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Included as part of the 21st Century Cures Act, the information blocking rule entered the first compliance phase in April 2021. Under this rule, post-acute long-term care (PALTC) facilities must not engage in any activity that interferes with accessing, using, or exchanging electronic health information. In addition, facilities must respond to information requests in a timely fashion and allow records to be readily available to patients and their delegates. Although hospitals have been slow to adapt to these changes, skilled nursing and other PALTC centers have been even slower. With a Final Rule enacted in recent years, awareness of the information-blocking rules became more crucial. We believe this commentary will help our colleagues interpret the rule for the PALTC setting. In addition, we provide points of emphasis to help guide those providers and administrative staff workers toward compliance and avoid potential penalties. [ABSTRACT FROM AUTHOR]

Risk managers and ethicists monitor adherence to codes of conduct in the delivery of medical services and proactively participate with providers to create protocols that minimize the moral, ethical, and legal risks inherent in many commonly used medical protocols. "Code/no code" medical orders work well for patients at the extremes who always or never want to undergo a procedure, but they create troubling uncertainties for others by preventing them from expressly requesting procedures under some circumstances but not others. Obeying binary orders such as DNAR (Do Not Attempt Resuscitation) can allow deaths that a patient might want to delay or can expose patients to prolonged suffering they wish to avoid. These risks can be reduced by: (1) fully explaining the nature of proposed interventions and their possible beneficial and adverse effects in varying circumstances; and (2) replacing the traditional dichotomy with a continuum of options from always, through conditionally sometime, to never orders adapted to a range of situations and preferences. The Conditional Medical Orders (CMO) form summarizes patients' preferences regarding resuscitation, ventilation, and artificial hydration and nutrition (ANH) is an efficient way to increases the chance that patients will undergo only the treatments they want. [ABSTRACT FROM AUTHOR]

The critically ill obstetric patient presents unique challenges. However, the general code of conduct, legal processes, and ethical principles continue to apply. Professionals need to keep themselves informed about the requirements of provisions within the legal framework. [ABSTRACT FROM AUTHOR]

Background: The COVID-19 pandemic has created challenges for provider teams working in intensive care units, including rapidly changing patient care regulations, staffing considerations, and preservation of personal protective equipment. The need for enhanced respiratory precautions for infected patients and patients under investigation has necessitated a new process for interventions and resuscitation. Local Problem: Along with changing regulations and equipment, significant staff anxiety surrounded caring for infected patients and preparing for emergency situations. Methods: A huddle process was implemented in the pediatric cardiac intensive care unit for acutely ill patients who required enhanced respiratory precautions and were at risk of imminent decompensation, or who required a bedside procedure. During a huddle, the multidisciplinary team used process maps displayed in patient rooms; the huddle process created a situational awareness of events among these teams. Intervention: After implementation of huddles, a survey was distributed to cardiac intensive care unit staff in order to understand their satisfaction with the huddle process. Results: A total of 36 staff responded to the survey. They thought the huddles helped them to prepare for resuscitation scenarios, helped limit the number of personnel responding to an emergency, and reduced their anxiety surrounding caring for these patients. Staff suggested generalizing this huddle process to all patients at acute risk for decompensation in the cardiac intensive care unit. Conclusions: A novel huddle process created situational awareness among staff caring for patients requiring enhanced respiratory isolation because of COVID-19. Multidisciplinary huddles allowed staff from various disciplines to apply a process map for interventions and resuscitations among critically ill children with heart disease. [ABSTRACT FROM AUTHOR]

An editorial is presented on the differences in the definition of brain death and their legal impact on intensive care practice. It expresses the view that adopting the definition of the particular medical condition by the international public health agency World Health Organization is likely to reduce the incidence of legal challenge and maintain public confidence in current death declaration practice internationally.

Objectives: To provide an overview of key elements of the Affordable Care Act. To evaluate ways in which the Affordable Care Act will likely impact the practice of critical care medicine. To describe strategies that may help health systems and providers effectively adapt to changes brought about by the Affordable Care Act.Data Sources and Synthesis: Data sources for this concise review include search results from the PubMed and Embase databases, as well as sources relevant to public policy such as the text of the Patient Protection and Affordable Care Act and reports of the Congressional Budget Office. As all of the Affordable Care Act's provisions will not be fully implemented until 2019, we also drew upon cost, population, and utilization projections, as well as the experience of existing state-based healthcare reforms.Conclusions: The Affordable Care Act represents the furthest reaching regulatory changes in the U.S. healthcare system since the 1965 Medicare and Medicaid provisions of the Social Security Act. The Affordable Care Act aims to expand health insurance coverage to millions of Americans and place an emphasis on quality and cost-effectiveness of care. From models which link pay and performance to those which center on episodic care, the Affordable Care Act outlines sweeping changes to health systems, reimbursement structures, and the delivery of critical care. Staffing models that include daily rounding by an intensivist, palliative care integration, and expansion of the role of telemedicine in areas where intensivists are inaccessible are potential strategies that may improve quality and profitability of ICU care in the post-Affordable Care Act era. [ABSTRACT FROM AUTHOR]

This is the first scientific statement from the American Heart Association on maternal resuscitation. This document will provide readers with up-to-date and comprehensive information, guidelines, and recommendations for all aspects of maternal resuscitation. Maternal resuscitation is an acute event that involves many subspecialties and allied health providers; this document will be relevant to all healthcare providers who are involved in resuscitation and specifically maternal resuscitation. [ABSTRACT FROM AUTHOR]

Background: Medical care of critically ill and injured infants and children globally should be based on best research evidence to ensure safe, efficacious treatment. In South Africa and other low and middle-income countries, research is needed to optimise care and ensure rational, equitable allocation of scare paediatric critical care resources. Ethical oversight is essential for safe, appropriate research conduct. Informed consent by the parent or legal guardian is usually required for child research participation, but obtaining consent may be challenging in paediatric critical care research. Local regulations may also impede important research if overly restrictive. By narratively synthesising and contextualising the results of a comprehensive literature review, this paper describes ethical principles and regulations; potential barriers to obtaining prospective informed consent; and consent options in the context of paediatric critical care research in South Africa.Discussion: Voluntary prospective informed consent from a parent or legal guardian is a statutory requirement for child research participation in South Africa. However, parents of critically ill or injured children might be incapable of or unwilling to provide the level of consent required to uphold the ethical principle of autonomy. In emergency care research it may not be practical to obtain consent when urgent action is required. Therapeutic misconceptions and sociocultural and language issues are also barriers to obtaining valid consent. Alternative consent options for paediatric critical care research include a waiver or deferred consent for minimal risk and/or emergency research, whilst prospective informed consent is appropriate for randomised trials of novel therapies or devices. We propose that parents or legal guardians of critically ill or injured children should only be approached to consent for their child's participation in clinical research when it is ethically justifiable and in the best interests of both child participant and parent. Where appropriate, alternatives to prospective informed consent should be considered to ensure that important paediatric critical care research can be undertaken in South Africa, whilst being cognisant of research risk. This document could provide a basis for debate on consent options in paediatric critical care research and contribute to efforts to advocate for South African law reform. [ABSTRACT FROM AUTHOR]

The article provides information on legal and philosophical issues on the withdrawal of life-sustaining treatment from patients considered in vegetative state (VS). It states that withdrawal of life-sustaining treatment on VS patients can be prevented if the patient's functional magnetic resonance imaging test (fMRI) shows a degree of consciousness. It also discusses the Mental Capacity Act 2005 as one of the legal practice concerning the withdrawal of the life support.

The article discusses proposed solutions for more rational reporting of serious adverse events in academic critical care trials of drugs in common use. According to the authors, investigators must clearly describe the serious adverse events that they plan to identify and report in their protocol before commencing the trial. They added that serious adverse events must be largely limited to serious events that are known to result from the study. Moreover, to avoid attributing deaths to serious adverse events related to the study drug as the trial is unfolding, caution must be exercised.

Focuses on a US court ruling on the requirements for state statutes governing resuscitative decisions. Establishment of the capacity to make treatment decisions; Surrogate decision to request DNR order; Statutory provision allowing surrogate to authorize DNA order on basis that resuscitative measures would pose an extraordinary burden for patient.

Objectives: 1) To establish a protocol within international and local ethical guidelines to obtain informed consent for critical care research, overcoming constraints previously described and 2) To evaluate eventual recruitment using this protocol.Design: Prospective descriptive study.Setting: Multidisciplinary ICU in a community-based university teaching hospital.Patients and Participants: Following approval by the University Ethics Committee and Hospital Review Board, patients admitted between January and May 1996 were assessed on weekdays for potential enrollment into existing clinical trials. Discussion with potential candidates and/or next-of-kin occurred at the earliest opportunity and informed consent was obtained preemptively. Next-of-kin was notified if enrollment subsequently occurred. We evaluated the number of patients screened, the number of potential study candidates, the number for whom consent was obtained or refused and the number subsequently enrolled.Interventions: NoneResults: Of 249 patients screened, 149 (60%) did not meet the inclusion criteria. Of 100 potential study candidates (40% of all patients screened), we failed to make contact with the next-of-kin in 29 cases (12% of all patients screened). Thus 71 patients or next-of-kin were counselled (28% of all patients screened). In all, 30 patients (12% of all patients screened) were subsequently enrolled into a study.Conclusions: A policy of pre-emptive informed consent enabled us to overcome some of the problems previously experienced in our unit with regards to patient enrollment in critical care research. Although overall recruitment remained low, predictions for future enrollment can be made from this study. [ABSTRACT FROM AUTHOR]

The article discusses the complexity of clinical research in critically ill patients, due to incompetency and inability to give valid consent. It relates on the legislative decree in Italy, wherein an informed consent may be granted by either the legal representatives or by the patients. However, it concludes that clinical research in critically ill patients in Italy is complicated, because the official consent requirement of a legal representative is not legally identified.

The author reflects on the implementation of the reformed regulations on specialization in anesthesia and intensive care in Italy in May 2007, which is a move by the Ministry of Education and Universities to update the 1996 regulations. He believes that the extensive description of the training curriculum for intensive care physicians includes only scant consideration of the ethical aspects of intensive medicine, particularly on the ability to communicate with the patients and their families.

The article addresses the problem of applying the due process approach to state laws governing end-of-life medical care and care giving. The concept of medical futility in the hospital setting is explored. A description of a due-process futility policy adopted by the Children's Hospital in Boston, Massachusetts is discussed. Reason explaining the discrepancy between a hospital policy and state laws is suggested.

Richard Griffith, Senior Lecturer in Health Law at Swansea University, reviews how the courts assist in settling disputes over the care of seriously ill babies and describes the test used to inform decisions about their treatment [ABSTRACT FROM AUTHOR]

A letter to the editor in response to the article "Controversies After Brain Death," that was published in a previous issue of the journal is presented.

The authors reflect on the dispute often encounter by clinicians and the patient's family concerning the provision of life-prolonging interventions in the intensive care unit. They stress that the dispute often focuses on the issue of using medical futility as the basis for unilateral decisions by physicians to override the demands for treatment of the family surrogates. They emphasize the significance for clinicians to consider futility as an essential part of careful prognostication.

The author reflects on the two new series being launched in Intensive Care Medicine. The first one concerns the process of clinical research, with a special focus on legal and ethical aspects in intensive care medicine. The author sadly comments that clinical research is carried out for the benefit of future patients although it may or may not benefit the particular patient under scrutiny. The research, he says, is like a never ending jigsaw puzzle.

This article reports that medical research involving human subjects in the Netherlands has been regulated since February 26, 1998 by the law, Wet medisch-wetenschappelijk onderzoek met mensen, or WMO, on "Medical Research Involving Human Subjects." The introduction of the WMO had several goals. The WMO provides legal protection to healthy subjects and patients participating in medical research. Protection is needed because medical research is not primarily for the benefit of the participating healthy subjects and patients but for the benefit of third parties, aimed at yielding generalizable knowledge. The WMO therefore outlines specific rules for obtaining informed consent, especially for minors and patients who are unable to assess their own interests, as is the case with most intensive care unit patients.

Reports the restriction of pain care medicine funding for patient treatments by the Oregon Medicaid. Prohibition of Oxycontin prescription for fatal disorders; Dosage regulation rule by the Oregon Medical Assistance Program; Permitted Oxycontin dosaging for cancer patients only; Other medical restrictions construed by OMAP.

Reports that the Superior Court of Pennsylvania held that a hospital may terminate life-sustaining treatment for a patient in a persistent vegetative state without a court order if it attains the consent of close family members and the approval of two physicians. Details of the case; Legal precedents; Policy implications on medical jurisprudence.

Discusses the so-called Baby Doe regulations promulgated during the Reagan administration which stipulate that the provider has no obligation to honor parental instructions to continue treatment when the treating physician believes that treatment is virtually futile and inhumane. Review of a case involving Sacred Heart Hospital in Spokane, Wash. and Ryan Nguyen who was born six weeks premature on October 27, 1994.

The article focuses on cardiopulmonary resuscitation (CPR) decisions for elderly people with hip fractures. An appeals court decision is cited in which it was made clear that doctors are not obliged to offer treatment they believe will be ineffective, simply because a patient wishes to receive it. If a cardiac arrest is foreseeable but prospects of CPR succeeding are very poor it should not be offered and a "do not attempt resuscitation" (DNAR) order should be made. A discussion of a doctor's procedure given that a patient receives a DNAR is presented.