Hospitals, insurance companies, health maintenance organizations and medical researchers say the rules, issued in the final weeks of the Clinton administration, would impose costly new burdens.

Members of Congress say privacy protections are immensely popular with consumers.

Bush administration officials say they are looking for ways to revise and simplify the Clinton rules, scheduled to take effect on Feb. 26.

Consumer advocates describe the rules as a milestone in the history of American medicine, the first comprehensive federal standards for medical privacy.

Under the rules, health care providers must obtain written consent from patients for the use or disclosure of information in their medical records.

The rules would affect virtually every doctor, patient, hospital, pharmacy and insurance plan in the United States.

Critics say the Clinton administration went overboard in pursuing a worthy goal. The rules, they say, are too prescriptive and, in many ways, unworkable.

Health-care providers of all types have flooded the new administration with requests to shelve the rules or reopen the rule-making process to solicit public comment on the need for major changes.

John Houston, a lawyer at UPMC Health System, affiliated with the University of Pittsburgh, said hospitals would have to buy expensive information technology, hire and train employees and rewrite contracts with hundreds of suppliers to comply with the rules. The rules, he said, are so restrictive that they "could impede patient care and disrupt essential operations" of hospitals.

Pharmacists say the consent requirement would be impractical in many situations.

How, they ask, can they obtain written consent from a patient whose doctor phones in a prescription that is picked up by a neighbor or a relative?

"Thirty-five to 40 percent of all prescriptions are picked up by someone other than the patient, in most cases a family member," said Todd Andrews, a spokesman for CVS Corp., which filled 300 million prescriptions at 4,100 drugstores in 31 states last year.

Sen. Jack Reed (D-R.I.) said the rules are causing "lots of unanticipated difficulties."

Sen. Pat Roberts (R-Kan.) said he was "stunned and terribly worried" by the rules. In many parts of Kansas, he said, hospitals are short of doctors and nurses and are "struggling to keep their doors open," so they cannot cope with the new regulations.

But Sen. Christopher Dodd (D-Conn.) said voters would punish politicians who weaken privacy protections.

Under the rules, every health-care provider must appoint a "privacy official" to develop privacy policies and procedures. Patients would, for the first time, have a federal right to inspect and copy their medical records and could propose corrections. A health-care provider would have to keep track of everyone who received medical information from the files, and a patient could demand that doctors and hospitals provide an accounting of all disclosures in the last six years.

A person who violates the rules would be subject to civil and criminal penalties, including a $250,000 fine and 10 years in prison if the offense was committed for commercial advantage. But no penalties would be imposed for violations committed during the first two years that the rules are in effect.

Doctors had pleaded with the government for strong privacy protections, but some have criticized the final rules.

"The rules miss the mark," said Dr. Donald J. Palmisano, a trustee of the American Medical Association. "They will increase costs and paperwork for physicians without improving patient care. The rules will not accomplish what they set out to do, because of loopholes for marketing, law enforcement and loosely defined `health care operations."'

Gary Claxton, the Clinton administration official who led efforts to write the rules, said he was dismayed by the recalcitrance of the health care industry.

"People in the industry should get on with the business of carrying out the rules, but instead they want to keep talking forever," Claxton said. "They are not interested in giving patients control or even a say over how their personal medical information is used."

Congress, unable to agree on a comprehensive health privacy law, directed the secretary of health and human services to issue rules. But many lawmakers said they never expected the standards to be as far-reaching as those issued by President Bill Clinton in December.

Janlori Goldman, director of the Health Privacy Project at Georgetown University, said, "The industry's proposals to weaken or withdraw the rules represent a hysterical reaction."

Goldman said the rules met a genuine need. Millions of Americans, she said, withhold information or provide inaccurate information to avoid the stigma or discrimination that might result from the disclosure of medical secrets.

Shannah Koss, an expert on health information technology at IBM, said: "It will be a real loss if these standards are significantly delayed or severely watered down. It would be better to try to fix the problems, because there's real value in privacy."

She added: "It will be incredibly difficult for any politician to stand up and say, `I don't support the public's right to health-care privacy.' That's not a winning proposition."

Copyright 2001 Chicago Tribune

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