Article | June 29, 2021

Understanding Data Privacy For Your Clinical Trials

By Kaitlin Sitchenko, Director of Compliance for Florence Healthcare

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Personal data privacy is not a new concept when it comes to healthcare. In fact, the right to privacy hasn’t changed in over 130 years.

In the mid-1990s, when the utility of the Internet was in question, the future-focused US Congress was determined to standardize electronic health information. In doing so, it rolled out nationwide security and privacy standards for protected health information (PHI), still in use today. With a similar vision for the future, Europe adopted its earliest protections on the movement and processing of personal data.

While personal health information protections have been established for decades, today’s booming rate of technology adoption and complexity of data flows has created a new demand for how patient and participant data is collected, stored and shared among sites, sponsors, CROs, internal and external stakeholders.

As healthcare slowly adopted new technologies, a revolutionary milestone happened – the launch of the General Data Protection Regulation (GDPR) in May 2018. This regulation revitalized an Internet-crazed world to reflect and recognize digital “privacy” as part of our fundamental human rights as set forth by the United Nations (UN) in 1948, through the GDPR’s framework. Since then, important parameters for technology use in clinical trials emerged.

Now as we rapidly shift towards remote-enabled technology, with around 80% of sites, sponsors, and CROs anticipating most monitoring to be remote by 2023, it is critical to understand how this regulation will impact your organization. The first step is understanding the basics.

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