ore than two dozen companies are racing to develop digital technology to keep tabs on patients in real time: monitoring their vital signs, getting them to take their pills, even releasing medication into their body as needed.
The payoff for success will be twofold: possibly huge profits and access to a lucrative new trove of personal data.
Startup Proteus Digital Health and the Japanese drug company Otsuka Pharmaceutical are among the latest to push the limits of such technology. Together, they are seeking regulatory approval for a microchip embedded in Abilify, the antidepressant and antipsychotic medication. As the pill dissolves in the stomach, an electrical circuit forms with trace amounts of magnesium and zinc, activating the chip, which transmits a message to a bandage-like sensor worn on the abdomen.
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A digital record is sent to the patient’s smartphone, and from there to a Proteus database, then back to the patient and family members — and doctors.
These technologies promise to benefit patients, medical research, and health management. After all, the health care system has long struggled to track whether people are taking their medications consistently.
But the new technologies also open up one of the most personal of activities — which drugs you take, when and how, and how your body responds — to unprecedented scrutiny, not just by doctors, but by corporations hungering for profitable data, and the legal system.
The technology is advancing so quickly that no one knows how best to protect patients and their personal information.
“Who keeps the records, and where do they go?” said Arthur Caplan, a professor of bioethics at New York University. “What happens if you get better? Do people ever clear your record? If you get a new job, and you don’t want that information out there, what happens?”
These devices and apps are in various stages of development. A digital sensor made by Propeller Health monitors when asthma inhalers are used. An implant made by Microchips Biotech can be programmed to dispense medication internally at scheduled times. A phone app called AiCure — currently being used in clinical trials — uses a phone’s camera to document when medication is taken, using facial recognition and other machine learning tools.
Diabetics usually measure their glucose levels by pricking a finger and using a kit to test the drop of blood. This is typically done only a few times a day. Dexcom makes a continuous glucose monitor. It employs a wire the width of a hair inserted in the skin, attached to a small electronic device that transmits a signal to a phone, minute-by-minute. Users can follow how their body responds to certain foods, to stress, or to the time of day. The finger pricks — here used to calibrate the device — remain, however.
“Think about a young child diagnosed with type 1 diabetes,” said Dexcom CEO Kevin Sayer. “Now parents can have access to their child’s glucose levels while they’re in school. The school nurse can keep track of it. Or if the child goes to a slumber party, you can keep track.”
By putting more knowledge in the hands of patients, this data should theoretically help them take better care of themselves. It will also provide scientific insights into how well some drugs work — currently, most data on drug effects comes from clinical trials during the approval process.
For good or ill, the whole US health system is heading in this direction.
“In so many other ways, the system is shifting responsibility to the individual,” said David Harlow, a health care lawyer and consultant who blogs at healthblawg.com. “There are larger co-pays and deductibles, but also a growing desire for people to have access to telemedicine tools, not having to go to doctor’s office to receive care. All of this puts more responsibility on the patient to manage his or her own care.”
As datasets grow, and algorithms can be deployed to mine them for patterns, the usefulness of these devices will grow — and they will be worth more and more money. Researchers and drug companies will use them to develop a better understanding of how drugs work in the real world, or how vital signs respond minute-by-minute. Health systems and insurance companies will want to use the data to design better, and more cost-effective, courses of treatment.
“Who keeps the records, and where do they go?”
Arthur Caplan, professor of bioethics at New York University
The field of precision medicine, for instance, could employ these datasets to better target prescriptions and other treatments. “If you can look into a database of tens of millions of patients and can identify a thousand whose experiences match the patient today, you can extrapolate from those most like those patient before you and come up with a clinical recommendation,” Harlow said.
Any benefits, however, could come with costs to privacy. The Health Insurance Portability and Accountability Act, the federal law governing medical records, mandates the confidentiality of medical records in the possession of health providers. But information generated by personal devices may or may not have HIPAA protections, depending on who possesses it.
This presents a challenge for companies. So far, most are taking measures to encrypt data transmitted from medical devices. But many are also planning to keep the data and use it (with the personal information stripped out). Dexcom and Google, for example, plan to collaborate on analyzing the glucose monitor data to better track how pre-diabetic conditions develop into type 1 or type 2 diabetes.
As such technologies grow more common, their data privacy provisions will probably work like those of other apps and devices — a checkable terms and conditions form that few people bother to read. So many people may check it without knowing what will ultimately become of “their” data.
The mere existence of that data could create demand for the information from employers, the courts, or police.
“There’s the question of who gets to see the outcome of your behavior,” said Caplan, the NYU ethicist. “Is it your doctors, your doctor and a psychiatrist, or the human resources department where you work, or the union? Say you’re supposed to be on your meds, suffering from mental illness symptoms — which parties get to watch?”
Personal medical monitoring could even end up becoming — in some cases, anyway — a new tool for authorities to regulate behavior. A court could order continuous monitoring of a drug addict or an alcoholic, for example, or that a patient use microchip-embedded drugs to verify treatment.
This could get messy, and the questions may not be worked out until courts, legislatures, or professional organizations are forced to resolve them.
“We need legislation, we need tech solutions, we need to vet this stuff among ethicists — but not enough attention is being paid to this,” said Eric Topol, the director of the Scripps Translational Science Institute, which aims to foster innovation across medical disciplines, including genetics and digital technology. “It’s growing, and it could be hard to reel it back in, hard to put genie back in the bottle. At the moment, the use of these tools is very limited. So this is the right time to get serious about it.”