Illustration of multicolored profiles. An overlay of strings of ones and zeroes is visible

Understanding Racial Bias in Medical AI Training Data

By Adriana Krasniansky

Interest in artificially intelligent (AI) health care has grown at an astounding pace: the global AI health care market is expected to reach $17.8 billion by 2025 and AI-powered systems are being designed to support medical activities ranging from patient diagnosis and triaging to drug pricing. 

Yet, as researchers across technology and medical fields agree, “AI systems are only as good as the data we put into them.” When AI systems are trained on patient datasets that are incomplete or under/misrepresentative of certain populations, they stand to develop discriminatory biases in their outcomes. In this article, we present three examples that demonstrate the potential for racial bias in medical AI based on training data. Read More

A More Transparent System for Clinical Trials Data in Europe – Mind the Gaps!

By Timo Minssen

Following the approval of the European Parliament (EP) earlier last month, the Council of the European Union (the Council) adopted on 14 April 2014 a “Regulation on clinical trials on medicinal products for human use” repealing Directive 2001/20/EC.  As described in a press-release, the new law:

“aims to remedy the shortcomings of the existing Clinical Trials Directive by setting up a uniform framework for the authorization of clinical trials by all the member states concerned with a given single assessment outcome. Simplified reporting procedures, and the possibility for the Commission to do checks, are among the law’s key innovations.”

Moreover, and very importantly, the Regulation seeks to improve transparency by requiring pharmaceutical companies and academic researchers to publish the results of all their European clinical trials in a publicly-accessible EU database. In contrast to earlier stipulations which only obliged sponsor to publish the end-results of their clinical trials, the new law requires full clinical study reports to be published after a decision on – or withdrawal of – marketing authorization applications. Sponsors who do not comply with these requirements will face fines.

These groundbreaking changes will enter into force 20 days after publication in the Official Journal of the EU. However, it will first apply six months after a new EU portal for the submission of data on clinical trials and the above mentioned EU database have become fully functional. Since this is expected to take at least two years, the Regulation will apply in 2016 at the earliest (with an opt-out choice available until 2018).

Read More