U.S. Department of Health and Human Services

The World Privacy Forum filed comments on the HHS data breach rulemaking and asked for substantive changes in several areas. In particular, WPF asked HHS to expressly state a requirement for a breach risk assessment in the final rule itself, and to set a requirement that the risk assessment must be conducted by an independent organization. The WPF also asked that HHS set breach risk assessment standards so that there is some uniformity and guidance as to what constitutes an appropriately rigorous risk assessment when a breach occurs. In the comments, WPF also discussed the relationship between medical identity theft and medical data breach and how this impacts patients and consumers.

Health IT — The Health IT Standards Committee will be meeting tomorrow, August 20, from 9 a.m. to 3 p.m. in Washington DC. Those interested in this meeting can participate in person, or via the phone and web. The privacy and security workgroup will report at 1:30 pm Eastern. Location and call-in information is available at the HHS web site.

The World Privacy Forum filed comments with the Department of Health and Human Services today regarding the HITECH Act guidance that HHS published along with a request for comments. The Forum urged the Department to tighten its proposed guidance, and to add more protections, oversight, and rules for “limited data set” breaches.

Medical privacy | HIPAA | FTC — According to a legal complaint, CVS pharmacies — the largest pharmacy chain in the United States — did not take appropriate steps to protect its customers’ and employees’ sensitive information when it improperly disposed of documents, labels, prescription bottles, and other items with clearly identifiable and highly sensitive personal information such as SSNs, prescription information, driver’s license numbers, and other information still on those materials. CVS agreed to pay $2.25 million to settle its violations of HIPAA as part of a Resolution Agreement with the Department of Health and Human Services. CVS has also signed a consent agreement with the FTC; the public can comment on this agreement until March 20, 2009. The World Privacy Forum will be filing comments with the FTC on the consent agreement with CVS, which we will post here.

In response to a Request for Information (RFI) from U.S. federal agencies regarding the recently passed GINA (Genetic Information Nondiscrimination Act), the World Privacy Forum filed a detailed response with suggestions on what aspects of GINA need clarification. The comments focus on a number of privacy issues the RFI raised, including model privacy notices and the issue of what the GINA statute calls “incidental collection” of genetic information. Currently, GINA states that some kinds of information are exempted from being considered as regulated for medical underwriting purposes. For example, medical information gleaned about patients for underwriting purposes from medical databases is regulated. But medical information gleaned about patients for underwriting purposes from, for example, marketing lists containing robust patient information may be unregulated if the law is not clarified in the regulatory process. The World Privacy Forum urged HHS and the Department of Labor to substantially clarify what constitutes “incidental collection,” and urged the agencies to consider lists containing identifiable patient information to be considered in the same category as a “medical database.”