Voluntary Consensus Standards Research Articles

Gaps, guesswork, and ghosts lurking in technology integration: Laws and policies applicable to student privacy

Technology integration and learning analytics offer insights to improve educational experiences and outcomes. In advancing these efforts, laws and policies govern these environments placing protections, standards, and developmental opportunities for higher education, students, faculty, and even the nation‐state. Nonetheless, evidence of educational restrictions, encumbered actions, and archaic approaches pervades the legal literature and case law demonstrating that these laws and policies do not always function well in evolving and emerging technology spaces. To examine these laws and policies of student privacy, the author employs the combination of a critical policy analysis, which derives from critical social research as a means to explore discourse and policy through drawing out the policy contexts, texts, and consequences, and Flood's liberating systems theory, which directs the analysis to a problem‐solving approach by examining the policy discourse from a systems‐thinking lens. Based on a review of 184 court cases, 74 policies from a diversified representation of US states/territories, and seven developed nations or multi‐nation consortia, this examination illuminates how context and text such as the type and setting of the privacy matter (eg, various freedom of information acts, educational records under the Family Educational Rights and Privacy Act, and General Data Protection Regulation in the European Union) presents opportunities for protections and standardization efforts; however, they also illustrate significant protection gaps, guesswork and insufficiency around the type and degree of data subject consent, and ghosting effects of data subjects' protections. While the extant literature already supports aspects of these findings, it does not account for this holistic view of these three privacy vulnerabilities—especially in light of the principles to which these laws purport to achieve. Moreover, the three identified privacy vulnerabilities suggest overlooked inclusion of two overarching privacy concepts—transparency and equity. This study recommends that key actors in the policy construction realm (ie, university leaders, policymakers, and judges) should engage in analyses, dialogue, and consideration about transparency and equity by considering contemporary privacy problems in the contexts of artificial intelligence, quantum computing, and cybersecurity as a way to improve transparent and equitable policies in these areas rather than exacerbating the privacy dilemmas already in place. Practitioner notesWhat is already known about this topic In the United States, the Family Educational Rights and Privacy Act of 1974 (FERPA) and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) are well documented evidence of privacy protections for education and health records, but they fail to offer sufficient protections for students as data subjects with emerging technologies. Existing federal‐level laws in the United States do not offer a systematic or uniform approach in the manner that data users obtain consent, so data subjects are largely unaware of what is being consented. Other than matters of consent, policy strategies based on student privacy laws (ie, voluntary consensus standards, basic practices to maintain privacy, an ethics review board, data/record retention and destruction, and data sanitation of equipment) are significant and informative largely from the university‐perspective, not the students as data subjects. What this paper adds A new comprehensive examination of US laws including statutes, regulations, and cases as well as seven key nation‐state or national consortia laws—especially the EU's General Data Protection Regulation and selected state laws in the United States, which offer consistent and greater student privacy protections. Insights about the principles designed among the laws, which centre around their application, essentiality, consent, and security. Attention to areas in which student privacy laws still present privacy concerns, but specifically identifying issues of significant gaps, guesswork and insufficiency around levels and types of consent, and ghosting effects of data subjects' protections. Implications for practice and/or policy Data subject consent should be established and consistent– whether an opt‐out provision, opt‐in provision, or some extensive engagement. Student privacy policies should incorporate principles of transparency and equity for data subjects and data treatment. Policymakers should consider now how the intersections of data subject privacy matters shall be addressed in the context of artificial intelligence, quantum computing, and cybersecurity.

My contributions to ultrasound metrology

My work in ultrasound metrology has centered around developing pre-clinical testing methods for therapeutic ultrasound devices. These test methods include radiation force balance systems and methods specifically for high-intensity therapeutic ultrasound, time-delay spectrometry methods for measuring hydrophone sensitivity, acoustic characterization of tissue-mimicking material that has been approved as a medical device development tool and a comparison protocol of computational and experimental acoustic characterization for therapeutic ultrasound devices. The purpose of this work at the FDA is to develop bench testing methods to ensure proper review of medical ultrasound devices to evaluate device safety and performance. The test instruments and methods developed have helped promote the development and recognition of voluntary consensus standards, as well as FDA industry guidance, that can provide the basis for least-burdensome data collection requirements by manufacturers and allow the FDA to assess device safety and effectiveness in a more consistent, methodical and scientifically rigorous manner.

Accuracy and Repeatability of Internet-ordered Spectacle Lenses.

Both consumers and eye care practitioners need to know how well online optical vendors conform with the accepted standards for quality and safety. We found that almost 1 in 10 prescriptions failed to meet national standards, which is a significant improvement over previous studies. The purpose of this study was to assess the accuracy and repeatability of spectacle lens prescriptions ordered from a sample of online vendors. Spectacle lens prescriptions were ordered by paid participants with no optical training who were masked to the study objectives. The prescription powers ordered (sphere, cylinder, and axis) were statistically sampled from 1000 previously filled prescriptions. A total of 100 orders were placed with each of three online vendors that included a range of high- and low-powered single vision lenses and progressive addition lenses, and duplicate orders to assess repeatability. An independent certified testing laboratory was contracted to assess conformance with voluntary consensus standards (ANSI Z80.1-2015) and Food and Drug Administration drop-ball safety testing. Lenses not meeting these standards were counted as failures. The overall failure rates for the three vendors were 11.2 ± 3.2% (vendor A), 8.0 ± 2.7% (vendor B), and 8.2 ± 2.8% (vendor C). The repeatability for 20 prescriptions ordered five times from each vendor was high, with correlation coefficients greater than 90%. There were no observed lens impact failures. Almost 1 in 10 spectacle lens prescriptions ordered from three online vendors failed to meet national standards for optical quality. Additional studies are needed to assess eyewear ordered online for other important patient-specific variables that can influence visual performance and ultimate acceptability of prescription eyewear, such as lens placement relative to the visual axis, frame fit, and cosmetic acceptability.

The U.S. Food and Drug Administration's role in improving radiation dose management for medical X-ray imaging devices.

The U.S. Food and Drug Administration (FDA) has been concerned with minimizing the unnecessary radiation exposure of people for half a century. Manufacturers of medical X-ray imaging devices are important partners in this effort. Medical X-ray imaging devices are regulated by FDA under both its electronic product regulations andits medical device regulations. FDA also publishes guidance documents that represent FDA's current thinking on a topic and provide a suggested or recommended approach to meet the requirements of a regulation or statute. FDA encourages manufacturers to develop medical devices that conform to voluntary consensus standards. Use of these standards is a central element of FDA's system to ensure that all medical devices marketed in the U.S. meet safety and effectiveness requirements. FDA staff participate actively in the development and maintenance of these standards, often advancing or introducing new safety and dose management requirements. Use of voluntary consensus standards reduces the amount of time necessary to evaluate a premarket submission and reduces the burden on manufacturers. FDA interacts with industry and other stakeholders through meetings with industry groups, public meetings, public communications, and through the development of voluntary consensus standards. In these interactions, FDA staff introduce new concepts for improving the safety of these devices and provide support for similar initiatives from professional organizations. FDA works with all stakeholders to achieve its mission of protecting and promoting the public health.

Barcoding animal species

Barcoding animal species

Collaborative robotics: New era of human–robot cooperation in the workplace

Abstract Introduction: Collaborative robot systems allow robots and humans to work together in ways that were previously impossible. This new capability brings new hazards and risks that must be evaluated for every application. This article discusses the nature of collaborative robots and how they are currently used in industry; voluntary industry consensus standards for safety of collaborative robot applications; and best practices in evaluating and mitigating new hazards related to collaborative robot applications. Discussion: Historically, workers have been kept safe around industrial robot systems by being kept physically separated from the robot systems through the use of safeguards. These safeguards may be physical barriers, or sensor-based systems (e.g., light curtains, safety laser scanners) that result in protective stops of the equipment if a worker crosses a boundary delineating the “safeguarded space”. Safety requirements for the design and implementation of industrial robot systems are specified in the industry standard ANSI/RIA R15.06-2012 (“R15.06”). Collaborative robotics represents a paradigm shift from traditional methods of keeping workers safe around industrial robots. With a properly implemented collaborative robot system, it may be possible to keep workers safe without the use of safeguards such as fences or light curtains. Risk assessment remains a crucial tool for safety with both collaborative and non-collaborative industrial robot systems. Safety requirements for collaborative robot systems are defined in the Technical Report (“TR”) RIA TR R15.606-2016, supplemental to R15.06. One method of conducting a task-based risk assessment for an industrial robot system is documented in RIA TR R15.306-2016. Conclusion: Voluntary industry consensus standards and supplemental technical reports provide information about best practices in keeping workers safe around industrial robotics, including collaborative robotics. Practical Applications: Organizations that design, implement, use, or manage industrial robot systems, including collaborative robot systems, should use the ANSI/RIA R15.06-2012 safety standard and its associated Technical Reports.

Acoustical standards in the national parks

U. S. National Parks began actively conserving park acoustic resources decades after U. S. community noise management practices were established. This presented opportunities to benefit from the knowledge acquired in community noise settings and challenges to adapt this knowledge and devise new methods as appropriate for national park settings. Participation in ANSI/ASA accredited standards development processes provided numerous benefits to the National Park Service (NPS): Access to a substantial fraction of the world’s experts in acoustics, noise measurement, and noise reduction, many of whom were deeply involved in the development of community noise standards, Participation in an open, formal, coordinated, consensus-based process to develop voluntary standards, Engagement of a diverse range of stakeholders to develop standards through processes of cooperation and compromise, Conformance with the Office of Management and Budget’s requirement to use voluntary consensus standards in lieu of government-unique standards (Circular A-119). NPS is an institutional member of two accredited standards committees and participates in the leadership of one committee and one working group. One standard has been published from this working group (ANSI S3-SC1.100 and ANSI S12.100: Methods to Define and Measure the Residual Sound in Protected Natural and Quiet Residential Areas). A second standard is in development.

“What’s the Risk?” Assessing and Mitigating Risk in Cardiothoracic Surgery

“What’s the Risk?” Assessing and Mitigating Risk in Cardiothoracic Surgery

An Updated Look at the Federal Policies Governing How Agencies Use Voluntary Consensus Standards in Regulatory, Procurement, and Science Documents

Voluntary consensus standards are a salubrious antidote to the pervasive cynicism about public institutions; the consensus standards process demonstrates that industry, civil society, academia, and government benefit the world by working together through a stable, sustained, and voluntary framework. This document provides an overview of the policies which govern participation by Executive Branch agencies in the development and use of voluntary consensus standards and conformity assessment activities. Also examined is the nuanced federal approach to standards which are not developed in accordance with consensus procedures. Although these “market-driven consortia” standards are often developed by industry for industry, this type of standard can be of use to federal agencies in scientific, procurement, and regulatory applications. The policies discussed below reflect the White House’s Office of Information and Regulatory Affairs’ (OIRA) January 2016 update to OMB Circular A-119 which was revised to better serve America’s economy in an increasingly interdependent world.

Eighteen years of recommendations to prevent industrial chemical incidents: results and lessons learned of the US Chemical Safety Board

ObjectivesThe US Chemical Safety Board (CSB), a federal agency that investigates significant chemical incidents and hazards, is interested in determining the impact of the recommendations resulting from its investigations, and how to better more effective recommendations to prevent chemical incidents. Study designThis is a descriptive study of the US Chemical Safety Board's safety recommendations. MethodsThe CSB coded and analysed its safety recommendations according to potential impact on reducing incidents, implementation status, purpose and recipient type. ResultsAs of March 31, 2015, the CSB has issued 733 recommendations, 75% (548) of which are closed and 25% (185) of which remain open. For recommendations categorised as having high, medium, and low impact, 38% (78), 76% (160), and 78% (245) were implemented, respectively. ConclusionsCSB recommendations have led to important and lasting safety changes through regulations, industry guidance and voluntary consensus standards, and individual companies; however, coding recommendations by potential impact do not fully capture the influence of CSB recommendations. While this methodology serves as a preliminary way to determine the effect of recommendations, further data are needed to determine the extent to which these safety changes have reduced the frequency or severity of industrial accidents.

Designing to the Test: Performance Standards and Technological Change in the U.S. Automobile after 1966.

Performance standards have played an important part in the regulation of technology for many years, yet they have received little attention from historians. This article presents a three-part framework of analysis for examining the role of regulatory performance standards in technological change. Parts one and two of the framework focus on how regulatory agencies construct and enforce standards for technological risks, or "negative externalities." The final part addresses the important question of whether and how firms choose to internalize these standards in their design procedures and other organizational routines. The article provides examples from the history of automotive regulation in the United States to illustrate each part of the framework, and it gives some thoughts on how regulatory performance standards fit within the voluminous literature on standardization, including other work on de facto and voluntary consensus standards.

Patents, Technical Standards and Standards-Setting Organizations: A Survey of the Empirical, Legal and Economics Literature

Despite their potential efficiency benefits, voluntary consensus standards have over the past decade become the subject of significant private litigation, regulatory enforcement and policy debate. Much of the controversy centers on the perceived proliferation of patents covering standardized technologies, potentially abusive enforcement of such patents against manufacturers and users of standardized products, and the terms on which patent holders may be required to license the use of those patents to others. This chapter offers a brief overview of the legal and economic literature concerning interoperability standards and standards-setting organizations, with a focus on empirical studies and contemporary patent and patent licensing concerns.

Harmonization of NIOSH Sampling and Analytical Methods With Related International Voluntary Consensus Standards

The NIOSH Manual of Analytical Methods (NMAM) is a compilation of analytical methods for air, biological, surface (including dermal), and bulk samples, as well as biological specimens, that have be...

Private Standards Organizations and Public Law

Legal information institutes ofthe world, meeting in Montreal, declare that:* Public legal information from all countries and international institutions is part of the common heritage of humanity. Maximising access to this information promotes justice and the rule of law;* Public legal information is digital common property and should be accessible to all on a non-profit basis and free of charge;* Organizations such as legal information institutes have the right to publish public legal information and the government bodies that create or control that information should provide access to it so that it can be published by other parties.We hear of tyrants, and those cruel ones: but, whatever we may have felt, we have never heard of any tyrant in such sort cruel, as to punish men for disobedience to laws or orders which he had kept them from the knowledge of.ABSTRACTSimplified, universal access to law is one of the important transformations worked by the digital age. With the replacement of physical by digital copies, citizens ordinarily need travel only to the nearest computer to find and read the texts that bind them. Lagging behind this development, however, has been computer access to standards developed by private standards development organizations, often under the umbrella of the American National Standards Institute (ANSI), and then converted by agency actions incorporating them by reference into legal obligations. To discover what colors the Occupational Safety and Health Administration (OSHA) requires for use in work-place caution signs, one must purchase from ANSI the standard OSHA has referenced in its regulations, at the price ANSI chooses to charge for it.The regulations governing incorporation by reference as a federal matter have not been revised since 1982, and therefore do not address the changes the digital age has brought about in what it means for incorporated matter to be reasonably available, as 5 U.S.C. § 552(a)(1) requires. This Article seeks to bridge that gap, suggesting a variety of approaches that might bring the use of incorporation by reference into conformity with modem rulemaking practices and respect the general proposition that documents stating citizens' legal obligations are not subject to copyright, while at the same time both honoring clear federal statutory policy favoring the use of privately developed standards in rulemaking and respecting the needs standards organizations have to find reasonable means to support the costs of their operations. Business models created in the age of print need to change; the challenge is to find ways to permit the market in privately developed voluntary standards to thrive, without thereby permitting the monopoly pricing of access to governing law.Introduction 499A. Voluntary Consensus Standards 499B. Their Occasional Conversion Into Legal Obligations 502C. And Hence the Problem to Be Discussed 507I. The Uncertain State of the Caselaw on the Copyrightability of Standards That Have Been Converted into Law 511n. Federal Regulation of Incorporation by Reference 518A. The Office of the Federal Register 518B. Copyright Preservation as Affirmative Federal Policy? Congress, the NTTAA, the NIST, and the OMB 524C. Possibilities of Change: An Administrative Conference Study, Rulemaking Proposal, and Reconsideration of OMB Circular A-119 529HI. Can the Public Have its Access-to-Law Cake and Standards Developers Eat Revenue from Standards Sales Too? 537A. Proposed Rulemaking and Digital Rights Management 537B. Standards Developed in the Expectation of Incorporation 543C. Standards Developed Independently of Any Expectation of Their Incorporation 546D. Must Incorporation by Reference Create Legal Obligations? 549IV. Changing Part 51 555Conclusion 559IntroductionA. Voluntary Consensus StandardsThis Article addresses the public/private confusions over standards developing organizations' work. …

Challenges in Evaluating All-Cause Hospital Readmission Measures for Use as National Consensus Standards

The National Quality Forum (NQF) aims to improve the quality of health care for all Americans through fulfillment of its three-part mission. The NQF uses its formal Consensus Development Process to evaluate and endorse consensus standards, including performance measures, best practices, frameworks, and reporting guidelines. To understand the opportunities and challenges in endorsing measures addressing all-cause readmissions to hospitals for use as national voluntary consensus standards for accountability and quality-improvement purposes. Report of standards development process. The Consensus Development Process was used to evaluate 3 candidate standards using the NQF Measure Evaluation Criteria. A 21-member steering committee rated each standard according to the criteria and made initial endorsement recommendations for all measures. Through the evaluation of measures for endorsement, several overarching issues in measuring all-cause readmissions were identified, including statistical modeling and the usability of the measures for quality improvement and accountability. Additionally, it was decided that, for the first time, quality monitoring and accountability of readmissions will take place at the health-plan level. Measuring at various levels of accountability reinforces the idea that multiple stakeholders have a responsibility and a role to reduce readmissions. These NQF-endorsed measures are a major step in promoting better understanding of readmissions and a reduction in hospital readmission rates, when appropriate. These measures can help reduce the substantial financial and emotional stress that readmissions place on the health care system, and patients will be able to communicate hospital-level performance on this important quality indicator.

A Call for Standardized Metrics to Assess Health IT Impact on Medication Safety

To the Editor: It has been repeatedly affirmed that increased technology use in health care is a cost-effective means of providing higher quality patient care. One main driver for expanded health information technology (IT) is the belief that it increases the safety of the medication use process. Through the use of substantial public and private investment, particularly the Health Information Technology for Economic and Clinical Health (HITECH) Act, as part of the 2009 Recovery Act, which amounted to $25.9 billion, this viewpoint has been validated.1 Furthermore, a 2011 American Society of Health-System Pharmacists (ASHP) national survey of hospital pharmacy practice that focused on technology utilization related to medication dispensing and administration found an increase in the level of adoption of various technologies such as computerized prescriber order entry (CPOE), barcode medication administration (BCMA), and smart infusion pumps.2 Health system administrators are left to devise their own metrics to determine whether their investment in such technologies is money well spent. We recently conducted a review of the literature to analyze whether there was any uniformity among health systems in choosing appropriate metrics to assess the impact of health IT implementation on medication safety-related outcomes. Using predetermined PubMed search criteria, we evaluated 43 articles, and, as expected, we observed broad diversity with 34 different metrics identified. About 59% of these metrics were utilized in just 2 or fewer articles, further emphasizing the variance observed in the literature review. The measurement of voluntarily reported medication errors was most commonly utilized, but this metric is inherently unreliable due to the difficulty in quantifying and qualifying such errors. Many confounding factors exist, and literature suggests that some types of health IT may introduce new errors, all leading to concerns whether this particular metric is the most accurate to use. Overall, our research suggests a lack of concordance as to how best to measure the impact of health IT on medication safety. What can be done to create a safer and more accurate method for assessing medication safety? The Institute of Medicine (IOM) has previously called for a uniform standard of metrics that would more easily determine the effectiveness of health IT on medication safety outcomes. In a November 2011 report titled Health IT and Patient Safety: Building Safer Systems for Better Care, the agency called on the Department of Health and Human Services (HHS) to promote the “development of new measures for reliably assessing the current state of health IT safety and monitoring for improvements.”3 The IOM urged HHS to “fund a new Health IT Safety Council, within an existing voluntary consensus standards organization.”3 The purpose of this council would be to develop criteria to judge the safe use of health IT and to evaluate how it is used to enhance safety.3 To date, this council has not yet been formed. Although there have been increments of advancement in the development of standards in measuring the impact of health IT on medication safety, it is clear there is more to accomplish in developing a framework by which such implementation can be assessed. A consensus of all major health care stakeholders is needed to create a uniform method to assess how health IT is impacting safety. Ultimately, there should be further development of validated metrics that more clearly demonstrate whether the adoption of health IT, which can cost millions of dollars, is cost-effective and is indeed improving the safety of the medication-use process.

Infant Formula and Adult/Pediatric Nutritional Methods Approved First Action Using the AOAC Voluntary Consensus Standards Process

Infant Formula and Adult/Pediatric Nutritional Methods Approved First Action Using the AOAC Voluntary Consensus Standards Process

Measurement of ultra-trace beryllium in occupational hygiene samples by extraction and fluorescence detection

Beryllium is widely used in industry and commercial products for its unique properties; however, occupational exposure to beryllium particles can cause dermal sensitization and a potentially fatal lung ailment, chronic beryllium disease (CBD). Consequently, exposure limits for beryllium particles in air and action levels on surfaces have been established in efforts to minimize exposure risks for workers. In recent research, a molecular fluorescence method for the determination of trace beryllium in workplace samples, i.e., air filters and dust wipes, was evaluated and validated through intra- and inter-laboratory testing. The procedure entails extraction of sampled beryllium in dilute ammonium bifluoride (aqueous), followed by fluorescence measurement of the complex formed between beryllium and hydroxybenzoquinoline sulfonate (HBQS). The estimated method detection limit is 400-fold excess concentration compared to that of beryllium) are negligible or minimal. The procedure is effective for the dissolution and quantitative determination of beryllium extracted from refractory beryllium oxide particles, and was successfully modified for measuring beryllium content in large BeO particles and in soil samples. The method performance compares favorably with methods employing sample digestion in acid mixtures that include hydrofluoric acid, followed by inductively coupled plasma-mass spectrometry. ASTM International voluntary consensus standards and US National Institute for Occupational Safety and Health methods based on the methodology have been promulgated.

Field-portable methods for monitoring occupational exposures to metals

Millions of workers are employed in manufacturing, mining, construction, and other industries where significant amounts of airborne metals and metal compounds are generated. Depending on the work practices, processes, techniques, and locations, exposures to airborne and surface sources of a variety of metals can cause occupational illness. These exposures can lead to a plethora of adverse health effects such as lung disease, anemia, cancer, asthma, dermal sensitization, dermatitis and neurological damage. The ability to monitor worker exposures to metals on-site in the field has been a goal of the National Institute for Occupational Safety and Health (NIOSH) since the early 1990s. In the last 15 years or so, several field-portable procedures for metals have been developed, evaluated and published as NIOSH methods. These methods, published in the NIOSH Manual of Analytical Methods, describe field screening tests and on-site analysis for lead, hexavalent chromium and beryllium. Some of these methods have also been published in the form of ASTM International voluntary consensus standards. This paper gives an overview of NIOSH research and development efforts on field screening and portable analytical methods for metals in the workplace. The goal of such efforts has been to provide screening and analytical tools that can be used on-site in the field to aid in the prevention of excessive exposures to toxic metals in the workplace.

Improving OMB Regulatory Review

The Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget (OMB) has played an important role in the federal regulatory process for many decades. The regulatory review process is multifaceted, and several Executive Orders and laws have been enacted over the years that added various requirements to improve the process. Existing requirements regarding drinking water regulation under the Safe Drinking Water Act (SDWA) are briefly reviewed in this article, including the following: administrative procedures; evaluation of significant regulatory actions; consideration of small entities; paperwork reduction; achieving regulatory flexibility; unfunded mandates reform; input from state and local governments; input from Indian tribal governments; protection of children; actions affecting energy supply, distribution, or use; use of voluntary consensus standards; environmental justice; SDWA consultation provisions; effect on technical, financial, and managerial capacity; congressional review; and, defining a new regulatory process.