First Digital Pill Approved to Worries About Biomedical ‘Big Brother’ image

New York Times, November 13, 2017
Pam Belluck, featuring I. Glenn Cohen (Faculty Director)


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For the first time, the Food and Drug Administration has approved a digital pill — a medication embedded with a sensor that can tell doctors whether, and when, patients take their medicine.

The approval, announced late on Monday, marks a significant advance in the growing field of digital devices designed to monitor medicine-taking and to address the expensive, longstanding problem that millions of patients do not take drugs as prescribed. [...]

Seeking to address concerns about privacy and coercion, Otsuka officials contracted with several bioethicists. Among them, I. Glenn Cohen, a Harvard law professor, said safeguards adopted include allowing patients to instantly stop physicians and others from seeing some or all of their data.

Asked whether it might be used in circumstances like probation or involuntary hospitalization, Otsuka officials said that was not their intention or expectation, partly because Abilify MyCite only works if patients want to use the patch and app. [...]

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bioethics biotechnology fda health information technology health law policy i. glenn cohen pharmaceuticals regulation