For the first time health authorities have approved a drug with a tiny digestible sensor that tracks whether patients have taken their pills.
The US Food and Drug Administration gave the green light to a pill called 'Abilify MyCite', which can be used for patients with schizophrenia, bipolar disorder and mania.
When the pill is swallowed, a tiny sensor in the pill sends a message to a wearable patch.
The patch sends the information to a mobile phone app so patients can track their medication use.
Patients can give permission to their doctors and up to four other people, such as carers or family members, to receive electronic data showing the time and date the pills are ingested.
CEO of the Consumers Health Forum of Australia, Leanne Wells, said as technology made such devices more common and feasible, they could become more common.
"We need to ensure right from the start of such innovations that there is clear evidence of their benefit and of safeguards against abuses, such as potential for adverse patient reactions, and the risk of invasion of patient privacy," she said.
Tracking could be useful for patients
Mitchell Mathis, from the FDA Centre for Drug Evaluation and Research, said whether the digital pill would increase patient compliance with medication had not been studied.
"Being able to track the ingestion of medications prescribed for mental illness may be useful for some patients," he said.
The drug was made in collaboration with Otsuka Pharmaceutical and Proteus Digital Health, which designed the sensor.
In Australia, Abilify is used to treat symptoms of schizophrenia and mania in bipolar disorder.
But the digital pill hasn't yet been approved for use here.
Ms Wells said advances that safely and economically supported patients in taking their medicine as prescribed had significant benefits to the patient and the health system in reducing the pain and costs of avoidable illness.
"However, we will need to be convinced that the overall therapeutic and costs benefits of the medication tracker make it worthwhile," she said.
Privacy concerns raised
While patients could choose not to take the pill, its approval could raise questions about privacy and whether some patients might feel pushed into taking the digital pill.
Makers of the pill said initially the drug would only be used in a small number of patients in the United States, to track the patients' experience with the medication.
In a statement, Proteus Digital Health CEO Andrew Thompson said he believed the time was right to make this type of technology available to people with serious mental illnesses.
"Consumers already manage important tasks like banking, shopping and communicating with friends and family as they go about their daily lives," he said.
"This technology can help enable individuals with serious mental illness to engage with their care team about their treatment plan in a new way."