- 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
- 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
- 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
- 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.