Data-Transmitting Smart Pills Raise Privacy Concerns

In this age of technology, there is no end to the innovations that we can experience. First, there was the smarter version of the mobile phone, aptly called a smartphone. Thus began the process of making every dump gadget smart.

There was the television becoming the smart TV, the watch becoming the smartwatch, the mattress becoming a smart bed, and the coffee maker becoming smart enough to wake you up every morning to a cup of fresh brew. Alexa can even run the house based on the instructions you provide her with.

Rapid Advancement

Every other day there is a new technological innovation coming up. It makes us wonder if there is anything that technology isn’t capable of. Given the rate at which technology is advancing, nothing is surprising anymore.

So when the world learned that there is a new kind of pill that automatically lets doctors and family members know if the patient is following the treatment regime it did not come as a surprise.

Both healthcare practitioners and family members will know that some patients can be difficult. Making them take their medicines on time can be a tough task. Whenever no one’s looking, the patient is only too happy to skip medications.

This is especially true in the case of children and the elderly. Therefore a smart pill is hoped to make the task easier for both doctors and the family members of the patient.

But like every other technology today the question remains: How safe is the smart pill for the patient’s privacy?

What is a Smart Pill?

Unlike regular medications smart pills have sensors built in them. These sensors are edible and become activated upon coming in contact with stomach fluid. This is the first smart pill in the world available only in the United States right now.

This is also the first time that the FDA has approved medication with embedded sensors for human ingestion. The pill is called Abilify MyCite, and will currently be used for schizophrenia and bipolar disorder. If this whole concept of a smart pill is successful, it is likely to be extended for other medical conditions.

When a smart pill is ingested, it records the time at which it was taken and sends the information to a wearable patch. From the patch, the information is passed on to a smartphone app. Once the app records the data it can be accessed by the patient’s doctor and family members on a web portal with the patient’s consent.

The pill and the sensor are manufactured separately by two different companies. Proteus Digital Health produces the sensor and patch. Otsuka Pharmaceutical Co. makes the schizophrenia drug Abilify.

The FDA approval came in November 2017. The pill started to be rolled out to some Medicaid patients since last month. Patient adherence is a very broad concept but smart pills hope to make the process easier.

The path to FDA approval

Since this is the first ingestible device to ever be rolled out the FDA approval did not come easily. The safety and efficiency of the device had been under the scanner for months, the process getting delayed with each component being reviewed and approved separately.

The patch, the sensor, and the drug had already been approved but using the three together in an ingestible form is what the FDA was not sure about.

The FDA has finally approved the device and it is being rolled out to patients already. They also issued a statement that the device has not been found to improve patient compliance. The statement also mentioned that the drug should not be used in an emergency or to track treatment regimen in real time because the records may be slightly delayed.

It is an irony that the first condition the drug is being used for is schizophrenia and bipolar disorder, in which patients need a little more monitoring than others.

Besides the safety of the drug the question that is on everybody is mind is whether or not such a drug is useful at all for making patients with a history of inconsistent compliance to stick to the treatment regimen.

Privacy risk

Abilify MyCite comes at a time when there is an increased awareness about data protection and privacy. The drug is connected to a wearable patch and to a smartphone application. All of them can be monitored not only by the healthcare professionals and caregivers but also by the manufacturing companies.

This means medical data about the patient is handed over to third parties. If there is no proper regulation regarding the use of the transmitted data, the technology will soon start being misused.

Both health and tech experts are of the opinion that a digital pill is not enough for patient adherence. Only time will tell if the smart pill is successful in the long run.