Two monkey wrenches in the Russian regulatory reform

The latest Russian regulatory reform (2016) sought to introduce the risk-orientated approach – a move away from the “blanket inspections” (or the risk regulation reflex – a term coined by Blanc in 2011) method that has been criticised by the Russian business community. The present paper aims to assess its success using administrative data on federal watchdogs’ inspections. We argue that this reform ultimately failed in its goal regarding the overall number of inspections, and thus the volume of regulatory burden did not change significantly throughout the reform. This failure resulted from two mechanisms. First, the legal framing of the reform radically redefined risk as the probability of incompliance (as opposed to the likelihood of accident). Second, the watchdogs used key performance indicators that incentivised “street-level” inspectors to maintain the pre-reform regulatory burden levels.

Towards a network theory of regulatory burden

Government overlap creates problems for the public and private sector across several government systems. Research suggests that overlap burdens the political and economic system by increasing costs in terms of money, time, and complexity, decreasing innovation and investment, and dampening economic growth. Previous research has identified frameworks for categorizing regulatory overlap. However, the literature has not considered factors that contribute to regulatory overlap nor effective methods for its reduction. This research introduces a proxy measure for regulatory overlap which measures the regulatory burden that a federal agency imposes within the regulatory system. This research proposes a network theory of regulatory burden which finds that burden is a function of network properties characterizing a federal agency’s position within the regulatory system. This research suggests that the federal government may reduce occurrences of regulatory overlap by managing its regulatory network and fostering collaboration among federal agencies within the regulatory system.

Reconsidering ‘minimal risk’ to expand the repertoire of trials with waiver of informed consent for research

BackgroundProgress in therapeutic research is slowed by the regulatory burden of clinical trials, which provide the best evidence for guiding treatment. There is a long delay from evidence generation to adoption, highlighting the need for designs that link evidence generation to implementation.ObjectiveTo identify clinical trial designs that confer minimal risk above that inherent in clinical care, to obviate the need for cumbersome consenting processes to enrol patients in prospective clinical research studies. These designs extend the scope of the Learning Healthcare System, a framework for leveraging retrospective ‘big data’ to advance clinical research, to include data collected from prospective controlled trials.SummaryPragmatic trials may use simplified eligibility criteria, unblinded interventions and objective outcome measures that can all be monitored through the electronic health records (EHR), to reduce costs and speed study conduct. Most pragmatic trials continue to suffer from substantial regulatory burden. Written consent to participate in research can be waived only if the research produces minimal risk above what is encountered in everyday life. However, the ‘consent’ processes for prescribing Federal Drug Administration-approved medications in clinical medicine are informal, even when they involve decisions of uncertain benefit and higher levels of risk. We propose that trial designs that mimic clinical decision-making in areas of uncertainty (clinical equipoise) and in which no data are generated outside of usual care (ideally by EHR embedding) confer minimal additional risk. Trial designs meeting this standard could, therefore, be conducted with minimal documentation of consent, even when interventions contain different risks. To align with risk encountered in clinical practice, allocation to treatment arms should change (adaptive randomisation) as data are collected and analysed. Embedding of informatics tools into the EHR has the additional benefit that, as adaptive randomisation progresses, evidence-generation transitions into implementation via decision-support tools—the ultimate realisation of the Learning Healthcare System.

Can machine learning, as a RegTech compliance tool, lighten the regulatory burden for charitable organisations in the United Kingdom?

Purpose Machine learning is having a major impact on banking, law and other organisations. The speed with which this technology is developing to undertake tasks that are not only complex and technical but also time-consuming and that are subject to constantly changing parameters is astounding. The purpose of this paper is to explore the extent to which machine learning can be used as a solution to lighten the compliance and regulatory burden on charitable organisations in the UK; so that they can comply with their regulatory duties and develop a coherent and streamlined action plan in relation to technological investment. Design/methodology/approach The subject is approached through the analysis of data, literature and domestic and international regulation. The first part of the study summarises the extent of current regulatory obligations faced by charities, these are then, in the second part, set against the potential technological solutions provided by machine learning as of July 2021. Findings It is suggested that charities can use machine learning as a smart technological solution to ease the regulatory burden they face in a growing and impactful sector. Originality/value The work is original because it is the first to specifically explore how machine learning as a technological advance can assist charities in meeting the regulatory compliance challenge.

Technologies of financial flows sustainable management of the Russian banking sector

Subject. This article deals with the issues of rational allocation and management of macro-financial flows of the banking sector. Objectives. The article aims to interpret technologies of sustainable management of financial flows of the banking sector. Methods. For the study, I used post evaluation, systems, functional and structural, evolutionary, and dynamic analyses, and the techniques of observation, classification, grouping, sampling, comparison, and generalization. Conclusions and Relevance. To manage the macro-financial flows of the banking sector, financial technologies should be used both within the banking sector and cooperation between the sector and the Bank of Russia, and different sectors of the economy. The introduction of financial technologies will help the banking sector manage macro-financial flows in a sustainable manner, reduce regulatory burden and improve the efficiency of compliance with the Bank of Russia's regulatory requirements, and risk management.

The Impact of Federal Home Loan Bank (FHLB) Advances on Small Business Lending by Community Banks—2010–2016

In this paper, we examine the relationship between small business loan growth and growth in core deposits and Federal Home Loan Banks (FHLBs) advances from 2010 to 2016. Controlling for other effects, we find that the relationships between small business loan growth is positively and significantly related to both FHLB advance growth and core deposit growth, with the coefficient on advance growth being significantly larger than the coefficient on core deposits over the entire sample period. We also tested whether this relationship changed after 2014:3 reflecting the Federal Reserve’s relaxation of the regulatory burden on smaller banks. We find that the relationship between loan growth and core deposit growth became more positive after the change, but the relationship between loan growth and FHLB advance growth did not. As a result, we could no longer reject the hypothesis that the coefficient on core deposit growth was equal to the coefficient on FHLB advance growth after 2014:3. This provides some empirical support that the regulatory changes in the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 (DFA) influenced small business lending by strengthening the impact of the growth in core deposits on the growth of small business lending, complementing the work of Bordo and Duca (2018) that changes in DFA had some unintended negative consequences for lending to small businesses. It also suggests that lowering the regulatory burden faced by community banks (which have a larger proportion of core deposits to total assets than non-community banks) could improve the incentive to increase small business lending. It also implies that FHLB advances remain an important funding tool at the margin to give commercial banking organizations greater liquidity and flexibility in funding their balance sheets.

Regulating Pharmacy Practice: Analysis of Pharmacy Laws in Ten States

Background: The National Association of Boards of Pharmacy (NABP) recently established a task force to help states develop regulations based on “standards of care” rather than “prescriptive rule-based regulation.” This signals a shift in orthodoxy as pharmacy has traditionally been a highly regulated profession. A benchmark report on the pharmacy, nursing, and medical statutes and regulations in Idaho found that pharmacy had a higher overall word count, more overall restrictions, and had to be amended more frequently to keep pace with change. Objective: To identify opportunities to make the transition to a “standard of care” regulatory model in pharmacy law, this manuscript attempts to quantify the regulatory burden for 10 Western U.S. states. Method: The relevant statutes and regulations were gathered from each of the 10 states, and key measures were extracted, including word count, restrictions, exemptions, and the composition. Results: States exhibited wide variation in overall regulatory burden as measured by word count (average of 65,882 words, SD=35,057). The top categories of pharmacy law are: 1) professional practice standards (25,249 ± 16,077 words); 2) facility standards (15,230 ± 10,240 words); and 3) licensing (11,412 ± 6,191 words). More than 65% of all pharmacy regulations are in rule adopted by board of pharmacy rather than in statutes passed by the legislature. Conclusions: States exhibited major variation in total regulatory burden, with the largest contributors to cross-state variation being regulations related to professional practice standards and facility standards. This analysis suggests these two areas should be the primary targets of states looking to decrease regulatory burdens and that regulatory boards have a significant opportunity to remove regulatory burdens even in the absence of legislative action.