Digital Pills Raise Informed Consent, Privacy Concerns
The FDA recently declined approval of what would have been the first mass-marketed drug to include an ingestible sensor.1 Once the patient takes the medication, a signal is transmitted to healthcare providers with the goal of improving patient adherence and clinical outcomes. Regardless of this recent setback, it is likely that digital pills will soon become available, experts suggest.
Empowerment, or ‘Big Brother?’
“Whether digital medicine is a tool for the empowerment or subjugation of patients will depend on how it is used,” says Ann Munro Heesters, director of Bioethics at University Health Network in Toronto, Ontario. “The control patients have over the information is key.”
Sean Young, PhD, executive director at the University of California Institute for Prediction Technology at UCLA, sees setting expectations as a central concern. “One of the big ethical questions is, ‘How are people informed beforehand about risks and benefits?’” he says.
Ethical issues include the following:
• “Smart” pills could empower patients.
Patients may be able to remain at home longer, for instance. “Digital pills might be seen as akin to robot caregivers or reminder systems for those with memory impairment owing to acquired brain injury, dementias, or brain metastases,” notes Heesters.
Heesters says digital pills are most helpful when patients are willing to participate, and stakes for missed doses are high — as with chemotherapy, anti-rejection drugs for transplant patients, or patients vulnerable to psychosis.
• The patient/physician relationship might be negatively affected.
“The potential for a significant change to the therapeutic relationship seems to be unexplored in this context,” says Heesters.
Patients might find digital pills allow them to reduce burdensome visits to healthcare providers. “But if the clinician can see the patient’s data without seeing the patient, this may come at a significant and unappreciated cost,” says Heesters.
More personalized care and better monitoring of adverse risks are two clear benefits to patients, in Young’s view. “The biggest risk for patients is being monitored, and who gets access to that information,” he adds.
People have become accustomed to tracking their own health and fitness with wearable devices. There is now some limited use of invasive medical devices giving physicians access to health data on their patients. “But digital pills are something different. When people are taking a drug on a daily basis, and for chronic disease, the implication is that you will be monitored for life,” explains Young.
A lot is at stake. “Cost associated with drugs forgotten, not taken, or improperly taken is enormous,” notes Heesters. Between $100 and $300 billion of avoidable healthcare costs in the U.S. annually are attributed to nonadherence, representing 3% to 10% of total healthcare costs.2
“Now that we have the ability to measure medication adherence, we run the risk of people making judgments against people who don’t adhere,” says Young.
Insurers might use the cost savings as a reason to deny coverage, or to charge particular patients more for it, Heesters says. “There is a theoretical potential for insurers to insist on this use: ‘Take the digital pill for blood pressure or we will raise your premiums,’” she adds.
If people are sanctioned in any way for not complying with recommendations to take digital pills, Young foresees significant public backlash. “We are monitoring in a way that people are not used to, and a lot of people won’t be comfortable with it,” he says.
On the other hand, people are becoming increasingly accepting of companies monitoring their behaviors. “Researchers will be studying this, but we don’t have clear answers right now,” says Young. “All we have are questions.”
- FDA snubs first smart pill. Nat Biotechnol 2016; 34(7):678.
- Benjamin RM. Medication adherence: Helping patients take their medicines as directed. Public Health Rep. 2012; 127(1):2–3.
- Ann Munro Heesters, Director of Bioethics, University of Toronto, Ontario, Canada. Phone: (416) 340-4800 x 8607. Email: [email protected].
- Sean Young, PhD, Executive Director, University of California Institute for Prediction Technology, University of California, Los Angeles. Phone: (310) 794-8530. Email: [email protected].
The FDA recently declined approval of what would have been the first mass-marketed drug to include an ingestible sensor.
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