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safe harbor laws

Robert L Fine
This essay offers a brief history of futility, in both sociocultural and medical contexts, with some personal reflection on the disappearance and reappearance of medical futility during the author's 40-plus years in medicine. It discusses the creation of the Texas Advance Directives Act (TADA), which, even with its flaws, creates the only legal safe harbor for physicians engaged in futility disputes. It also offers reflection on the commendable Multiorganization Policy Statement on "potentially inappropriate treatment" yet comes to the same conclusion as Schneiderman...
2018: Perspectives in Biology and Medicine
Jini L Roby, Melanie Vincent
Domestic minor sex trafficking (DMST) is a rapidly growing problem in the United States, yet legislative efforts to address victim needs have begun only recently. DMST is an issue that spans several areas of social work practice, as emerging research shows that most children and youths exploited in commercial sex have typically experienced prior abuse, neglect, or other forms of trauma. Many have been involved with the child welfare and juvenile justice systems and are often lured by promises of love, security, protection, and belonging...
July 1, 2017: Social Work
David J Cote, William T Burke, Joseph P Castlen, Chih H King, Hasan A Zaidi, Timothy R Smith, Edward R Laws, Linda S Aglio
Although some studies have examined the efficacy and safety of remifentanil in patients undergoing neurosurgical procedures, none has examined its safety in transsphenoidal operations specifically. In this study, all transsphenoidal operations performed by a single author from 2008 to 2015 were retrospectively reviewed to evaluate the safety of remifentanil in a consecutive series of patients. During the study period, 540 transsphenoidal operations were identified. Of these, 443 (82.0%) patients received remifentanil intra-operatively; 97 (18...
April 2017: Journal of Clinical Neuroscience: Official Journal of the Neurosurgical Society of Australasia
(no author information available yet)
Current federal laws and FDA regulations have significantly restricted the sharing of clinical and health economic information on biopharmaceuticals that have yet to receive FDA approval. Over the past several years, organizations that make health care coverage decisions, including those that set copayments, premiums, and formulary placement, have expressed a need for receiving this information before approval, as long as appropriate safeguards exist to prevent this information from reaching unintended entities...
January 2017: Journal of Managed Care & Specialty Pharmacy
(no author information available yet)
In this final rule, OIG amends the safe harbors to the anti-kickback statute by adding new safe harbors that protect certain payment practices and business arrangements from sanctions under the anti-kickback statute. The OIG also amends the civil monetary penalty (CMP) rules by codifying revisions to the definition of "remuneration," added by the Balanced Budget Act (BBA) of 1997 and the Patient Protection and Affordable Care Act, Public Law 111-148, 124 Stat. 119 (2010), as amended by the Health Care and Education Reconciliation Act of 2010 (ACA)...
December 7, 2016: Federal Register
Heather L Harrell, Mark A Rothstein
Privacy is protected in biobank-based research in the US primarily by the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the Federal Policy for Protection of Human Subjects (Common Rule). Neither rule, however, was created to function in the unique context of biobank research, and therefore neither applies to all biobank-based research. Not only is it challenging to determine when the HIPAA Privacy Rule or the Common Rule apply, but these laws apply different standards to protect privacy...
March 2016: Journal of Law, Medicine & Ethics: a Journal of the American Society of Law, Medicine & Ethics
Elizabeth S Barnert, Susan Abrams, Veronica F Azzi, Gery Ryan, Robert Brook, Paul J Chung
Several states have recently enacted "Safe Harbor" laws to redirect child victims of commercial sexual exploitation and child sex trafficking from the criminal justice system and into the child welfare system. No comprehensive studies of Safe Harbor law implementation exist. The nine state Safe Harbor laws enacted by 2012 were analyzed to guide state legislators, health professionals, law enforcement agents, child welfare providers, and other responders to the commercial sexual exploitation of children on the development and implementation of state Safe Harbor laws...
January 2016: Child Abuse & Neglect
James M Spears, Jeffrey K Francer, Natale A Turner
The Food and Drug Administration (FDA) plays a unique role in protecting the public health and minimizing the risk of the distribution of unsafe or ineffective medicines in the United States. Perhaps equally as important for public health, however, is the need for healthcare professionals to be well informed about the benefits and risks of the medicines they prescribe. In this way, information sharing is critical to healthcare delivery. FDA's current interpretation of laws and regulations governing healthcare communications prohibits biopharmaceutical companies from sharing certain accurate, data-driven information about FDA-approved uses and medically accepted alternative uses of FDA-approved drugs with healthcare professionals...
2015: Food and Drug Law Journal
Ryan T Shields, Elizabeth J Letourneau
Commercial sexual exploitation of children is an enduring social problem that has recently become the focus of numerous legislative initiatives. In particular, recent federal- and state-level legislation have sought to reclassify youth involved in commercial sexual exploitation as victims rather than as offenders. So-called Safe Harbor laws have been developed and centered on decriminalization of "juvenile prostitution." In addition to or instead of decriminalization, Safe Harbor policies also include diversion, law enforcement training, and increased penalties for adults seeking sexual contact with minors...
March 2015: Current Psychiatry Reports
Alicia A Russo, Jason Johnson
Experiments with patented compounds or processes are sometimes necessary for Food and Drug Administration approval of a small-molecule drug, biologic, or medical device. The law exempts certain research and development activities using these patented compounds or processes. The two exemptions are (1) a judicially created exemption developed through case law and (2) an exemption created by the Hatch-Waxman Act (the "safe harbor" provision). This article analyzes the history of these exemptions and how the courts have interpreted their scope and provides future perspectives on protecting research and development activities from liability...
October 30, 2014: Cold Spring Harbor Perspectives in Medicine
Michelle M Mello, David M Studdert, Allen Kachalia
For many physicians, the prospect of being sued for medical malpractice is a singularly disturbing aspect of modern clinical practice. State legislatures have enacted tort reforms, such as caps on damages, in an effort to reduce the volume and costs of malpractice litigation. Attempts to introduce similar traditional reform measures at the federal level have so far failed. Much less prominent, but potentially more important, are proposed alternative approaches for resolving medical injuries; a number of these efforts are currently being tested in federally sponsored demonstration projects...
November 26, 2014: JAMA: the Journal of the American Medical Association
Robert Weinstock, Daniel Bonnici, Ariel Seroussi, Gregory B Leong
In 2013, legislation went into effect clarifying that the Tarasoff duty in California is now unambiguously solely a duty to protect. Warning the potential victim and the police is not a requirement, but a clinician can obtain immunity from liability by using this safe harbor. In situations in which a therapist believes warning might exacerbate the patient's risk, however, alternative protective actions can satisfy the duty to protect. For a clinician to be found liable, those alternative actions would have to be proven negligent...
2014: Journal of the American Academy of Psychiatry and the Law
Robert B Leflar
New rules and methods for medical injury dispute resolution have been launched in New Hampshire and New York, and demonstration projects are underway elsewhere. This article describes major medical malpractice reforms undertaken and proposed in recent years. Reforms are classified as (1) liability-limiting initiatives favoring health-care providers; (2) procedural innovations promoted as improving dispute resolution processes, such as patient compensation funds, "sorry" laws, disclosure and early offer laws, health courts, and safe harbor laws; and (3) major conceptual reforms to move liability away from physicians to hospitals or administrative no-fault compensation systems...
July 2013: Chest
Paul Howard, James Copland
No abstract text is available yet for this article.
March 2013: Missouri Medicine
Thaddeus Mason Pope, Mitchell F Palazzo
This article outlines current safe harbors in the law for healthcare practitioners who work in a disaster setting. It reviews available legal protection in crisis situations with respect to the Emergency Medical Treatment and Labor Act (EMTALA), criminal liability, and licensure.
2010: Journal of Clinical Ethics
L M Penyak
No abstract text is available yet for this article.
1999: Hispanic American Historical Review
Douglas Peddicord, Ann B Waldo, Marc Boutin, Tina Grande, Luis Gutierrez
Current laws, practices, and concerns about privacy inhibit access to health data for research. Barriers include inconsistent Institutional Review Board policies and complicated and costly procedures to obtain the consent of patients for release of their information. To realize the promise of comparative effectiveness research, it is essential to develop a new policy framework that will allow and encourage the use of health information in all forms--fully identifiable, partially anonymized, and deidentified...
November 2010: Health Affairs
Gregg Blesch
No abstract text is available yet for this article.
October 11, 2010: Modern Healthcare
C J Stimson, Roger Dmochowski, David F Penson
PURPOSE: We reviewed the state of medical malpractice tort reform in the context of a new political climate and the current debate over comprehensive health care reform. Specifically we asked whether medical malpractice tort reform is necessary, and evaluated the strengths and weaknesses of contemporary reform proposals. MATERIALS AND METHODS: The medical, legal and public policy literature related to medical malpractice tort reform was reviewed and synthesized...
November 2010: Journal of Urology
Susanne H Goodson
Many facets of drug discovery involve the use of patented materials and methods, subjecting the researcher to potential liability from infringement of the underlying patents. Enacted in 1984, the Hatch-Waxman Act established a “safe harbor” for activities that would otherwise constitute infringement of a patented invention, if those activities were “solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products”...
2010: Current Topics in Medicinal Chemistry
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