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HHS Moves to Dismiss HIPAA Complaint

(from AAPS News, Jan, 2002).

As expected, on November 30 the US Department of Health and Human Services filed a Motion to Dismiss the complaint filed by AAPS, Congressman Ron Paul, and several citizens, challenging the HIPAA privacy regulations.

As AAPS member Taj Becker, M.D., of Utah explained: "A Court is like a boxing ring. But to get your day in Court, you have to overcome a number of barriers designed to keep you out of the ring."

Disregarding all the expense that physicians are supposed to incur in preparation for the April, 2003, deadline, HHS asserts that the plaintiffs' claim is unripe because they have not yet suffered any injury due to enforcement. Patients' fears of disclosure of their records to the government, and the resulting chill on patient-physician communications, is called a mere hypothetical that depends on "a succession of increasingly unlikely events." After all, "the Secretary may decide not to request access to any protected health information," and the chance of accessing that of the individual plaintiffs is "statisti-cally remote." Privacy is thus relative and subject to lottery.

HHS apparently believes that the scope of regulations can be much broader than the actual content of a law. The fact that Congress included only electronic transmissions does not limit rulemaking, in HHS's view, as long as the regulations "contain" the standards called for by law along with whatever else is "reasonable and appropriate to effectuate the purpose of the Act." That purpose, as HHS perceives in its omniscience, was "to promote the computerization of medical information." Congressional intent would be thwarted "if, by reverting to paper, covered entities could circumvent parts of the statute and the regulations." Congressional inaction after the rule was promulgated is taken by HHS to mean acceptance.

On the other hand, HHS does seem to recognize the Constitutional problems that would result from federal regulations of patient-physician communications that are not arguably part of a national, multi-billion-dollar industry:

It bears repeating that the Privacy Rule applies only to covered entities. The proverbial country doctor who deals only in paper, or who has a computer but conducts none of the transactions referred to in section 1173(a) electronically, would not be a covered entity and would not be subject to this legislation.

As to the Regulatory Flexibility Act, the Secretary demonstrated "reasonable compliance" by "retain[ing] an outside consultant to assess concerns raised in the public comments about the cost of systems compliance by small businesses." Prosecutors, of course, apply a much higher standard to physicians accused of fraud and abuse.

The Paperwork Reduction Act, HHS argues, does not provide for judicial review. The "sole remedy ... is the ability to raise non-compliance with the Act as a defense to an enforcement action." If a form lacks the required control number, "no person shall be subject to penalty for failure to comply with the collection of information."

Even if some provisions of the rule might not pass Constitutional muster, HHS argues that the "final" rule might change before it is enforced, rendering the complaint moot.

This Motion gives an interesting insight in the HHS view of privacy: (1) HIPAA "protects" privacy in that it only permits but does not require disclosure to government. (2) "There is no common law or federal physician-patient privilege." (3) Invasions of privacy are merely an "unpleasant" aspect of many facets of health care. (4) Being in a government data base is a small price to pay for preventing the x-ray technician from getting an unnecessary glimpse of your chart.

The Judge has scheduled a conference for January 4.

Doctors, Patients Harmed by Privacy Regs

(from AAPS News, Feb., 2002)

In response to the government's assertion in AAPS et al. v. HHS that any harm from the Privacy Rule is a mere hypothetical, a number of AAPS members have come forward to file affidavits attesting to the costs and other harmful effects they are already experiencing. Additionally, patient plaintiff Dawn Richardson declares that not only have her communications with physicians been chilled, but her access to medical care for her children is significantly reduced.

"Now that government has access to patient records, physicians have already expressed to me and members of PROVE [Parents Requesting Open Vaccine Education] that they will no longer care for children who have not been fully vaccinated in compliance with all government vaccine recommendations and mandates because they fear penalty."

Mrs. Richardson also testified to personal involvement with parents who had been threatened with seizure of their children because of lawful decisions to decline a controversial vaccine. "The Privacy Rule discourages patients ... from providing medical history ... that can be used against them."

Among the arguments in a 50-page memorandum responding to the government's Motion to Dismiss, AAPS points out that the Defendant actually left out the last four words in quoting the Tenth Amendment-"or to the people" - attempting to deny that "the Constitution divides authority between federal and state governments for the protection of individuals," as "State sovereignty is not just an end in itself" (Coleman v. Thompson, Blackmun dissenting).

The HHS claim that the narrow delegation of authority to regulate electronic records constitutes nearly unlimited authority to regulate all medical information "is akin to the Federal Communications Commission (FCC) claiming that because it can regulate interstate phone calls, it can also regulate other activities of persons if they ever make an interstate phone call."

AAPS requests discovery on a number of points: the ratio of paper to electronic records; the accuracy of the HHS allegation that "an overwhelmingly large number of comment-ers" urged the expansion of regulation to all records; the facts relevant to claiming an exemption from the Paperwork Reduction Act; and the actual steps the agency took to minimize the impact on small entities as required by the Regulatory Flexibility Act. The mere fact that an outside consultant was retained is not enough.

A hearing was held in Houston on Jan. 4.