Bush revises medical privacy

Clinton-era consent rules on use of records eased

Comprehensive standard set

White House toughens restrictions on marketing


WASHINGTON - The Bush administration formally rolled back yesterday some major protections for the privacy of medical records adopted by President Bill Clinton. But at the same time, it also set new standards for the use of personal data to market prescription drugs and other health care products.

The rules, the first comprehensive federal standards for medical privacy, will affect virtually every doctor, patient, hospital, drugstore, health insurance company and medical researcher in the United States.

The rules issued yesterday are the final version of changes proposed in March. They embody more than five years of work and have the force of law. Most health care providers and insurers must comply by April 14 or face civil and criminal penalties, including a $250,000 fine and 10 years in prison for the most serious violations.

The Bush administration decided to abandon the core of the Clinton rules, a requirement that doctors, hospitals and other health care providers obtain written consent from patients before using or disclosing personal medical information for treatment or the payment of claims. Instead, health care providers will have to provide patients with notice of their remaining rights, and they must make "a good-faith effort to obtain a written acknowledgment of receipt of the notice."

Administration officials proposed the change despite opposition from consumer advocates, patients' rights groups and psychiatrists.

Tommy G. Thompson, the secretary of health and human services, said the rules struck a common-sense balance. "The prior regulation, while well-intentioned, would have forced sick or injured patients to run all around town signing consent forms before they could get care or medicine," he said.

The rules guarantee patients access to their medical records and limit the amount of information that can be disclosed for various purposes.

The issue of medical privacy now goes to the political arena. Some Democrats are already making an issue of the new rules.

Democratic Sen. Edward M. Kennedy of Massachusetts said the administration was "favoring the interests of powerful corporations over those of ordinary Americans."

In a recent speech, Terry McAuliffe, chairman of the Democratic National Committee, said the White House seemed to worry less about the privacy of medical records than about the secrecy of Vice President Dick Cheney's energy task force.

Under this administration, McAuliffe said, "it's OK to reveal personal medical information about the American people, but when the oil companies meet with policy-makers to ask for special favors, that's guarded like a state secret."

The new rules won praise from the American Hospital Association and the American Association of Health Plans, which represents health maintenance organizations. Susan M. Pisano, a spokeswoman for the HMO group, said, "The final rules represent a balanced, workable approach that protects privacy without undermining patients' health care."

The new rules appear to set strict standards on the use of personal medical data from patients for the purpose of marketing. The rules explicitly prohibit drugstores from selling such information to a drug company or other business that wants to market products or services.

In the past few years, some drug companies have paid pharmacies for customer health information and used it to try to sell products.

Mary R. Grealy, president of the Health Care Leadership Council, which represents large health care corporations, said the Bush rules were "stronger and tougher" than the Clinton rules on marketing.

Lobbyists for hospitals, drugstores and insurance companies saw the Clinton rules as unworkable. Pharmacists said it would be difficult to obtain written consent from a patient whose doctor phoned in a prescription that was picked up by a neighbor or a relative.

The Mayo Foundation of Rochester, Minn., said the consent requirement was an "affront to patients" and "bad medical practice," because it would force doctors to secure written consent from patients before inquiring about their problems.

But Democrats and consumer groups said stricter standards were necessary because of an explosion in information technology that permits people to easily disseminate medical data, including genetic information.

The new rules include these provisions:

In general, information from a person's medical records cannot be disclosed to an employer unless the patient specifically authorizes the disclosure.

Patients can review their medical records and request changes to correct any errors.

Researchers can use medical records to track an outbreak of disease if they strip the records of the patients' names, addresses, Social Security numbers and other "direct identifiers."

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