Even lawyers do not like legalese.

Across modern civilization, societal norms and rules are established and communicated largely in the form of written laws. Despite their prevalence and importance, legal documents have long been widely acknowledged to be difficult to understand for those who are required to comply with them (i.e., everyone). Why? Across two preregistered experiments, we evaluated five hypotheses for why lawyers write in a complex manner. Experiment 1 revealed that lawyers, like laypeople, were less able to recall and comprehend legal content drafted in a complex "legalese" register than content of equivalent meaning drafted in a simplified register. Experiment 2 revealed that lawyers rated simplified contracts as equally enforceable as legalese contracts, and rated simplified contracts as preferable to legalese contracts on several dimensions-including overall quality, appropriateness of style, and likelihood of being signed by a client. These results suggest that lawyers who write in a convoluted manner do so as a matter of convenience and tradition as opposed to an outright preference and that simplifying legal documents would be both tractable and beneficial for lawyers and nonlawyers alike.

Contract development and manufacturing organization selection: critical considerations that can make or break your cell and gene therapy development.

BACKGROUND AIMS: With the increase in cell and gene therapy (CGT) clinical trials in recent years has come a subsequent increase in the number of contract development and manufacturing organizations (CDMOs). Successful transition from development and early-phase clinical trials to commercialization of a CGT product often depends on selecting the best-suited CDMO. However, many CGT companies are small biotech companies that lack expertise in the field or do not have experience selecting and transferring a process to a CDMO. METHODS: Given the interest in this topic, a roundtable with CGT developers and CDMO members at the 2023 annual meeting of the International Society of Cell and Gene Therapy Paris discussed these critical aspects of product development, including technical expertise, risk sharing and timing of partnerships. RESULTS AND CONCLUSIONS: Here, we'll analyze the considerations discussed by the panel and elaborate on other factors crucial for CGT development.

Use of locums in the Regular GP Scheme 2016-22. / Vikarlegebruk i fastlegeordningen 2016­22.

Background: Under the Regular GP Scheme, locum GPs must be used when GPs are absent or when a patient list has no GP. We have studied the prevalence and development of locum contracts registered in the Regular GP Scheme in the period from 1 January 2016 to 31 December 2022. Material and methods: In this descriptive registry study, we categorised 21 418 locum contracts from the period 1 January 2016 to 31 December 2022 according to municipality and duration. We divided the municipalities into groups according to Statistics Norway's six centrality classes. Classes 1‒2 are central; 3‒4 are less central; and 5‒6 are the least central municipalities. The analysis is based on frequency tables, contingency tables and rates. Results: In the period studied, the number of registered locum contracts increased in Norway from 916 to 5003 (446 %). The increase was largest in centrality group 5‒6. The average duration of the locum positions was 195 days in centrality groups 1‒2 (95 % confidence interval (CI) 190‒200), 130 days in centrality groups 3‒4 (95 % CI 127‒134) and 67 days in centrality groups 5‒6 (95 % CI 64‒69). Centrality groups 5‒6 had twice as many locum contracts for full-time positions compared to centrality groups 1‒2, where part-time positions were more common. Locum contracts per list without a GP increased nationally from 0.5 to 4.7 in the study period. Interpretation: The GP Registry provides increasingly useful, nationwide information on the use of locum GPs. Use of locums in the Regular GP Scheme has increased significantly since 2016, and this may represent a challenge to equal access to health services. Future research should examine the causes and consequences of increased use of locum GPs.

Steering clear of Akrasia: An integrative review of self-binding Ulysses Contracts in clinical practice.

In many jurisdictions, legal frameworks afford patients the opportunity to make prospective medical decisions or to create directives that contain a special provision forfeiting their own ability to object to those decisions at a future time point, should they lose decision-making capacity. These agreements have been described with widely varying nomenclatures, including Ulysses Contracts, Odysseus Transfers, Psychiatric Advance Directives with Ulysses Clauses, and Powers of Attorney with Special Provisions. As a consequence of this terminological heterogeneity, it is challenging for healthcare providers to understand the terms and uses of these agreements and for ethicists to engage with the nuances of clinical decision-making with such unique provisions surrounding patient autonomy. In theory, prospective self-binding agreements may safeguard patient's "authentic" wishes from future "inauthentic" changes of mind. In practice, it is unclear what may be comprised within these agreements or how-and to what effect-they are used. The primary focus of this integrative review is to curate the existing literature describing Ulysses Contracts (and analogous decisions) used in the clinical arena, in order to empirically synthesize their shared essence and provide insights into the traditional components of these agreements when used in practice, the requirements of their consent processes, and the outcomes of their utilization.

Signing at the beginning versus at the end does not decrease dishonesty.

Honest reporting is essential for society to function well. However, people frequently lie when asked to provide information, such as misrepresenting their income to save money on taxes. A landmark finding published in PNAS [L. L. Shu, N. Mazar, F. Gino, D. Ariely, M. H. Bazerman, Proc. Natl. Acad. Sci. U.S.A. 109, 15197-15200 (2012)] provided evidence for a simple way of encouraging honest reporting: asking people to sign a veracity statement at the beginning instead of at the end of a self-report form. Since this finding was published, various government agencies have adopted this practice. However, in this project, we failed to replicate this result. Across five conceptual replications (n = 4,559) and one highly powered, preregistered, direct replication (n = 1,235) conducted with the authors of the original paper, we observed no effect of signing first on honest reporting. Given the policy applications of this result, it is important to update the scientific record regarding the veracity of these results.

The utility of accessibility clauses in resident contracts.

Resident organizations and unions have a powerful role in advocating for resident physicians with disabilities. Ongoing efforts to ensure accessibility for resident physicians with disabilities would be promoted through the inclusion of clauses in resident contracts that ensure accessible work environments.

Examining the case for direct contracting: A multistakeholder case study.

BACKGROUND: Employers and pharmacies are challenged by a complex system for prescription payment. Cost plus direct contracts for prescriptions and bundled services may yield benefits. OBJECTIVES: This study aimed to (1) explore direct contracting using multistakeholder interviews, (2) compare employer costs and employee copays for 6 months of prescription charges under their pharmacy benefit manager (PBM) with projected costs under a pharmacy direct contract, (3) project pharmacy revenue, costs, and net profit had these prescriptions been processed through the direct contract, and (4) assess employee satisfaction under the direct contract. METHODS: Semistructured stakeholder interviews were recorded transcribed and analyzed to identify different perspectives on direct contracting. Employer PBM invoices for 412 employee prescriptions over 6 months were analyzed to calculate employer and employee costs and reanalyzed for the invoice cost plus $12 professional fee direct contract. For the pharmacy financial analysis projection, invoice costs and a $9.82 cost of dispensing were subtracted from total revenue to yield an estimated profit had the parties been under the arrangement. A 34-item satisfaction survey was mailed using a 4-contact design with cash incentives to the 20 employees serviced by the direct contract that were analyzed descriptively. RESULTS: Eight stakeholder interviews described the benefits and potential challenges of such direct contracts. The financial analysis suggested the employer costs would be $5664 lower and employee copays would have been $1918 lower had all prescriptions been paid using the direct contract. The estimated profit for the pharmacy was projected at $899. Survey respondents were generally satisfied with the direct contract, but few used the bundled services. CONCLUSION: The direct contract may be financially beneficial for all parties. It also may offer more transparent pricing that may be desirable for the employer and pharmacy. Greater uptake of bundled services may increase the value to the employer.

Justifying a morally permissible breach of contract: kantian ethics, nozickian justice, and vaccine patents.

Although some have argued that COVID-19 vaccine patents are morally justified, a broader argument on the morality of breaching contracts is necessary. This article explores the ethics of breaching unfair contracts and argues that it is morally justified to breach contracts with pharmaceutical companies concerning vaccine patents. I offer two arguments to support this view. Firstly, contracts may be breachable in some situations. The ones I point out are that contracts can be broken when the costs of not violating vaccine patents are too high or when the process for agreement is not fair, or when an urgent ethical issue needs to be addressed and it is possible to compensate the other party for their loss. Secondly, I argue that because the contracts with the pharmaceutical companies do not treat people as ends in themselves, there is no moral obligation to respect them.

Evidence-related requirements in Swedish public sector procurement of health and welfare technologies - a systematic review.

BACKGROUND: Health and welfare technologies (HWT) are becoming increasingly employed in the Nordic countries, and in Sweden in particular. The amount of HWT public procurement is likely increasing at a similar rate, but requirements for evidence for effectiveness placed on bidders during this process may be lacking. METHOD: This study investigated the use of evidence as a requirement in public sector tendering process of HWT, and how it affected bidder attributes and procurement outcomes. A novel type of systematic review and content analysis of requests for tenders for HWT announced prior to June 2021 was therefore conducted in Swedish public procurement databases. RESULT: Ninety requests for tenders for 11 types of HWT met the inclusion criteria for review, accounting for potential contracts worth 246 to 296 million EUR. Criteria requiring evidence for effectiveness were used in 16 requests for tenders, accounting for 183 million EUR in potential contracts. Eight of the requests referred to an established independent standard to confirm such evidence, such as CE standard of conformity, MDR and/or MDD. This prevalence appears to cut across all types of procuring organisations and all types of HWT. The use of any evidence criteria, or lack thereof, does not appear to affect the outcomes of the tendering process. CONCLUSION: Criteria requiring evidence for effectiveness are used in less than a fifth of all public procurements of health- and welfare technologies in Sweden, and less than 10% refer to some form of independent standard as confirmation of such evidence. The procurement process therefore risks creating a legacy of sub-optimal technologies in health- and social care services. More prevalent and specific requirements for evidence and its continual generation in the procurement process are highly recommended. Recommendations for decision makers, procurement managers, and developers are provided.

Autonomy concerns with using contracts to enhance patient adherence.

The failure of many patients with chronic conditions to correctly follow medical advice that they hope or intend to follow is a major concern, especially as effective long-term therapies for chronic conditions materialize. Some US healthcare providers have responded with strategies that involve implementing contracts with their patients, including provisions that may deny future treatments after continued nonadherence. This is among the first articles to explicitly discuss the ethics of patient contracts.

Does health service funding go where the need is? A prototype spatial access analysis for new urban contracts data.

BACKGROUND: Much of spatial access research measures the proximity to health service locations. We advance this research by focusing on whether health service funding is within walkable reach of neighborhoods with high hardship. This is made possible by a new administrative data source: financial contracts data for those human services that are delivered by nonprofits under contract with the government. METHODS: In a prototypical spatial access study we apply a classic 2-step floating area catchment model for walkable network access to analyze 2018 data about contracted nonprofit health services funded by the Chicago Department of Public Health (CDPH). CDPH collected the data for the purpose of this study. RESULTS: We find that the common container approach of aggregating contract amounts by provider headquarter locations in a given area (ignoring satellite service sites) underestimates the share of funding that goes to Chicago neighborhoods with higher hardship. Once service sites and spatial access are taken into account, a larger share of CDPH funds was found to be within walkable reach of Chicago's high hardship areas. This was followed by low hardship areas (which could be driven by more headquarter locations there that do serve areas throughout the city). Medium hardship areas trail both, perhaps warranting closer attention. We explore these results by program type and neighborhood with a spatial decision support system developed for the health department. CONCLUSIONS: The typical approach for analyzing human service contracts based on headquarters is misleading -- in fact, we find that results are reversed when service sites and walkable access are taken into account. This prototype provides an alternative framework for avoiding these misleading results.

Ethical and Professionalism Implications of Physician Employment and Health Care Business Practices: A Policy Paper From the American College of Physicians.

The environment in which physicians practice and patients receive care continues to change. Increasing employment of physicians, changing practice models, new regulatory requirements, and market dynamics all affect medical practice; some changes may also place greater emphasis on the business of medicine. Fundamental ethical principles and professional values about the patient-physician relationship, the primacy of patient welfare over self-interest, and the role of medicine as a moral community and learned profession need to be applied to the changing environment, and physicians must consider the effect the practice environment has on their ethical and professional responsibilities. Recognizing that all health care delivery arrangements come with advantages, disadvantages, and salient questions for ethics and professionalism, this American College of Physicians policy paper examines the ethical implications of issues that are particularly relevant today, including incentives in the shift to value-based care, physician contract clauses that affect care, private equity ownership, clinical priority setting, and physician leadership. Physicians should take the lead in helping to ensure that relationships and practices are structured to explicitly recognize and support the commitments of the physician and the profession of medicine to patients and patient care.

Understanding Fishermen's Willingness and Preferences for Eco-compensation of Lake Conservation Projects: A Case Study From Nansi Lake Nature Reserve, China.

Lake regions face a tradeoff between water environmental conservation and social development. Although lake conservation projects along with eco-compensation policies are considered the solutions to this problem, it is often controversial and unsustainable. Therefore, it is essential to understand the key stakeholders' willingness to participate in lake conservation projects under the different compensation schemes. In this work, we conducted a choice experiment to estimate fishermen's willingness and preference for the returning fishponds to lake (RFTL) project in the Nansi Lake Nature Reserve (NLNR). Socioeconomic, perception and spatial factors are employed to analyze the preference heterogeneity of fishermen. We employed conditional logit, mixed logit and latent class models to estimates the parameters of factor variables considering the heterogeneous preferences and choice randomness across respondents. The results indicate that on average, fishermen are unwilling to change the status quo and are most concerned about the subsidy amount and contract duration in compensation contracts. However, there is obvious spatial heterogeneity in fishermen's choice preference, mainly manifested in their habitation distance to a town and fishpond location in different zones of the NLNR. Specifically, perceptions of supply and demand for water yield and water quality services significantly influence fishermen's choice, but they have opposite effects. Moreover, we estimated marginal willingness to accept (MWTA) of attributes in compensation contract and measured compensating surplus (CS) to compare different eco-compensation policy scenarios. Our results contribute to designing targeted payment policies, and promote the effective implementation of lake conservation projects and regional sustainable development.

The role of BIS/BAS in effective coping with psychological contract breach.

Psychological contract (PC) breach perceptions are formed when employees detect discrepancies between obligated and delivered inducements. PCB stresses and strains employees to varying degrees and has detrimental consequences for employees and the organisation. Employees activate various coping strategies to respond to the stress elicited by PCB, and effective coping helps enhance employees' well-being. In this study, we propose and test a moderated mediation model, where approach and avoidance coping strategies mediate the relationship between PCB and stress, and employees' goal-based personality (i.e., behavioural inhibition system-BIS and behavioural activation system-BAS) moderates the relationship between PCB and coping strategies. We further examine the effectiveness of the subdimensions of coping, as well as how BIS/BAS influences the choice of these subdimensions in a sample of Western employees. Our results suggest approach coping effectively reduces stress elicited by PCB, whereas avoidance coping increases stress. Moreover, employees with higher BAS are more likely to engage in approach coping, whereas those with higher BIS use avoidance coping. We advance the research on coping with PCB by showing a more nuanced understanding of the subdimensions of coping as well as exploring diverse personality models in moderating the choice of coping strategies.

Federal Out-of-Network Balance Billing Legislation: Context and Implications for Radiology Practices.

Out-of-network (OON) balance billing, commonly known as surprise billing but better described as a surprise gap in health insurance coverage, occurs when an individual with private health insurance (vs a public insurer such as Medicare) is administered unanticipated care from a physician who is not in their health plan's network. Such unexpected OON care may result in substantial out-of-pocket costs for patients. Although ending surprise billing is patient centric, patient protective, and noncontroversial, passing federal legislation was challenging given its ability to disrupt insurer-physician good-faith negotiations and thus impact in-network rates. Like past proposals, the recently passed No Surprises Act takes patients out of the middle of insurer-physician OON reimbursement disputes, limiting patients' expense to standard in-network cost-sharing amounts. The new law, based on arbitration, attempts to protect good-faith negotiations between physicians and insurance companies and encourages network contracting. Radiology practices, even those that are fully in network or that never practiced surprise billing, could nonetheless be affected. Ongoing rulemaking processes will have meaningful roles in determining how the law is made operational. Physician and stakeholder advocacy has been and will continue to be crucial to the ongoing evolution of this process. © RSNA, 2021.

The Impact of COVID-19 on Job Prospects and Educational Training for Pediatric Gastroenterology Fellows.

OBJECTIVES: The COVID-19 pandemic has significantly affected graduate medical education with redistribution of trainees, altered clinical care, and decreased research. For graduating trainees, there remains concern that financial stability of health systems will affect the availability of new positions and hiring practices. This survey aims to evaluate the pandemic's impact from pediatric gastroenterology fellows' perspectives. METHODS: An anonymous survey was distributed by e-mail from June 11 to July 1, 2020 to all North American pediatric gastroenterology and advanced training fellows. The survey was tailored for the fellows' year of training including questions on education, clinical experience, research, and job outlook. RESULTS: Of the 434 pediatric gastroenterology fellows, 145 completed the survey. Of all respondents, negative impact was reported in 52% on clinical training, 46% research projects, and 41% procedural confidence. A majority (93%) of third-year respondents had a job contract signed at the time of the survey; however, 18% of those contracts were subsequently altered with 5 respondents having job contracts rescinded due to hiring freezes. Fifty-four percent of first- and second-year fellow respondents reported concern regarding finding a job with the majority being second-year fellows (78%). CONCLUSIONS: The COVID-19 pandemic continues to affect the medical system and healthcare professionals. This survey identified significant impact on job acquisition for graduating pediatric gastroenterology fellows and other critical components of training, which are likely applicable to other pediatric trainees. The survey results raise questions about potential strategies to improve medical education and job search success for graduating trainees.

Patient-controlled admissions to inpatient care: A twelve-month naturalistic study of patients with schizophrenia spectrum diagnoses and the effects on admissions to and days in inpatient care.

BACKGROUND: Patients with schizophrenia spectrum diagnoses have a poor prognostic outlook and rates of recovery. Inpatient care is common, but the decision to initiate such care is not solely up to the patient but also influenced by the healthcare providers. Recent ideas about shared decision-making however challenges this idea. Patient-Controlled Admissions (PCA) refers to a care model where a patient signs a contract that allows the decision for admission into inpatient care to be transferred onto the patient. METHODS: In Region Stockholm's public healthcare PCA was introduced to patients with schizophrenia spectrum diagnoses deemed to have the greatest care needs. Outcomes of a 12-month naturalistic within-group follow-up was analyzed using Wilcoxon signed-rank test. RESULTS: In total, 56 patients fulfilled the study's inclusion criteria, with between 20 to 42 patients having complete data and being able to analyze statistically, depending on the variable. Number of admissions, inpatient days, number of involuntary admissions, and involuntary admission days decreased, but only significantly so for inpatient days, p < .01 (a mean reduction of 11.5 days). Neither self-rated well-being, as assessed using the EQ5D-3L, or a clinician-administered rating of overall health status, the Clinical Global Impression Scale, demonstrated a significant change. CONCLUSIONS: The use of PCA points towards a trend in decreased hospitalization for patients with schizophrenia spectrum diagnoses, although this needs to be explored further in larger samples and over a longer follow-up.

A critical look at the Portuguese public-private partnerships in healthcare.

The pre-conceived idea that contracts in a public-private partnership (PPP) regime, in healthcare or in any other economic sector, are, as a rule, ruinous and appealing for only a share of the stakeholders, lacks a solid basis that confirms it. This idea, outset and nurtured by the media, has been instigating the distrust of the users who, in turn, demand a more rigorous and efficient utilisation of public resources. Being Portugal in the top of countries that resort to PPPs, it is urgent to inquire if its respective contracts originated an inefficient and ineffective management of resources. It is precisely this discussion that we address in this paper, focusing our efforts in the Portuguese healthcare sector.

Ethical Issues in Consent for the Reuse of Data in Health Data Platforms.

Data platforms represent a new paradigm for carrying out health research. In the platform model, datasets are pooled for remote access and analysis, so novel insights for developing better stratified and/or personalised medicine approaches can be derived from their integration. If the integration of diverse datasets enables development of more accurate risk indicators, prognostic factors, or better treatments and interventions, this obviates the need for the sharing and reuse of data; and a platform-based approach is an appropriate model for facilitating this. Platform-based approaches thus require new thinking about consent. Here we defend an approach to meeting this challenge within the data platform model, grounded in: the notion of 'reasonable expectations' for the reuse of data; Waldron's account of 'integrity' as a heuristic for managing disagreement about the ethical permissibility of the approach; and the element of the social contract that emphasises the importance of public engagement in embedding new norms of research consistent with changing technological realities. While a social contract approach may sound appealing, however, it is incoherent in the context at hand. We defend a way forward guided by that part of the social contract which requires public approval for the proposal and argue that we have moral reasons to endorse a wider presumption of data reuse. However, we show that the relationship in question is not recognisably contractual and that the social contract approach is therefore misleading in this context. We conclude stating four requirements on which the legitimacy of our proposal rests.

THE INVALIDITY OF CONTRACTS IN THE FIELD OF MEDICAL SERVICES AS A WAY TO PROTECT THE RIGHTS OF THE PATIENT.

OBJECTIVE: The aim of this article is to reveal the essential features of contracts providing medical services. The author also focused on the grounds for the invalidity of such contracts - entering into medical services contract without license or permission, prohibition of some medical services or methods of treatment, the imposing of unnecessary medical services, a contradiction to corporate regulations, fraud. A significant part of the work is devoted to the consequences of the invalidity of the contract - the restitution of the money received under the contract and compensation of harm. PATIENTS AND METHODS: Materials and methods: The study is based on the statutory acts of European Union countries, the USA, and others. The author also uses acts of international law in the field of medical services and cases of court practice. CONCLUSION: Conclusions: Although the invalidity of contracts in the field of medical services is not one of the most common ways to protect a patient's rights, it is in many cases essential to the reliable delivery of medical services. The patient has the right to initiate a legal dispute regarding the invalidity of the contract. The restitution of the money paid by the patient, as well as compensation for the harm caused, can be applied not only within the framework of tort law but also under the responsibility for the breach of the contract.