Understanding the myriad regulations governing clinical trials in the U.S., the underlying ethics, and the social implications of safeguarding health data is not just about protecting patients. It is the foundation of good research.
“Most students are surprised once they start thinking about the responsibilities of being a steward of patient data,” says Silicon Valley researcher Tom Rico Pamukcu who teaches Data Privacy and Security for Healthcare and Biosciences (starting Nov. 16) at UCSC Silicon Valley Extension.
“There’s incredible complexity behind the scenes in making sure we’re doing everything we can to protect the patient.”
Tools for Privacy Compliance
In Data Privacy and Security for Healthcare and Biosciences, people who are planning on starting a clinic or company that revolves around health data learn the tools they need to be HIPPA and privacy data compliant.
“Because we don’t have a single law governing health data as they do in Europe, there’s a lot of room to fall through the cracks,” Pamukcu says.
Clinical Roles & the Bigger Picture
All clinical researchers must comply with data regulations, which can be harder depending on their role in the process. This course helps people understand their role and how it plays into the bigger picture.
“It helps people understand how all the U.S. laws fit together,” Pamukcu says. “Sometimes people are surprised by how complicated things are, but they’re also surprised that we have laws for things that should be common sense.”
Developing a Compliance Plan
While exploring the breadth of issues—from private and public law to mobile health, medical devices, and regulatory issues on the horizon—students have the opportunity to develop a privacy and security compliance plan.
“Because a clinical trial is all about data, we have a tremendous responsibility to the patient and to the trial to understand privacy and security regulations around data.”
Data Privacy and Security for Healthcare and Biosciences is an elective in the Clinical Trials Design and Management certificate program.
The Roddenberry Foundation recently awarded Pamukcu a fellowship for his work in healthcare equity.