By Lisa Seachrist
WASHINGTON - Calling medical privacy legislation "a complicated issue," the Biotechnology Industry Organization (BIO) has nevertheless decided to urge Congress to pass comprehensive patient confidentiality measures that will at the same time protect the research enterprise.
Facing the statutory deadline of August 1999 imposed by the Health Insurance Portability and Accountability Act to either pass federal privacy standards for medical records or accept regulations developed by the Department of Health and Human Services, Congress has incentive to take up the measure.
BIO said it wants to ensure that in doing so, Congress not only considers the illegitimate uses of medical information, but the desired uses, such as medical research.
"It is in BIO's best interest that patients are very comfortable with who is using their medical information, and why they are using it," said Nancy Bradish Myers, director of federal government relations at BIO. "Most people realize that there is value to researchers having access to such information. It's just that there should be sufficient protections for patients whose information is being used."
Myers said the first issue legislators must tackle is defining what information should be protected by federal laws. In lobbying Congress on the issue, BIO will maintain that any medical information created by the health care provider or the health plan that identifies the individual and relates to the past, present or future health or health care of the individual should be protected.
Those protections should not, however, extend to information that doesn't identify an individual's identity, such as information in which the name, address and social security numbers have been stripped or encrypted, BIO said.
"We need to provide sufficient penalties that there will be a deterrent for misusing information," Myers said. "But we shouldn't prevent the legitimate uses of that information in an effort to ensure privacy."
Researchers often use medical records information to conduct vital epidemiological studies, and to unearth associations between genetic characteristics and the predisposition for disease. Myers noted that several members of the House have requested that BIO review legislative language to determine whether it will unduly inhibit research.
"I think that there is going to be a real push to make this legislation happen," Myers said. "I think it's likely that it will be a bipartisan effort as well."
BIO holds firmly that any privacy legislation should treat genetic, mental health and infectious disease information in the same manner as all medical information is treated. Myers pointed out that many diseases have some genetic component.
In addition, BIO argues that any federal law that is passed must provide a federal "ceiling" which supersedes any state privacy provisions. In the absence of federal privacy protections, some states have moved to establish privacy protections of their own.
The problem with such a patchwork of laws is that most major clinical studies, including Phase III trials, involve many different states. As a result, researchers would be compelled to comply with a plethora of potentially conflicting privacy laws.
Archives of tissue samples serve as an invaluable resource to biomedical researchers. BIO would like privacy protections that permit researchers unfettered access to these samples, by not imposing sample destruction requirements or specific consent requirements for using the tissue samples stored from a variety of medical procedures.
"Stringent consent requirements could add a whole lot of administrative burden to such research," Myers said. "Then, the poor researcher trying to find a cure for cancer is the likely one that is going to be penalized."
Myers said BIO is urging Congress to consider medical-privacy legislation on its own, and to tackle medical discrimination issues in separate legislation. In addition, some members of Congress have proposed adding medical-privacy language to patients'-rights legislation introduced this year.
"We think this is a complicated-enough issue that it needs its own attention, so we'd rather see it as stand-alone legislation," Myers said.