- Mary Crossley, Giving Meaning to ‘Meaningful Access’ in Medicaid Managed Care, SSRN/Ky LJ,
- Robert Kocher and Bryan Roberts, The Calculus of Cures, N Engl J Med
- David Hyman and William Kovacic, Why Who Does What Matters: Governmental Design, Agency Performance, the CFPB and PPACA, SSRN
- Shi-Ling Hsu, A Cost-Benefit Analysis of Sugary Drink Regulation in New York City, SSRN
- Tim Jost, Beyond Repeal — A Republican Proposal for Health Care Reform, N Eng J Med
- Larry Gostin, Legal and Ethical Responsibilities Following Brain Death,
- The McMath and Muñoz Cases, JAMA
- Erin Fuse Brown, Irrational Hospital Pricing, SSRN/Houston J H L & P
- Joseph Hall and Deven McGraw, For Telehealth To Succeed, Privacy And Security Risks Must Be Identified And Addressed, Health Affairs
- Abbe Gluck, A Legal Victory for Insurance Exchanges, N Eng J Med
- George Annas & Sherman Elias, 23andMe and the FDA, N Eng J Med
- Joseph Kvedar Molly Joel Coye and Wendy Everett, Connected Health: A Review Of Technologies And Strategies To Improve Patient Care With Telemedicine And Telehealth, Health Affairs
- Jonathan Darrow, Pharmaceutical Efficacy: The Illusory Legal Standard, SSRN/Wash & Lee L.Rev.
- Bill Sage and David Hyman, Let’s Make A Deal: Trading Malpractice Reform For Health Reform, Health Affairs
- Jennifer Pomeranz, A Comprehensive Strategy to Overhaul FDA Authority for Misleading Food Labels, SSRN/Am J L Med.
- Alicia Ouellette, Context Matters: Disability, the End of Life, and Why the Conversation Is Still so Difficult, SSRN/NYLS L.Rev.
- Roy Spece et al, Would Disclosures of Conflicts of Interest Change Patients’ Decisions and, If So, Would that Make Them ‘Material’ Information? SSRN
For privacy advocates the last week contained something of a gut-check when the UK’s splendidly descriptive Health and Social Care Information Centre announced something of a bonanza for big data companies; the NHS’s care.data program, here, will make anonymized clinical data broadly available to researchers and commercial interests with few limitations, here.
For once, however, the US attitude to the growing big data phenomenon has appeared more robust. Writing on the White House Blog, here, Presidential counselor John Podesta announced he will be leading “a comprehensive review of the way that ‘big data’ will affect the way we live and work; the relationship between government and citizens; and how public and private sectors can spur innovation and maximize the opportunities and free flow of this information while minimizing the risks to privacy.” Results are promised in 90 days.
For health lawyers, however, the most interesting recent development has been the FTC’s denial of LabMD’s motion to dismiss, here. The LabMD complaint involves the data security practices of a clinical testing laboratory. The FTC alleged “unfair . . . acts or practices” under Section 5(a)(1) of the FTC Act. One of LabMD’s arguments for dismissal was that the specific HIPAA and HITECH statutes dealing with the health privacy and security obligations of covered entities blocked the FTC from enforcing its more general authority. According to the FTC:
Nothing in HIPAA, HITECH… reflects a “clear and manifest” intent of Congress to restrict the Commission’s authority over allegedly “unfair” data security practices such as those at issue in this case. LabMD identifies no provision that creates a “clear repugnancy” with the FTC Act, nor any requirement in HIPAA or HITECH that is “clearly incompatible” with LabMD’s obligations under Section 5.
LabMD is an important development. I have argued at length, here, that big data activities outside of HIPAA-protected space have illustrated the gaps in data protection because of the manner in which the US has regulated discrete vertical industries. LabMD suggests that the FTC is prepared to fill in the gaps.
I recently posted this draft on SSRN. Feedback much appreciated. Here is the abstract:
Fragmentation and lack of coordination remain as some of the most intractable problems facing health care. Attention has often alighted on the promise of Health care Information Technology not least because IT has had such positive impact on many other personal, professional and industrial domains. For at least two decades the HIT-panacea narrative has been persistent even though the context has shifted. At various times we have been promised that patient safety technologies would solve our medical error problems, electronic transactions would simplify healthcare administration and insurance and clinical data would become interoperable courtesy of electronic medical records. Today the IoM is positioning HIT at the center of its new “continuously learning” health care model that is in large part aimed at solving our fragmentation and lack of coordination problems. While the consensus judgment that HIT can reduce fragmentation and increase coordination has intuitive force the specifics are more complicated. First, the relationship between health care and IT has been both culturally and financially complex. Second, HIT has been overhyped as a solution for all of health care’s woes; it has its own problems. Third, the HIT-fragmentation solution presents a chicken-and-egg problem — can HIT solve health care fragmentation and lack of coordination problems or must health care problems such as episodic care be solved prior to successful deployment of HIT? The article takes a critical look at both health care and HIT with those questions in mind before concluding with some admittedly difficult recommendations designed to break the chicken-and-egg deadlock.
- Stephanie Greene, After Caronia: First Amendment Concerns in Off-Label Promotion, SSRN/San Diego L. Rev.
- Bill Sage et al, How Policy Makers Can Smooth The Way For Communication-And- Resolution Programs, Health Affairs
- Tim Jost, Implementing Health Reform: Four Years Later, Health Affairs
- Nancy E. Morden et al, Choosing Wisely — The Politics and Economics of Labeling Low-Value Services, N Eng J Med
- Bill Sage, Putting Insurance Reform in the ACA’s Rear-View Mirror, SSRN/Houston L. Rev.
- Alta Charo, Physicians and the (Woman’s) Body Politic, N Engl J Med
- Karen Jordan, The Contraceptive Mandate: Compelling Interest or Ideology? SSRN
- Rodney Smith, Solving the Concussion Problem and Saving Professional Football, SSRN/TJ L. Rev.
- Michael Frakes & Anupam Jena, Does Medical Malpractice Law Improve Health Care Quality? SSRN
- Amy Fairchild et al, The Renormalization of Smoking? E-Cigarettes and the Tobacco “Endgame,” N Engl J Med
- Evelyn Tenenbaum, The Union of Contraceptive Services and the Affordable Care Act Gives Birth to First Amendment Concerns, Albany LJ Sci & Tech
- Sharon Long et al, The Health Reform Monitoring Survey: Addressing Data Gaps To Provide Timely Insights Into The Affordable Care Act, Health Affairs
- Kevin Outterson,The Drug Quality and Security Act — Mind the Gaps, N Engl J Med
- Jonathan Oberlander and Krista Perreira, Implementing Obamacare in a Red State — Dispatch from North Carolina, N Eng J Med
- Sara Rosenbaum, The Enduring Role Of The Emergency Medical Treatment And Active Labor Act, Health Affairs
- Nicole Huberfeld, Dynamic Expansion, SSRN
- Leemore Dafny, Hospital Industry Consolidation — Still More to Come? N Eng J Med
- Seema Mohapatra, Using Egg Freezing for Non-Medical Reasons: Fertility Insurance or False Hope? – Legal, Ethical, and Policy Considerations, SSRN
- Alyna Chien & Meredith B. Rosenthal, Medicare’s Physician Value-Based Payment Modifier — Will the Tectonic Shift Create Waves? N Engl J Med
- Cathy Schoen et al, Access, Affordability, And Insurance Complexity Are Often Worse In The United States Compared To Ten Other Countries, Commonwealth Fund/Health Affairs
- Jan Walker et al, The Road toward Fully Transparent Medical Records, N Engl J Med
The political ripples from the poorly managed exchange roll-out likely will endure through at least one election cycle. Maybe, late night comedians will run out of material sooner. While criticism and inquiry are appropriate given the foreseeable nature of the problem (some months ago at SEALS even I was moved to highlight the OIG’s predictions that there would be little time for testing the data hub) mostly we will witness technical flaws being fashioned into a cudgel with which to beat the Affordable Care Act and its champion-in-chief.
As Ezra Klein has noted, “the politics here will be driven by the reality. If the policy continues to fail, then there’s nothing the White House can do to keep from being dragged down. Conversely, if the Web site is fixed come mid-December, and the policy begins working pretty well, then there’s no amount of Republican messaging that can make it a failure.”
Sitting here in mid-to-late November, it may be appropriate (or at least refreshing) to seek out some broader lessons that we may take away from this mess. In an illuminating post at the Commonwealth Fund blog David Blumenthal contrasted his experiences inside and outside of government and concluded that the federal government needed to reform its IT procurement system. Extrapolating even further from the current disaster Clay Shirky uses healthcare.gov to pose some fundamental questions about how managers communicate with technologists and how politicians approach Internet interaction with citizens. His “litmus test” for “whether out political class grasps the internet”? “Can anyone with authority over a new project articulate the tradeoff between features, quality, and time?” Those managing healthcare.gov failed that test.
- Alyna Chien and Meredith Rosenthal, Medicare’s Physician Value-Based Payment Modifier — Will the Tectonic Shift Create Waves? N Engl J Med
- Brendan Maher, The Affordable Care Act, Remedy, and Litigation Reform, SSRN/American University L.Rev.
- Thad Pope, Making Medical Decisions for Patients without Surrogates, N Engl J Med
- World Medical Association Declaration of Helsinki, Ethical Principles for Medical Research Involving Human Subjects, 7th Rev. 2013, JAMA
- Thomas Gallagher et al, Talking with Patients about Other Clinicians’ Errors, N Engl J Med
- Arti Rai, Biomedical Patents at the Supreme Court: A Path Forward, SSRN/Stan. L.Rev. Online
- Allison Hoffman, An Optimist’s Take on the Decline of Small-Employer Health Insurance, SSRN/Iowa L.Rev.
- Jessica Mantel, The Myth of the Independent Physician: Implications for Health Law, Policy, and Ethics, SSRN/Case Western Reserve L. Rev.
- Cynthia Ward, Mental Illness and Danger to Self, SSRN
- Nicole Huberfeld, With Liberty and Access for Some: The ACA’s Disconnect for Women’s Health, SSRN/Fordham ULJ
- Robert Huckman & Mark Kelley, Public Reporting, Consumerism, and Patient Empowerment, NEJM
- Joanna Shepherd, Selective Contracting in Prescription Drugs: The Benefits of Pharmacy Networks, Minn J L Sci & Tech
October 4, 2013
Hall Center for Law and Health
Will Neuroscience Redefine Mental Injury?
Legal systems have traditionally treated physical and mental injuries differently. Advances in neuroscience provide insights that challenge this dichotomy. This multidisciplinary half-day conference will examine some of the evolving technologies used to demonstrate mental injury and explore the potential impact of this neuroscientific data in legal decision making.
- Thomas W. McAllister, Albert E. Sterne Professor and Chair, Department of Psychiatry, Indiana University School of Medicine
- Tracy D. Gunter, Associate Professor Clinical Psychiatry Indiana University School of Medicine and Adjunct Professor Law, IU McKinney School of Law
- Stacey A. Tovino, Lincy Professor of Law, William S. Boyd School of Law, University of Nevada, Las Vegas
- Betsy J. Grey, Professor of Law and Alan A. Matheson Fellow, and Faculty Fellow in the Center for Law, Science, and Innovation, Arizona State University, Sandra Day O’Connor College of Law, Tempe, Arizona
- William Winingham, Partner, Wilson Kehoe Winingham, LLC
- Ross D. Silverman, Professor of Health Policy and Management, IU Fairbanks School of Public Health
- Jennifer A. Drobac, Professor of Law, IU McKinney School of Law
More information here.
- Jacob Sherkow & Hank Greely,The Future of Gene Patents and the Implications for Medicine, JAMA Intern Med.
- Mark Rothstein, Tarasoff Duties after Newtown, SSRN/JLME
- Frank Wharam, Dennis Ross-Degnan, & Meredith Rosenthal, The ACA and High-Deductible Insurance — Strategies for Sharpening a Blunt Instrument, NEJM
- Thomas Buchmueller, Colleen Carey & Helen Levy, Will Employers Drop Health Insurance Coverage Because Of The Affordable Care Act? Health Affairs
- Lisa Heinzerling, The FDA’s Plan B Fiasco: Lessons for Administrative Law, SSRN/Georgetown LJ
- Katherine Neuhausen, Michael Spivey, & Arthur Kellermann, State Politics and the Fate of the Safety Net, NEJM
- Christopher Robertson, When Truth Cannot Be Presumed: The Regulation of Drug Promotion Under an Expanding First Amendment, SSRN/BU L.Rev.
- Henry Aaron & Kevin W. Lucia, Only the Beginning — What’s Next at the Health Insurance Exchanges?NEJM