"What the federal government is doing is giving...blanket permission on behalf of individuals for the use and disclosure of their health information, regardless of the individual's wishes," said Jim Pyles, attorney for the plaintiffs.
"The regulations have a rather ominous facet to them in that they not only eliminate the right of the individual to give or withhold consent, but they also confer essentially a federal license on thousands of organizations to go get your information, and they call that 'regulatory permission,'" Pyles added.
When patients realize that others can now get access to their medical files, Pyles believes, they will be reluctant to share as much information with their own doctors, thus jeopardizing the nation's health care system.
The lawsuit was brought by a coalition of health privacy groups and physicians, including the American Psychoanalytic Association and the National Coalition of Mental Health Professionals.
The suit alleges that the privacy rule as written runs contrary to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and that the rule violates the Fifth Amendment protection of liberty.
The suit was filed in federal district court in Philadelphia because of the city's historical significance in the nation's founding principles, Pyles said.
Critics like Pyles point to provisions of the rule that allow disclosure of personal health information without patient consent for purposes related to treatment, payment and a long list of "health care operations."
Rep. Edward Markey (D-Mass.) believes that "health care operations" includes not just treatment and payment, but also a wide range of business planning, underwriting and fundraising activities.
Markey has introduced a bill (H.R. 1709) that would require patient consent before disclosure of medical information (with exceptions for filling prescriptions and making referrals), require marketing companies to disclose to consumers their financial ties to drug companies and prohibit disclosures to the FDA for all but a limited list of public health reasons.
Rep. Ron Paul (R-Texas) has introduced a bill to repeal the privacy regulations in their entirety.
Bill Pierce, spokesman for the Department of Health and Human Services, declined to comment on the lawsuit because agency officials have not seen it. But criticisms of the regulations are misplaced, Pierce believes.
"We think we have struck the appropriate balance between protecting patients' privacy and not interfering with the delivery of health care," said Pierce. "And we think that's very important.
"What we've done is not interfered with the delivery and the expectation of the health care and at the same time provided first-ever federal protections," said Pierce. "Up to this point, there have never been federal protections in this area."
Pyles blames not just the Bush administration, but also the insurance industry lobby for the final regulations.
"The insurance industry is pushing hard to eliminate the right of consent for the public because they want unrestricted access to as much health information as they can get," said Pyles.
"That helps them reduce their financial risk" and creates a valuable, marketable database of patient information, he said.
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