Privacy fears over the first FDA-approved drug with a sensor that records it’s been ingested may be easier to swallow in an age people have embraced the concept of “the quantified self.”
With widespread adoption of fitness trackers like Fitbit and genetic testing providers like 23andMe, the public may be comfortable with “digital drugs” such as Abilify MyCite, Pepper Hamilton LLP’s Sharon Klein told Bloomberg Law for a story on the newly approved product.
“I think it’s trending that way,” she said. “People are wanting more information.”
The drug, to be sold by Otsuka America Pharmaceutical Inc., contains a sensor made by Proteus Digital Health Inc. that’s activated by stomach fluids. It transmits data, such when the drug was taken and the patient’s activity level at the time, to a patch attached to the patient’s body. The patch then sends the data to a smartphone application, which the patient can share with health-care providers and family members.
“This is just a natural extension of precision medicine,” Klein said, referring to the use of person-specific data (such a patient’s genetic makeup and lifestyle) to prevent and treat disease. “You’re trying to get to the person, and what better way to get to the person than having something ingested, whether it’s a sensor or an embedded microchip?”
Abilify is used to treat schizophrenia and bipolar disorder, and it can serve as an adjunct treatment for depression. A key benefit of Abilify MyCite is the ability to track patients’ compliance with their treatment regimen.
The sensitive data Abilify MyCite will generate poses privacy risks—such as theft or unauthorized use—but there’s no need to be alarmist, former FDA health information privacy official Deven McGraw told Bloomberg Law.
Although there a legal tools and restrictions can provide protection, earning and keeping patients’ trust is the key to making a drug like this successful, McGraw said.
As health privacy director at the Center for Democracy & Technology, she got her hands on Proteus’ grain-of-sand-sized sensor and kept some in a desk drawer. The company was adamant promoting the benefits of treatment compliance and mitigating the risks its product might pose.
“It’s about deciding you’re going to create partnerships with patients and consumers around tools like this,” she said, “and not create the power dynamic that results in mistrust of the tool.”
Read my full story here.
Stay on top of new developments in health law and regulation, and learn more, by signing up for a free trial to Bloomberg Law.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to firstname.lastname@example.org.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to email@example.com.
Put me on standing order
Notify me when new releases are available (no standing order will be created)