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Bush Rolls Back Rules on Privacy of Medical Data

August 10, 2002
By ROBERT PEAR






WASHINGTON, Aug. 9 - The Bush administration today formally
rolled back 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 information to market prescription drugs and other
health care products.

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

The rules are the final version of changes proposed in
March, embody more than five years of work and have the
force of law. Most health care providers and insurers have
to 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 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 paying claims. Instead,
providers will have to notify patients of their remaining
rights and have to make "a good-faith effort to obtain a
written acknowledgment of receipt of the notice."

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

The secretary of health and human services, Tommy G.
Thompson, 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," Mr. Thompson said.

The rules guarantee patients access to their medical
records and limit the 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.

Senator Edward M. Kennedy, Democrat 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, Mr. McAuliffe said, "it's O.K.
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.

A spokeswoman for the H.M.O. group, Susan M. Pisano, said,
"The final rules represent a balanced, workable approach
that protects privacy without undermining patients' health
care."

The rules appear to set strict standards on using personal
data from patients for marketing. They prohibit drugstores
from selling personal medical information to a drug company
or other business that wants to sell products or services.

In the last few years, some drug companies have paid
pharmacies for customer health information and used it to
try to sell products to individuals with conditions like
osteoporosis, diabetes or depression.

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

Representative Edward J. Markey, Democrat of Massachusetts,
said the Bush administration had made some improvement in
the marketing rules, but left some loopholes.

"The final regulations appear to shut down some of the
existing avenues of commercial exploitation of personal
medical data by third parties without the knowledge or
consent of the patient," said Mr. Markey, who is
co-chairman of the Congressional Privacy Caucus. "But the
regulations still allow a drug company to pay a pharmacy to
act as its agent and allow the pharmacy to do the marketing
without disclosing the financial arrangement."

Although a drugstore could not sell health information on a
patient to a drug company, Mr. Markey said, the drug
company could pay a pharmacist to recommend that patients
switch from one drug to another. The definition of
"marketing" in the new rules excludes communications to a
patient by a health care provider who is promoting goods
and services offered by the provider itself.

An administration official confirmed that reading of the
rules.

Dr. Paul S. Appelbaum, president of the American
Psychiatric Association, criticized the decision to drop
the consent requirement.

"This abolishes the traditional control that patients have
had over access to their medical records," Dr. Appelbaum
said. "It may discourage patients from revealing
information to their physicians that's necessary for their
treatment, and it may encourage doctors not to record
important but embarrassing information in the patients'
medical charts."

Lobbyists for hospitals, drugstores and insurance companies
saw the Clinton rules as unworkable. Pharmacists had 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 even inquiring about their
problems.

But Democrats and consumer groups said those standards were
needed because of an explosion in information technology
that permitted the dissemination of medical data with the
click of a computer mouse.

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 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."

The federal rules establish minimum protections for medical
privacy. State laws providing more protection will still
apply.

Under the rules, the "incidental use or disclosure" of
personal information is allowed. For example, doctors can
still use sign-in sheets in waiting rooms and talk to
patients in semiprivate hospital rooms without fear of
violating the rules.

http://www.nytimes.com/2002/08/10/politics/10PRIV.html?ex=1029982981&ei=1&en=3fe87b5b9a502618



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