Originally published on September 22, 2017, on the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics Bill of Health blog.

Pancreatic cancer is one of the deadliest illnesses out there.  The five-year survival rate of patients with the disease is only about 7%.  This is, in part, because few observable symptoms appear early enough for effective treatment.  As a result, by the time many patients are diagnosed the prognosis is poor.  There is an app, however, that is attempting to change that.  BiliScreen was developed by researchers at the University of Washington, and it is designed to help users identify pancreatic cancer early with an algorithm that analyzes selfies.  Users take photos of themselves, and the app’s artificially intelligent algorithm detects slight discolorations in the skin and eyes associated with early pancreatic cancer.

Diagnostic apps like BiliScreen represent a huge step forward for preventive health care.  Imagine a world in which the vast majority of chronic diseases are caught early because each of us has the power to screen ourselves on a regular basis.  One of the big challenges for the modern primary care physician is convincing patients to get screened regularly for diseases that have relatively good prognoses when caught early.

I’ve written before about the possible impacts of artificial intelligence and algorithmic medicine, arguing that both medicine and law will have to adapt as machine-learning algorithms surpass physicians in their ability to diagnose and treat disease.  These pieces, however, primarily consider artificially intelligent algorithms licensed to and used by medical professionals in hospital or outpatient settings.  They are about the relationship between a doctor and the sophisticated tools in her diagnostic toolbox — and about how relying on algorithms could decrease the pressure physicians feel to order unnecessary tests and procedures to avoid malpractice liability.  There was an underlying assumption that these algorithms had already been evaluated and approved for use by the physician’s institution, and that the physician had experience using them.  BiliScreen does not fit this mold — the algorithm is not a piece of medical equipment used by hospitals, but rather part of an app that could be downloaded and used by anyone with a smartphone.  Accordingly, apps like BiliScreen fall into a category of “democratized” diagnostic algorithms. While this democratization has the potential to drastically improve preventive care, it also has the potential to undermine the financial sustainability of the U.S. health care system.

Democratized diagnostic algorithms should be a source of financial concern for the health care system because of the malpractice risks they will create for physicians who disagree with them. A study published in JAMA Oncology in 2015 found that patients demand specific medical interventions in 8.7% of encounters.  As democratized diagnostic apps proliferate in app stores, patients with “diagnoses” may begin to appear in doctors’ offices — smartphones in hand — demanding tests and procedures more frequently. These apps will likely be wrapped in legal language disclaiming all diagnostic accuracy — telling users to consult a physician for an actual evaluation — but a jury may find a “diagnosis” from such an app sufficient to establish that a physician who failed to pursue further testing or treatment was negligent.  Thus, if a patient presents with a cancer warning from an app, a physician may feel obligated to run a barrage of tests to confirm or refute the algorithm’s determination — even if the patient exhibits none of the symptoms typically associated with the diagnosis.

The potential influx of patients will be exacerbated by the liability concerns faced by the apps themselves.  It’s a common joke that patient information websites like WebMD will identify any set of symptoms as a potential indicator of a terminal illness.   But this makes sense given the liability landscape.  WebMD does not want to risk discouraging patients from seeking medical attention — or pursuing more traditional preventive screenings — because of assurances received on the website.  Diagnostic apps will want to avoid similar liability, and as a result they may be designed to either over-diagnose or tell patients to consult a physician regardless of the algorithm’s analysis.

The systemic harm of this perfect storm will be its impact on defensive medicine.  As previously mentioned, defensive medicine is when a physician orders more diagnostic tests and procedures than a patient’s condition warrants, and it puts an immense burden on the U.S. health care system.  In a 2013 survey of private-sector physicians, 75 percent admitted to using defensive medicine to avoid lawsuits, resulting in an estimated $650 billion spent annually on unnecessary care.  As democratized diagnostic apps proliferate, it is easy to see how defensive medicine will increase commensurately.  Regardless of a patient’s symptoms, no physician will want to disregard an app diagnosis only find herself in front of a jury trying to explain why she ignored the algorithm’s warning.

The underlying issue here is fundamentally one of quality control.  If these artificially intelligent algorithms were universally superior to physicians in their diagnostic capabilities, they could decrease defensive medicine by limiting expensive testing to cases where the likelihood of a positive finding is very high.  However, when any coder can spin up a “diagnostic” algorithm and throw it on an app store, it will be difficult for physicians to determine which apps to trust and which to ignore.  Some of these apps, including BiliScreen, may be able to diagnose diseases earlier and more accurately than physicians with decades of experience, but it’s unlikely that all medical apps available from an app store for $0.99 will be so good.  Indeed a 2014 study published in Translational Behavioral Medicine reported an “enormous range of quality among [mobile health] apps.” While accuracy rate could be a helpful metric, physicians will still face the difficulty of determining how low the accuracy rate must be for an app’s diagnosis to be safely ignored.  Would a jury find that disregarding an algorithm with 75% accuracy constitutes negligence?  What about 60% or 45% accuracy?  This will be almost impossible for any individual physician to predict.  As a result, medical providers may feel pressure to order confirmatory tests in cases involving all but the least accurate apps.

One possible solution is vetting of diagnostic algorithms by a trusted third party. Having a curated set of accurate democratized diagnostic apps would serve two functions critical for reaping the benefits of these innovative technologies while avoiding their pitfalls.  First, it would give physicians — and juries — guidelines for determining which algorithms warrant diagnostic deference.  A physician could point to a poor rating by a vetting organization as a justification for her decision not to pursue additional testing for a patient with no clinically relevant symptoms.  Second, a curated set of reliable apps would help guide patients to the most accurate diagnostic algorithms available, decreasing the likelihood of erroneous diagnoses and expensive physician-ordered tests to refute them.  This quality control would maximize the ability of democratized diagnostic apps to serve both individual patients and the health care system as a whole — accurately identifying diseases early and decreasing the prevalence of defensive medicine by taking some diagnostic liability away from health care providers.

There are many ways this vetting could be accomplished.  It could be done by a non-profit or university that reviews the evidence supporting diagnostic algorithms and rates them according to their accuracy, or it could be taken on by the platforms purveying these apps to users, such as the iOS App Store or the Google Play store.  These tech companies already serve as gatekeepers, vetting both code and content before an app will be offered for download, so it would not be outlandish for them to require a certain degree of diagnostic accuracy prior to allowing a medical app on their platforms.

The promise of democratized diagnostic algorithms is immense — but as with all technological advancements, where there is promise there is also peril.  If not vetted and implemented properly, each $0.99 app has the potential burden the health care system with additional unnecessary diagnostic testing.  Empowering patients to conduct their own preventive screening could save countless lives — so long as it doesn’t cause the already bloated health care system to collapse under its own weight.

Originally published on the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics Bill of Health blog.

For-profit hospitals have taken their fair share of flack over the years. Much maligned by many in the medical community, they are seen as money-hungry corporate machines that pervert the medical profession by putting the bottom line before patient care. This skepticism of profit-driven hospitals feels right. Medicine has long been the purview of charitable organizations and religious institutions. It’s supposed to be a calling — a public service to which practitioners are drawn — not a check to cash at the bank.

As for-profit hospitals proliferated, there was research done suggesting they had quality and cost issues stemming from their profit motives. For-profit hospitals had higher mortality rates, employed fewer trained professionals per bed, and were more expensive than their non-profit and government counterparts. Researchers speculated that this was the result of duties owned to shareholders by corporate leaders or compensation incentives for executives based on profitability rather than quality of care. These studies seemed to confirm what many thought they already knew: medicine and money don’t mix well.

More recent studies, however, suggest that for-profit hospitals may have turned over a new leaf. Since 2010, for-profit hospitals have out-performed non-profits in the “Top Performer” evaluation carried out by The Joint Commission — an organization that accredits hospitals in the US — with a higher percentage of for-profit hospitals qualifying for the honor than non-profits. A study published in JAMA from the Harvard T.H. Chan School of Public Health found that hospitals that converted from non-profit to for-profit improved their financial position by increasing their total margins and experienced no change in mortality rates.

The same researchers from Harvard reported a preliminary analysis comparing non-profit and for-profit hospitals in 2012, showing that — across a number of metrics associated with quality — for-profit hospitals were comparable to non-profit ones. Interestingly, the analysis also showed that the most dangerous hospitals for patients by far were government hospitals, which underperformed in almost every quality metric when compared with both non-profit and for-profit private medical facilities. The basic takeaway from the analysis was that there is variation in quality from hospital to hospital, but that variation it is not correlated with for-profit status.

Given the strides for-profit hospitals have made, why does the perception persist that they crank out profit at the expense of patient care?

Perhaps this negative perception endures because some continue to critique for-profit hospitals by focusing on the ways in which the predominantly private health care system in the United States lags behind government-run programs in other developed countries. It’s well established that the United States has higher costs and poorer outcomes compared to its peer nations. The U.S. spends far more of its gross domestic product on health care than any other industrialized country, and is 37^th in the World Health Organization’s health system ranking. The U.S. strategy of having competing insurers individually negotiate with hospitals — which are gaining market power as they consolidate — simply doesn’t make economic sense. But while the health care system in the United States has some substantial issues, that’s an indictment of the private system as a whole — not of the for-profit hospitals within that system. Conflating criticism of a non-governmental health care system with that of for-profit hospitals within it is unfair to those hospitals which — at least as of late — have been performing just as well as their non-profit counterparts, but this confusion may explain why many still harbor negative feelings towards for-profit medical facilities.

Another reason for the continued skepticism of for-profit hospitals may be connected to concern over fiduciary duties owed by directors and officers to shareholders. As previously mentioned, some critiques of for-profit hospitals have posited that the fiduciary duty of care could force directors and executives to maximize profits at patients’ expense. This critique, however, doesn’t accurately reflect the obligations imposed on corporate directors and officers by the duty of care. When evaluating whether corporate management has satisfied the duty of care, courts have turned to a surprisingly deferential standard known as the business judgment rule. See, e.g., Kamin v. American Express Co., 383 N.Y.S.2d 807 (Sup. Ct. 1976). If a decision satisfies the requirements of the business judgment rule, courts will generally defer and not second-guess directors. According to the American Bar Association, a decision is a business judgment when it is made by disinterested directors who have been reasonably informed, and who are acting in good faith to advance the corporation’s interest. See Am. Bar Ass’n, Corporate Director’s Guidebook (2d ed. 1994). In other words, provided the board isn’t conflicted, uninformed, or acting in bad faith, the decision will be upheld even if it ends up having detrimental impacts on the corporation or its shareholders. Thus, it’s highly unlikely that shareholders could successfully use the duty of care to prevent measures designed to put patients over short-term profits.

This is by no means a comprehensive account or analysis of the criticisms of for-profit hospitals. It is simply meant to point out that some common concerns may not be entirely fair or accurate. To be sure, the jury is still out on for-profit hospitals. They have made impressive strides over the past few years, but still have a history tainted by poor quality of care and — at times — outright fraud. The intuition against them is appealing — I can sympathize with the discomfort some feel towards injecting profit motives into an area traditionally conceived of as a public service. But we should not let our biases impact our assessment of these institutions. If for-profit hospitals are delivering better or less expensive care than non-profit ones, they should get credit for that. At the end of the day, quality and cost of patient care should be the priority — wherever it’s given.