HHS seeks to fix’ aspects of privacy rule
Marketing, loopholes attacked in proposal
While critics of the proposed changes to the federal health care privacy rule are most concerned about the elimination of a signed consent, they also say some of the other proposals will seriously undermine patients’ right to privacy. The Department of Health and Human Services (HHS) has proposed these changes:
• Allow treatment-related conversations while maintaining the "minimum necessary" rule. The proposed change would make it clear that doctors could discuss a patient’s treatment with other professionals involved in the patient’s care without fear of violating the privacy rule. Improper disclosures, such as failing to protect against incidental disclosures, would still violate the rule.
• Parental access to their children’s records is assured, subject to state laws.
Permission required for marketing
• Records are prohibited from being used for marketing purposes, but appropriate communication is permitted. Pharmacies, health plans, and other covered entities are required to first obtain an individual’s specific authorization before sending them any marketing materials.
• Researchers would not be required to use multiple consent forms and could instead use a single combined informed consent/privacy form.
• Rather than requiring covered entities to have contracts with their business associates to ensure they follow the privacy rule, covered entities would be able to adhere to model business associate contract provisions, which are easier to follow and less costly.
• A single type of authorization form could be used to obtain a patient’s permission for a specific use or disclosure that otherwise would not be permitted under the rule.
Sixteen members of Congress, in an April 26, 2002, letter to HHS secretary Tommy Thompson, say they are concerned about the proposed changes in how the privacy rule will affect marketing. "The Administration’s proposed authorization requirement for marketing activities is rendered virtually meaningless by the proposal’s creation of broad exceptions to the marketing’ definition," the congresspeople write.
"For example, in contrast to the final rule, under the Administration’s proposal, communications to an individual regarding medical products or services are not considered marketing’ even if (1) the communications are made by a party other than the individual’s health care provider or health plan, and (2) the individual’s health care provider disclosed the individual’s medical records to the party for the purpose of the communications and received remuneration for this disclosure," the letter states.
Drug companies could get private info
This change could pose critical disclosure problems for patients, particularly those with HIV, says Scott Brawley, MSW, director of public policy for AIDS Action in Washington, DC. "If an HIV patient sees a doctor and receives a prescription, then maybe the company that makes the drug will contact the pharmacist to have the patient reminded to have the prescription filled," Brawley says.
Under the final privacy rule, the pharmacist would have to let patients know that the pharmacy is being paid by the drug company to give patients this notice, and if a person doesn’t wish to receive these notifications, then the person can call and be taken off the mailing list, Brawley says. That’s not going to be possible under the proposed changes, because communication related to health or treatment may not be considered marketing, he adds. Then there are non-health related marketing practices that many people might find offensive, such as companies that send AIDS patients notices that they can sell their life insurance policies in exchange for cash advances, Brawley says.
Under the final privacy rule, a patient would need to give informed consent before any health care provider could supply these sort of companies with private information. It’s unclear with the changes proposed whether patients still are protected from these non-health-care marketing tactics, Brawley says.
With the proposed changes to the marketing aspect of the rule, it’s possible that patients could be inundated with health care material they do not wish to receive, says Jeffrey Crowley, MPH, project director of the Institute for Health Care Research and Policy at Georgetown University in Washington, DC. "It could be a nuisance or it could be harmful," Crowley says. "Like, what happens if a mother sees that her son is receiving mailings about AIDS drugs, and she didn’t know he was infected?"
The disclosures HIV patients probably will have to worry about the most are those that they have no idea are occurring, says Catherine A. Hanssens, JD, director of the AIDS Project for Lambda Legal Defense and Education Fund in New York City. "I think a lot of times people with HIV will not know that disclosures are happening without their knowledge," Hanssens says. "I learned from a physician of mine that a drug manufacturer sent him a complete print-out of all of my prescribing history, when I had taken a certain drug, and what other products the physician might want to recommend or prescribe."
If Hanssens’ doctor had not told her about this, she would never have known that her private medical information was being used by a drug manufacturer in an effort to increase business. "This means the manufacturer of my drug pays the pharmacy chain for personal information about my prescribing history, and it’s not in the hands of people who are devoted to my medical care," Hanssens says.
Minors would lose some privacy rights
The congresspeople also expressed concerns about changes to the rules governing minors’ privacy rights. In some states, this would mean providers could disclose private health information to parents without the minor’s knowledge or permission, even in cases where the minor is legally permitted to obtain health care without parental consent.
Another proposed change that the congresspeople oppose involves the proposal to eliminate the right of an individual to receive an accounting of disclosures of the individual’s medical records by an entity pursuant to the individual’s authorization, the letter to Thompson says. "The Administration’s proposal to take away this right would effectively leave no check on what an entity does with an individual’s health information once the individuals have signed an authorization," the congresspeople write. "We urge you to abandon this proposal."
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