Assessing the Thin Regulation of Consumer-Facing Health Technologies.

This article addresses the data protection and product safety regulatory models currently applied to consumer-facing health technologies. It explains how the design and structures of existing data protection and safety regulation in the U.S.

Regulating mobile mental health apps.

Mobile medical apps (MMAs) are a fast-growing category of software typically installed on personal smartphones and wearable devices. A subset of MMAs are aimed at helping consumers identify mental states and/or mental illnesses. Although this is a fledgling domain, there are already enough extant mental health MMAs both to suggest a typology and to detail some of the regulatory issues they pose.

Regulatory Disruption and Arbitrage in Health-Care Data Protection.

This article explains how the structure of U.S. health-care data protection (specifically its sectoral and downstream properties) has led to a chronically uneven policy environment for different types of health-care data.

Mobile health: assessing the barriers.

Mobile health (mHealth) combines the decentralization of health care with patient centeredness. Mature mHealth applications (apps) and services could provide actionable information, coaching, or alerts at a fraction of the cost of conventional health care. Different categories of apps attract diverse safety and privacy regulation.

The emergence of national electronic health record architectures in the United States and Australia: models, costs, and questions.

Emerging electronic health record models present numerous challenges to health care systems, physicians, and regulators. This article provides explanation of some of the reasons driving the development of the electronic health record, describes two national electronic health record models (currently developing in the United States and Australia) and one distributed, personal model. The US and Australian models are contrasted in their different architectures ("pull" versus "push") and their different approaches to patient autonomy, privacy, and confidentiality.

Mixed messages: legal incentives and disincentives confronting technologically mediated care.

The "systems" approach to reducing medical errors is increasingly viewed as dependent upon technology. Issues with the legal system, however, may impede needed reforms. Historically there has been a pervasive disconnect between the legal system and changes in healthcare business models and structures.

Electronic health records: international, structural and legal perspectives.

The EHR is a database record that incorporates a patient's health care details from conception to death and which can be distributed over a number of sites or aggregated at a particular source. This article describes the function and concept of the EHR by relating it to other medical information technologies, parallel changes in health care delivery, and a holistic health information model. The article compares the progress that Europe, Australia and the United States have made in the journey towards EHR implementation and concludes by highlighting some of the costs, barriers and consequences associated with the transition to a comprehensive EHR system.