the day of their issuance, Leavitt said.

Leavitt told the audience at the HIMSS Summit-Achieving National Healthcare Transformation, that these measures "will dramatically intensify the pace of progress in health information technology."

Bush has directed that payers and providers move toward EHRs to simplify the vast recordkeeping involved in the healthcare industry. Leavitt said that clinicians today don't have a guide as to the best way to go about transitioning to EHRs in their practices. In fact, he said the whole industry "can't afford to be wrong" about which direction it takes with technology. HIMSS defines an EHR as a "digital collection of a patient's medical history and could include items like diagnosed medical conditions, prescribed medications, vital signs, immunizations, lab results and personal characteristics like age and weight." HHS will spend an estimated $86.5 million on health IT in FY05, and Bush has requested $125 million for health IT in FY06.

"The president intends to have the AHIC, as we'll refer to it today, [as] the place where major government players, such as the Centers for Medicare & Medicaid Services, [the Department of] Veterans Affairs, the Department of Defense [will come together]," Leavitt said. "It's the place where they will join together with private payers, provider groups, and vendors and consumer organizations, as well as state and local government interests, to [form] a common framework that achieves interoperability."

AHIC will be formed under the auspices of the Federal Advisory Committee Act. The charter for AHIC will call for the body's dissolution within five years and will set forth the process for creating its successor body.

Leavitt said AHIC would be "open, transparent, inclusive collaboration." He said he would solicit nominations for people to serve on the AHIC and from those will appoint 17 commission members. There also will be an "advisory system" to the AHIC designed to enlist broad participation by a variety of groups. He said he was making the decision after consulting with some of the largest private payors in the country, employers, providers, technology vendors, consumer advocates, privacy advocates, and leaders of Congress and state officials.

"It's clear to me that the challenge of health IT and its vendor interoperability is so compelling, it's such a significant national problem, that it's going to require an unusual and extraordinary measure to be sure that it occurs," Leavitt told the audience.

However, he also said that AHIC would be formed as a standard-setting body only and will not be "an entity that's building infrastructure or an entity that's writing software code." He stressed that AHIC will "build upon the vast amount of standardization that's already achieved inside and outside the healthcare industry."

AHIC will have five specific tasks, with the first being to make recommendations as to how to protect privacy and how to protect security.

"I want to be very clear that the first principle in dealing with this is that the records of Americans need to be protected," Leavitt said.

Second, he said, AHIC will be "identifying and making recommendations for prioritized health information technology achievement." Also, AHIC will address certification and certification compliance.

Finally, Leavitt said, "We need to make recommendations for a nationwide architecture that uses the Internet to carry healthcare information that's secure and timely in its manner."

Leavitt emphasized that he will set an aggressive timetable to see results quickly. "I want this to work rapidly; speed is life here," he said. "We need to see deliverables and see them quickly, and I think within a matter of months not years, months we need to start seeing the results of this work."

Religious leaders question biotech benefits'

The ethics of the biotech industry and its oft-heard promises of miracle cures came under some heavy scrutiny at BIO 2005, the largest annual gathering of the biotech industry, held last month in Philadelphia. A panel of religious leaders at this major gathering of biotech voiced concerns that the industry is overselling the benefits of biotechnology with no reference to the associated risks. "There are ethical questions implicit in this industry," said Rev. Eileen Lindner of the National Council of Churches during a session on balancing the risks and benefits of biotechnology." And she noted that a variety of demonstrations outside the convention center were "noisily" highlighting this issue. Simon Best, chair of the Bioethics Committee of the sponsoring Biotechnology Industry Organization (BIO; Washington), agreed there is a gulf hindering a dialogue between the industry and religious leaders. "The industry has too often got carried away by excitement about our science and needing to attract investment," he said. "We portrayed what we did as revolutionary, not evolutionary."

Boyd Clarke, president and CEO of Neose Technologies (Horsham, Pennsylvania), said that as an evangelical Christian, he is more highly aware of such a gulf. "I am struck by how these two camps cannot talk to each other," he said. The few colleagues with whom he has discussed his religious affiliations are inclined to ask questions along the lines of, "What kind of folk dancing do you do?" But, said Clarke, "On the other hand, I have listened to more than 2,000 sermons in my time, and the number of times I have heard a cogent message on science, or economics, or work even, can be counted on one hand."

John Haas, president of the National Catholic Bioethics Center, said that contrary to the perceptions of many there is an assumption on the part of the Catholic Church that the biotech industry is committed to doing what is good. "There is a tremendous enthusiasm that biotech will solve health issues," he said. But he said there is a fear that many advances may be achieved at the expense of those who are weak and vulnerable. "Regrettably, humanity has a long history of using the weak for the advantage of others," Haas said. "The temptation is there to apply a utilitarian calculus to the value of one human over another."

There is "an incredible power for good" in biotechnology, agreed Rabbi David Teutsch, director of the Center for Jewish Ethics of the Reconstructionist Rabbinical College. Even so, the science is seen as "scary." He said that the "scariest part of it is that regulations cannot move fast enough to keep up with research." Issues like genetic engineering and cloning need a level of ethical consideration and legal compliance that so far is absent. "Employers need to do training in ethics from the top down," Teutsch said. "They need to press for greater regulation; they need to think about revealing information without compromising commercial interests."

Study: New PVC-exposure data in infants

A study released last month by scientists at Harvard University (Cambridge, Massachusetts) reports that babies in hospital neonatal intensive care units (NICUs) receiving intensive therapy with polyvinyl chloride- (PVC) softened medical devices were exposed to a toxic phthalate at very high levels an average of 25 times higher than the general population and up to 50 times higher for the most exposed. As their medical treatments intensified, the sick infants were exposed to progressively higher exposures of di(2-ethylhexyl) phthalate (DEHP), according to the study. DEHP is described by the researchers as "a toxicant that alters development of the male reproductive system in laboratory animal studies." The phthalate is used to soften PVC (vinyl) plastic medical devices such as IV bags and tubing, with various studies already having demonstrated that it leaches out of the plastic and into the human body.

The study looked at neonates in two Level III hospital NICUs in Boston those institutions not named, except for being described as "A" and "B" for a period of three days in March and April 2003. It specifically examined urinary levels of mono(2-ethylhexy) phthalate (MEHP), a metabolite of DEHP. And the study concludes that "the use of DEHP-containing medical devices is associated with a monotonic increase in urinary levels of MEHP . . . In particular, urinary MEHP levels among infants in the high' DEHP exposure group were five times as high as those in the low DEHP exposure group, after adjustment for infants' sex and institution of care. Urinary MEHP levels among infants in the medium' DEHP exposure group were twice as high as levels among infants in the low' DEHP exposure group."

It concluded that the study data are "generalizable to infants of other Level III NICUs."

Importantly, however, the researchers wrote that they had no knowledge of data "on whether such exposures are associated with adverse health effects in these neonates" and that only "[l]imited data describe the effects of neonatal exposures on health later in life."

While the health risks of using DEHP-containing medical equipment is still under debate, the FDA warned healthcare providers concerning the potential effects of these devices, especially noting the risk to certain vulnerable patients including male infants.

An organization that is convinced of the potential harm is Health Care Without Harm (HCWH; Washington), a healthcare watchdog group that has targeted, among other issues, the potential harm of DEHP, mercury in medical devices and poor medical waste disposal practices.

Stacy Malkan, communications director for HCWH, told BBI's sister publication, Medical Device Daily, that while the study did not look at the risks of disease, these risks have been demonstrated in a variety of other studies, primarily in animals. And she said an easy extrapolation suggests ongoing health risks "the higher the exposure."

She pointed to the FDA's public notification about possible risks and said that HCWH will continue to address the hospital/manufacturing communities on the issue.