The European Union (EU) approach to data protection consists of assessing the adequacy of the data protection offered by the laws of a particular jurisdiction against a set of principles that includes purpose limitation, transparency, quality, proportionality, security, access, and rectification. The EU's Data Protection Directive sets conditions on the transfer of data to third countries by prohibiting Member States from transferring to such countries as have been deemed inadequate in terms of the data protection regimes. In theory, each jurisdiction is evaluated similarly and must be found fully compliant with the EU's data protection principles to be considered adequate. In practice, the inconsistency with which these evaluations are made presents a hurdle to international data-sharing and makes difficult the integration of different data-sharing approaches; in the 20 years since the Directive was first adopted, the laws of only five countries from outside of the EU, Economic Area, or the European Free Trade Agreement have been deemed adequate to engage in data transfers without the need for further administrative safeguards.

Better health requires sectors like housing and education, and healthcare, to collaborate. That needs three strategies. Make full use of waivers to foster experimentation. Use techniques to encourage agencies at all levels to work together. And use new incentives to foster local partnerships.

Reflecting on their service as mentors in the fellowship program, the authors describe their experiences and offer thoughts on lessons learned about mentoring, individuals' roles in institutional changes, their own professional growth, and implications for and evaluation of legal and interprofessional education.

Like many other countries, South Korea has recognized the importance of biobanks as a tool for medical research and has engaged in two very important tasks to foster biobanking infrastructure: funding biobanks and setting up rules to protect the integrity of biobanks that share potentially sensitive personal information.

Diverse legal and regulatory measures are used internationally to control the information provided during pharmaceutical sales visits. Little is known about the comparative effectiveness of these measures however. We analyzed the perceptions of regulators, pharmaceutical industry officials, health professionals, and consumer respondents concerning these approaches in Canada, France, and the United States using an empirical realist interests-based approach. Interviews focused on the aims and effectiveness of regulation, barriers and enablers to regulation and suggestions for improvement. An alignment was found in North America regulator and industry respondents' satisfaction with the status quo and their view that further intervention is unfeasible and unnecessary. Health professionals generally expressed a lack of confidence in the impact of regulations on sales visit information while consumer advocates voiced their disappointment in both regulators and health professionals for their failure to counteract the influence of pharmaceutical marketing. Regulator and industry respondents in France differed from their North American counterparts in their willingness to increase and diversify the scope of regulatory interventions. As the first international comparison of regulatory experiences in this sector, the findings highlight the universal need for more focused and inclusive discussions among groups about how to tailor regulations to achieve public health goals.

The HIPAA Privacy Rule is notoriously weak because of its incomplete coverage, numerous exclusions and exemptions, and limited rights for individuals. The three areas in which it provides the most protection are fundraising, marketing, and research. Provisions of the 21st Century Cures Act, pending in Congress, and the Notice of Proposed Rulemaking to amend the federal research regulations (Common Rule), awaiting final regulatory action, would weaken the privacy protections for research. If these measures are adopted, the HIPAA Privacy Rule would have so little value that it might not be worth the aggravation and burden.

Along with technical issues, biobanking frequently raises important privacy and security issues that must be resolved as biobanks continue to grow in scale and scope. Consent mechanisms currently in use range from fine-grained to very broad, and in some cases participants are offered very few privacy protections. However, developments in information technology are bringing improvements. New programs and systems are being developed to allow researchers to conduct analyses without distributing the data itself offsite, either by allowing the investigator to communicate with a central computer, or by having each site participate in meta-analysis that results in a shared statistic or final significance result. The implementation of security protocols into the research biobanking setting requires three key elements: authentication, authorization, and auditing. Authentication is the process of making sure individuals are who they claim to be, frequently through the use of a password, a key fob, or a physical (i.e., retinal or fingerprint) scan. Authorization involves ensuring that every individual who attempts an action has permission to do that action. Finally, auditing allows for actions to be logged so that inappropriate or unethical actions can later be traced back to their source.

Genetic testing can be used to determine if unexplained fractures in children could have resulted from a predisposition to bone fractures, e.g., osteogenesis imperfecta. However, uncertainty is introduced if a variant of unknown significance (VUS) is identified. Proper interpretation of VUS in these situations is critical because of its influence on clinical care and in court rulings. This study sought to understand how VUS are interpreted and used by practitioners when there is a differential diagnosis including both osteogenesis imperfecta and non-accidental injury.

A 15-question survey was emailed to physicians who requested analysis of two genes, COL1A1 and COL1A2, from the University of Washington from 2005-2013 for patient cases involving suspicion of child abuse.

Among the 89 participants, responses differed about when genetic testing should be ordered for osteogenesis imperfecta, who should be consulted about utilization of VUS test results, follow-up procedures, and who should receive the VUS results.

There are no clear guidelines for how to interpret and follow up on VUS. In the legal setting, misinterpreted VUS could lead to unintended consequences and deleterious ramifications for family members. The need for better practice guidelines to help promote more equitable handling of these sensitive legal cases is clear.

This article describes the benefits of including institutional leadership (the deans) in a faculty fellowship program where faculty were tasked with implementing a curricular innovation at their home institution. These benefits included: (1) serving as an ally, advocate, and defender for the faculty fellow; (2) seeing the bigger picture and how the fellowship can be leveraged to benefit the institution in other ways; and (3) assisting to ensure the fellowship project will be ongoing at their institution.

Laws in the 20 jurisdictions studied for this project display many similar approaches to protecting privacy in biobank research. Although few have enacted biobank-specific legislation, many countries address biobanking within other laws. All provide for some oversight mechanisms for biobank research, even though the nature of that oversight varies between jurisdictions. Most have some sort of controlled access system in place for research with biobank specimens. While broad consent models facilitate biobanking, countries without national or federated biobanks have been slow to adopt broad consent. International guidelines have facilitated sharing and generally take a proportional risk approach, but many countries have provisions guiding international sharing and a few even limit international sharing. Although privacy laws may not prohibit international collaborations, the multi-prong approach to privacy unique to each jurisdiction can complicate international sharing. These symposium issues can serve as a resource for explaining the sometimes intricate privacy laws in each studied jurisdiction, outlining the key issues with regards to privacy and biobanking, and serving to describe a framework for the process of harmonization of privacy laws.

This study – the first to explore how infertility providers confront several critical dilemmas concerning sex selection of embryos for nonmedical, social reasons – highlights key challenges and questions. Clinicians struggle, for instance, with how to define “family balalancing”, when to offer it, and how to decide.

Consumption of sugar-sweetened beverages (SSBs) contributes to multiple health problems including obesity, diabetes, and tooth decay, especially among children. Excise taxation has been proven efficacious in changing purchasing behaviors related to tobacco use with resulting improvements in public health outcomes. Similar taxes applied to SSBs are starting to take hold internationally and domestically. SSB taxes have been proposed in over 30 U.S. jurisdictions since 2009, but only Berkeley (CA) has passed and implemented one to date. Given empirical evidence of their effectiveness, governments should consider implementation of SSB excise taxes based on uniform definitions of SSBs and other factors.

The RWJF public health law faculty fellowship provided an opportunity for legal and public health scholars to come together to develop innovative approaches for teaching public health law in schools of law, public health, medicine, and social work nationally. The fellowship program emphasized the importance of integrating individual change (personal and professional development) with organizational change as twin pillars of the core competencies necessary for advancing public health law education. This article describes the curriculum and learning formats used throughout the fellowship to guide the fellows' development in the areas of leading change, managing conflict, building collaborative partnerships, and maintaining personal resilience.

Georgia State University College of Law, through the Center for Law, Health & Society, developed a pair of online libraries for faculty teaching public health law in schools of law or public health. Development of these libraries was funded by a grant from the Robert Wood Johnson Foundation as part of The Future of Public Health Law Education: Faculty Fellowship Program. This article describes the goals of the program addressed by the libraries, the development process, the resources included, and how faculty may benefit from the materials and provide materials benefitting other faculty across the country.

The food supply is complicated and consumers are increasingly calling for labeling on food to be more informative. In particular, consumers are asking for the labeling of food derived from genetically modified organisms (GMO) based on health, safety, and environmental concerns. At issue is whether the labels that are sought would accurately provide the information desired. The present study examined consumer (n = 181) perceptions of health, safety and the environment for foods labeled organic, natural, fat free or low fat, GMO, or non-GMO. Findings indicated that respondents consistently believed that foods labeled GMO are less healthy, safe and environmentally-friendly compared to all other labels (ps < .05). These results suggest that labels mean something to consumers, but that a disconnect may exist between the meaning associated with the label and the scientific consensus for GMO food. These findings may provide insight for the development of labels that provide information that consumers seek.

The forced marriage of minors is child abuse, consequently duties exist to stop them. Yet over 14 million forced marriages of minors occur annually in developing countries. The American Bar Association (ABA) concludes that the problem in the US is significant, widespread but largely ignored, and that few US laws protect minors from forced marriages. Although their best chance of rescue often involves visits to health care providers, US providers show little awareness of this growing problem. Strategies discussed to stop forced marriages include recommendations from the UN, the ABA, and the UK. The author anticipates and responds to criticisms that first, no duty to intervene exists without better laws and practice guidelines; and second, that such marriages are not child abuse in traditions where parental rights or familism allegedly justify them.