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Instrumental and Transformative Medical Technologies
Get PDFThis Article considers how medical technologies impact universality in health care. The universality principle, as embodied in the Patient Protection and Affordable Care Act (A CA), eliminated widespread discriminatory practices and provided financial assistance to those otherwise unable to become insured a democratizing federal act that was intended to stabilize health care policy nationwide. This Article posits that medical technology, as with all of medicine, can be universalizing or exclusionary and that this status roughly correlates to its being instrumental technology or transformative technology. Instrumental technology acts as a tool of medicine and often serves an existing aspect of health care; in contrast, transformative technology is pioneering, meaning it creates a new form of care or otherwise is novel. Instrumental and transformative medical technologies provide end points on a continuum, which provides a lens through which to examine whether medical technology has greater potential to facilitate universality or exclusion. The Article first examines where technologies fit on the instrumental-transformative continuum and then considers measures more specific to universality, namely improving the quality of medical care, access to care, or the cost of care. These considerations help to pinpoint the moment at which a technology may have a universalizing effect, if at all. The Article concludes with preliminary thoughts regarding whether the instrumental-transformative continuum helps to determine whether certain technologies should be adopted or supported publically or allowed to develop (or fail) organically.
Scalia and Antitrust
Get PDFAsk almost anyone in Massachusetts, or in any other predominantly liberal American state, what they think about Justice Antonin Scalia, and you are bound to hear comments, not a few of them derisory, about original intent as an approach to constitutional law. This was true long before his death on February 13, 2016, and is still true today. The theory of originalism, the notion that the Constitution should be interpreted in accordance with the intent of its framers, had become so closely associated with Scalia that the man had become the living embodiment of the theory
Review of The Civic Constitution: Civic Visions and Struggles in the Path Toward Constitutional Democracy by Elizabeth Beaumont
No full textAmericans have long struggled over not only substantive ideas of liberty and equality, but also the propriety of popular methods for defending these values. The author approves the shelter of runaway slaves, which held out the prospect of violence, but would she countenance such practices as the creation of armed citizen groups to resist the return of fugitive slaves or slave stealing, which entailed waylaying traveling slaveholders and liberating slaves whether or not they had asked for help
Blockchain (Distributed Ledger Technology) Solves VAT Fraud
Get PDFAt the World Economic Forum more than 800 executive and technology experts were asked when they thought a particular “tipping point” would be reached – when would we see a government collect tax with blockchain? The agreed date was 2023 (on average). A full 73% of the respondents however, expected the tipping point to have been reached by 2025.
This paper argues that the EU VAT will be an early adopter, if not the earliest adopter of blockchain. There are a number of reasons why. Blockchain will bring substantial efficiencies to VAT collection. It will reduce costs, and build critical inter-governmental trust relationships. Most importantly, blockchain will immediately end revenue losses well in excess of €50 to €60 billion per year in missing trader intra-community fraud (MTIC).
Blockchain will also be essential for making the EU Commission’s April 2016 Action Plan on VAT work. Blockchain should be a critical part of the detailed legislative proposal (expected in 2017). This plan will bring in a “definitive VAT system” dealing with intra-EU cross-border trade, which will be based on taxation in the country of destination. This paper predicts that the EU will bring in the “definitive system” on the back of blockchain technology.
Blockchain is a revolutionary improvement on any centralized data system. Tax administrations are inherently based upon centralized repositories of taxpayer data. They are prime candidates for the kinds of efficiency improvements that come through blockchain. This is particularly the case for transaction taxes, and even more so for a VAT fraud prevention application, like the Digital Invoice Customs Exchange (DICE), which relies on a real-time exchange of encrypted data
VAT in the GCC - Missing Trader Frauds
Get PDFAll VATs are susceptible to missing trader (MT) fraud. VATs adopted in an economic community are particularly more susceptible. The EU, for example, loses in excess of €100b annually to this fraud. Given the anticipated adoption of a European-style credit-invoice VAT in the GCC by January 1, 2018, this paper offers a technology-based solution involving the real-time tracking of taxable transactions with centrally collected (securely encrypted) data flows that are risk-analyzed by artificial intelligence (AI)
Progress in the Fight Against Multidrug Resistant Bacteria?: A Review of FDA-Approved Antibiotics 2010-2015
Get PDFA weak antibiotic pipeline and the increase in drug-resistant pathogens have led to calls for more new antibiotics. Eight new antibiotics were approved by the U.S. Food and Drug Administration (FDA) between January 2010 and December 2015: ceftaroline, fidaxomicin, bedaquiline, dalbavancin, tedizolid, oritavancin, ceftolozane-tazobactam, and ceftazidime-avibactam. This study evaluates the development course and pivotal trials of these antibiotics for their innovativeness, development process, documented patient outcomes, and cost. Data sources were FDA approval packages and databases (January 2010 to December 2015); the Red Book (Truven Health Analytics); Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (FDA); and supplementary information from company filings, press releases, and media reports. Four antibiotics were approved for acute bacterial skin and skin-structure infection. Seven had similar mechanisms of action to those of previously approved drugs. Six were initially developed by small to midsized companies, and 7 are currently marketed by 1 of 3 large companies. The drugs spent a median of 6.2 years in clinical trials (interquartile range [IQR], 5.4 to 8.8 years) and 8 months in FDA review (IQR, 7.5 to 8 months). The median number of patients enrolled in the pivotal trials was 666 (IQR, 553 to 739 patients; full range, 44 to 1005 patients), and median trial duration was 18 months (IQR, 15 to 22 months). Seven drugs were approved on the basis of pivotal trials evaluating noninferiority. One drug demonstrated superiority on an exploratory secondary end point, 2 showed decreased efficacy in patients with renal insufficiency, and 1 showed increased mortality compared with older drugs. Seven of the drugs are substantially more expensive than their trial comparators. Limitations are that future research may show benefit to patients, new drugs from older classes may show superior effectiveness in specific patient populations, and initial U.S. prices for each new antibiotic were obtained from public sources. Recently marketed antibiotics are more expensive but have been approved without evidence of clinical superiority
Federal Administrative Law, 7th ed.
No full textThis casebook emphasizes current doctrine and its historical evolution in exploring the four basic foundations of federal administrative law: separation of powers, statutorily- and constitutionally-required procedures for agency adjudication and rulemaking, scope of judicial review of agency action, and the availability and timing of judicial review. The book concentrates on federal rather than state administrative law in order to provide the fundamental knowledge and concepts necessary to understand the subject, on the belief that an understanding of federal law can be translated into other settings. The book also maintains the straightforward organization and don’t-hide-the-ball presentation that has characterized the book since its inception. The Seventh Edition contains five new principal cases, eight major new note cases, ten shorter new note cases, and updated treatments of all major topics. It also includes a revised Chapter I that includes an extended treatment of statutory interpretation to accommodate the increasing inclusion of Administrative Law in the first-year curriculum.https://scholarship.law.bu.edu/books/1029/thumbnail.jp
International Law Constraints as Executive Power
Get PDFThe use of international law to understand domestic authority has a long pedigree. It is also the subject of heated debate, which focuses predominantly on the extent to which international law can or should serve as a limit on political actors, in particular the President, and the extent to which it can be invoked to expand our understanding of domestic individual rights. Yet there is another significant dynamic at work in this interplay between international and domestic law. This is the invocation of international law not as a constraining force on government actors, but as an enabling force within the domestic system. This Article explores the U.S. Executive’s invocation of international law to support expansive interpretations of statutory or constitutional grants of authority; to narrow domestic prohibitions on executive action and narrow protections for individuals; and to justify the displacement of the ordinary operation of domestic legal rules, at times exchanging the domestic legal architecture for a more permissive framework based in international law.Despite these dramatic effects, this “empowerment phenomenon” often goes unnoticed. In and of itself, the existence of international law empowerment is not inherently problematic. The dangers lie in the lack of attention and understanding paid to how it operates. In its most aggressive form, the empowerment phenomenon can result in an executive branch released from traditional statutory and constitutional constraints, free to act up to the limits of international law norms that the Executive itself asserts the authority to interpret. The hazards in this phenomenon lie in multiple factors: the insufficiency of international law itself as a sole check in the domestic legal realm; the discretion the Executive exercises over international law through its interpretive power; and the frequent lack of expertise and engagement with international law by those charged with checking executive authority. This Article examines the mechanisms through which the empowerment phenomenon operates, and navigates the tension between granting the Executive sufficient flexibility on the international plane and reining in that authority when it threatens to undermine fundamental domestic constraints
Still Learning From the Birmingham Jail
No full textThis month presents an opportune moment to reflect upon what guidance Dr. King’s poignant words can offer our society in addressing what some have called “the new civil rights movement”: the same-sex marriage movement.April 16, 2013 marks the 50th anniversary of the day that Dr. Martin Luther King, Jr. began to write his masterpiece, “Letter from a Birmingham Jail.” Thus, this month presents an opportune moment to reflect upon what guidance Dr. King’s poignant words can offer our society in addressing what some have called “the new civil rights movement”: the same-sex marriage movement. This important letter’s lessons are as profound today on the question of gay marriage as they were in 1963 on the question of racial civil rights. They make it clear why justice simply cannot wait