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The article deals with the regulatory and jurisprudential evolution of medical criminal responsibility from the 70s to the Gelli-Bianco law of 2017. Subsequently it winds through the contribution of the last important judgments of the subject up to the decisions of the Supreme Court with United Sections of 2018, finally to conclude with an economic analysis on the increasement of the legal disputes registered in recent years., (Copyright by Società Italiana di Nefrologia SIN, Rome, Italy.)

Ovum donation affords countless couples that under natural circumstances would not be able to produce offspring the ability to carry out natural pregnancies. With advancements in biotechnology including egg collection and in vitro fertilization (IVF), physicians can now successfully implant fertilized embryos. Due to Israel's tremendous involvement in IVF for its own citizens, the national laws that govern egg donation are of great importance. On September 5th 2010, the Israeli Parliament (Knesset) passed a law that allows young women between the ages of 21 and 35 to donate their eggs for paid financial compensation. The new law allows infertile women between the ages of 18 and 54 to request egg donation and IVF, which will partially be covered under state insurance plans. This article provides a description of the new Israeli law regulating ovum donation and the practical, moral and ethical debate surrounding the new system., (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)

Public health law focuses on the nexus between law, public health and the legal tools applicable to public health issues. Though there have been consistent interventions to address public health concerns in the past, there exists a need for a contemporary framework to appropriately use modern legal tools for complex health challenges. We identify a checklist of imperative indicators to assess whether public health legislations would be an effective form of intervention to bring about the desired social change.

Periods in which the costs of personal injury litigation and liability insurance have risen dramatically have often provoked calls for reform of the tort system, and medical malpractice is no exception. One proposal for fundamental reform made during several of these volatile periods has been to relocate personal injury disputes from the tort system to an alternative, administrative forum. In the medical injury realm, a leading incarnation of such proposals in recent years has been the idea of establishing specialized administrative "health courts." Despite considerable stakeholder and policy-maker interest, administrative compensation proposals have tended to struggle for broad political acceptance. In this article, we consider the historical experience of administrative medical injury compensation proposals, particularly in light of comparative examples in the context of workplace injuries, automobile injuries, and vaccine injuries. We conclude by examining conditions that may facilitate or impede progress toward establishing demonstration projects of health courts.

Our article analyzes whether the federal government may constitutionally supplant a traditional system of common-law trials before state judges and juries with new federal institutions designed by statute for compensating victims of medical injuries. Specifically, this article examines the federal constitutional issues raised by various proposals to replace traditional medical malpractice litigation in state courts with a federal system of administrative "health courts." In doing so, we address the following constitutional issues: 1. Is there federal authority to preempt state law (the commerce clause and spending clause issues)? 2. May jurisdiction be created in non-article 3 tribunals, and may claims be decided without trial by jury (the separation of powers and Seventh Amendment issues)? 3. Would pilot programs that require some claims to be pursued in a federal administrative forum while other claimants are left to pursue traditional state tort law remedies be constitutional (the equal protection issue)? The article concludes that a federal compensation system through administrative health courts should be constitutional provided the statute is appropriately drafted and that appropriate factual findings are made concerning the benefits to patients and the public as well as to doctors and their insurers.

This issue brief explores the continuing evolution of the Medicaid program on several fronts. It discusses the benefits and cost-sharing flexibility that is included in the Deficit Reduction Act of 2005 (DRA) and examines the implications of these provisions for states, beneficiaries, and providers. The paper also explores recent trends in section 1115 waiver development and considers the use of waivers as a vehicle for restructuring Medicaid financing systems and for testing completely new approaches to health care delivery. The role of section 1115 waivers in the context of the DRA and as a mechanism for continued state innovation is also discussed.

The current malpractice crisis has been called the "perfect storm". Doctors are finding practice costs unsustainable. Patients are finding access to care jeopardized. Cost of care is escalating. The system does not deter medical error, compensate most injured victims, produce any result quickly. These factors are creating enough of a crisis to urgently address and merit prompt solution. However, if history is any guide, the debate over malpractice will continue to rage. Reforms will likely be slow. Thus the practicing gastroenterologist, while working for or supporting efforts toward a solution, is well advised to keep up to date with the practice of gastroenterology, but also understand the medical legal matters and have a risk management strategy that will hopefully help keep the malpractice crisis a theoretical rather than personal concern. The following articles in this series are intended to help.

The first step in the process of regulating cell-based products in Australia was taken in 1991, when the code of good manufacturing practice (cGMP) for 'Blood and Blood Components' was instituted. Paradoxically, it focused on the regulation of plasma fractionation, the non-cellular component of blood. Subsequently, Australia's regulatory body for medicinals, the Therapeutic Goods Administration (TGA), has clearly stated that all cell-based therapies utilizing components of blood and/or tissues will be regulated. The final landscape for the regulation of cellular therapies has yet to be defined, but is likely to be clarified within the next 12 months. The current cGMP for 'Blood and Tissues' is the regulatory document for all aspects of cell processing, including standard blood components (cellular and plasma), cord blood and allogeneic cells for storage. Currently, there are some exemptions to government regulation, and the most important of these is autologous hemopoietic stem cells (HSC). Indeed, no licensing is required for processing of HSC at the moment, although most centers subject themselves to a self-imposed auditing system through the National Association of Testing Authorities, Australia. However, it is anticipated that within 12 months this and the other exemptions within the Act will be removed. The TGA will become the formal regulator of all cell-based therapies, and laboratories will be required to apply for cGMP auditing and licensing. It is likely that the Foundation for the Accreditation of Cellular Therapy (FACT) guidelines or others of a similar nature, will form the basis of one of the regulatory standards for HSC processing. Of particular note is the inclusion of apheresis as an integral component of cGMP licensing.

A point-of-service (POS) option is a type of plan offered by managed care organizations (MCOs), including health maintenance organizations (HMOs), that allows people who are willing to pay higher out-of-pocket costs to see out-of-plan providers. Mandating a point-of-service option essentially eliminates the use of closed-panel HMOs. This issue brief addresses only bills that mandate managed care plans to offer a point-of-service option.

When a health care provider leaves or is terminated by a managed care plan, how long can patients continue to receive covered treatment from that provider for a life-threatening condition, pregnancy, disability or other circumstance that requires continuous medical care? Lawmakers in 36 states have answered that question.

This final rule implements a bonus payment, in addition to the amount normally paid under the allowable charge methodology, to physicians in medically underserved areas. For purposes of this rule, medically underserved areas are the same as those determined by the Secretary of Health and Human Services for the Medicare program. Such bonus payments shall be equal to the bonus payments authorized by Medicare, except as necessary to recognize any unique or distinct characteristics or requirements of the TRICARE program, and as described in instructions issued by the Executive Director, TRICARE Management Activity. This rule promotes a reimbursement enhancement to a limited number of physicians designed to increase TRICARE beneficiary access to care.

In the discussion of increasing costs of health care in Germany, the frequent and long hospital stays of elderly patients are often pointed out. Since these patients very frequently suffer from psychiatric disorders, psychiatric consultation is often required. This study was aimed at investigating whether new German laws concerning guardianship and the structure of health care providers change conditions for psychiatric consultation services. For this purpose, the documentation of all consultations in the years 1991 to 1995 was retrospectively evaluated. In about 3% of all patients aged over 65 referred to the General University Hospital of Lübeck, psychiatric consultation was ordered. The most frequent diagnosis was senile dementia. Comparison of the requests and psychiatric recommendations show a significant increase in wishes and recommendations for guardianship. Moreover, there is evidence of the increasing need of consultation in elderly patients. Possibly due to the new law concerning the structure of health care providers and the number of requests and recommendations to transfer patients to psychiatric wards, these results show that the new laws do affect psychiatric consultation.

This study was designed to determine the fiscal impact of a theoretical legislative ban on elective terminations for prenatally diagnosed abnormalities at Hutzel Hospital/Wayne State University. A fiscal comparison was completed for patients who had second trimester elective terminations for prenatally diagnosed abnormalities versus not allowing the procedure. An eight-year database of genetics cases and hospital and physician cost estimates for performing elective terminations for prenatally diagnosed abnormalities, and published reports of the average lifetime costs per selected birth defects, were used to calculate the net cost. The estimated lifetime cost for an average cohort year of a legislative ban on elective terminations for prenatally diagnosed abnormalities was found to be at least $8.5 million for patients treated at Hutzel Hospital. Extrapolated, a similar ban on second trimester elective terminations would have a net cost of $74 million in Michigan and $2 billion annually in the United States., (Copyright 2000 Wiley-Liss, Inc.)

The traditional function of the principles of medical law has been to protect the person of the patient against the use of power in health care. These principles have not generally been seen as factors which would also protect the patient economically. An analysis of the significance of the use of power in health care and a review of the field of damage sustained through erroneous procedures in the care relationship, make it possible to observe that the patient's need for legal protection is particularly great not only as regards factors related to the person, but also as regards the finances of the patient. On the other hand, evaluation of the relevant contents of the principles shows beyond doubt that they are to be conceived of generally as norms safeguarding the patient's rights. In Western countries in particular, where some years ago an economic recession set in, serious note should be taken of the wider interpretation of the principles of medical law as one potential means of furthering the well-being of the patient. In the application of legal rules affecting the legal position of the patient the principles of medical law may--like legal principles in general--be utilized both to guide the choice of a solution norm and to complement/ specify the solution norm. In both these roles the principles yield criteria for application of the law which lead to the taking into consideration of aspects relating to the patient's financial interests and assessments.