Evolution or Revolution in Telehealth Regulation

A frequently repeated adage, attributed to a wide range of authors and orators, holds that a serious crisis should never be allowed to go to waste. The moment in which we find ourselves renders this adage particularly timely. Responses to one of the defining crises of our age—the COVID–19 pandemic—have mostly been reactive. This includes the responses of multiple actors involved with telehealth. Congress, federal regulators, state legislatures, state regulators, private insurers, and health care providers, confronting the challenges of the pandemic, have responded by making ad hoc adjustments to the regulation and use of telehealth. Moving the conversation beyond this reactive posture, Professor Deborah Farringer’s article, A Telehealth Explosion: Using Lessons from the Pandemic to Shape the Future of Telehealth Regulation, surveys the history of telehealth regulation, the pandemic-era adjustments, and recent proposals for the future finds an opportunity instead. The article seeks to put a crisis to good use—taking “advantage of the momentum that the COVID–19 public health emergency has created”—to inform the creation of “a comprehensive and integrative approach” to telehealth regulation. I find it possible to read A Telehealth Explosion in two ways: as an article with narrow aims and as an article with much broader aims. Parts I and II present these two readings. In Part III, I situate the broader reading within the context of earlier expansions of federal regulation of the health care enterprise to pose the question of how likely it is that the current crisis can be put to the good use that Professor Farringer seeks

Emergent Regulatory Systems and Their Challenges: The Case of Combination Medical Products

Where regulatory systems overlap, courts and scholars often focus on the undesirable aspects of the overlap—the ways in which systems conflict. One such context involves the regulation of prescription drugs and medical devices by the FDA’s premarket evaluation processes and by state common-law tort and products liability actions. FDA regulation and state common law are often described as separate, conflicting regulatory systems. This Article challenges that description by proposing a model in which FDA premarket evaluation and state common law function as a single regulatory system. This model brings order to the Supreme Court’s seemingly inconsistent medical products preemption cases, permitting the Court’s decisions in Medtronic v. Lohr, Riegel v. Medtronic, Wyeth v. Levine, PLIVA v. Mensing, and other cases to be understood as having created an emergent, coherent, multilayered regulatory system that calibrates the requirements imposed by each layer to the deficit in information about the risk of each product category. The model also provides a strong critique of scores of recent lower court preemption decisions involving “combination products,” a new product category whose members consist of both a new drug and a high-risk device. In finding common law actions preempted, these courts claim to have faithfully applied Riegel’s holding. But using the model developed here, it is clear that courts have disrupted the calibrated regulatory system, allowing thousands or millions of people in the United States to be exposed to dangerous products whose risks have not been wellcharacterized. Using the combination products decisions as a cases study, the model also highlights the far-reaching effects that even small changes to any one input may have on the function of an emergent system and the field that it regulates

Accelerated epigenetic aging in Werner syndrome.

Individuals suffering from Werner syndrome (WS) exhibit many clinical signs of accelerated aging. While the underlying constitutional mutation leads to accelerated rates of DNA damage, it is not yet known whether WS is also associated with an increased epigenetic age according to a DNA methylation based biomarker of aging (the "Epigenetic Clock"). Using whole blood methylation data from 18 WS cases and 18 age matched controls, we find that WS is associated with increased extrinsic epigenetic age acceleration (p=0.0072) and intrinsic epigenetic age acceleration (p=0.04), the latter of which is independent of age-related changes in the composition of peripheral blood cells. A multivariate model analysis reveals that WS is associated with an increase in DNA methylation age (on average 6.4 years, p=0.011) even after adjusting for chronological age, gender, and blood cell counts. Further, WS might be associated with a reduction in naïve CD8+ T cells (p=0.025) according to imputed measures of blood cell counts. Overall, this study shows that WS is associated with an increased epigenetic age of blood cells which is independent of changes in blood cell composition. The extent to which this alteration is a cause or effect of WS disease phenotypes remains unknown

Instant messaging and the facilitation of collaborative, student-led learning and teaching-support: The NZCEL EAP scenario

Abstract In the last couple of decades, the increased use of technology in the education sector has led to smartphone use becoming more prevalent in supporting students’ learning. Apart from applications (apps) specifically designed for language educational purposes, such as Duolingo, there are also instant messaging apps that are not specifically designed for education purposes, but that can be useful in supporting learners. These include instant messaging apps such as, WhatsApp and WeChat. Instead of relegating phone app use to merely a source of entertainment and distraction, teachers increasingly use them as a vital form of communication to enhance education, including language learning. Apps have thus shifted from a tangential position to the forefront of the learning space. For the purposes of this research project, WeChat was used as the messaging app. This article focuses on the initial findings of a pilot study and concentrates on the perceived purposes for the participants’ posts as they relate to the use of the app as a tool for collaboration, peer-support, and knowledge sharing. Data was gathered through an online survey, semi-structured interviews, and an analysis of the WeChat posts. Analysis of the posts and comments made by students during the interviews suggest that the tool formed a vital link between them, their classmates and teachers, and, at times, served as a social platform underlying the key educational purposes of the programme

WeChat and the facilitation of collaborative learning, teacher-support and student-reflection: the NZCEL EAP scenario

WeChat and the facilitation of collaborative learning, teacher-support and student-reflection: the NZCEL EAP scenario In the last couple of decades, the increased use of technology in the education sector has led to smartphone use becoming more prevalent in supporting students’ learning. Apart from apps specifically designed for educational purposes, there are also other messaging applications that are not specifically designed for education purposes, but that could be really useful in supporting learners, including the messaging apps Whatsapp and Wechat. For the purposes of this project, Wechat was used as the messaging app, partly because of the prevalence of use with the cohort of language learning students chosen for the project. Research into the use of Wechat as an educational support tool has largely focused on usage in China and some studies such as that conducted by Jian and Li (2018) on linking up learners of Chinese in Australia with native Chinese speakers. However, there does not appear to be any research on the use of Wechat to establish a supportive and collaborative environment for English Language Learners in an English as another language environment. This presentation reports on the initial findings of a pilot study which aimed to evaluate the use of WeChat as a tool to facilitate collaborative, supportive and reflective learning for students in a New Zealand Certificate in English Language (NZCEL), Level 4 Academic course, within an EAP tertiary environment. The findings focus on the participants’ views of the app as a tool for peer-support, teacher-support, students sharing knowledge (collaboration) and reflection. Data was gathered through an online survey, semi-structured interviews and an analysis of the Wechat posts. Analysis of the Wechat posts and comments made by students during the interviews suggest that the tool formed a vital link between them, their classmates and teachers, at times serving as a social platform underlying the key educational purposes. This research aims to offer new insights into the use of a socio-cultural theoretical approach, incorporating a smartphone app. such as WeChat as a supporting tool for language learning, student collaboration, reflection and support

Ultra-Fast Low Concentration Detection of Candida Pathogens Utilizing High Resolution Micropore Chips

Although Candida species are the fourth most common cause of nosocomial blood stream infections in the United States, early diagnostic tools for invasive candidemia are lacking. Due to an increasing rate of candidemia, a new screening system is needed to detect the Candida species in a timely manner. Here we describe a novel method of detection using a solid-state micro-scale pore similar to the operational principles of a Coulter counter. With a steady electrolyte current flowing through the pore, measurements are taken of changes in the current corresponding to the shape of individual yeasts as they translocate or travel through the pore. The direct ultra-fast low concentration electrical addressing of C. albicans has established criteria for distinguishing individual yeast based on their structural properties, which may reduce the currently used methods’ complexity for both identification and quantification capabilities in mixed blood samples

Training for Better Management: Avante Zambézia , PEPFAR and Improving the Quality of Administrative Services Comment on “Implementation of a Health Management Mentoring Program: Year- 1 Evaluation of Its Impact on Health System Strengthening in Zambézia Province, Mozambique”

The United States President’s Emergency Plan for AIDS Relief (PEPFAR) emphasizes health systems strengthening as a cornerstone of programmatic success. Health systems strengthening, among other things, includes effective capacity building for clinical care, administrative management and public health practice. Avante Zambézia is a district-level in-service training program for administrative staff. It is associated with improved accounting practices and human resources and transportation management but not monitoring and evaluation. We discuss other examples of successful administrative training programs that vary in the proportion of time that is spent learning on the job and the proportion of time spent in classrooms. We suggest that these programs be more rigorously evaluated so that lessons learned can be generalized to other countries and regions

Position Statement Executive Summary: Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus

Background: Multiple laboratory tests are used in the diagnosis and management of patients with diabetes mellitus. The quality of the scientific evidence supporting the use of these assays varies substantially. Approach: An expert committee compiled evidence-based recommendations for the use of laboratory analysis in patients with diabetes. A new system was developed to grade the overall quality of the evidence and the strength of the recommendations. A draft of the guidelines was posted on the Internet, and the document was modified in response to comments. The guidelines were reviewed by the joint Evidence-Based Laboratory Medicine Committee of the AACC and the National Academy of Clinical Biochemistry and were accepted after revisions by the Professional Practice Committee and subsequent approval by the Executive Committee of the American Diabetes Association. Content: In addition to the long-standing criteria based on measurement of venous plasma glucose, diabetes can be diagnosed by demonstrating increased hemoglobin A1c (HbA1c) concentrations in the blood. Monitoring of glycemic control is performed by the patients measuring their own plasma or blood glucose with meters and by laboratory analysis of HbA1c. The potential roles of noninvasive glucose monitoring, genetic testing, and measurement of autoantibodies, urine albumin, insulin, proinsulin, C-peptide, and other analytes are addressed. Summary: The guidelines provide specific recommendations based on published data or derived from expert consensus. Several analytes are found to have minimal clinical value at the present time, and measurement of them is not recommended