The FDA has just determined that the New Drug Application combining schizophrenia medication Abilify with a chip / ingestible sensor, is sufficiently complete to allow for a substantive review. The technology essentially allows the patient to log his medication and communicates with doctors and caregivers notifying them when the medication was taken. While the chip itself had been previously approved, the approval was limited to placebo pills in the past. This is the first time it is combined with an existing medication.
The company behind this device is California based Proteus Digital Health, whose investors include Oracle and Novartis. The digital pill is aimed at solving the known problem of medication adherence and the resulting unnecessary escalation of conditions and therapies. Patients who don’t take their prescription medication as prescribed (about 50% of them), cost the U.S. health care system an estimated $290 billion in avoidable medical costs each year. According to Proteus, “this is a problem with the product, not the patient.” They believe that providing the right technology to individuals who deliver and receive healthcare, can be the basis of a more effective health system “focused on daily care and new information-based business models.”
Proteus’s “digital pill” includes a patch worn on the torso and an app on a Bluetooth-enabled mobile device. The chip in the pill is about the size of a grain of sand and is made mostly out of silicon, but also contains small amounts of copper and magnesium. Once the pill reaches the stomach and is ingested, the magnesium and copper in it reacts with the acid in the stomach to create a small electrical charge that can be read from the surface of the skin through the detector patch. The technology not only allows doctors to know if/when patients have taken their medications but can also allow them to better assess if a person is responding to a given dose, or if that dose needs to be adjusted. Earlier releases of the technology suggest that sensors on the chip also detect heart rate and can estimate the patient’s amount of physical activity, though it is not clear if these features are included in the most recent application.
While medication adherence is in fact a serious problem with serious costs, it is hard not to think of the privacy implications such devices can have down the line. Similarly to all health apps, there are novel privacy issues in play. The FDA may very well have assessed their safety issues, but it surely is not the appropriate body to assess the privacy risks. As with all new technologies, the privacy debate is more likely to escalate later in the process, but this can be especially problematic given the time and costs of going through the FDA approval process and getting specific patents granted and approved. It would arguably be more efficient to engage in the discussion earlier, paralleling the idea of “privacy by design” instead of retro-actively fighting for changes in finalized versions of specifically approved and patented technologies. It is hardly a stretch to imagine digital pills being used to extract a lot more data than simple medication adherence information, and marketers viewing them as data gold mines that can be used to infer all sorts of information.
The extent to which these devices will be covered by HIPPA is not clear and can depend on the players in question and the exact data transmitted, for instance whether data falls under Protected Health Information. Perhaps the FTC guidelines on mobile app disclosures can be a starting point for the discussion, at a minimum providing a framework for developers to think through the design and functionality of the products in light of privacy issues.
References:
https://iapp.org/news/a/digital-pill-closer-to-approval/
http://www.ft.com/intl/cms/s/0/decece84-57b1-11e5-a28b-50226830d644.html#axzz3lSyzOqE8
https://gigaom.com/2013/05/01/company-behind-digital-pill-with-embedded-chip-raises-62-5m/