- Louise Trubek et al, Transformations in Health Law Practice: The Intersections of Changes in Healthcare and Legal Workplaces, SSRN/Ind. HLRev
- Kevin Outterson, Clinical Trial Transparency — Antidote to Weaker Off-Label-Promotion Rules, N Engl J Med
- Jonathan Adler, The Conflict of Visions in NFIB v. Sebelius, SSRN/Drake LRev
- Lindsay Wiley, Sugary Drinks, Happy Meals, Social Norms, and the Law: The Normative Impact of Product Configuration Bans, SSRN/Conn LRev
Sutter Health v. Superior Court, 2014 WL 3589699 (Cal. App. 2014), is a medical data breach class action case that raises questions beyond the specifics of the Californian Confidentiality of Medical Information Act.
The stakes were high in Sutter — under the California statute medical data breach claims trigger (or should trigger!) nominal damages at $1000 per patient. Here four million records were stolen.
Plaintiffs’ first argued the defendant breached a section prohibiting unconsented-to disclosure. The not unreasonable response from the court was that this provision required an affirmative act of disclosure by the defendant which was not satisfied by a theft.
A second statutory provision argued by the plaintiffs looked like a winner. This section provided, “Every provider of health care … who creates, maintains, preserves, stores, abandons, destroys, or disposes of medical information shall do so in a manner that preserves the confidentiality of the information contained therein.” Continue reading
- Kevin Schulman et al, Shifting toward Defined Contributions — Predicting the Effects, N Engl J Med
- Richard Bonnie, The Impending Collision Between First Amendment Protection for Commercial Speech and the Public Health: The Case of Tobacco Control, SSRN
- Ann Marie Marciarille, The Medicaid Gamble, SSRN/J Health Care L & Pol
- Erika G. Martin et al, Liberating Data to Transform Health Care New York’s Open Data Experience, JAMA
- Melissa M Goldstein & Daniel Bowers, The Patient as Consumer: Empowerment or Commodification? SSRN/JLME
- Carrie H. Colla et al, First National Survey Of ACOs Finds That Physicians Are Playing Strong Leadership And Ownership Roles, Health Affairs
- Young MJ, Scheinberg E, Bursztajn H. Direct-to-Patient Laboratory Test Reporting: Balancing Access With Effective Clinical Communication, JAMA
- Amitabh Chandra et al, The Economics of Graduate Medical Education, N Engl J Med
While today’s unanimous (sans Justice Breyer, who recused himself) decision by the Supreme Court in POM Wonderful LLC v. Coca-Cola Co. was certainly not a surprise, especially after the clear tenor of the oral argument, the case may have some implications for FDA law going forward. In this case, POM Wonderful sued Coca-Cola under the Lanham Act, alleging that the label on Coca-Cola’s pomegranate blueberry juice was false and misleading, and that this deception caused it to lose sales. Coca-Cola argued that because its label complied with the Food, Drug, and Cosmetic Act, POM’s Lanham Act claim should be precluded. The district court and the Ninth Circuit agreed. Continue reading
- Ashish M. Bakshi, Gene patents at the Supreme Court: Association for Molecular Pathology v. Myriad Genetics, J. L. & Biosci
- Lindsay F. Wiley, The U.S. Department of Agriculture as a Public Health Agency? A ‘Health in All Policies’ Case Study, SSRN/J Food L and Pol
- David Orentlicher, Thad Pope & Ben Rich, The Changing Legal Climate for Physician Aid in Dying, SSRN/JAMA
- Kristin Madison, Building a Better Laboratory: The Federal Role in Promoting Health System Experimentation, SSRN/Pepperdine L.Rev.
Privacy is never easy to think about. This week it became harder. Two pieces framed my week. First, Eben Moglen’s essay in The Guardian (based on his Columbia talks from late last year) took my breath away; glorious writing and stunning breadth combined to deliver a desperately sad (but not entirely hopeless) message about government and corporate overreaching in data collection and processing.
A wry speech posted by software developer Maciej Ceglowski also helped frame my thoughts. He wrote, “The Internet somehow contrives to remember too much and too little at the same time, and it maps poorly on our concepts of how memory should work.” There’s the problem in a nut. Ceglowski alludes to the divide between how human (offline) memory operates (it’s “fuzzy” and “memories tend to fade with time, and we remember only the more salient events”) and the online default of remembering everything. Government and Google and, for that matter, Big Data Brokers tell us that online rules now apply across the board and ‘that’s just peachy’ because we’ll have better national security, better searches, or more relevant advertising. But, that’s backwards. Continue reading
- George P. Smith II, Re-Negotiating a Theory of Social Contract for Universal Health Care in America or, Securing the Regulatory State? SSRN/Cath U. L. Rev.
- Mark Rothstein, The Latest Challenge to Health Privacy: Health Care Consolidation, SSRN/Hastings Center Bioethics Forum
- Nathan Cortez, Regulating Disruptive Innovation, SSRN/Berkeley Tech L J
- Rob Cunningham, The Payment Reform Paradox, Health Affairs
A resident of Spain allegedly owed back taxes triggering attachment proceedings. The local newspaper published the details of an upcoming auction of his property in early 1998. At some point the issue was settled. However, the matter was not forgotten—the newspaper was online and a Google search of the gentleman’s name returned this history. He complained to the Spanish data protection agency (AEPD) that he had a right to have older, irrelevant information erased and that Google should remove the links. The AEPD agreed and Google sued for relief. The Spanish High Court referred the interpretation of the Data Directive (95/46) to the European Court of Justice in 2010 and in 2013 the Advocate-General issued an advisory opinion supportive of Google’s position. Somewhat surprisingly the European Court of Justice has now taken the opposite view (Case C‑131/12, Google Spain SL v. AEPD, May 13, 2014). Continue reading
- Allison Hoffman, Health Care Spending and Financial Security after the Affordable Care Act, SSRN/NC L.Rev.
- Diane E. Meier, ‘I Don’t Want Jenny To Think I’m Abandoning Her’: Views On Overtreatment, Health Affairs.
- Abbe Gluck, Federalism from Federal Statutes: Health Reform, Medicaid, and the Old-Fashioned Federalists’ Gamble, Abbe Gluck, SERN/Fordham L.Rev.
- Joseph Antos, Health Care Reform after the ACA, N Engl J M.
- Michael A. Carrier, Payment after Actavis, SSRN/ Iowa L. Rev.
- Mark Rothstein, Autonomy and Paternalism in Health Policy, SSRN/JLME
- Christopher Robertson, The Presumption Against Expensive Health Care Consumption, SSRN/Tulsa L.Rev.
- John A. Robertson, Egg freezing and egg banking: empowerment and alienation in assisted reproduction, J Law Biosci
Bloomberg Visual Data has published an incredibly effective visual exploration of US mortality data, here.
- Diana Winters, Intractable Delay and the Need to Amend the Petition Provisions of the FDCA, SSRN/Ind L.J.
- Xiaoyan Huang and Meredith Rosenthal, Transforming Specialty Practice — The Patient-Centered Medical Neighborhood, N Engl J Med
- Ameet Sarpatwari, Jerry Avorn, and Aaron S. Kesselheim, Using a Drug-Safety Tool to Prevent Competition, N Engl J Med
- Adam Candeub, Digital Medicine, the FDA, and the First Amendment, SSRN/Ga. L.Rev.
- Nicholas Bagley, The Legality of Delaying Key Elements of the ACA, N Engl J Med
- Timothy Jost and Simon Lazarus, Obama’s ACA Delays — Breaking the Law or Making It Work?, N Engl J Med
- Michael Frakes, The Surprising Relevance of Medical Malpractice Law, SSRN/Chicago L. Rev.
- Sallie Sanford, Emergency Response: A Systemic Approach to Diaper Rash, Chest Pain and Medicaid in the ED, SSRN/Ky L.J.
- Aaron Kesselheim & Michelle M. Mello, Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection, SSRN/N.Ca. L.Rev.
Last week the President celebrated the enrollment of 7.1 million Americans in health insurance with the words “The debate over repealing this law is over… The Affordable Care Act is here to stay,” here. Indeed, as the number of insured under the Act has grown, Medicaid has gained another 3 million enrollees, here, and other ACA provisions have kicked in so the conventional wisdom has emerged that while a political turn in favor of Republicans would lead to some important “tweaks,” the so-called “popular parts” such as guaranteed issue would survive. This world view seemed confirmed when Senators Burr, Coburn and Hatch introduced the first true Republican alternative to the ACA, here. Tim Jost commended that effort for going beyond the rhetoric of repeal noting, here, “Republicans seem to be coming to terms with the fact that the ACA has permanently changed the health policy landscape.” However, House Budget Committee Chairman Paul Ryan seems to be having none of this suggesting, here, that total reform remains the objective and that “We can have in this country universal access to affordable health insurance for everybody, including people with preexisting conditions without a costly government takeover of one-sixth of our economy.” It’s going to be a long election season.
- Charity Scott, Ethics Consultations and Conflict Engagement in Health Care, SSRN/Cardozo J. of Conflict Resolution
- Dan L. Burk, The Curious Incident of the Supreme Court in Myriad Genetics, SSRN/Notre Dame L.Rev.
- Brendan Saloner et al, Pinching the Poor? Medicaid Cost Sharing under the ACA, N Engl J Med
- Amanda Pustilnik, Painful Disparities, Painful Realities, SSRN
- Ryan Abbott, Documenting Traditional Medical Knowledge, SSRN/WIPO
Details and registration are here.
March 28, IU Robert H. McKinney School of Law, Indianapolis. The Hall Center for Law and Health and the Indiana Health Law Review present a major conference on neuroscience and the law. Speakers include:
- Oliver R. Goodenough, Professor of Law, Vermont Law School
- Geoffrey K. Aguirre, Associate Professor of Neurology, Perelman School of Medicine, University of Pennsylvania
- Brenna C. McDonald, Assistant Professor of Radiology and Neurology, Stark Neurosciences Research Institute, Indiana University School of Medicine
- Matthew Mitten, Professor of Law and Director, National Sports Law Institute, Marquette University Law School
- Jean M. Eggen, Distinguished Professor of Law, Widener University School of Law
- Tracy D. Gunter, Associate Professor of Clinical Psychiatry, Indiana University School of Medicine
- Robert M. Pascuzzi, Professor and Chairman, Department of Neurology, Indiana University School of Medicine
- Leslie A. Hulvershorn, Assistant Professor of Psychiatry, Indiana University School of Medicine
- Amanda C. Pustilnik, Associate Professor of Law, University of Maryland Francis King Carey School of Law
- Jennifer A. Drobac, Professor of Law, Indiana University McKinney School of Law
- Andrew J. Saykin, Raymond C. Beeler Professor of Radiology and Director, Indiana University Center for Neuroimaging, Department of Radiology, Indiana University School of Medicine
- Rebecca S. Dresser, Daniel Noyes Kirby Professor of Law and Professor of Ethics in Medicine, Washington University School of Law
- Eric Racine, Director, Neuroethics Research Unit, University of Montreal and McGill University
- Ryan Abbott & Ian Ayres, Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices, SSRN
- Joanna Shepherd, Biologic Drugs, Biosimilars, and Barriers to Entry, SSRN
- Platt R, Kass NE, McGraw D., Ethics, Regulation, and Comparative Effectiveness Research: Time for a Change. JAMA
- Henry Greely & David Kaye, A Brief of Genetics, Genomics and Forensic Science Researchers in Maryland v. King, SSRN/Jurimetrics
- Haavi Morreim, Dumping the ‘Anti-Dumping’ Law: Why EMTALA Is (Largely) Unconstitutional and Why It Matters, SSRN/Min. J L Sci Tech
- David Orentlicher, Health Care Reform and Efforts to Encourage Healthy Choices by Individuals, SSRN/N Carolina L Rev
- Kevin Outterson, New Business Models for Sustainable Antibiotics, SSRN/Centre on Global health Security Working Group Papers
- Diana Winters,The Magical Thinking of Food Labeling: The NLEA as a Failed Statute, SSRN