This is a request for records that have originated within the GAO. We are making this request pursuant to GAO’s Public Availability of General Accounting Office Records regulations at 4 CFR Part 81.
The FDA has not paid attention to privacy standards that should be applied to RiskMAP programs. Unfortunately, this lack of FDA attention has resulted in inappropriate and unethical marketing to patients using patient information gathered for treatment purposes. If these marketing activities were being conducted by HIPAA-covered entities, the activities would be illegal. These activities may well be illegal in California, which has a strong state-level medical privacy law that goes beyond HIPAA.
The American Health Information Community Workgroup on Confidentiality, Privacy and Security requested public feedback regarding its working hypothesis. WPF responded to the request with public comments encouraging the adoption of a unified policy architecture and encouraging AHIC to focus on enforcement mechanisms that are intended to directly benefit consumers. WPF also encouraged AHIC to look comprehensively at the demands a new national electronic health exchange network will make on privacy in the health care sector.
The World Privacy Forum believes that the capability of identifying individuals from subsets of genetic information will expand greatly in the future. In public comments filed with the National Institutes of Health on pharmacogenomics (PGx) research, or research using genetic information to create highly personalized medicine, the World Privacy Forum recommended that all research activities that involve any type of patient-specific genetic information be required to have certificates of confidentiality, whether that information appears identifiable or not. The WPF also urged the NIH to require strong data use agreements to protect individuals’ privacy. The WPF also urged NIH and the Department of Health and Human Services to reinstate the position of “privacy advocate” so as to provide oversight in this area. Read the comments (PDF). For more information, see the genetic section of the WPF Medical Privacy Page.
The World Privacy Forum and the Electronic Frontier Foundation (EFF) filed joint comments with the Department of Homeland Security about the proposed national ID system, REAL ID. The comments discuss the substantial flaws in the proposed REAL ID system including concerns about the overall structure of the program, the cards, the databases attached to the cards, the lack of controls on “function creep,” the possibilities for discrimination, the potential for increased risk of identity theft, issues related to potential gaps in coverage for recipients on Federal programs, among other issues. Read the comments (PDF). See the EFF REAL ID pages for background about REAL ID.