By Kim Coghill
WASHINGTON - The Clinton administration released the nation's first-ever standards for protecting the privacy of Americans' personal health records.
The regulation released Wednesday will protect medical records and other personal health information maintained by health-care providers, hospitals, health plans and insurers. According to a statement released by Donna Shalala, secretary of Health and Human Services, the new standards limit the nonconsensual use and release of private health information; give patients new rights to access their medical records and to know who else has accessed them; restrict most disclosure of health information to the minimum needed for the intended purpose; establish new criminal and civil sanctions for improper use or disclosure; and establish new requirements for access to records by researchers and others.
"The implications here are that the rule is designed to try to prevent the inappropriate use of personal medical information, and that would include genetic information," said Michael Werner, director of federal government relations and bioethics counsel for the Washington-based Biotechnology Industry Organization. "We all know that one of the implications of the genome project is that we are going to start getting important medical information, so rules that protect the inappropriate use of that information are important and valuable.
"BIO's position has always been that we would support legislation or regulations that would protect people and protect their confidentiality and make them confident that their personal medical information would be used appropriately," Werner told BioWorld Today.
The rule also requires that most providers get their patients' consent for routine use and disclosure of health records in addition to requiring their authorization for non-routine disclosures.
Employees will be protected against unauthorized use of medical records, as employers will not be able access health information without authorization from the patient.
With few exceptions, under the new regulation an individual's health-care information will be used for health purposes only, including treatment and payment. For example, an employer may not access the information for hiring, firing or promotions without permission from individuals.
"The idea that the government would create a standard to protect people's information is appropriate and we would support it," Werner said. "The question is whether or not when they create those rules, they create them in such a way as to make important research more difficult, more expensive and in fact, burdensome."
The American Medical Association released a statement agreeing in principle with the government's effort to safeguard the privacy of medical records, but cautioned that patients and physicians will not know the real benefits, burdens and costs until the complex maze of new rules and regulations is closely analyzed.
Werner agreed and would not comment further on the rule because he had not finished reading the 900-page document.
AMA Says GMO Foods Need No Special Labeling
The American Medical Association released a report in mid-December saying there is no scientific justification for special labeling of genetically modified foods, as a class, and voluntary labeling is without value unless it is accompanied by consumer education.
The report was based on a review of the technology used to produce transgenic crops and genetically modified foods, including the current regulatory framework, possible human health effects, potential environmental impacts, and other consumer-related issues.
Genetic engineering is capable of introducing allergens into recipient plants, but the overall risks of introducing an allergen into the food supply are believed to be similar to or less than that associated with conventional counterparts. The risk of horizontal gene transfer from plants to environmental bacteria or from plant products consumed as food to gut microorganisms or human cells is generally acknowledged to be negligible, but one that cannot be completely discounted, according to the AMA.
USDA Requires Organic Foods Labeling
The USDA said it will begin labeling organic fruits, vegetables and meats produced without pesticides or hormones as part of the new rules on organic food.
Foods will be labeled "100 percent organic," "organic" or "made with organic ingredients."
Under the USDA's rules, foods labeled organic cannot include bioengineered ingredients or be irradiated to kill bacteria and lengthen shelf life. Meats sold as organic cannot be produced from animals that receive antibiotics.
"Organic" foods must consist of at least 95 percent organically produced ingredients while foods "made with organic ingredients" must contain at least 70 percent organic ingredients.