Drug adherence programs have significantly evolved over the last few years with drug companies, health plans, and providers taking steps to monitor patient medication compliance. Drug adherence is the degree to which a patient complies with medication administration advice for treatment of chronic disease. Beyond the obvious benefits to patients’ health and health entities’ bottom lines, drug adherence can have a large effect on public health and social communities. Therefore, although it is no surprise that the health care industry has turned its focus to adherence in a big way, it may be surprising that in an industry where confidentiality is king, the most recent strategy may be turning to big brother.

U.S. Food & Drug Administration Announcement

This past November, the U.S. Food & Drug Administration (“FDA”) announced approval of a new solution to medication noncompliance – digital tracking. The FDA has not broadly blessed the practice, which has been around since 2012, but rather took a large leap in that direction by approving the digital drug Abilify MyCite – a collaboration between drug manufacturer Otsuka and technology company Proteus Digital Health. The drug is used for the treatment of schizophrenia, episodes associated with bipolar I disorder, and certain depression diagnoses in adults, and Abilify MyCite, specifically, uses an ingestible sensor embedded in the drug tablet to trigger an electrical signal upon reacting with stomach acids. The signal is sent to a wearable patch and a mobile application, which records that medication was taken. The medication compliance can be tracked by patient relatives and caregivers so that they may directly access the information through a similar application or web-based portal.[1]

Privacy Concerns and Obtaining Consent

As the industry looks to improve public health and reduce health care costs (medication noncompliance is estimated to cost $100 billion/year in the U.S.), it works to balance the need to uphold patient rights, including patient privacy, especially where disease increases patients’ vulnerability. While HIPAA and state laws generally allow the access to and disclosure of patient information with consent as well as for treatment purposes,[2] regulation regarding this kind of monitoring by third parties and resulting use of the data is less explicit. Just as states are beginning to take a stronger stance on protection of biometric and genetic information, digital drugs and medication compliance may be next to receive additional scrutiny and increased protections.
Continue Reading Big Brother is a Pill: Digital Tracking Drugs