The World Privacy Forum submitted comments to the Food and Drug Administration in response to its request for public input on its draft guidance on the cybersecurity of medical devices. The privacy considerations for medical devices is significant. Because there are a large number of stakeholders in the life cycle of cyber medical devices, the stakeholders are subject
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.
Our principal concern with iPledge is that the FDA has failed to set privacy standards for the iPledge program  or for similar programs that mandate patient tracking. As a result, the iPledge registry has privacy shortcomings that may potentially impact the individuals who take Accutane or Isotretinoin generics.
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.