“Big Data” is a phrase that has been used pervasively by the media and the lay public in the last several years. While many definitions are possible, the common denominator seems to include the “three V’s” – Volume (vast amounts of data), Variety (significant heterogeneity in the type of data available in the set), and Velocity (speed at which a data scientist or user can access and analyze the data).
Defined as such, health care has become one of the key emerging use cases for big data. For example, Fitbit and Apple’s ResearchKit can provide researchers access to vast stores of biometric data on users from which to test hypotheses on nutrition, fitness, disease progression, treatment success, and the like. The Centers for Medicare & Medicaid Services (CMS) have vast stores of billing data that can be mined to promote high value care and prevent fraud; the same is true of private health insurers. And hospitals have attempted to reduce re-admission rates by targeting patients that predictive algorithms indicate are at highest risk based on analysis of available data collected from existing patient records. Continue reading →
April 18, 2016, 5-7 PM Hauser Hall 105
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA 02138
The materials for the presentation, “Mining the Genomic Data Mountain: Legal and Policy Challenges,” can be downloaded here.
Robert Cook-Deegan is a research professor in the Sanford School of Public Policy at Duke University, with secondary appointments in Internal Medicine (School of Medicine), and Biology (Trinity College of Arts & Sciences). He was the founding director for Genome Ethics, Law & Policy in Duke’s Institute for Genome Sciences & Policy from July 2002 through December 2012. He is the author of The Gene Wars: Science, Politics, and the Human Genome and an author on over 250 articles.
Dr. Cook-Deegan’s areas of expertise include genomics and intellectual property, history of genomics, global health, science and health policy, and health research policy. His current research focuses on policy implications of genomics, bioethics, intellectual property, and innovation.
Nathan Cortez is Associate Dean for Research and Associate Professor in Dedman School of Law at Southern Methodist University. He teaches and writes in the areas of health law, administrative law, and FDA law. His research focuses on emerging markets in health care and biotechnology. He has become one of the world’s leading legal scholars on medical tourism, patient mobility, and cross-border health insurance.
His research also addresses mobile health technologies, how to regulate innovations that disrupt static regulatory regimes, the First Amendment restraints on FDA regulation (including FDA’s graphic tobacco warnings), immigration federalism, and alternative modes of regulation.
Editor’s Note: The Petrie-Flom Center is now accepting applications for Student Fellowships for the 2016-2017. See our website for more information about applying!
Last week, the New England Journal of Medicine published a Perspectives article describing the “Immersion Day” it holds for its board members. On the Immersion Day, participants don scrubs and shadow front line employees across various parts of the hospital – this might include attending ICU rounds or observing a surgery. The day gives board members the opportunity to meet and engage with staff in a meaningful way as they go about their jobs, painting a vivid picture of the issues and concerns that arise on paper in the board room. In its third year, the program is a resounding success, garnering rave reviews from the trustees. In fact, the hospital has now created an Immersion Day for state policymakers.
Having worked as a clinician before moving into policy and research, this piece resonated deeply with me. I have found my clinical experience to be essential and formative for how I view policy questions. In addition, as I approach the end of my year as a student fellow, I realized that this piece and the concept of immersion describes my experience with the Petrie-Flom Center. Continue reading →
Nicolas P. Terry is the Hall Render Professor of Law at the Indiana University Robert H. McKinney School of Law. He serves as Executive Director of the Hall Center for Law and Health. Professor Terry teaches Torts, Products Liability, Health Information Technology, Law & Science, and Health Care Quality.
Educated at Kingston University and the University of Cambridge, Professor Terry began his academic career as a member of the law faculty of the University of Exeter in England. He has served as a Senior Fellow at Melbourne Law School and held visiting faculty positions at the law schools of Santa Clara University, the University of Missouri-Columbia, Washington University, and the University of Iowa. From 2000-08, Professor Terry served as co-director of Saint Louis University’s Center for Health Law Studies. From 2008-10, Terry served as the School of Law’s Senior Associate Dean.
Professor Terry’s research interests lie primarily at the intersection of medicine, law, and information technology. He is a permanent blogger at the HealthLawProf Blog and at Harvard Law School’s Bill of Health. Professor Terry is also is the co-presenter of the “The Week in Health Law” podcast.
The Project on Advanced Care and Health Policy will foster development of improved models of care for individuals with serious advanced illness nearing end-of-life, through interdisciplinary analysis of important health law and policy issues.
March 28, 2016 – The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Coalition to Transform Advanced Care (C-TAC) today announced a new collaboration, The Project on Advanced Care and Health Policy.
This initiative is prompted by the fact that current health law policy and regulation, developed largely in a fee-for service environment with siloed providers, creates barriers that may impede widespread adoption of improved models of care for those with advanced illness. The Project will seek to address this problem through policy and research projects that will identify and analyze these barriers, and propose policy solutions that promote development and growth of successful programs. This may entail developing proposed regulatory approaches for the advanced care delivery model that could be adopted by policymakers at the state and federal levels, as well as exploration of potential payment methodologies for this model of care. Continue reading →
Jamie Metzl, JD ’97, Senior Fellow for Technology and National Security of the Atlantic Council. He has served on the U.S. National Security Council, State Department, and Senate Foreign Relations Committee, as Executive Vice President of the Asia Society and with the United Nations in Cambodia. A globally syndicated columnist and regular guest on national and international media, he is the author of a history of the Cambodian genocide and the novels The Depths of the Sea and Genesis Code.
Topic: The National Security Implications of the Genetics Revolution
George J. Annas, JD, MPH, William Fairfield Warren Distinguished Professor and Chair of the Department of Health Law, Bioethics & Human Rights, Boston University School of Public Health; Professor in the Boston University School of Medicine, and School of Law
Topic: Post-9/11 Uses of Public Health and Medicine by National Security Agencies
Jonathan D. Moreno, PhD, David and Lyn Silfen University Professor of Ethics, Perelman School of Medicine, University of Pennsylvania
Topic:National Security and Biology
This event is free and open to the public. Lunch will be provided.
Wellness programs remain a popular feature of the employer landscape, but the legal environment surrounding them has long been uncertain. In April 2015, the Equal Employment Opportunity Commission took a significant step toward resolving this uncertainty by formally proposing a ruleclarifying the applicability Americans with Disabilities Act of 1990 (ADA) to wellness programs.
In doing so, it staked out middle ground between an approach that would have sharply limited the use of incentives in wellness programs, and a more permissive approach consistent with regulations already in place under the Affordable Care Act (ACA). The proposed rule has the potential to shape, or reshape, future wellness programs. The extent to which it will do so, however, remains uncertain. […]
Ever since the first patent was issued in 1790, the United States has had a single patent law to protect inventions in all fields. Over the past three decades, that law has been strained to the breaking point in covering both the life sciences and other technologies.
On the life sciences side, patents protect platform technologies as well as specific products and are important at every stage of a product’s life cycle. Many scientific breakthroughs arise from federally funded research in universities and other institutions. Under the Bayh-Dole Act, these institutions license the resulting patents to companies, often start-ups, which develop the technology until it is ready to be marketed.
During the many years of the development process, companies need to attract investment, and investors often assess the merits of the patent portfolio as an indicator of the ultimate strength of the company. Once a product is released to the market, patents still matter; each day of patent protection for a blockbuster drug is worth millions. Patent litigation in the life sciences is typically between competitors and reflects an effort by one of those competitors to maintain its exclusivity. […]
The notion that the American health care system should transition from paying for volume to paying for value has become nearly ubiquitous. There is a broad consensus that health care providers should be paid more if they deliver higher value care (i.e. care that results in substantial health gains per dollar spent).
These beliefs have led to a proliferation of value-based payment programs in both public and private sectors. For example, at the beginning of 2015, Sylvia Burwell announced the federal government’s commitment to tie 90 percent of fee-for-service Medicare payments to quality or value measures by 2018. In January of 2015, a newly formed alliance of health care providers, insurers, and employers called the Health Care Transformation Task Force committed to shifting 75 percent of their business to contracts that provide incentives for quality and efficiency by 2020.
The details of existing value or quality-based payment programs vary enormously and without regard to any conceptual framework. For example, they vary in the size of incentives and the measures used. They also vary in whether quality payments are contingent on financial savings and whether the value-based payment model is budget neutral. Even the term value is inconsistently defined. […]
It appears that 2016 will follow 2015 as another year of massive consolidation in the health care sector. It therefore follows that 2016 will, also like 2015, be another year in which assorted health care industries receive significant antitrust scrutiny. Against this backdrop, it is timely and revealing to examine the current state and trajectory of antitrust law as it intersects and shapes health care policy.
Beginning in the late 1980s, when hospitals and hospital systems started an intense consolidation trend that continues today, many were challenged by the Federal Trade Commission (FTC) for creating anticompetitive and therefore illegal pricing power. Yet the FTC was unsuccessful in convincing courts that this was a harmful trend, and the Commission earned a costly, long losing streak, suffering defeats in each of six landmark cases between 1994 and 1999 (Note 1). The district courts reasoned that the hospitals’ mergers would provide better and more efficient care, that patients would travel to obtain cheaper care, and in any event, because the hospitals were nonprofit, they would not exercise market power to increase prices.
All these predictions have been proven incorrect. Hospital mergers (including those involving nonprofits) have significantly increased prices, and there has been no evidence of increased efficiencies. In fact, evidence suggests that, because the administration of health insurance both reduces the impact of marginal price increases and limits demand in close substitutes, hospital monopolists are even more costly than “typical” monopolies. One significant development in 2015 is new research which revealed that cost variation in the US is largely determined by hospitals market power. The string of FTC losses and the consequent wave of hospital consolidations can only be described as a collective and massive failure of antitrust policy. […]
Nearly six years after the passage of the Affordable Care Act (ACA), health law and policy experts continue to painstakingly track the progress of the Act’s Medicaid expansion. The original intention of the ACA was to expand Medicaid in every state, leading to gains in coverage by all individuals below a certain income.
Most of the states that have expanded Medicaid thus far have done so through the standard procedure, following the statutory guidelines set forth by the ACA and the Centers for Medicare & Medicaid Services (CMS) and incorporating the newly eligible enrollees into their existing programs as a new beneficiary group. But some states have successfully negotiated customized expansions with CMS through the use of the Section 1115 waiver process, seeking to expand Medicaid only on their terms. […]
This post is based in part on a debate which took place between Jerry Avorn and Mit Spears. After reading this piece, check out the counter argument. You can also watch a video of the debate.
The ability of pharmaceutical companies to provide information about medicines to health care professionals beyond that which is contained in the Food and Drug Administration (FDA)-approved labeling is a topic that has generated a great deal of discussion, particularly in light of the August 2015 Amarin decision rendered by a US District Court in the Southern District of New York, and the FDA’s recent settlement of the case.
In Amarin, Judge Paul Engelmayer ruled that the FDA’s regulation of information provided by pharmaceutical companies violated the First Amendment’s Commercial Speech doctrine to the extent that they prohibited the communication of truthful and non-misleading speech, even where the information provided went beyond the FDA-approved labeling. On March 8, FDA and Amarin settled the case in a way that preserves Amarin’s ability to share truthful, non-misleading information about its medicine. In fact, the FDA even agreed to provide advisory review of two such communications per year with a 60-day timeline.
This case followed on the heels of the Second Circuit’s 2013 decision in Caronia and the Supreme Court’s 2011 ruling in Sorrell v. IMS Health, Inc., in which the Courts affirmed that the First Amendment’s protections of commercial speech extended to pharmaceutical companies and their employees. […]
It’s well known that the U.S. is in the midst of a prescription opioid overdose and abuse epidemic. Adverse outcomes from prescription opioid abuse have dramatically escalated over the past decade and a half, with fatal prescription opioid overdoses roughly quadrupling and emergency department visitsinvolving prescription drugs (mostly opioids) more than doubling.
Outrageous statistics—such as that opioids were involved in almost 29,000 drug overdose deaths in 2014, or that 46 people die from a prescription opioid overdose every day—have less “shock” value now than they did several years ago. Moreover, the opioid crisis has become personal: many (including presidential candidates) have experienced a close friend or family member struggle with addiction. […]
In 2013 the Center for Medical Progress appeared to have secured tax-exempt status for a fake company it set up called Biomax Procurement Services. The company’s “representatives” contacted the non-profit women’s health provider Planned Parenthood staffers and led them into conversations that were secretly recorded. The result, according to their website (as reported by CNN), was “a 30-month-long investigative journalism study by The Center for Medical Progress, documenting how Planned Parenthood sells the body parts of aborted babies.”
The videos were edited down and released slowly in a way designed to paint Planned Parenthood in the worst light. While some have called it a “hoax,” that’s not a word I would use in this case. When I think of great journalistic hoaxes I think of Orson Welles’s War of the Worlds (though more recent historical work suggests that the panic it caused may have been mythological). Instead what happened here, I want to suggest, is what I will call a “manufactured controversy.” [..]
On February 3, 2016 the full U.S. Court of Appeals for the 11th Circuit agreed to rehear the appeal inWollschlaeger v. Florida, commonly known as the case of the “docs versus the glocks.” Wollschlaegerconcerns a Florida law that bars physicians from routinely asking their patients whether they have guns or store them safely. In agreeing to rehear the appeal, the full court vacated a decision issued last December by a three-judge panel which had replaced two of its own prior opinions. Each of the panel’s three decisions upheld the law, and each raised serious questions about the ability of health professionals to provide their patients with relevant health information.
Public health professionals have long viewed gun safety as a major public health problem. Likewise, many physicians believe that good primary care includes questioning and counseling patients, especially those with children, about firearm safety, just as they talk to patients about seatbelts, cigarettes, and the need to exercise. […]
This multidisciplinary program is co-sponsored by the Center for Bioethics at Harvard Medical School and the Petrie Flom Center at Harvard Law School to inform and deliberate with health care professionals, bioethicists, attorneys, and the public about how to address social justice issues in health care—such pressing problems as worsening drug shortages, continuing racial inequities, providing health care for refugees, uninsured and undocumented persons, and the like.
Using selected examples we will discuss the efforts of health care administrators and others to identify and address such large scale health system problems. Is there a role for ethics committees in handling social justice issues—should the attention of hospital ethicists and ethics committees expand to address broader institutional policies and programs? Faculty experts and participants will describe successful efforts to address specific problems and engage in thoughtful discussion with participants about strategies and struggles of ethic committees that move beyond individual case consultation to organizational ethics.
Support for this conference has been provided by Oswald DeN. Cammann Fund at Harvard University.
Michael Frakes is an Associate Professor of Law at Northwestern Law. He is also a Faculty Research Fellow at the National Bureau of Economic Research and a Faculty Fellow at Northwestern’s Institute for Policy Research. He was previously an Assistant Professor of Law at Cornell Law School from 2011-2014. From 2009 to 2011, he was anAcademic Fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. He is generally interested in empirical research in the areas of health law and innovation policy. His research in health is largely focused on understanding how certain legal and financial incentives affect the decisions of physicians and other health care providers. His research in innovation policy centers around the relationship between the financing of the U.S. Patent and Trademark Office and key aspects of its decision making. His scholarship has appeared in, or is forthcoming in, the American Economic Review, the Stanford Law Review, the University of Chicago Law Review, the Journal of Empirical Legal Studies, the Vanderbilt Law Review, the American Law and Economics Review, and the Journal of Health Economics.