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The Global Alliance for Genomics and Health (GA4GH) proposes a data access policy model-"registered access"-to increase and improve access to data requiring an agreement to basic terms and conditions, such as the use of DNA sequence and health data in research. A registered access policy would enable a range of categories of users to gain access, starting with researchers and clinical care professionals. It would also facilitate general use and reuse of data but within the bounds of consent restrictions and other ethical obligations. In piloting registered access with the Scientific Demonstration data sharing projects of GA4GH, we provide additional ethics, policy and technical guidance to facilitate the implementation of this access model in an international setting.

The Global Alliance for Genomics and Health (GA4GH) created the Beacon Project as a means of testing the willingness of data holders to share genetic data in the simplest technical context-a query for the presence of a specified nucleotide at a given position within a chromosome. Each participating site (or "beacon") is responsible for assuring that genomic data are exposed through the Beacon service only with the permission of the individual to whom the data pertains and in accordance with the GA4GH policy and standards.While recognizing the inference risks associated with large-scale data aggregation, and the fact that some beacons contain sensitive phenotypic associations that increase privacy risk, the GA4GH adjudged the risk of re-identification based on the binary yes/no allele-presence query responses as acceptable. However, recent work demonstrated that, given a beacon with specific characteristics (including relatively small sample size and an adversary who possesses an individual's whole genome sequence), the individual's membership in a beacon can be inferred through repeated queries for variants present in the individual's genome.In this paper, we propose three practical strategies for reducing re-identification risks in beacons. The first two strategies manipulate the beacon such that the presence of rare alleles is obscured; the third strategy budgets the number of accesses per user for each individual genome. Using a beacon containing data from the 1000 Genomes Project, we demonstrate that the proposed strategies can effectively reduce re-identification risk in beacon-like datasets.

The article discusses the problem of defining the term severely handicapped and examines and evaluates previously advanced definitions. (Author/CL)

Theory and research from the field of environmental psychology are reviewed and implications regarding environmental programing for severely handicapped individuals are discussed. A challenge is issued to design for severely handicapped persons environments which are both manageable and consistent with normalization tenets. (Author)

Objective The Patient-Centered Access to Secure Systems Online () project is designed to apply state-of-the-art-security to the communication of clinical information over the Internet. Design The authors report the legal and regulatory issues associated with deploying the system, and results of its use by providers and patients. Human subject protection concerns raised by the Institutional Review Board focused on three areas—unauthorized access to information by persons other than the patient; the effect of startling or poorly understood information; and the effect of patient access to records on the record-keeping behavior of providers. Measurements Objective and subjective measures of security and usability were obtained. Results During its initial deployment phase, the project enrolled 216 physicians and 41 patients; of these, 68 physicians and 26 patients used the system one or more times. The system performed as designed, with no unauthorized information access or intrusions detected. Providers rated the usability of the system low because of the complexity of the secure login and other security features and restrictions limiting their access to those patients with whom they had a professional relationship. In contrast, patients rated the usability and functionality of the system favorably. Conclusion High-assurance systems that serve both patients and providers will need to address differing expectations regarding security and ease of use. [ABSTRACT FROM PUBLISHER]

Introduction: Individuals have a moral claim to be involved in the governance of their personal data. Individuals' rights include privacy, autonomy, and the ability to choose for themselves how they want to manage risk, consistent with their own personal values and life situations. The Fair Information Practices principles (FIPPs) offer a framework for governance. Privacy-enhancing technology that complies with applicable law and FIPPs offers a dynamic governance tool for enabling the fair and open use of individual's personal data., Perceptions of Risk: Any governance model must protect against the risks posed by data misuse. Individual perceptions of risks are a subjective function involving individuals' values toward self, family, and society, their perceptions of trust, and their cognitive decision-making skills., The Hipaa Privacy Rule Puts Some Governance in the Hands of Individuals: Individual privacy protections and individuals' right to choose are codified in the HIPAA Privacy Rule, which attempts to strike a balance between the dual goals of information flow and privacy protection. The choices most commonly given individuals regarding the use of their health information are binary ("yes" or "no") and immutable. Recent federal recommendations and law recognize the need for granular, dynamic choices., Building a Governance Framework Based in Trust Avoiding Surprises: Individuals expect that they will govern the use of their own health and genomic data. Failure to build and maintain individuals' trust increases the likelihood that they will refuse to grant permission to access or use their data. The "no surprises principle" asserts that an individual's personal information should never be collected, used, transmitted, or disclosed in a way that would surprise the individual were she to learn about it., Fair Information Practices Principles: The FIPPs provide a powerful framework for enabling data sharing and use, while maintaining trust. We introduce the eight FIPPs adopted by the Department of Health and Human Services, and provide examples of their interpretation and implementation., Reducing Risk Through Consumer Engagement: Privacy risk and health risk can be reduced by giving consumers control, autonomy, and transparency, and by engaging them in managing their own health. Explicit "consent" may not always be necessary - the FIPPs offer multiple ways to engender trust and avoid surprises.