HIPAA

PHRs that operate outside of HIPAA can negatively affect the privacy interests of consumers in various ways. The best to hope for is that a PHR will not make privacy significantly worse. However, it is not likely that even that weak standard can be met. The existence of electronically available and centralized health information outside the traditional health care system will attract new users and create new risks. The mere adding of health records to a PHR vendor’s files may undermine existing privacy protections of old records. Security is a concern for any electronic records. A consumer’s ability to control the disclosure of PHR records can easily be compromised. The consumer’s ability to correct errors in PHR records may be problematic. Advertising support may not meet a PHR’s profit goals unless at least some consumer information is available for close targeting of ads. Promised PHR privacy protections may vanish overnight if the privacy policy is changed.

Version 1: October 16, 2007   The World Privacy Forum, as part of its ongoing in-depth research into medical identity theft issues and responses, has outlined 8 best-practice responses to the crime by the health care sector. These best practices are based on interviews with victims, providers, and other stakeholders. These 8 best practices are

Medicare – CMS — The World Privacy Forum filed extensive pubic comments on the substantive changes to the Medicare database release policy that the Centers for Medicare and Medicaid Services (CMS) has proposed in a System of Records Notice. As it currently stands, CMS is planning to release the individually identifiable protected health information of patients in the Medicare database to third parties in some circumstances. CMS has not established strong enough checks and controls on its release policy, and it has not explained how it is able to do this under HIPAA. The comments state that CMS has an obligation to explain how each routine use in its new policy is consistent with the authority in the HIPAA privacy rule. If a routine use allows disclosures that are broader than those permitted by HIPAA, then the routine use must be narrowed so that it is consistent with HIPAA. The comments also note that nothing in the CMS notice discusses substance abuse rules and other legal restrictions of the protected health data. The World Privacy Forum asked CMS to specify that the qualifications of any data aggregators who may potentially receive the data exclude any entity that sells other consumer data for any general business, credit, identification, or marketing purpose.

Medical privacy | NCVHS | HIPAA — The World Privacy Forum has sent a letter to Dr. Simon P. Cohn, Chairman of the National Committee on Vital and Health Statistics, supporting the Committee’s formal conclusion that all entities that create, compile, store, transmit, or use personally identifiable health information should be covered by a federal privacy law. More needs to be done about health care data that is left unprotected by HIPAA. The Forum’s letter included a discussion of two HHS programs that operate outside of HIPAA: FDA RiskMAPS, and the National Institutes of Health, which is not a covered entity under HIPAA.

iPledge Program | FDA — The World Privacy Forum testified before the Dermatologic and Ophthalmic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the Food and Drug Administration regarding privacy issues related to iPledge, a mandatory program for patients taking the drug Accutane or isotretinoin generics. The FDA has stated that the program, which it requires four drug manufacturers to have in place, does not fall under HIPAA. The program collects substantive amounts of patient information. The Forum urged the FDA to set privacy standards for all RiskMAPs in general, and to resolve privacy issues in the iPledge program specifically. The Forum requested that all marketing provisions of the iPledge program privacy policy be removed, that patients be expressly informed the program does not fall under HIPAA, and that patients be given a printed copy of the iPledge program privacy policy, among other requests.