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The Digital Pill Presents Privacy Issues

Kurt R. Mattson, J.D., LLM, M.L.I.S.

January 04, 2018


In November, the FDA approved Abilify MyCite, a pill with a sensor that digitally monitors whether a patient has taken his or her medication.

It’s a significant advance in the growing field of digital devices designed to monitor medicine-taking and to address the expensive, longstanding problem of patients failing to take their meds as prescribed.

The so-called “digital pill” can tell physicians—and potentially others—if and when a patient takes his or her medication and claims to be a solution to prescription medication nonadherence. That problem costs the American health care system between $100 billion and $289 billion a year, according to a review in Annals of Internal Medicine. Much of that price tag is attributable to patients getting sicker and requiring additional treatment or hospitalization. More significantly, prescription medication nonadherence is responsible for roughly 125,000 deaths annually, according to the report.

Many healthcare professionals say that the digital pill has the potential to improve public health, especially for individuals who want to take their medication but neglect to do so. While there are admitted medical and financial benefits of the digital pill, healthcare and data privacy practitioners are concerned about data security and patient consent, seeing it as a slippery slope. The participation of health plans and insurance companies is the basis for much of these privacy concerns. Attorneys can see a time when pharmaceutical companies, insurers, and employers could offer incentives to take the digital pill—begging the question of whether its use in those situations would truly be voluntary and constitutes informed consent.

The digital pill is a version of the antipsychotic medication Abilify that’s used primarily to treat patients with schizophrenia. Patients who consent to using the pill can allow their physician and up to four other people, including family members, to get electronic data about the time and date of ingestion of the pill.

There’s a smartphone app that will allow them to block recipients if they change their mind. While the digital pill is voluntary, the new medical technology is likely to generate questions about privacy and whether patients might feel pressured to take medication in a form their doctors can monitor. Like many types of technology, a user agrees to share his or her data, but they may not have a clear understanding of how it’s being used. Beyond monitoring a patient’s compliance with his or her doctor’s orders, others may attempt to monetize the data and use it for other purposes.

Attorneys ask when incentives are provided to patients who adhere, is that authorization or voluntary submission really voluntary? They also see the issue of voluntariness extending to potentially controversial uses like mandating digital medication as a condition for release from prison or inpatient psychiatric treatment, potentially abridging individuals’ personal freedom. And with all technology and personal information, there’s the issue of data security and the potential for hacking and use of sensitive medical information by unauthorized individuals.

Other companies are developing digital medication technologies, like another ingestible sensor and visual recognition technology that can confirm if a patient has placed a pill on his or her tongue and has swallowed it. Some of the new digital pills in development may not require FDA clearance, as some are already being used or tested in patients with heart problems, stroke, H.I.V., diabetes, and other conditions.

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