U.S. Department of Health and Human Services

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.”

SAN DIEGO, Ca., Sept. 24 — The World Privacy Forum’s latest report, Red Flag and Address Discrepancy Requirements: Suggestions for Health Care Providers, discusses the applicability of the new FTC regulations to the health care sector along with suggestions for providers. The report addresses newly issued regulations by the Federal Trade Commission that require financial institutions and creditors to develop and implement written identity theft prevention programs. Health care providers – whether they are for-profit, non-profit, or governmental entities – may have obligations under the new rules.

Patient Safety Organizations | Proposed rulemaking — The World Privacy Forum filed extensive comments today regarding privacy protections for patients whose health care information will be shared with patient safety safety organizations under newly proposed Department of Health and Human Services regulations. After a landmark Institute of Medicine report on the prevalence of medical errors and their harmful impact on patients (To Err is Human), the U.S. Congress eventually passed the Patient Safety Act (2005). The Patient Safety Act allows extensive health care data of patients to go to patient safety organizations. The idea is to provide a form of quality control. The Agency for Heathcare Research and Quality (AHRQ), part of HHS, has published its proposed regulations implementing the Act. The World Privacy Forum has made 14 recommendations for substantive changes in the proposed rules to protect patient privacy. The World Privacy Forum asked the Agency to expressly mandate that all patient data be de-identified or anonymized to the greatest extent possible, that the proposed rule should expressly require data use agreements for any data sharing, that the patient information be labeled as subject to the Patient Safety Act, and strongly urged that patient safety organizations be required to maintain an accounting of disclosures at least equal to HIPAA, among other recommendations.

The World Privacy Forum filed extensive comments today regarding privacy protections for patients whose health care information will be shared with patient safety safety organizations under newly proposed Department of Health and Human Services regulations. After a landmark Institute of Medicine report on the prevalence of medical errors and their harmful impact on patients (To Err is Human), the U.S. Congress eventually passed the Patient Safety Act (2005). The Patient Safety Act allows extensive health care data of patients to go to patient safety organizations. The idea is to provide a form of quality control. The Agency for Healthcare Research and Quality (AHRQ), part of HHS, has published its proposed regulations implementing the Act. The World Privacy Forum has made 14 recommendations for substantive changes in the proposed rules to protect patient privacy. The World Privacy Forum asked the Agency to expressly mandate that all patient data be de-identified or anonymized to the greatest extent possible, that the proposed rule should expressly require data use agreements for any data sharing, that the patient information be labeled as subject to the Patient Safety Act, and strongly urged that patient safety organizations be required to maintain an accounting of disclosures at least equal to HIPAA, among other recommendations.

New publication | PHRs and privacy — The World Privacy Forum has published a new legal and policy analysis examining Personal Health Records — or PHRs — and the privacy issues associated with them. This analysis, Personal Health Records: Why Many PHRs Threaten Privacy, was prepared by Robert Gellman for the World Privacy Forum. The analysis finds that significant, serious threats to privacy exist in some PHRs.