Robert Wood Johnson Foundation's Project HealthDesign included funding of an ethical, legal and social issues (ELSI) team, to serve in an advisory capacity to the nine design projects. In that capacity, the authors had the opportunity to analyze the personal health record (PHR) and personal health application (PHA) implementations for recurring themes. PHRs and PHAs invert the long-standing paradigm of health care institutions as the authoritative data-holders and data-processors in the system. With PHRs and PHAs, the individual is the center of his or her own health data universe, a position that brings new benefits but also entails new responsibilities for patients and other parties in the health information infrastructure. Implications for law, policy and practice follow from this shift. This article summarizes the issues raised by the first phase of Project HealthDesign projects, categorizing them into four topics: privacy and confidentiality, data security, decision support, and HIPAA and related legal-regulatory requirements. Discussion and resolution of these issues will be critical to successful PHR/PHA implementations in the years to come.

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United States health care is engaged in an ambitious project to make its clinical and administrative records "100% electronic." Substantial benefits are expected in both clinical care delivery and medical research (especially for public health surveillance and outcomes/effectiveness studies). Substantial costs also potentially accrue, beyond the large outlays for an expanded computer and telecommunications infrastructure. Privacy and confidentiality are obviously at risk if such systems cannot be made secure. Limited empirical evidence currently available suggests health information systems security may not be very good, at least in the "average" institutional setting. Privacy-focused critics of electronic record-keeping are sometimes accused of taking Luddite stands, insufficiently attentive to IT's benefits. It may also be fair to worry about a certain Panglossian tendency in "industry" commentary, insufficiently attentive to potential problems. Better federal and state laws structuring health data use will help; the industry must also attend more candidly to the technical uncertainties.

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