WASHINGTON -- The Bush administration on Friday officially eliminated many
protections for the privacy of medical records by issuing final rules that allow
doctors and hospitals to distribute patients' health information without the patients'
The new rules, the first comprehensive federal standards for medical privacy, would affect virtually all patients, hospitals, drug stores, health insurance companies and medical researchers in the country.
is yet another example of the Bush administration favoring the interests of powerful
corporations over those of ordinary Americans.
Edward Kennedy (D-Mass.)
The rules would establish a series of new safeguards for medical records.
Doctors would be specifically prohibited from sharing medical information with
a patient's employer without written approval.
Patients would be allowed to inspect their records and correct mistakes. They also would be able to find out who has looked at their records and seek punishment of those who misuse the information.
But in a reversal of regulations proposed by former President Bill Clinton, Bush would allow doctors and hospitals to share patients' medical information with insurance companies, health maintenance organizations and, in some circumstances, marketing companies, without patients' prior approval.
The Bush plan does retain a Clinton-era change that would allow law-enforcement agencies access to patients' records without patients' permission. Civil liberties groups have sharply criticized the provision.
In unveiling the final rules, Health and Human Services Secretary Tommy Thompson called them a "common-sense balance" between patients' desire for privacy and the need for doctors, insurance companies and other health-care professionals to share information necessary for treatment and payment.
The Clinton-era regulations would have increased paperwork, slowed treatment and "forced sick or injured patients to run all around town getting signatures before they could get care or medicine," Thompson said.
For instance, the Clinton rules, which Bush effectively blocked from taking effect, would have required patients to keep a signature card on file at their pharmacy to have prescriptions filled.
Under the new regulations, doctors and other health-care providers would have to notify patients of their privacy policies, but they would not be required to secure the patients' signature acknowledging awareness of the policy.
Privacy advocates and congressional Democrats denounced the administration's rule changes as an invasion of patient privacy. Activists said a legal challenge could be mounted to block the rules from taking effect in the spring.
"This is very bad news," said Richard Sobel, a senior research associate at Harvard Medical School. "It's very short-sighted."
Sobel and others charged that the administration was caving in to political pressure from the medical and insurance lobbies that had tried without success to eliminate the privacy provision during the Clinton administration.
"This is yet another example of the Bush administration favoring the interests of powerful corporations over those of ordinary Americans," said Sen. Edward Kennedy (D-Mass.), chairman of the Senate Health, Education, Labor and Pensions Committee.
`A serious setback'
"These regulations are a serious setback for medical privacy," Kennedy said. "Action by Congress is clearly needed to guarantee all Americans that the privacy of their medical records will not be abused."
The rule changes do not require congressional approval, but Kennedy could try to restrict the provisions through separate legislation.
Groups representing the medical and insurance industries hailed the rule changes as a victory for patients, saying they would help reduce the costs of health care by eliminating excessive paperwork while speeding up treatment.
"We think they have really removed a barrier to getting health care," said Mary Grealy, president of the Healthcare Leadership Council, a consortium of hospitals, drug companies and HMOs.
"For the health-care industry, they've made the rule much more manageable than it was before," she said.
The American Association of Health Plans said in a statement that the more restrictive Clinton-era rules would have undercut patient care by "unduly restricting the flow of vital health information between physicians, hospitals and health plans."
The group, the nation's largest association of HMOs and other health-care organizations, called the Bush plan "a balanced, workable approach that protects the privacy of patients without undermining their health care."
The Bush administration first announced its intention to change the rules in March. It collected 11,000 public comments on the rules, though critics charge that the administration cut the comment period short and virtually ignored any criticisms of the changes.
The final rules the administration unveiled Friday appeared virtually unchanged from what it proposed in March, according to advocates on both sides of the issue who were scrambling late Friday to interpret the regulations.
The rules state that a doctor or hospital must get written permission before releasing "protected information" for "marketing activities." But it makes an exception if the marketing company only wishes to provide a patient with "a promotional gift of nominal value," such as unsolicited pamphlets about treatments or samples of drugs related to whatever illness the patient suffers.
Critics charge that allowing marketers such access could stigmatize patients by revealing their sensitive medical conditions to neighbors, co-workers or other outsiders. A 59-year-old Florida woman with a history of depression recently initiated a class-action lawsuit against drugmaker Eli Lilly and three doctors after she received in the mail a free one-month sample of the anti-depression medication Prozac and a note congratulating her on being on her way to "full recovery."
The rule changes take effect Aug. 14, 2003, for patients covered by large health plans. Smaller health plans would have until Aug. 14, 2004, to meet the new regulations.
The debate over privacy regulations dates back to 1996 when Congress proposed making them part of the Health Insurance Portability and Accountability Act. Congress set a three-year deadline to enact the provisions, but failed to meet it. The job was then given to Clinton's Department of Health and Human Services, which released its rules in December 2000, Clinton's last month in office.
Those rules would have taken effect last spring, but the Bush White House
put them on hold for a year until it could consider the changes it wanted to make.