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Just when it seemed that our new Republican administration was going to repeal all possible regulations drafted by the Clinton administration, the Bush administration recently surprised even people otherwise “in the know” by allowing omnibus medical privacy regulations to take effect. The regulations provide considerable control to patients over their medical records. Indeed, it appears that practically whenever medical information is to be exchanged between parties, patient consent will be required. The healthcare industry is quite concerned about the burden and expense of complying with the regulations. The regulations are found at 45 Code of Federal Regulations Parts 160 and 164. To say that they are incredibly complicated is an understatement. The regulations span multiple dozens of pages and cover a number of topics. Among other things, they require establish new criminal and civil sanctions for the improper use or disclosure of information, require doctors to get patients’ consent for the use and disclosure of medical information and restrict most disclosure of health information to the least amount needed to accomplish a specific task. As a practical matter, health insurance providers, hospitals and pharmacies say they are burdensome, costly, and will undermine the quality of patient services because efforts will be diverted to compliance rather than care. While the summary to the regulations states, “the use of these standards will improve the efficiency and effectiveness of public and private health programs by providing enhanced protections for individually identifiable health information,” it remains to be seen whether “efficiency and effectiveness” truly will be the end result. Let there be no mistake; protecting personal privacy is a laudable goal. However, it is not so certain that these regulations will be the best vehicle for getting that job done. Interestingly, the Bush administration often has announced its opposition to government regulations that encumber business activities. Thus, the betting money said that the Bush administration would not support the new medical privacy regulations. Many are at a loss to explain the latter-day support provided by the Bush administration, especially those in the medical industry who had thought that their intense pressure surely would doom the regulations. Even more curious is the fact that having now given support to the medical privacy regulations, President Bush and Secretary of Health Tommy Thompson are indicating an intention to modify the regulations after they go into effect to remedy unspecified problems with the regulations. This begs the question: Why did the Bush administration end up supporting the regulations in the first place? Thompson is promising future guidelines that supposedly will “clarify” some of the “confusion” as to the impact the regulations may have on “health care delivery and access.” Thompson also plans to consider modifications that will “ensure that quality of care does not suffer inadvertently” as a result of the regulations. Thus, at best, we are left with extremely vague promises, which we hope will soon lead us through the regulatory labyrinth. Eric J. Sinrod is a partner in the San Francisco office of Duane Morris LLP, where he focuses on technology and litigation matters. His Web site is sinrodlaw.com and his firm’s site is Duane Morris LLP .

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