The question of who owns the patient’s data also generates a number of issues.
The spread of new electronic pills with built-in sensors creates both ethical and legal challenges, researchers warn.
The new electronic pills can collect data, for example, on the state of the stomach and intestines, and this creates new opportunities for diagnosing diseases. The pills can also be used to monitor medication (e.g., in patients with mental disorders).
Pills with built-in sensors are already a reality in both Europe and the US, and in the future, they will fill pharmacy shelves.
“The data that the pills collect constitutes a data trail that reveals your state of health and your medicinal consumption. This is very sensitive data, which in the hands of third parties may affect a person’s life insurance premiums or job opportunities,” says Timo Minssen, a professor at the Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) at the University of Copenhagen. “There is therefore a need for complete transparency and clarity on how pharmaceutical manufacturers will use and handle this data.”
Electronic pills can be used, among other things, to monitor whether patients with mental disorders are taking their medication. The information about when patients take the pills is transferred to an app and the patient can choose to give family members or friends access to data through the app. This can be a good option from a health point of view, but it also presents legal challenges.
Unlike doctors, relatives are not subject to medical confidentiality and therefore the handling of such sensitive data by relatives is not regulated legally, 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’s data also generates a number of issues. It may be unclear how the pharmaceutical manufacturer stores the data collected in the app, whether the manufacturer can use anonymized data for its own analyses, how long the manufacturer may store data, and if the patient can demand the deletion of his data. The issue of safe data storage is particularly relevant in view of the risk of the patient’s data in the app being hacked using software viruses or spyware.
According to Minssen, all these ambiguities can help to create uncertainty in patients. The consequence may be that patients opt out of the new products, and thereby do not benefit from the new health options.
“It is important that the public have confidence in the product. The manufacturers of electronic pills and the treatment system must both win and earn the confidence of patients when it comes to the handling and use of the collected data. In this process, the protection of privacy, cybersecurity, accountability, transparency, fairness, and robustness are essential,” Minssen says.
In the article, the researchers point out that ethical and legal issues should be considered during the development of the product, rather than tackling the problems once the product has been developed.
“Pharmaceutical companies are trying to meet ethical and safety standards, but even though there are developments in the regulatory area in both the EU and the US, there is still uncertainty as to exactly what these standards involve,” Minssen says.
“The consequence is that the industry is beginning to ‘self-regulate’ and set up its own standards, and it is therefore important that pharmaceutical companies in the future development of electronic pills are aware of and comply with the legislation that the EU and the US are currently developing. If we are to reap the health benefits of the new technologies, the confidence of patients is essential.”
The paper appears in Nature Electronics. Additional researchers from Copenhagen and from Harvard Law School contributed to the paper.