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Purpose of the Review: Laboratory-developed tests (LDTs) are essential for the clinical care of immunocompromised individuals. These patients often require specialized testing not available from commercial manufacturers and are therefore dependent on the laboratory to create, validate, and perform these assays. Recent paradigm-shifting legislation could alter the way that LDTs are operationalized and regulated., Recent Findings: On March 5th, 2020 the Verifying Accurate and Leading-Edge In-Vitro Clinical Tests Development Act (VALID) was introduced in the US Congress. This statute would overhaul existing regulatory framework by unifying the oversight of LDTs and commercial in-vitro diagnostic tests (IVDs) through the FDA. If enacted, LDTs would be subject to regulatory requirements like those found in commercial submissions for market review. Stakeholders continue to discuss the details and scope of the proposed legislation in the setting of the Severe Acute Respiratory Syndrome Coronavirus 2 pandemic, where LDTs are integral to the national COVID-19 response., Summary: Congressional lawmakers have introduced legislation to alter the regulatory framework governing LDTs. Moving forward, a balance must be struck to ensure the availability of safe and accurate testing without delays or overregulation that could be harmful to patients. The downstream implications of how VALID and other legislation will impact laboratories, clinicians, and patients warrant close examination.

The importance of law in the organization and operation of public health systems has long been a matter of interest to public health lawyers and practitioners, but empirical research on law as a factor in health system performance has been limited in quantity and sophistication. The emergence of Public Health Law Research and Public Health Systems and Services Research within a coordinated effort to strengthen public health research and practice has dramatically changed matters. This article introduces Public Health Law Research as an integral part of Public Health Systems and Services Research, discusses the challenges of integrating the 2 fields, and highlights 2 examples of current research that demonstrate the benefits of an integrated approach to improve the use of law in public health practice.

Purpose of Review: The European Clinical Trials Directive was issued in 2001 and aimed to simplify and harmonize the regulatory framework of clinical trials throughout Europe, thus stimulating European research. However, significant complexity and inconsistency remains due to disparate interpretation by European Union member states, creating substantial financial and administrative challenges for investigators., Recent Findings: Critical care research has been particularly impacted by the Directive due to variable and often restrictive consenting procedures for incapacitated patients. Furthermore, the absence of a waiver of consent threatened to put an end to emergency research in Europe. Approval procedures by ethics committees are equally inconsistent, particularly those relating to provision of a single opinion for multicentre trials. This complexity as well as a general increase in administrative and financial burden following the Directive has been widely shown to cause a reduction in clinical trial activity in Europe., Summary: Various changes to the Directive have been called for by clinical researchers from diverse disciplines, including a risk-based approach to ethical approval, insurance, and monitoring; clarification of terms; and a general simplification of administrative procedures to reduce complexity and cost. This widespread advocacy has led to a planned revision of the Directive in 2011.

This article traces the evolution of the mental health parity debate in American politics, with a focus on how interest groups and politicians have attempted to influence perceptions about treatment effectiveness and the cost of benefit expansion. When parity laws are in place, they require health plans operating in the private health insurance market to provide an equivalent level of coverage for mental health and general medical care. Business and insurance industry groups oppose parity due to cost concerns. The mental health community has framed parity as an antidiscrimination measure that would achieve greater insurance equity across disease groups. The role of personal experience with mental illness among lawmakers and others in framing the parity debate is also considered.

Background: The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, intended to address potential threats to patient privacy posed by the computerization and standardization of medical records, provides a new floor level of federal protection for health information in all 50 states. In most cases, compliance with the Privacy Rule was required as of April 2003. Yet considerable confusion and concern remain about the Privacy Rule and the specific changes it requires in the way healthcare providers, health plans, and others use, maintain, and disclose health information. Researchers worry that the Privacy Rule could hinder their access to health information needed to conduct their research., Objectives: In this article, we explain how the final version of the Privacy Rule governs disclosure of health information, assess implications of the Privacy Rule for research, and offer practical suggestions for researchers who require access to health information., Conclusion: The Privacy Rule is fundamentally changing the way that healthcare providers, health plans, and others use, maintain, and disclose health information and the steps that researchers must take to obtain health data. The Privacy Rule requires researchers who seek access to identifiable health information to obtain written authorization from subjects, or, alternatively, to demonstrate that their research protocols meet certain Privacy Rule requirements that permit access without written authorization. To ensure continued access to data, researchers will need to work more closely than before with healthcare providers, health plans, and other institutions that generate and maintain health information.

This study examines individual client- and community-level sources of variation in service use among clients entering 18 community treatment programs for homeless mentally ill persons as part of a national demonstration project. Assessment data on 1,828 clients were used to evaluate the relationship of a) individual client characteristics and b) site of entry, to both the intensity and diversity of service use. Hierarchical multiple regression was used to identify the relative importance of client characteristics and site of entry. Client characteristics explained only 2% to 3% of the variance in service use. Inter-site variation accounted for 2 to 3 times as much of the variance. Inter-site differences account for substantially more of the variance in service use among homeless persons with mental illness than individual client characteristics. Further studies are needed to identify specific community-level factors that account for these variations.