The expansiveness of data mining has reached a whole new level with the development of a “smart pill” capable of measuring and documenting your body’s physiological responses and other personal health information.

Otsuka Pharmaceuticals Co. and Proteus Digital Health joined forces to develop a schizophrenia drug embedded with an ingestible sensor in a single tablet. Otsuka’s antipsychotic drug ABILIFY combined with Proteus’ ingestible chip, will detect whether or not a patient has taken their medication, as well as collect other personal health information such as sleep patterns, body temperature, body angle, heart rate and more.

The U.S. Food and Drug Administration (FDA) approved the device in 2012, but widened its application for medication adherence in July 2015. In Sept., the FDA approved the New Drug Application for the combination product of ABILIFY embedded with Proteus’ censor chip.⁽¹⁾

 “Smart pill” catalogs sensitive health information before sending it to patch worn by patient

An individual’s “metrics” will then be remotely communicated to a wearable patch worn by the patient. Once the medication has made contact with the dissolving acid in the stomach, the patch will time-stamp the information from the ingestible chip while also collecting other personal data from users under the blanket description “activity patterns.”

The individual’s bodily metrics will then be uploaded to the patient’s mobile or any Bluetooth device “using a secure and local software application,” says Proteus. With consent, the information stored on the patient’s patch will be remotely sent to their doctor and other healthcare providers.

While the drug’s makers are promoting the product as a revolutionary breakthrough for the mentally ill because of its ability to monitor patients’ compliance in taking prescribed medication, others are worried that the “smart pill” may violate users’ privacy and leave their very sensitive personal health information vulnerable to hacking.

Does “smart pill” leave users vulnerable to hacking?

Medical records are now considered more valuable than credit score reports. Healthcare system breaches are increasingly more common as hackers have a lot to gain from accessing sensitive personal health and payment information, as well as intellectual property, says Information Week.⁽²⁾

“As providers, payers, employees, patients, and partners become increasingly intertwined through shared data, transparency, and analytics, the opportunities for loss, error, or theft grow exponentially.”

The most valuable commodity in the 21^st century is personal information, a.k.a. Big Data, particularly for the pharmaceutical industry, as the U.S. and New Zealand are the only countries that allow direct-to-consumer (DTC) drug advertising. This leads to vast overprescription and rising medical costs for patients, prompting the American Medical Association to recently call for a ban on DTC advertising.⁽³⁾

If Big Pharma were able to access sensitive information detailing your body’s inner workings, unnecessary and likely harmful drug product development is sure to soar and will be directly marketed to consumers.

Could “smart pills” be used coerce people into unwanted and maybe even unnecessary treatment?

Another concern is that the “smart pill” will be abused by the justice system through court-ordered treatment, a controversial practice considered to be “institutional and coercive” by some mental health groups, according to U.S. News and World Report. Connecticut, Maryland, Massachusetts, New Mexico and Tennessee are the only states that claim to prohibit court-ordered treatment, according to the Treatment Advocacy Center.⁽⁴⁾

Jennifer Mathis, director of programs at Bazelon Center for Mental Health Law, is concerned about the use of the antipsychotic “smart pill” in involuntary treatment.

“Atypical antipsychotics can have very serious side effects, and uncertain efficacy for many individuals, so we should be extremely careful about technology that could be used to promote coercive delivery of these medications,” she told U.S. News in an email.

Otsuke and Proteus insist that only approved doctors and caregivers will have access to patients’ personal health information. However, if it’s uploaded to any Wi-Fi-enabled device, it’s absolutely prone to hacking.

The government will also gain access to it as well. When the National Security Administration dragnet steals your cell phone data, it’ll be accessing a whole new area of sensitive, personal and never-before-seen health data.

Stay tuned for more information regarding invasive healthcare technology as we follow this developing story.

Sources:

1. Proteus.com
2. InformationWeek.com
3. Evil.news
4. USNews.com
5. BusinessInsider.com.au
6. ModernHealthcare.com