快猫短视频

Your next prescription might include pills with embedded sensors that can collect and transmit data on whether you鈥檙e taking them as instructed.

Abilify MyCite, a pill-app combination that can be used to track the ingestion of drugs for bipolar disorder and schizophrenia, was the first such product approved by the US Food and Drug Administration (FDA), in November 2017. Its roll-out to some Medicaid patients was announced last month.

鈥淪mart pills鈥� like these are part of a larger class of digital medicine products that include insulin pumps with continuous glucose monitoring and pacemakers that get software updates much like smartphones. Many others are in the pipeline. The hope, albeit one that still needs much more empirical investigation, is that such devices will provide doctors with more up-to-date information about patients between visits and assist researchers and agencies like the FDA to better monitor health outcomes in the real world.

Many, though, have reacted to these products with fear and concern. Terms like 鈥渟nitch pill鈥� and 鈥渂iomedical big brother鈥� have been bandied about. A paper co-written by one of us (I. Glenn Cohen), published in the American Journal of Bioethics this week, by these products.

Firstly, it will be a real challenge to ensure people understand user agreements for the battery changes, sensor replacements and software updates that are involved. The distinction between informed consent and terms of use (those endless tracts of legalese that most of us agree to without reading) may become more fraught.

Data capture

And because these devices are designed to capture data 鈥� for some, that is one of their main selling points 鈥� there are thorny issues about data ownership and the right to withdraw data already collected.

What鈥檚 more, while for some products, like Abilify MyCite, there is a non-digital alternative on the market, so people can choose whether they wish to use a digital medicine, that鈥檚 not true in all cases. What happens when there is only a digital medicine available? Should insurers or national health systems be allowed to insist that a digital medicine be used with good adherence results if they are to pay for the treatment? And what about implanted devices, such as pacemakers? To what extent should people have the option of using the technology but not allowing the collection of their data, or be able to choose to withdraw data already collected?

While much of the initial attention has focused on gathering information on people who use digital medicines, these devices also generate data on physicians and other providers of medical services. Where the device enables the provider to check a patient鈥檚 adherence to a treatment regime, insurers and hospital systems can also learn to what extent the provider is ensuring this. Moreover, the pattern of provider diligence in this regard may become important for malpractice claims if people experience adverse effects and lawyers seek to access the records of provider behaviour in response to alerts and other information.

All of these issues arise in the context of willing patients and willing physicians choosing to use a digital medicine product together. But this isn鈥檛 the only potential way a digital medicine could be used.

Digital medicine

Some people undergo directly observed therapy for treating tuberculosis, for example, which involves a doctor watching them take their medication. Is a digital medicine a welcome, less intrusive option, or an encroachment on their freedom? Even further into the future, could a court mandate that a person on probation submit to medication adherence monitoring? And could a psychiatrist threaten involuntary hospitalisation unless a patient agrees to adherence monitoring technologies?

Digital medicine products have the potential to improve health care for all involved. But if a person鈥檚 first encounter with these devices elicits sentiments like 鈥渃reepy鈥� or 鈥渋nvasive鈥�, or seem to be too close to comfort to a 鈥渟urveillance state鈥�, much of that potential may be squandered.

Ethicists, companies and healthcare providers must work very hard to maintain patients鈥� trust. At a minimum, we must be transparent about how data on both patients and providers is collected, how it is used, and what rights people will or won鈥檛 have after the data has been collected. We must also ensure that people are making informed, voluntary choices to use this technology.