The growth in electronic medicines offers significant potential to better monitor the effectiveness of treatments, but new research from the University of Copenhagen also highlights the ethical and legal complications the technology brings.
The new pills are capable of collecting data on the environment they find themselves in, such as the stomach and intestines. This has obvious implications for our ability to successfully diagnose diseases, while also opening up the possibility to monitor medication in areas such as mental health.
“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,” the researchers say. “There is therefore a need for complete transparency and clarity on how pharmaceutical manufacturers will use and handle this data.”
New capabilities
Electronic pills come with a number of new capabilities, such as the ability to monitor whether patients are actually taking their medication. Data on their medicine adherence can be shared with loved ones or medical professionals, but while this is useful, it also throws up various legal obstacles.
Friends and loved ones aren’t bound to the same medical confidentiality as doctors, so the handling of such sensitive data lacks the regulatory protection typically afforded to medical data sharing.
There are also issues surrounding the ownership of the patient’s data. For instance, the pharmaceutical manufacturer might store the data collected, and it’s far from certain that this data will be stored in anonymized form and it may be stored indefinitely. Indeed, it’s not guaranteed that patients can even request their data be deleted.
An uncertain landscape
All of these factors can create a sufficient degree of uncertainty in patients minds that they decide to opt out of using the technology entirely.
“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,” the authors say.
The paper urges the industry to address the ethical and legal aspects of the technology during the development of the medicines rather than as an afterthought to be addressed later on.
“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,” they say. “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.”
