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Medical Records Privacy
AAHF filed comments on the Department of Health and Human Services proposed rulemaking on "Standards of Privacy of Individually Identifiable Health Information." These regulations apply to records that are, or have ever been, in electronic form; define and limit the circumstances in which health information may be used or disclosed by health plans, health care clearing houses, and health care providers. AAHF felt the proposed regulations were extremely flawed and, in fact, offered next to no protection to patients and actually created a situation that was worse than what states had in place. There are so many exceptions, that access to individuals' records without consent would be possible virtually whenever the government, a physician, a hospital or an insurance company deems it necessary. Under the regulations, which are now final, the Federal Government has the power to decide whether or not patients' records are sent over the Internet, even if the patients have not given their consent. We were joined by Dr. Julian Whitaker, the Whitaker Wellness Institute and Robert and Janet Kephart.

The regulations were proposed under the Clinton Administration and due to take effect early in the Bush Administration. A temporary hold was placed on this, along with many other regulations similarly bridging administrations, so they could be examined and possibly amended or revoked. After opening a new comment period on the privacy regulations, and after reviewing those comments, U.S. Secretary of Health and Human Services Tommy Thompson decided to let the regulations stand as planned, but noted that they may be fine tuned in the months ahead.

http://aspe.hhs.gov/admnsimp/
http://www.emord.com/publicat.htm


Compliance Program for Solo and Small Group Practices
AAHF filed comments in November 1999 on proposed regulations by the U.S. Department of Health and Human Services Office of the Inspector General concerning the development of a compliance program guidance for solo and small group physician practices. The guidance document was to cover seven elements ranging from written policies and procedures to enforcement standards. We believed that the guidance posed distinct risks for all physicians, but particularly alternative practitioners. We were joined by Dr. Julian Whitaker and the Whitaker Wellness Institute. In June 2000, the OIG published it draft compliance program, which largely ignored our objections and trivialized physicians' concerns. In response, we filed a second round of comments in July 2000, joined by Julian Whitaker, M.D.; the Whitaker Wellness Institute; James Shortt, M.D.; Richard Wilkinson, M.D.; Samuel Snyder, D.O. and George Mitchell, M.D. In September 2000, the OIG issued its Compliance Program Guidance for Individual and Small Group Physician Practices which, although not perfect, does reflect many of the concerns we included in our comments. The full text of the Guidance can be found at http://oig.hhs.gov/new.html


Definition of Significant Scientific Agreement Standard for Supplements (Implementation of Pearson Decision)
In the Pearson decision outlined above, the Appeals Court held that the U.S. Food and Drug Administration must define, either on a case by case basis or on a sub-regulation by sub-regulation basis, a standard for reviewing health claims for supplements, and explain what it means by significant scientific agreement. The agency's dependence on an undefined standard was the crux of our law suit and the Constitutional violation which resulted in our victory. Instead of complying with the Court order, however, on December 22, 1999, the agency merely issued a Guidance explaining what kind of information it considers during a review. That Guidance fails to comply with the court mandate and seems to imply that the FDA will only authorize a claim if it is backed by proof of direct causality and randomized controlled clinical trials. This, basically, is the same level of proof expected of drugs and is far from what Congress had in mind when it passed the Dietary Supplement Health and Education Act. The Guidance is also misleading because it makes it appear that if a claim doesn't reach this still undefined level of significant scientific agreement, it is prohibited. In fact, the Court specifically said the agency must allow the use of disclaimers.
http://www.emord.com/scientific_agreement.htm
http://vm.cfsan.fda.gov/~dms/ds-labl.html
http://vm.cfsan.fda.gov/~dms/ds-labl.html#claims


Structure/Function Claims
In response to proposed regulations affecting structure/function claims allowed under the Dietary Supplement Health and Education Act, the FDA published proposed regulations that went far beyond the intent of Congress and, we believe, beyond the agency's regulatory authority. In our comments, we held that the agency lacked authority to proceed with a rulemaking because the Dietary Supplement Commission did not issue a final report and failed to address the issues mandated by Congress. In effect, the FDA had nothing upon which to base its proposed rules. We also objected to the agency's proposal to adopt a new definition for disease; a clear attempt to expand the scope of prohibitions on statements made without agency approval. The proposed rules would also have prohibited the use of specific terms in product names, logos and labeling; a violation of the First Amendment. In fact, the agency's final regulations addressed most of our concerns and went farther than we expected in relaxing its prohibitions on names and logos that may imply health claims. In addition, the FDA abandoned its efforts to redefine disease.
http://www.emord.com/publicat.htm
http://vm.cfsan.fda.gov/~dms/ds-labl.html#structure

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