Big Data, Predictive Analytics, Health Care, Law, and Ethics

Update: The Moore Foundation has generously paid to make my article available as open access on their website here. Today I am speaking at Health Affairs’ “Using Big Data to Transform Health Care” in DC, that will also launch its new issue devoted to the topic. I have a co-authored paper in the volume entitled “The Legal And Ethical Concerns That Arise From Using Complex Predictive Analytics In Health Care” that has just been released. Ironically the article is behind a paywall (while data wants to be free, I guess big data is different!) Here is the abstract.

Predictive analytics, or the use of electronic algorithms to forecast future events in real time, makes it possible to harness the power of big data to improve the health of patients and lower the cost of health care. However, this opportunity raises policy, ethical, and legal challenges. In this article we analyze the major challenges to implementing predictive analytics in health care settings and make broad recommendations for overcoming challenges raised in the four phases of the life cycle of a predictive analytics model: acquiring data to build the model, building and validating it, testing it in real-world settings, and disseminating and using it more broadly. For instance, we recommend that model developers implement governance structures that include patients and other stakeholders starting in the earliest phases of development. In addition, developers should be allowed to use already collected patient data without explicit consent, provided that they comply with federal regulations regarding research on human subjects and the privacy of health information.

I will also have a related paper on mobile health coming out later this summer that I will blog about when it comes out…

Patient Empowerment and 23andMe

For those interested in the FDA’s decision to regulate 23andMe’s direct-to-consumer genetic testing service, it is worth reading a recent comment in Nature by Robert Green and Nita Farahany.  The piece raises two core objections to the FDA’s decision that deserve further attention.

One objection is that the FDA’s decision runs contrary to “the historical trend of patient empowerment that brought informed-consent laws, access to medical records and now direct access to electronic personal health data.”  Green and Farahany suggest that 23andMe and manufacturers of other consumer medical products (such as mobile health apps) “democratize health care by enabling individuals to make choices that maximize their own health,” and that we must not “stifle all innovations that do not fit into the traditional model of physician-driven health care.”

While I agree with Green and Farahany that we should not be locked into physician-driven health care, I am not sure that the information provided by 23andMe and medical apps is unambiguously “patient-empowering” and “democratizing” (a framing of personalized medicine that pervades both marketing materials and academic journals). Continue reading

Medical Advice and the Limits of Therapeutic Influence

By Michael Young

It is estimated that 500,000 patients are discharged from U.S. hospitals against the recommendations of medical staff each year.  This category of discharges, dubbed discharges against medical advice (DAMA), encompasses cases in which patients request to be discharged in spite of countervailing medical counsel to remain hospitalized.  Despite safeguards that exist to ensure that patients are adequately informed and competent to make such decisions, these cases can be ethically challenging for practitioners who may struggle to balance their commitments to patient-centered care with their impulse to accomplish what is in their view best for a patient’s health.

Writing in the most recent issue of JAMA, Alfandre et al. contend that “the term ['discharge against medical advice'] is an anachronism that has outlived its usefulness in an era of patient-centered care.”  They argue that the concept and category of DAMA “sends the undesirable message that physicians discount patients’ values in clinical decision making.  Accepting an informed patient’s values and preferences, even when they do not appear to coincide with commonly accepted notions of good decisions about health, is always part of patient-centered care.”  The driving assumption here seems to be that if physicians genuinely include patients’ interests and values in their assessments, then the possibility of “discharge against medical advice” is ruled out ab initio, since any medical advice issued would necessarily encapsulate and reflect patients’ preferences.  They therefore propose that “[f]or a profession accountable to the public and committed to patient-centered care, continued use of the discharged against medical advice designation is clinically and ethically problematic.”

While abandoning DAMA procedures may well augment patients’ sense of acceptance among medical providers and reduce deleterious effects on therapeutic relationships that may stem from having to sign DAMA forms, it leaves relatively unaddressed the broader question of how to mitigate health risks patients may experience following medically premature or unplanned discharge.  Alfandre and Schumann’s robust interpretation of patient-centeredness also raises the question of how to handle situations in which patients refuse medically appropriate discharge.  On this interpretation, can the ideal of patient-centered care be squared with concerns for optimizing the equity and efficiency of resource allocations more broadly?

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Disruptive Innovation and the Rise of the Retail Clinic

By Michael Young

The Association of American Medical Colleges (AAMC) projects that by 2025 the United States will face a shortage of 130,600 physicians, representing a near 18-fold increase from the deficit of 7,400 physicians in 2008.  The widening gap between physician supply and demand has grown out of a complex interplay of legal, political, and social factors, including a progressively aging population, Congressionally mandated caps on the number of Medicare-funded residency slots and funding for graduate medical education, and waning interest among medical school graduates in pursuing careers in primary care.

These issues generate unprecedented opportunities for healthcare innovators and entrepreneurs to design solutions that can effectively address widening disparities between healthcare supply and demand, particularly within vulnerable and underserved areas.

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House Holds mHealth Hearings, FDA Promises Final Guidance Forthcoming

by Dan Vorhaus

[Cross-posted from Genomics Law Report]

Digital Hospital - 262 wideThree days of hearings by a House of Representatives committee concluded yesterday with a pledge from an FDA official to finalize long-awaited guidance on the regulation of mobile medical applications “in coming weeks“; at the latest by the end of the FDA’s fiscal year (i.e., September 30th).

The hearings, convened jointly by several subcommittees of the House Energy and Commerce Committee, were announced last week following a pointed letter to the FDA (pdf) from seven committee members on March 1st. In the letter, the Congressmen pressed the FDA for information on the agency’s mHealth regulatory timeline and the implications for innovation and industry of the proposed regulations.

A Preview of Guidance to Come. As covered previously here at the Genomics Law Report, in July 2011 the FDA released draft guidance (pdf) outlining its intent to regulate a limited subset of mobile medical applications based on their perceived risk to patients and consumers.

In testimony before Congress, which was supported by a formal written response to the House subcommittee’s inquiry (pdf) as well as a recent FDA blog post, the FDA provided substantial additional clarity regarding its regulatory intent and the timeline for finalized mHealth regulatory guidance. Here are the highlights:

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mHealth on the Horizon: Federal Agencies Paint Regulatory Landscape with Broad Brushstrokes

by Dan Vorhaus and Phil Ross (cross-posted from Genomics Law Report)

For years, and with increasing frequency, health care and information technology companies have touted the potential of mobile medical and health applications and technologies to improve the quality and delivery of health care through the use of technology. While the future of mobile health (frequently referred to as “mHealth”) is undoubtedly filled with promise, the legal and regulatory landscape in which mHealth technologies reside is only now beginning to take shape.

As mHealth developers, funders and even users consider investing in the field, or including in particular mHealth technologies, they should keep in mind the emergent and fluid nature of the mHealth regulatory landscape. Here, we outline the likely key players and discuss several recent and projected initiatives with respect to the oversight of mHealth technologies:

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