By Kim Coghill
WASHINGTON - Although industry leaders on either side of the issue can find positive points to the medical privacy rules passed by Bill Clinton, which are scheduled to become law this month, questions are being raised about their usefulness.
Lawrence Gostin, a law professor at Georgetown University in Washington, said the former administration was on the right track in making an attempt to protect the American public, but the regulations approved create an unnecessary burden and likely will not serve their purpose.
"These rules are substantial - breathtakingly substantial," Gostin said Thursday during the FDA's 2001 Science Forum at the Washington Convention Center. "These rules are very deep and one would question whether the Bush administration can overrule them."
Industry groups have raised objections and Bush administration officials are studying whether the 1,500-page regulations can be simplified. They are scheduled to take effect Feb. 26.
In a broad sense, the rules give power to patients by way of requiring health care providers to obtain written consent from patients for the use or disclosure of any information within their medical records. The written consent is voluntary - sort of, Gostin said.
"It's not voluntary because without the signature a patient may not be able to get care or insurance," Gostin said. "It is not informed consent because the patient is not going to sign a consent every time he goes into the physician's office. They will sign a consent the first time - but they don't know what is in the medical record the first time they sign it or down the road. This creates a large burden on the industry and it doesn't protect the patient."
The public believes that privacy rights are not adequately protected in the health care setting and the new rules don't do much to ease the concern, he said. Public fear and distrust of both technology and bureaucracy is likely to increase as collection, storage and dissemination of information becomes even more automated.
As scientists gain ground deciphering the human genome, trust from the public will become increasingly important.
"Already, your genetic information can be collected before you are born and after you are dead," he said. "Surveys show that most people believe they have lost their privacy."
But medical privacy is not necessarily threatened by unauthorized, illegal use of information, but of unauthorized legal use. It begins with the employer, the health insurer, the hospital and goes all the way down to a myriad of physicians, Gostin said.
"There is a systematic vertical and horizontal movement of health information," he said. "There was a time when a doctor would write your health information in a file and stack it in a locked closet and no one would ever see it. But now, information can move from New York to Minnesota by hitting a button."
And the Clinton administration has made health care professionals accountable for privacy violations of their contractors.
The provision also provides that patients will have to be informed as to whom medical information is given, including friends or family.
Under the rules, patients would have the right to review their records and propose changes.
With few exceptions, under the new regulation an individual's health care information will be used for health purposes only, including treatment and payment. For example, an employer may not access the information for hiring, firing or promotions without permission from individuals. n