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.
Legal Implications and Liability of Monitoring Health Data
While Abilify MyCite and similar products breaking into the industry appear to intend to rely on the consent of the patient, questions may arise about whether the individual has been sufficiently educated on the mechanics of the adherence monitoring and understands the potential implication of drug compliance being collected and distributed. Moreover, state mental health laws, which significantly vary, may similarly struggle to define this type of monitoring while considering the effects of monitoring those with paranoia and other highly sensitive mental health diagnoses. Privacy advocates note that such monitoring could be used for other legal purposes, where such information is available; even federal[3] and state wiretapping laws, generally making it a crime to capture the communications of others without court approval or consent of a party, could be notable in certain circumstances where information is trackable.
In addressing some of these issues, safeguards adopted for digital drugs include allowing patients to instantly stop physicians and others from seeing some or all of their data. Ostuka has stated that it was not their intention or expectation for Abilify MyCite to be used in the context of probation or involuntary hospitalization.[4] Nevertheless, the concept of guardianship and who may have a “right to know” of noncompliance is remains of interest, as there are different instances in which it may seem more or less appropriate, or necessary, for third parties to be aware of noncompliance, especially where the behavior may result in high risk to the patient or those around the patient. Another issue to consider is whether there could ever be any liability imposed on the provider or manufacturer with access to the drug tracking product for not detecting such lapse.
Biomedical drug adherence monitoring presented by products such as Abilify MyCite create interesting and complicated legal and ethical considerations moving forward. With several more digital tracking drugs due out in 2018, this is a field that will continue to grow and that deserves further monitoring – pun intended.
[1] Press Release, Proteus Digital Health, Otsuka and Proteus Announce the First U.S. FDA Approval of a Digital Medicine System: Abilify MyCite (aripiprazole tablets with senor) (Nov. 14, 2017).
[2] 45 C.F.R. § 164.506(c)(2); See Office for Civil Rights, Permitted Uses & Disclosures: Exchange for Treatment (2016) (describing the broad interpretation of treatment purposes, including care plans for post-acute care).
[3] 18 U.S.C. § 2511(1).
[4] Pam Belluck, First Digital Pill Approved to Worries About Biomedical ‘Big Brother’, The N.Y. Times (Nov. 13, 2017), https://www.nytimes.com/2017/11/13/health/digital-pill-fda.html.
