HHS's Leavitt Announces New Privacy Principles and Tools

Photo: HHS Secretary Mike Leavitt.

The growing computerization, exchange and analysis of patient data offer the potential to improve the quality of care and reduce costs and medical errors, but those benefits won't be fully realized until privacy concerns are effectively addressed, HHS Secretary Mike Leavitt said last week.

In a keynote address to the Nationwide Health Information Network Forum, Leavitt announced key privacy principles and a toolkit to guide efforts to harness the potential of new technology and more effective data analysis, while protecting privacy. Leavitt emphasized that appropriate privacy and security measures will be an essential sociological enabler of groundbreaking technology.

"Finding the balance between increased access to information and privacy is very important. If we don't have it, we won't succeed," Leavitt said. "Consumers shouldn't be in a position to have to accept privacy risks they don't want. Each consumer should be able to choose products and services that best fit their health needs and privacy preferences.

"Consumers need an easy-to-read, standard notice about how their personal health information is protected, confidence that those who misuse information will be held accountable, and the ability to choose the degree to which they want to participate in information sharing," Leavitt said. "Over time, consumer confidence in the handling of health information is likely to grow just as consumer confidence in online banking has grown, but that won't happen without similar protections and transparency about the use of their information."

Privacy Principles

The privacy principles articulated by Secretary Leavitt are as follows:

• Individual Access -- Consumers should be provided with a simple and timely means to access and obtain their personal health information in a readable form and format.
• Correction -- Consumers should be provided with a timely means to dispute the accuracy or integrity of their personal identifiable health information, and to have erroneous information corrected or to have a dispute documented if their requests are denied. Consumers also should be able to add to and amend personal health information in products controlled by them such as personal health records (PHRs).
• Openness and Transparency -- Consumers should have information about the policies and practices related to the collection, use and disclosure of their personal information. This can be accomplished through an easy-to-read, standard notice about how their personal health information is protected. This notice should indicate with whom their information can or cannot be shared, under what conditions and how they can exercise choice over such collections, uses and disclosures. In addition, consumers should have reasonable opportunities to review who has accessed their personal identifiable health information and to whom it has been disclosed.
• Individual Choice -- Consumers should be empowered to make decisions about with whom, when, and how their personal health information is shared (or not shared).
• Collection, Use and Disclosure Limitation -- It is important to limit the collection, use and disclosure of personal health information to the extent necessary to accomplish a specified purpose. The ability to collect and analyze health care data as part of a public good serves the American people and it should be encouraged. But every precaution must be taken to ensure that this personal health information is secured, deidentified when appropriate, limited in scope and protected wherever possible.
• Data Integrity -- Those who hold records must take reasonable steps to ensure that information is accurate and up-to-date and has not been altered or destroyed in an unauthorized manner. This principle is tightly linked to the correction principle. A process must exist in which, if consumers perceive a part of their record is inaccurate, they can notify their provider. Of course the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule provides consumers that right, but this principle should be applied even where the information is not covered by the Rule.
• Safeguards -- Personal identifiable health information should be protected with reasonable administrative, technical, and physical safeguards to ensure its confidentiality, integrity, and availability and to prevent unauthorized or inappropriate access, use or disclosure.
• Accountability -- Compliance with these principles is strongly encouraged so that Americans can realize the benefit of electronic health information exchange. Those who break rules and put consumers' personal health information at risk must not be tolerated. Consumers need to be confident that violators will be held accountable.

In addition, Leavitt announced several tools to help consumers and health information exchanges advance toward privacy protection and consumer access to their information. For example, the "Leavitt Label," modeled after the nutritional labels on food packaging, would allow consumers to quickly compare personal health record products.