Title: Researchers must address regulatory regimes to scale up adoption of urine diversion systems in the U.S.
Abstract Urine diversion (UD) is a system-of-systems that involves source separation of waste to maximize recovery of valuable nutrients, including phosphorus. Recent research shows how UD systems offer valuable ecological benefits and can aid in water conservation efforts, and public perception studies suggest that UD systems are generally viewed positively by end-users and the general public. Nevertheless, adoption and implementation of this promising sustainability solution remains limited in many countries, including the United States (U.S.). In this perspective, we argue that in order to scale up adoption in the U.S., UD researchers and innovators must do more to address regulatory barriers. We draw on insights from political science research on ‘regulatory regimes’ to introduce the array of regulations that apply to UD systems, with a focus on commercial and institutional buildings. We examine regulatory regimes all along the UD system-of-systems, beginning at the point of collection and ending at the point of beneficial reuse. We then propose next steps to address current regulatory challenges that impact adoption, with an emphasis on the importance of stakeholder coordination. Throughout, we argue that law and regulation plays a critical role in shaping adoption of UD technologies because: (1) different regulatory regimes will be important at different points in the system-of-systems, (2) there may be multiple regulatory regimes that apply to a single subsystem, and (3) it is important to consider that legal and regulatory definitions of a technology may not match scientific understanding. more »« less
Lloyd, Elisabeth A.; Oreskes, Naomi; Seneviratne, Sonia I.; Larson, Edward J.
(, Climatic Change)
null
(Ed.)
Abstract Standards of proof for attributing real world events/damage to global warming should be the same as in clinical or environmental lawsuits, argue Lloyd et al. The central question that we raise is effective communication. How can climate scientists best and effectively communicate their findings to crucial non-expert audiences, including public policy makers and civil society? To address this question, we look at the mismatch between what courts require and what climate scientists are setting as a bar of proof. Our first point is that scientists typically demand too much of themselves in terms of evidence, in comparison with the level of evidence required in a legal, regulatory, or public policy context. Our second point is to recommend that the Intergovernmental Panel on Climate Change recommend more prominently the use of the category “more likely than not” as a level of proof in their reports, as this corresponds to the standard of proof most frequently required in civil court rooms. This has also implications for public policy and the public communication of climate evidence.
Adams, Rachel M; Davies, Holly; Peek, Lori; Mordy, Meghan; Tobin, Jennifer; Breeden, Jolie; McBride, Sara K; de_Groot, Robert M
(, International Journal of Disaster Risk Reduction)
The U.S. Geological Survey-managed ShakeAlert® earthquake early warning system is the first public alerting system in the United States to provide rapid mass notification when an earthquake is detected. Although public alert delivery via mobile phones began in California in 2019 followed by Oregon and Washington in 2021, little is known about what might drive widespread implementation in at-risk institutional settings such as schools. For example, there has been limited research on how to best integrate earthquake early warning into existing emergency plans, alert systems, and drills to keep school children and personnel safe in an earthquake. To address this gap, in the spring of 2022, every school district superintendent in Alaska, California, Oregon, and Washington was sent a 15-min online survey. The survey assessed superintendent knowledge of ShakeAlert, preferences for alert messaging, and perceived opportunities and barriers to incorporating the system in schools. The results showed that superintendents had low awareness of ShakeAlert but held positive perceptions of the system's potential to enable life-saving protective actions. A major barrier to adoption included the perceived financial cost of implementing and maintaining the system. There were some statistically significant differences in state responses, and future research could investigate the specific needs of each state based on school district size and composition, hazard exposure, and earthquake experience. Together these findings can help inform targeted strategies to increase ShakeAlert adoption in schools and ultimately improve the safety of school children and staff during earthquakes.
Hansen, Ryan N.; Saour, Basil Matthew; Serafini, Brian; Hannaford, Blake; Kim, Lanu; Kohno, Takayoshi; James, Ryan; Monsky, Wayne; Seslar, Stephen P.
(, Telemedicine and e-Health)
Background: There are well-recognized challenges to delivering specialty health care in rural settings. These challenges are particularly evident for specialized surgical health care due to the lack of trained operators in rural communities. Telerobotic surgery could have a significant impact on the rural-urban health care gap, but thus far, the promise of this method of health care delivery has gone unrealized. With the increasing adoption of telehealth over the past year, along with the maturation of telecommunication and robotic technologies over the past 2 decades, a reappraisal of the opportunities and barriers to widespread implementation of telerobotic surgery is warranted. Here we report the outcome of a rural telerobotic stakeholder workshop to explore modern-day issues critical to the advancement of telerobotic surgical health care. Materials and Methods: We assembled a multidisciplinary stakeholder panel to participate in a 2-day Rural Telerobotic Surgery Stakeholder Workshop. Participants had diverse expertise, including specialty surgeons, technology experts, and representatives of the broader telerobotic health care ecosystem, including economists, lawyers, regulatory consultants, public health advocates, rural hospital administrators, nurses, and payers. The research team reviewed transcripts from the workshop with themes identified and research questions generated based on stakeholder comments and feedback. Results: Stakeholder discussions fell into four general themes, including (1) operating room team interactions, (2) education and training, (3) network and security, and (4) economic issues. The research team then identified several research questions within each of these themes and provided specific research strategies to address these questions. Conclusions: There are still important unanswered questions regarding the implementation and adoption of rural telerobotic surgery. Based on stakeholder feedback, we have developed a research agenda along with suggested strategies to address outstanding research questions. The successful execution of these research opportunities will fill critical gaps in our understanding of how to advance the widespread adoption of rural telerobotic health care.
Winter, J.S.
(, Telecommunications Policy Research Conference (TPRC).)
Patient-generated health data (PGHD), created and captured from patients via wearable devices and mobile apps, are proliferating outside of clinical settings. Examples include sleep tracking, fitness trackers, continuous glucose monitors, and RFID-enabled implants, with many additional biometric or health surveillance applications in development or envisioned. These data are included in growing stockpiles of personal health data being mined for insight via big data analytics and artificial intelligence/deep learning technologies. Governing these data resources to facilitate patient care and health research while preserving individual privacy and autonomy will be challenging, as PGHD are the least regulated domains of digitalized personal health data (U.S. Department of Health and Human Services, 2018). When patients themselves collect digitalized PGHD using “apps” provided by technology firms, these data fall outside of conventional health data regulation, such as HIPAA. Instead, PGHD are maintained primarily on the information technology infrastructure of vendors, and data are governed under the IT firm’s own privacy policies and within the firm’s intellectual property rights. Dominant narratives position these highly personal data as valuable resources to transform healthcare, stimulate innovation in medical research, and engage individuals in their health and healthcare. However, ensuring privacy, security, and equity of benefits from PGHD will be challenging. PGHD can be aggregated and, despite putative “deidentification,” be linked with other health, economic, and social data for predictive analytics. As large tech companies enter the healthcare sector (e.g., Google Health is partnering with Ascension Health to analyze the PHI of millions of people across 21 U.S. states), the lack of harmonization between regulatory regimes may render existing safeguards to preserve patient privacy and control over their PHI ineffective. While healthcare providers are bound to adhere to health privacy laws, Big Tech comes under more relaxed regulatory regimes that will facilitate monetizing PGHD. We explore three existing data protection regimes relevant to PGHD in the United States that are currently in tension with one another: federal and state health-sector laws, data use and reuse for research and innovation, and industry self-regulation by large tech companies We then identify three types of structures (organizational, regulatory, technological/algorithmic), which synergistically could help enact needed regulatory oversight while limiting the friction and economic costs of regulation. This analysis provides a starting point for further discussions and negotiations among stakeholders and regulators to do so.
Winter, J.S.; Davidson, E.
(, Telecommunications Policy Research Conference)
Patient-generated health data (PGHD), created and captured from patients via wearable devices and mobile apps, are proliferating outside of clinical settings. Examples include sleep tracking, fitness trackers, continuous glucose monitors, and RFID-enabled implants, with many additional biometric or health surveillance applications in development or envisioned. These data are included in growing stockpiles of personal health data being mined for insight via big data analytics and artificial intelligence/deep learning technologies. Governing these data resources to facilitate patient care and health research while preserving individual privacy and autonomy will be challenging, as PGHD are the least regulated domains of digitalized personal health data (U.S. Department of Health and Human Services, 2018). When patients themselves collect digitalized PGHD using “apps” provided by technology firms, these data fall outside of conventional health data regulation, such as HIPAA. Instead, PGHD are maintained primarily on the information technology infrastructure of vendors, and data are governed under the IT firm’s own privacy policies and within the firm’s intellectual property rights. Dominant narratives position these highly personal data as valuable resources to transform healthcare, stimulate innovation in medical research, and engage individuals in their health and healthcare. However, ensuring privacy, security, and equity of benefits from PGHD will be challenging. PGHD can be aggregated and, despite putative “deidentification,” be linked with other health, economic, and social data for predictive analytics. As large tech companies enter the healthcare sector (e.g., Google Health is partnering with Ascension Health to analyze the PHI of millions of people across 21 U.S. states), the lack of harmonization between regulatory regimes may render existing safeguards to preserve patient privacy and control over their PHI ineffective. While healthcare providers are bound to adhere to health privacy laws, Big Tech comes under more relaxed regulatory regimes that will facilitate monetizing PGHD. We explore three existing data protection regimes relevant to PGHD in the United States that are currently in tension with one another: federal and state health-sector laws, data use and reuse for research and innovation, and industry self-regulation by large tech companies We then identify three types of structures (organizational, regulatory, technological/algorithmic), which synergistically could help enact needed regulatory oversight while limiting the friction and economic costs of regulation. This analysis provides a starting point for further discussions and negotiations among stakeholders and regulators to do so.
Merck, Ashton, Grieger, Khara, Crane, Lucas, and Boyer, Treavor. Researchers must address regulatory regimes to scale up adoption of urine diversion systems in the U.S.. Environmental Research: Infrastructure and Sustainability 4.2 Web. doi:10.1088/2634-4505/ad59c3.
Merck, Ashton, Grieger, Khara, Crane, Lucas, & Boyer, Treavor. Researchers must address regulatory regimes to scale up adoption of urine diversion systems in the U.S.. Environmental Research: Infrastructure and Sustainability, 4 (2). https://doi.org/10.1088/2634-4505/ad59c3
Merck, Ashton, Grieger, Khara, Crane, Lucas, and Boyer, Treavor.
"Researchers must address regulatory regimes to scale up adoption of urine diversion systems in the U.S.". Environmental Research: Infrastructure and Sustainability 4 (2). Country unknown/Code not available: IOP Publishing. https://doi.org/10.1088/2634-4505/ad59c3.https://par.nsf.gov/biblio/10519748.
@article{osti_10519748,
place = {Country unknown/Code not available},
title = {Researchers must address regulatory regimes to scale up adoption of urine diversion systems in the U.S.},
url = {https://par.nsf.gov/biblio/10519748},
DOI = {10.1088/2634-4505/ad59c3},
abstractNote = {Abstract Urine diversion (UD) is a system-of-systems that involves source separation of waste to maximize recovery of valuable nutrients, including phosphorus. Recent research shows how UD systems offer valuable ecological benefits and can aid in water conservation efforts, and public perception studies suggest that UD systems are generally viewed positively by end-users and the general public. Nevertheless, adoption and implementation of this promising sustainability solution remains limited in many countries, including the United States (U.S.). In this perspective, we argue that in order to scale up adoption in the U.S., UD researchers and innovators must do more to address regulatory barriers. We draw on insights from political science research on ‘regulatory regimes’ to introduce the array of regulations that apply to UD systems, with a focus on commercial and institutional buildings. We examine regulatory regimes all along the UD system-of-systems, beginning at the point of collection and ending at the point of beneficial reuse. We then propose next steps to address current regulatory challenges that impact adoption, with an emphasis on the importance of stakeholder coordination. Throughout, we argue that law and regulation plays a critical role in shaping adoption of UD technologies because: (1) different regulatory regimes will be important at different points in the system-of-systems, (2) there may be multiple regulatory regimes that apply to a single subsystem, and (3) it is important to consider that legal and regulatory definitions of a technology may not match scientific understanding.},
journal = {Environmental Research: Infrastructure and Sustainability},
volume = {4},
number = {2},
publisher = {IOP Publishing},
author = {Merck, Ashton and Grieger, Khara and Crane, Lucas and Boyer, Treavor},
}
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