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safe harbor laws

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...
February 2015: 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
Alexander H Swirnoff, Daniel M Becker
Life science companies often seek guidance on whether certain current or proposed activities fall within the Hatch-Waxman safe harbor, which exempts from infringement the making, using, offering to sell or sale within the US, or the importation into the US, of "a patented invention ... 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 ...". In 2005, the US Supreme Court provided some clarity as to the scope of this safe harbor...
April 2010: Expert Opinion on Therapeutic Patents
Laxmaiah Manchikanti, Erin Brisbay McMahon
The United States spends more of its wealth on healthcare than any other developed country, and that share is rising. Supporters of the free market system point to the regulatory burden on the healthcare industry. Estimates of the regulatory costs of US healthcare range from dollars 58 billion to dollars 339 billion. A recent report indicates that approximately dollars 8 billion of the US healthcare budget of dollars 1.9 trillion is spent on physicians' extra income derived from their ownership in outpatient facilities, such as ambulatory surgery centers, diagnostic imaging centers, and diagnostic testing and procedure laboratories...
November 2007: Pain Physician
Keri Tonn
This article explores the problems within a niche area of health law, the Health Professional Shortage Area (HPSA) safe harbor of the Anti-Kickback Statute. The author advocates for its removal by discussing how the HPSA designation is being used incorrectly to curb fraudulent behavior and how the current provision serves few hospitals. The author concludes by suggesting innovative solutions to remedy the problems with the current HPSA designation system.
2007: Annals of Health Law
(no author information available yet)
As required by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), Public Law 108-173, this final rule establishes a new safe harbor under the Federal anti-kickback statute for certain arrangements involving the provision of electronic prescribing technology. Specifically, the safe harbor would protect certain arrangements involving hospitals, group practices, and prescription drug plan (PDP) sponsors and Medicare Advantage (MA) organizations that provide to specified recipients certain nonmonetary remuneration in the form of hardware, software, or information technology and training services necessary and used solely to receive and transmit electronic prescription information...
August 8, 2006: Federal Register
Scott A Edelstein
Recent proposals by the U.S. Department of Health and Human Services for more antikickback safe harbors and exceptions to the Stark law are intended to ease the restrictions on electronic medical records and E-prescribing arrangements, and support government efforts to promote widespread adoption of the technology. Do these proposals go far enough? This article examines the agency's proposals and their practical effects.
March 2006: Managed Care Interface
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