HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Friday, September 28, 2012

Worth Reading This Week

Thursday, September 27, 2012

Presidential Candidates in the NEJM

The Democratic and Republican presidential candidates' positions on healthcare and visions for the future of American Healthcare have just been printed in the New England Journal of Medicine.  The journal's editors invited President Obama and former Governor Romney to submit their essays, which were published late last night online.  The essays are addressed to NEJM's physician audience.  President Obama described and defended the Affordable Care Act and explained why it should make physicians' jobs easier by protecting their patients.  Focusing on policies particularly of interest to physicians, the President wrote:

If I am elected for a second term, I will follow through on all the work we have started together to implement the Affordable Care Act. I have also been clear that additional steps are needed. We need a permanent fix to Medicare's flawed payment formula that threatens physicians' reimbursement, rather than the temporary measures that Congress continues to send to my desk. I support medical malpractice reform to prevent needless lawsuits without placing arbitrary caps that do nothing to lower the cost of care. I also know we must continue to support life-sciences research and ensure that our regulatory system helps bring new treatments and tools to pharmacies, doctors' offices, and hospitals across the country. I will keep Medicare and Medicaid strong, working to make the programs more efficient without undermining the fundamental guarantees.

My opponent in this election, Mitt Romney, has a radically different vision for the future of our health care system — even if it means running from his past as the architect of health reform in Massachusetts.

This, of course, highlights the most mystifying aspect of Former Governor Romney's position in his campaign, because he denies the legacy he left in Massachusetts in order to attack what he calls ObamaCare.  Writing to the physician audience, Romney wrote:

A strengthened system must also be one where America continues to lead the world in innovation and where we continue to attract the best and the brightest, both from our own towns and from around the world, to the practice of medicine. Doctors should spend more time treating patients and less time practicing defensive medicine or processing paperwork. Innovators should increase their investments in new cures, and those cures should reach the market faster. Achieving these goals requires medical malpractice reform, a streamlined regulatory framework to support the interoperability of information technology, and strong Food and Drug Administration leadership committed to a practical and predictable approval process that appropriately evaluates risk.

Finally, for our health care system to work for all Americans, we must have government programs that effectively serve our senior citizens and people in need without breaking the bank. In other words, we need genuine entitlement reform.

The comments to these unsurprising essays range quite a bit, but a few ask the very question I had: why did NEJM bother to make the invitation?  Neither candidate offers insights, both supply now familiar soundbites.  Seems like a wasted opportunity.


September 27, 2012 | Permalink | Comments (0) | TrackBack (0)

Protecting Patient Privacy in the Age of Big Data

In a new essay, available here, that is part of a Symposium collection, here, recommending legislative/regulatory action to the incoming Administration ("The Next Four Years") I argue for some enhanced privacy protections in the face of emerging "big data" models.

This essay discusses the threats to health privacy posed by “big data;” an ongoing revolution in data collection and processing. The essay takes the position that big data poses an exceptional group of problems for health care, its providers, researchers, and patients. Faced with increased privacy risks an exhaustive overhaul of HIPAA/HITECH is not proposed. Rather, this essay suggests an incremental approach, adopting aspects of the recent privacy proposals published by the White House and the Federal Trade Commission. The essay suggests that the battle to preserve health privacy needs to be fought on three fronts. First, while HIPAA/HITECH provides increasingly robust protections against unauthorized uses of health information by a relatively narrow set of traditional health care provider data stewards, it does almost nothing to regulate the collection of health data. It is time that the federal government put real limits on the collection and processing of personal information. Second, the U.S. has adopted a sector-based approach to data protection. HIPAA, as amended by HITECH, and the “privacy” and security regulations made thereunder apply only to a narrowly constructed version of the vertical health care market. Such sector-based approaches to regulation are frequently flawed because of poor calibration. Further, the very concept of health sector specific regulation is flawed because health related or medically inflected data frequently circulates outside of the traditionally recognized health care sector. Third, there is great value in patient information that could be extracted and used by responsible medical and public health researchers. Responsible public policy suggests that researchers should be able to request that information from patients. Many of the existing HIPAA and HITECH security and confidentiality protections apply here but are fundamentally flawed. Neither current policy nor regulations supply the key component: a coherent choice architecture for dealing with appropriate patient decision-making regarding research use of personal or familial health data.


September 27, 2012 | Permalink | Comments (0) | TrackBack (0)

Wednesday, September 26, 2012

Global Outlaws and Pharma Trade

I was recently listening to a podcast by Carolyn Nordstrom of her 2008 Franke Lecture in the Humanities, emergent(cies).  Nordstrom discusses the extraordinary power wielded by those in control of an underground economy of weapons, drugs, and human trafficking.  Paul Farmer attested to Nordstrom's extraordinary dedication to ferreting out the transactions that knit together so many imperiled and privileged lives.  I look forward to reading her book Global Outlaws

To write this book, she spent three years traveling to hot spots in Africa, Europe, Asia, and the United States investigating the dynamics of illegal trade around the world—from blood diamonds and arms to pharmaceuticals, exotica, and staples like food and oil. Global Outlaws peels away the layers of a vast economy that extends from a war orphan in Angola selling Marlboros on the street to powerful transnational networks reaching across continents and oceans.

Nordstrom's extraordinary fieldwork includes interviews with scores of informants, including the smugglers, victims, power elite, and profiteers who populate these economic war zones. Her compelling investigation, showing that the sum total of extra-legal activities represents a significant part of the world's economy, provides a new framework for understanding twenty-first-century economics and economic power. Global Outlaws powerfully reveals the illusions and realities of security in all areas of transport and trade and illuminates many of the difficult ethical problems these extra-legal activities pose.

The secrecy surrounding such trade (and even manufacture, in the case of cigarettes) has many causes. In a tour de force narrative in the lecture, Nordstrom describes how the fate of a child shot in Angola could be directly related to global market forces.  Pirate banking systems enable the flows of funds for "goods" ranging from arms to fake pharmaceuticals. Those struggling for transparency in these systems occasionally score some victories.  But without much more serious efforts to monitor the flow of money and goods, we should expect the "global outlaws" to exercise more influence in ever more rogue economies.


September 26, 2012 | Permalink | Comments (0) | TrackBack (0)

Reporting information about clinical trial data: passing the torch from HHS to the FDA

In 2007, motivated by concerns that pharmaceutical companies were not sharing negative data about what had been learned in clinical trials, Congress established enhanced reporting requirements,

A series of articles published in January 2012 in the British Medical Journal demonstrates that data reporting remains deeply problematic, especially for industry-sponsored trials. (The articles can be found at and are very much worth reading). 

A posting Sept. 26 in the Federal Register indicates that the Secretary of HHS has delegated authority to to oversee the reporting process to the FDA,  Whether this signals improved monitoring of clinical trial data submissions remains to be seen,  One can only hope.


September 26, 2012 | Permalink | Comments (0) | TrackBack (0)

Filing a complaint with HHS about a HIPAA violation: a warning about "how (not) to"

I posted in June about the fact that my social security number (and possibly other personal information) had been downloaded to an unknown site in Eastern Europe as part of a large security breach from the Utah state health department,  In connection with that breach, I have filed a complaint with the Office for Civil Rights at HHS (OCR).

I thought readers might like to know, however, that the process of complaining about a HIPAA violation to OCR is cumbersome indeed.  There are forms available on line, here,  You can open them, and fill in information, but you can't save them.  If you close the form, you lose all the data. You also can't file them online--you have to print them out and fax them off.  (You are helpfully told, however, to "print out a copy for your records.")  I finally figured out that if you save the form to notepad before you fill it out, you can then email it to HHS--but this required a telephone call to the appropriate regional office of HHS.

When I pointed out to OCR that this process is not exactly user-friendly, they indicated that they are "working on it." Imagine someone without a home computer, or a home fax machine, or a home printer, using public library computers in the effort to reach OCR about what they regard as a significant problem with their health information. Surely in a world of blue buttons and digital Medicare strategies, see Responsive Design and the New,, the ability to file a complaint about possible violations of health information security or confidentality should be an easier online process. 


September 26, 2012 | Permalink | Comments (0) | TrackBack (0)

Monday, September 24, 2012

More Bad News on Electronic Health Records

During the debate over the Affordable Care Act, the Obama administration and other proponents of electronic health records (EHRs) cited a RAND study projecting cost-savings of $80 billion a year from EHRs. More recent data have cast doubt on those estimates. In March, for example, a study in Health Affairs found that physicians with access to electronic records were more likely to order MRI scans and other diagnostic tests. Last week, the New York Times reported that EHRs apparently lead hospitals and physicians to bill more aggressively for their services, using higher billing codes than justified by the services they provide. (For an earlier post on the disappointing impact of EHR, see here.)


September 24, 2012 | Permalink | Comments (0) | TrackBack (0)

Sunday, September 23, 2012

Will ACA Create a Doctor Shortage--And If So, What Should We Do About It?

Being in my native land of Connecticut reminds me that Mark Twain is famously, if inaccurately, quoted as saying that everyone talks about the weather but no one ever does anything about it.  Nowhere is this concept more true today than in the handwringing over the coming shortage of physicians following the passage of Affordable Care Act.  We hear dire predictions that the patients who now have access to health care will flood the system resulting in poor care not just for them, but for those among us who were lucky enough to already have health insurance.  The American Academy of Family Physicians has recently expressed its concern that the shortage will be made up by nurse practitioners rather than physicians. 

This is a situation where the shortage, if it exists, has nothing to do with fear of law suits.  Applications to U.S. medical schools have been steadily increasing.  Moreover, the shortage isn’t of doctors in general, it is of primary care physicians.  There are still a fair number of dermatologists and plastic surgeons, but not so many physicians who provide the kind of primary and preventive care that actually improve the public’s health.  

 Uwe Reinhardt, the Princeton health care economist, has been following this issue closely and in a series of posts for the New York Times’ Econmix Blog has been aggressively skeptical about the existence of the shortage as well as the actions taken so far by the Federal Government to address it.  He also questions the need both for the residency system as currently structured and for the benefit to the public of subsidizing it through Medicare given what a poor job it does in producing the primary care doctors the public really needs.  Last week, he undertook an extensive analysis of medical school debt which showed that by charging students intending to be high paid specialists the same as those who might go into primary care has created a loan burden that makes it difficult for any but the most dedicated to turn away from training for the most lucrative specialty for which they can qualify.

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September 23, 2012 | Permalink | Comments (0) | TrackBack (0)