The spread of new electronic pills with integrated sensors creates both ethical and legal challenges, researchers warn.
The new electronic pills (otherwise known as digital pill) can collect data on the state of the stomach and intestines. This creates new possibilities for diagnosing diseases. The pills can also be used to monitor medications.
Pills with integrated sensors are a micro monitoring device already a reality in Europe and the United States and in the future they will fill the shelves of pharmacies.
“The data collected by the pills constitutes a trace that reveals your health status and your medicine consumption. Very sensitive data, which in the hands of third parties can affect a person's life insurance premiums or job opportunities". It says so Timo Minssen, professor at the Center for Advanced Studies in Biomedical Innovation Law (CeBIL) at the University of Copenhagen. “Therefore there is a need for complete transparency and clarity on how pharmaceutical manufacturers will use and manage this data.”
How electronic pills work
Electronic pills can be used, among other things, to monitor whether mentally ill patients are taking their medications.
Information about when patients take pills is transferred to an app, and the patient can choose to allow family or friends to access the data via the app.
This may be a good health option, but it also has legal pitfalls.
Unlike doctors, relatives are not subject to medical confidentiality and therefore the treatment of such sensitive data by relatives is not legally regulated, but must rely on general advice, which may prove insufficient and put the patient in an uncertain position .
The question of who owns the patient data also generates a number of different problems.
It may not be clear how the pharmaceutical manufacturer stores the data collected in the app, whether the manufacturer can use the anonymized data for its own analyses, how long the manufacturer can store the data, and whether the patient can request deletion of their data.
The issue of secure data storage is particularly relevant given the risk of patient data in the app being hacked using software viruses or spyware.
Digital pill, ethical doubts
“It is important that the public has confidence in the product. E-pill manufacturers and the treatment system must both earn money and the trust of patients when it comes to the management and use of the collected data. In this process, protection of privacy, cybersecurity, accountability, transparency, fairness and robustness are essential”, he claims Minssen.
In the article, the researchers point out that ethical and legal issues should be considered during product development. This is better than dealing with problems once the product has been developed.
Pharmaceutical companies are trying to meet ethical and safety standards. Yet, even though there are developments in the regulatory area in both the EU and the US, there is still uncertainty about what exactly these standards entail.
The article appears on Nature Electronics. Other researchers from Copenhagen and Harvard Law School contributed to the document.
Source: University of Copenhagen
