Why should researchers care about privacy and security in clinical trials?
Just as the value of medical data is increasing, the effort required to launch a cyber attack is decreasing, giving the bioscience industry reason for concern.
“It means that healthcare and bioscience companies will become greater targets in the future,” says Tom Pamukcu, principal founder of Sounder Trials Consulting, the incoming vice president for the Northern California chapter of the Association of Clinical Research Professionals (NCC ACRP), and a new instructor in the UCSC Silicon Valley Extension community.
“Not only is this bad for business, but it’s bad for patients.” Companies will face fines, loss of data, and breach of patient trust; patients stand to suffer an even more personal cost as privacy violations could result in delayed approvals for therapy.
Pamukcu is delving into this topic in a new Clinical Trials Design and Management Certificate Program course—Data Privacy and Security for Healthcare and Biosciences—starting Saturday, Nov. 23.
“Fortunately, there are safeguards we can use to protect our patients’ data from the start,” Pamukcu says. “And, some early actions will actually speed up, instead of hinder, our research.”
Three Factors: Technology • Systems • Process
He cites three significant factors to consider in data security and privacy: technology, systems, and process.
“Technology is key, of course. It ensures that things, such as hashing and encryption, are used when storing patient data necessary,” he says.
Systems are the next piece.
“It’s important to understand the entire ecosystem of your data and ensure that the strong, iron wall on the front door isn’t undermined by an open window in the back” Pamukcu, says.
The most important factor of them all, however, may be process.
“It’s often an undervalued factor,” Pamukcu says. “The processes we use to access and work with the data in our day jobs frequently can be the greatest vulnerability.”
Fortunately, there are ways to ensure that security is maintained all the way from the patient to the database.
Learn more in Data Privacy and Security for Healthcare and Biosciences, Nov. 23–Dec. 21. In this blended five-week course, students gain an understanding of the regulations and requirements relevant to their industry and learn to develop a compliance plan. They’ll meet two full Saturdays at the Silicon Valley campus and then submit final work online two weeks later.
About the Instructor
TOM RICO PAMUKCU, BS, principal and founder of Sounder Trials Consulting, has over a decade of experience in clinical research across institutions and indications during which he has leveraged technology to improve clinical research. He is also CEO of a startup devoted to helping patients navigate the clinical trials landscape. In previous roles at Genentech, Pamukcu managed global clinical operations for late stage oncology trials, specializing in pediatric oncology trials. He created new technology tools, ranging from data capture to artificial intelligence, to enhance clinical trials. At Stanford University School of Medicine, he managed clinical research within the Stanford Sleep Medicine Center. At the Stanford Systems Neuroscience and Pain Lab, he managed individual trials, as well as a division’s entire research portfolio including contributing investigators and staff. Pamukcu obtained his bachelor’s degree in Cellular and Developmental Biology from UC Santa Barbara and has completed post-bachelor training in Statistics and Computer Science. He is the incoming vice president for the Northern California chapter of the Association of Clinical Research Professionals (NCC ACRP).