eResearchTechology (ERT), an “eClinical” software company known for its electronic patient-reported outcomes (ePRO) solution, has been used in literally hundreds if not thousands of clinical trials and isn’t much thought of as it simply is one of the more prevalent applications used for the conduction of a study. That’s changed: first, it’s become important for the intense rush of clinical trials associated with COVID-19; second, the system was hacked recently, a target for ransomware pirates that actually impeded some COVID-19 trials. Several customers, including the largest contract research organization (CRO) IQVIA (Quintiles and IMS), were forced to go back to pen and paper to conduct their COVID-19 and other trials. Some of the CRO’s customers include Bristol Myers Squibb as well as the AstraZeneca COVID vaccine trial (AZD1222). Other waves of hacking and malware are causing havoc and even a death in Germany at University Hospital Düsseldorf.
As reported by Nicole Perlroth for the New York Times, no patient data was compromised and thankfully it appears IQVIA is running systems to its quality management system (e.g. regular backups, etc.), but the incident evidences the very real threat hackers and other cyber criminals represent. And with the advent of COVID-19 and the race for what can be considered priceless vaccines, online espionage represents an imminent and dangerous threat to pharmaceutical and biotech firms, academic medical centers and government regulators not to mention local trial site organizations.
Ms. Perlroth reported that ERT’s vice president of marketing Drew Bustos confirmed that the ransomware effort impacted their systems by Sept. 20. ERT took down its systems, went to pen and paper and called the Federal Bureau of Investigation (FBI).
Ransomware Attack in Germany Leads to Death of Patient
Other attacks have occurred, such as at Universal Health Services, a major hospital chain, reported by NBC News first as “one of the largest medical cyberattacks in United States History.” The New York Times reports that attacks also occurred in Germany (University Hospital Düsseldorf) where purportedly Russians seized 30 servers and the emergency hospitals had to decline patients. There, a woman in severe condition had to be transported to a hospital in Wuppertal, 20 miles away, and died from the delay.
What’s the basis for linking to Russian hackers? Well, according to one German account in The Local, German authorities identified the software used by the cyber gangsters, known as Doppelpaymer, is actually linked with a Russian cybercriminal group. Of course, this isn’t direct smoking gun evidence. Cologne prosecutors are looking into a rare change of involuntary manslaughter against what are yet unknown defendants.