- 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
- 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
- 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
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- 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.
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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.