Novartis says it's closing in on producing a pill that, once swallowed, can transmit data on the drug's effect on the patient. And of all the regulatory issues the smart pill will raise, near the top of the list is data security.
The Swiss drugmaker invested $24 million to get hold of Proteus Biomedical's chip-in-a-pill technology. It plans to test the concept on an already approved drug that helps prevent post-transplant organ rejection.
The Proteus chip technology, according to the company, is based on "ingestible event markers," which are sensors made from food ingredients. The sensors are activated by stomach fluids and produce a digital signal that's picked up by a microelectronic recorder inside a bandage-like skin patch. The chips are manufactured at "wafer scale" on silicon, yielding a cost of a few cents per sensor in large quantities, says Proteus.
The detector notes the date and time that it first hears from the ingested chip. It also decodes such information as type of drug, dose, and place of manufacture. More important to doctors and patients, it measures and reports such physiologic parameters as heart rate, activity and respiratory rate.
European regulators "have been very encouraging," Novartis tells Reuters. But they're asking how the company will protect patient data as it is transmitted from inside their bodies by wireless and Bluetooth.
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