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Moderator, "New Regulatory Models Ensuring Safety And Accelerating Treatments", Mary Ann Chirba Dec 2013

Moderator, "New Regulatory Models Ensuring Safety And Accelerating Treatments", Mary Ann Chirba

Mary Ann Chirba

No abstract provided.


Health Care Reform: Law And Practice, Mary Ann Chirba, Alice Noble, Michael Maddigan Oct 2013

Health Care Reform: Law And Practice, Mary Ann Chirba, Alice Noble, Michael Maddigan

Mary Ann Chirba

On March 23, 2010, President Obama signed comprehensive health reform, the Patient Protection and Affordable Care Act (PPACA) and commonly referred to as "Obamacare" or the Affordable Care Act (ACA), into law. With the passage of the ACA, Congress put an end to the century-long quest to secure coverage for all Americans facing steadily rising costs for increasingly sophisticated health care. In closing the book on that struggle, however, the law opened another. Health Care Reform: Law and Practice is designed to assist health care and legal professionals who need to understand what the law says, how it works, and …


The Affordable Care Act, Dean Hashimoto Oct 2013

The Affordable Care Act, Dean Hashimoto

Dean M. Hashimoto

No abstract provided.


Evolving Global Regulation Of Adult Stem Cell Therapies And Technologies, Mary Ann Chirba Oct 2013

Evolving Global Regulation Of Adult Stem Cell Therapies And Technologies, Mary Ann Chirba

Mary Ann Chirba

No abstract provided.


Ethics For Health Care Providers And Counsel, Bobbi Boyd Oct 2013

Ethics For Health Care Providers And Counsel, Bobbi Boyd

Bobbi Jo Boyd

Boyd presented an interactive, hour-long continuing legal education (CLE) session for event attendees.


The Potential Impact Of The Affordable Care Act On Workers' Compensation, Dean Hashimoto Sep 2013

The Potential Impact Of The Affordable Care Act On Workers' Compensation, Dean Hashimoto

Dean M. Hashimoto

No abstract provided.


An Introduction To The Affordable Care Act, Dean Hashimoto Sep 2013

An Introduction To The Affordable Care Act, Dean Hashimoto

Dean M. Hashimoto

No abstract provided.


Bioethics And Law In The United States: A Legal Process Perspective, Charles Baron Aug 2013

Bioethics And Law In The United States: A Legal Process Perspective, Charles Baron

Charles H. Baron

No abstract provided.


The Impact Of The Affordable Care Act, Dean Hashimoto Aug 2013

The Impact Of The Affordable Care Act, Dean Hashimoto

Dean M. Hashimoto

The most significant healthcare legislation to become law in America in decades is the Affordable Care Act (ACA), now confirmed as Constitutional by the U.S. Supreme Court. Not intended to directly affect state workers’ compensation laws, there is no question that it will, especially since medical care is so important and a major component of any workers’ compensation system, regardless of jurisdiction. This knowledgeable panel will help WC adjudicators understand this complex new law and developing rules and regulations with a focus on their effect on workers’ compensation. Adjudicators must understand the effect of their decisions on the “new realities” …


The Affordable Care Act And Workers' Compensation, Dean Hashimoto Jul 2013

The Affordable Care Act And Workers' Compensation, Dean Hashimoto

Dean M. Hashimoto

No abstract provided.


Throwing Dirt On Doctor Frankenstein's Grave: Accesss To Experimental Treatments At The End Of Life, Michael J. Malinowski Jul 2013

Throwing Dirt On Doctor Frankenstein's Grave: Accesss To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

Abstract

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research …


Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski Jul 2013

Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …


Pain Management: Dealing With The Opioid Epidemic, Dean Hashimoto Apr 2013

Pain Management: Dealing With The Opioid Epidemic, Dean Hashimoto

Dean M. Hashimoto

No abstract provided.


Moderator, Youth In Prison: The Reality Of The System, Francine Sherman Apr 2013

Moderator, Youth In Prison: The Reality Of The System, Francine Sherman

Francine T. Sherman

On April 30, 2013, Professor Sherman served as the moderator for the Youth in Prison: The Reality of the System at Boston College. The panel discussed the realities of the prison system and efforts being implemented to create positive change.


Partcipant, Juvenile Detention Alternatives Initiative Inter-Site Conference, Francine Sherman Apr 2013

Partcipant, Juvenile Detention Alternatives Initiative Inter-Site Conference, Francine Sherman

Francine T. Sherman

Professor Sherman participated in two workshops, Reducing Disparities at the Intersection of Gender, Race and Ethnicity and Eliminating the Use of Detention for Commercially Sexually Exploited Children, at the Juvenile Detention Alternatives Initiative Inter-site Conference held in Atlanta, Georgia.


Opioid Problem In Workers' Compensation, Dean Hashimoto Mar 2013

Opioid Problem In Workers' Compensation, Dean Hashimoto

Dean M. Hashimoto

No abstract provided.


Overview On The Current Challenges Of The Massachusetts Workers' Compensation System, Dean Hashimoto Mar 2013

Overview On The Current Challenges Of The Massachusetts Workers' Compensation System, Dean Hashimoto

Dean M. Hashimoto

No abstract provided.


In Search Of Regulatory Consistency: The Role Of Ivf Regulations In Improving Fda Oversight Of Autologous Stem Cell Therapies, Mary Ann Chirba Feb 2013

In Search Of Regulatory Consistency: The Role Of Ivf Regulations In Improving Fda Oversight Of Autologous Stem Cell Therapies, Mary Ann Chirba

Mary Ann Chirba

No abstract provided.


Bioethics And Law In The United States: A Legal Process Perspective, Charles Baron Feb 2013

Bioethics And Law In The United States: A Legal Process Perspective, Charles Baron

Charles H. Baron

No abstract provided.


Regulation Vs. The Practice Of Medicine, Mary Ann Chirba Feb 2013

Regulation Vs. The Practice Of Medicine, Mary Ann Chirba

Mary Ann Chirba

Professor Chirba presented on the impact of federal and cross-border regulation on the development and delivery of adult stem cell therapies and other emerging forms of regenerative medicine. She also participated on a panel of researchers and clinicians to discuss practical strategies for attaining regulatory reform.


The Illusion Of Interchangeability: The Benefits And Dangers Of Guidance-Plus Rulemaking In The Fda's Biosimilar Approval Process, Jonathan Stroud Jan 2013

The Illusion Of Interchangeability: The Benefits And Dangers Of Guidance-Plus Rulemaking In The Fda's Biosimilar Approval Process, Jonathan Stroud

Jonathan R. K. Stroud

On March 23, 2010, President Obama signed into law the ambitious Patient Protection and Affordable Care Act. While media attention focused largely on the sweeping changes the bill makes to the nation’s healthcare system, there was also a less-noticed rider to the bill, the Biologics Price Competition and Innovation Act of 2009 (Biosimilars Act). The Biosimilars Act grants the Food and Drug Administration (FDA) broad new authority to create an accelerated premarket approval pathway for generic competition to biologics in an attempt to drive biologic drug prices down and reduce the overall costs of health care. Traditionally, inventors of medical …


Advancing Human Rights In Patient Care: The Law In Seven Transitional Countries (Forthcoming), Leo Beletsky, Tamar Ezer, Judith Overall, Iain Byrne, Jonathan Cohen Dec 2012

Advancing Human Rights In Patient Care: The Law In Seven Transitional Countries (Forthcoming), Leo Beletsky, Tamar Ezer, Judith Overall, Iain Byrne, Jonathan Cohen

Leo Beletsky

No abstract provided.


Speaker, Workshop Organizer, Moderator And Presenter, Francine Sherman Dec 2012

Speaker, Workshop Organizer, Moderator And Presenter, Francine Sherman

Francine T. Sherman

Professor Sherman has served as a Speaker, Workshop Organizer, Moderator, and Presenter for a range of workshops on topics related to detention reform and girls at the Annie E. Casey Foundation Juvenile Detention Alternatives Initiative Annual Conferences since 2000.


“Religious Freedom,” The Individual Mandate, And Gifts: On Why The Church Is Not A Bomb Shelter, Patrick Mckinley Brennan Dec 2012

“Religious Freedom,” The Individual Mandate, And Gifts: On Why The Church Is Not A Bomb Shelter, Patrick Mckinley Brennan

Susan Rexford

The Health and Human Services' regulatory requirement that all but a narrow set of "religious" employers provide contraceptives to employees is an example of what Robert Post and Nancy Rosenblum refer to as a growing "congruence" between civil society's values and the state's legally enacted policy. Catholics and many others have resisted the HHS requirement on the ground that it violates "religious freedom." They ask (in the words of Cardinal Dolan) to be "left alone" by the state. But the argument to be "left alone" overlooks or suppresses the fact that the Catholic Church understands that it is its role …