FDA regulation of medical software

Currently the FDA is reviewing its policy on the regulation of computer software in the medical arena. Healthcare practitioners hope that the FDA will take the least possible regulatory action required by law to fulfill its public health responsibility and will take into account the unique status of the ever-changing software industry. Innovations in telemedicine and medical informatics have yielded significant improvements in the quality and cost of healthcare, and the imposition of cumbersome regulatory requirements on the medical software industry would slow the development and introduction of medical software products.     

THE MEDIATOR'S ASSESSMENT OF SAFETY ISSUES AND CONCERNS (MASIC): A SCREENING INTERVIEW FOR INTIMATE PARTNER VIOLENCE AND ABUSE AVAILABLE IN THE PUBLIC DOMAIN

Screening for intimate partner violence and/or abuse (IPV/A) in family mediation is important, perhaps particularly among cases without attorney representation. While most mediators agree that it is ideal to consider IPV/A in case planning, there is less agreement regarding the need to universally and systematically screen for IPV/A among all cases. Such attitudes are of concern, given research in other fields (e.g., medicine, couples therapy) and our own research in a family mediation clinic, which documents that the lack of consistent and formal IPV/A assessment results in underdetection of IPV/A. While a variety of IPV/A screening measures exist, each has shortcomings. Thus, our research and clinical experience led us to develop a new IPV/A screening measure, the Mediator's Assessment of Safety Issues and Concerns (MASIC). We discuss features of the MASIC and provide the full measure in the Appendix. The MASIC is a behaviorally specific IPV/A screen that assesses various types of abuse (e.g., coercive control, stalking, physical violence) over the course of the relationship and in the past year. It is administered as an interview to build rapport and assesses lethality indicators and offers optional recommendations for procedural changes in mediation based on IPV/A. Although we have begun relevant research, it is important to note that the MASIC has not yet been validated. Nonetheless, we recommend the use of systematic IPV/A screens in family mediation and suggest that such measures may prove especially important in providing unrepresented parties a safe and appropriate environment for mediation.     

Court‐Based Interventions in Spain for Families in Divorce Transition: Challenges in the Implementation of (Co)‐Parenting Coordination

Families facing separation or divorce in Spain encounter a number of obstacles, including a primarily adversarial and slow justice system, nonspecialized courts and judges, and a lack of resources to help them through the process. Recent legislation at the regional level (autonomous communities) is moving toward emphasizing shared parental responsibility and introducing parenting plans, while at the national level, legislation advances slowly. One of the main challenges professionals are facing in high‐conflict couple separation is protecting children from the effects of being in the middle of their parents’ conflict. Traditional psychological, legal, and social services are insufficient to support parents and protect their children from interparental hostile conflict—which can be exacerbated by litigation, professional intervention, domestic violence, or addiction. This article illustrates, through a case study, the implementation of parenting coordination in Spain. Different jurisdictions in Spain are slowly implementing (co‐)parenting coordination, an in‐depth intervention designed to support these families. The objective is to help families focus on children's needs and follow the court‐approved parenting plans or court orders, reduce relitigation, and improve parental communication and conflict resolution skills. This article analyzes different aspects and challenges relating to the implementation of parenting coordination in Spain. Recommendations are then made to address them.     

A new lexicon and framework for analyzing the internal structures of the U.S. Advanced Technology Program and its analogues around the world

Analogues of the U.S.’s Advanced Technology Program can be found in many countries around the world. These government programs provide financial assistance to firms and other entities to develop innovative technologies in the conviction that these developments will contribute to future economic strength. For political and economic reasons, these programs tend to be complex and intricate in their design. No informed evaluation and comparison of such programs can take place without a clear understanding of their internal structures. This paper analyzes the anatomy of such programs and constructs a vocabulary for understanding program design choices. It identifies and discusses a representative sample of important program design features—eligibility requirements, the nature of the research, technical scope, the selection process, and public-private financial arrangements—and provides examples of national programs embodying alternative design choices. This paper should interest policymakers, program administrators, program evaluators, and others involved in program design, management and evaluation. This paper is drawn from a draft reprot, “A Multi-Country, Binational Comparison of the ATP and its Analogues,” by the author, prepared for the National Institue of Standards and Technology. The draft reprot covers additional program features of a number of programs in different countries.