This editorial appears in the July Issue of the American Journal of Bioethics
Jesse Gray’s article “On Mobile Health, Empowerment, and the Limits of Task Shifting in Healthcare,” has much to recommend it. Let me single out two features for particular praise: First, treating the idea of task-shifting as one for normative interrogation by bioethicists is very useful. While individual instances of the phenomenon, like at-home individual glucose monitoring technologies, might draw our attention, the article usefully frames the larger phenomenon as worth thinking about in more totality. Second, I think it takes a hard look at the narrative of patient “empowerment.” Like many good articles it raises more questions than it can answer, and I will itemize a few—some are more interrogative while others spaces for extension.
First, I want to push on the question of baselines. We get a loose definition of task-shifting early on the paper as the “shifting medical tasks onto patients, technology, and less-skilled health personnel, these policies aim to reduce burdens on health systems and allow them to provide more equitable care. Gray also defines an adjacent and arguably more central concept of “[t]ask expanding” technologies, that “encourage patients, and other nonmedical experts, to take on tasks once reserved for traditional medical actors” (emphasis added).
To say a task has been “shifted” or “expanded” in a way that has some bioethical oomph requires a conception of where the task belongs, a defense of a “baseline” would be the idiom legal scholars would. Where do Gray’s baselines come from? At some points in the article’s descriptive portions, it appears the baseline is provided by history. Where (between patient and provider) was this task located, and where does the technology relocate it? As a first approximation, that is not a bad way to define the concept for descriptive purposes—although we would still need normative work on why that historical baseline matters, more on that in a moment.
But, even as a descriptive matter, a complication is that many tasks we now think of as medical have shifted a good deal over the course of history and across cultures. When I studied hospital systems across the world for my 2014 book Patients with Passports: Medical Tourism, Law and Ethics, I was struck by how many of the functions undertaken by nurses and other medical workers in the U.S. at the time were undertaken by family members in India, for example. Park et al., for example note that in many Asian countries the tasks undertaken by family members in hospital care include “ (1) direct contact activities (i.e. changing the position of the patient, toileting, sponging, assisting with ambulation); (2) indirect contact (i.e. administering medication, making beds), and (3) aerosol-generating procedures (i.e. feeding via NG tube, and suctioning) to their sick family members at the bedside.” Similarly, which tasks belong with the medical and allied professions has also shifted historically. Pregnancy and childbirth are excellent examples: historically doctors were not present at many childbirths unless there was an emergency and family and community members had a much larger role in contraception and fertility help.
At other times, it appears that Gray means to call on a normative baseline either standing alone or as a gloss or constraint on the historical. Gray discusses “patient wellbeing and safety” as criteria for normative justification in a beneficence frame. When it comes to autonomy, he discusses making sure patients are informed and freely choosing, “enabling agents to do what they truly care about”, and even (quite novelly) “further[ing] the autonomous interests of healthcare providers.” He quickly moves on to examples and legal categories such as general wellness products, but this construction of the normative baseline and its relationship is fertile ground for more development. In particular, I wondered if Gray’s project would benefit from engagement with questions about the moral limits of medicine, questions that sometimes come up in discussions of what is a “disease,” the treatment-enhancement line, and whether medicine’s focus on avoiding or mitigating disease or improving well-being.
A third baseline is also introduced, when Gray writes that “task shifting [must be] predicated on reliable and coherent processes epistemically justified.” Gray seems to have a hopeful implicit assumption that much of what goes on in medical practice is “predicated on reliable and coherent processes” as the baseline and that the examples he discusses are exceptional by contrast. Unfortunately, that assumption may not uniformly be true across medicine. Consider the American Board of Internal Medicine Foundation’s Choosing Wisely campaign, which began in 2012 “with nine national specialty societies (representing 375,000 clinicians) offering 45 examples of tests or treatments that were commonly used in their fields but lacked strong supporting evidence”.
A different issue with this epistemic baseline is to question what work it is doing beyond the portion of the normative baseline Gray associates with beneficence. That is, the reliability and coherence of the process used seems to matter normatively to us because of its contribution to patient well-being (and, we might add, avoidance of harm). So the epistemic constraint seems like just a way to get at the normative constraint, which is what really does the work for the argument. This leaves slightly underspecified how Gray thinks about the normative and the epistemic criteria working together. Within the section on normative justification, Gray seems at pains to make clear that beneficence is not the only normative justification, emphasizing that “it may be permissible to deprioritize beneficence to pursue other moral aims” and that “beneficence is just one value among many.” But if I am right to associate the epistemic criteria with beneficence for its moral force, then this dethroning of beneficence is a little hard to square with the fact that he describes task-shifting as having to be both epistemically and normatively justified.
The back half of the article moves from theory to more practical questions as applied to examples. Here I have two primary observations: First, related to some of the discussion above about baselines, it is not always clear what work the concept of task shifting or expanding is doing as part of the argument structure. As to specific examples, Gray, appropriately raises concerns about things like reliability, evidence base, and the feeding of a narrative as to empowerment that the author thinks are problematic. If task shifting or expanding is just an intermediate conclusion, a label for this bundle, so be it. But there are times when it feels like the fact that the task has been shifted or expanded is supposed to do its own normative work, but it is not clear what the work Gray thinks it is doing. Otherwise put, if the article was written without ever using the term task shifting or expanding but the more specific concerns, would the result be stylistic or substantive?
Second, Gray draws, among other things, on my work with David Simon and Carmel Shachar to critique the FDA line drawing between medical devices and general wellness products. Unsurprisingly given our prior work, I am broadly in agreement that this line drawing is unsatisfying and encourages developers to engage in a practice we have called “skating the line.” But it is important to recognize that even if an mHealth medical intervention falls on the medical device and not the general wellness side of the line, that may not have the kind of “epistemic justification” Gray is looking for. The vast majority of AI/ML-enabled products that are classified as devices are considered low to moderate risk devices and reach the U.S. market through the 510(k) pathway.1 That means that clearance by FDA does not require “provid[ing] reasonable assurance of its safety and effectiveness” (21 U.S.C. 360c(a) (1)(C)), often through clinical trials, but instead showing there is a predicate device that is substantially equivalent to their device. But many of these “are based on predicates that are based on other predicates, and so on, even down to a predicate that was launched before 28 May 1976, at a time when the safety and effectiveness of devices had not yet been assessed”. When it comes to harm from FDA-cleared AI/ML medical devices, there is significant data missing on the reporting of adverse events suggesting gaps in postmarket surveillance, and that the existing reporting categories leave much to be desired in terms of allowing evaluation of safety. All this is to say that under the desiderata Gray sets out in the article, while classification as a medical device rather than general wellness product is certainly better, it is far from a panacea.
Notes
Gray seems view the category of interest as mHealth. mHealth is not completely coincident with AI/ML, to be sure, but there is a good amount of overlap and for the latter we have good data analyses at FDA so that is what I reference, while acknowledging the distinction.
I. Glenn Cohen, JD