It wasn't the idea of paperless prescriptions or bar codes for drugs or even the concept of an electronic medical record that got people to their feet. However, when Secretary of Health and Human Services Tommy Thompson told the audience that they would have access to a standardized medical vocabulary system, that's when they enthusiastically responded. The announcement was made to health information specialists attending the National Health Information Infrastructure meeting in Washington early last month.

The Office of the Assistant Secretary for Planning and Evaluation sponsors the National Health Information Infrastructure and seeks to develop a consensus on a national action agenda for further development of a national infrastructure for health information. Building a unified electronic medical record system whereby an emergency department physician in, say, Poughkeepsie, could gain access to your medical record in Petaluma gained momentum with Thompson's announcement. HHS reached an agreement last month, he said, with the College of American Pathologists (Northfield, Illinois) to license English and Spanish-language editions of its Snomed Clinical Terms (Snomed CT), Snomed standing for systematized nomenclature of medicine.

The $32.4 million, five-year contract with HHS' National Library of Medicine (Bethesda, Maryland) will give providers free access to the core content and all version updates to Snomed CT starting in January 2004. "'Why would the government make this valuable resource available free of charge?' you might ask," said Thompson, preempting an obvious question. "It's because we want you to use it, and we want all of the nation's healthcare providers to use it." Payment for the use of Snomed will be shared by HHS, the Department of Veterans Affairs and the Department of Defense.

Hailed as the world's most comprehensive multilingual clinical reference terminology available, Snomed CT was developed in collaboration with the United Kingdom's National Health Service and is based on content from both organizations. The agreement opens the door to creating a common medical language as a key element in building a unified electronic medical record system in the U.S., Thompson noted. "For over 40 years, the College of American Pathologists has been a recognized world leader in the continuing evolution and maintenance of clinical terminology," said the organization's president, Paul Raslavicus, MD. "The college has long held that by using a common approach to clinical coding, the coordination and exchange of information is enhanced across the continuum of care," he said. "Patient care is enhanced, biosurveillance becomes realizable."

He added that the organization's agreement with the National Library of Medicine "lays the foundation to support significant advances in all areas of healthcare. The college is pleased with this collaboration because it will advance quality healthcare and patient safety." Additionally, HHS has commissioned the Institute of Medicine to design a standardized model for an electronic medical record, Thompson told the attendees. The healthcare standards organization known as HL7 will evaluate the model once it's been designed, he noted. HHS will share the standardized model with all components of the healthcare system once it's established, which is expected for sometime in 2004, he added.

Banks and financial institutions all across the country can talk to each other electronically, which has streamlined customer transactions and reduced errors," Thompson noted. He added, "In fact, a high school teenager can swipe your groceries over a scanner at the grocery store and make no errors, but the chances for errors in the hospital are higher." Thomson said, "We want to create the same infrastructure for the American healthcare system. We want to build a standardized platform on which physicians' offices, insurance companies, hospitals and others can all communicate electronically, which will improve patient care while reducing the medical errors and the high costs plaguing our healthcare system."

Use of Snomed also will facilitate research and detect public health trends faster through immediate data. Referring to a recent article in the New England Journal of Medicine which charged that half of the adult population is getting substandard care, Thompson emphasized the need for current data. "That study which [to me] is very disappointing used data that were three years old. All of you, more than most providers, realize the importance for data right now," he said.

The National Library of Medicine is part of the National Institutes of Health (also Bethesda) and is the world's largest library of health sciences.

Medical technology economics argued

What is unique to the healthcare industry so that new technologies and healthcare innovations seem not to result in greater efficiency and lower production costs? That's the question lawmakers attempted to answer last month during a hearing of the Joint Economic Committee, which includes members from both legislative chambers. "In most sectors of the economy the introduction of new technologies and other innovations often result in greater efficiencies and lower production costs," said Sen. Bob Bennett (R-Utah) in his opening remarks to members of the committee. "In healthcare," he said, "the opposite appears to be true." Bennett, chair of the committee, convened the hearing to discuss "Technology, Innovation and the Costs of Healthcare."

In written testimony presented to the committee, the Advanced Medical Technology Association (AdvaMed; Washington) argued the contrary view, that medical technology does benefit the economy but that those benefits are not always short-term or obvious. It offered the view that medical technology produces enormous long-term benefits for patients, the healthcare system and the overall economy. Rapid medical technology innovation fueled by record investments in research and development is the reason for the benefits, AdvaMed said.

"Medical technology is one of the key reasons healthcare in the U.S. is the best in the world. Medical technology is transforming healthcare in a variety of ways, and the results are measurable and impressive. In addition to the benefits to patients, these innovations improve productivity and health system efficiency," the organization said in its statement.

The hearing came on the heels of a study released a day before that found that uninsured Americans have less access to medical technologies and that this may be a cause for increased costs. The study, published in the July 8 issue of the journal Health Affairs, concluded that medical technology advances aren't reaching the millions of uninsured in America, an access gap the researchers estimate is costing the nation $1.1 billion a year. The "Uninsured and the Benefits of Medical Progress" article stated that medical technology offers positive net benefits for several conditions, especially heart disease, cataracts and depression.

Researchers compared the use of high-tech treatments for heart attack, cataracts and depression among insured and uninsured patients aged 55-64. In each case, the uninsured group received the high-tech treatments at lower rates compared with the insured group. The discrepancy amounts to an estimated annual loss of $350 in excess morbidity and mortality costs per uninsured person in this age group, the researchers found. The study was funded by the Commonwealth Fund's (New York) Task Force on the Future of Health Insurance.

Historically, cost inputs for medical technology have been measured through increases in healthcare spending, noted AdvaMed. The trend in recent years, however, is that researchers are measuring the benefits of the health and economic outputs from the expenditures, the organization added. "Medical technology holds the potential to help the U.S. and the world cope with increasing healthcare demands by patients and an aging population. Innovation is enabling patients to live longer and healthier lives, require less medical care and allowing our healthcare system to get more for every dollar spent," according to AdvaMed.

It pointed to two studies that demonstrate the value of medical technology. It concluded that society received up to $2 of benefits for every $1 spent on healthcare in the 1980s, the last decade with complete data that exist. The second study found that medical technology is helping to dramatically reduce disability levels in the U.S., which improves quality of life, increases productivity and reduces healthcare costs, the association said. Federal and state obstacles to innovation still exist, AdvaMed said, and steps should be taken to eliminate barriers to patient access. Fully funding FDA to reduce product review times, as well as streamlining Medicare coverage, coding, and payment processes lasting 15 months to five years to make new technologies available to patients are a few needed steps, it added.

Harmonization of submissions going global

The FDA is embarking on a voluntary pilot program to test the notion that we truly operate in a global economy. The ambitious program, outlined in new guidance document, was published in the June 26 issue of the Federal Register and is designed to give device manufacturers the opportunity to submit premarket applications with the least amount of conflicting burdens among different countries.

Dubbed a "globally harmonized alternative," the idea is to assist the device industry and FDA staff with a submission process that meets regulatory requirements in five countries.

The alternative submission process is described in "Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices," otherwise known as the "draft STED document." The STED document was developed by a study group of the Global Harmonization Task Force and was published as a draft document in December 2000.

The Global Harmonization Task Force (GHTF) is a voluntary group of medical device regulatory officials and industry representatives from the U.S., Canada, Australia, the European Union and Japan.

The goals of GHTF are to encourage convergence in regulatory practices with respect to ensuring safety, effectiveness, performance and quality of medical devices; promoting technological innovation; and facilitating international trade. Because all countries will participate in the pilot program, GHTF encourages manufacturers to prepare submissions using the draft STED document for a device to as many of the participating countries as possible.