New Privacy Laws May Catch Investigator Sites Off-Guard

“Investigator sites that don’t understand new privacy rules that went into effect this year in many states will find it very difficult to conduct clinical trials in 2021,” says Al O. Pacino II, president and CEO of BlueCloud by HealthCarePoint.

For example, the General Data Protection Regulation (GDPR) and the California Consumer Privacy Act of 2018 (CCPA) (which has been technically amended by California Senate Bill 1121) both aim to guarantee strong protection for individuals regarding their personal data and apply to businesses that collect, use, or share consumer data, whether the information was obtained online or offline, Pacino says.

The GDPR, which went into effect in May 2018, is one of the most comprehensive data protection laws in the world, Pacino notes. Meanwhile, absent a comprehensive federal privacy law in the U.S., the CCPA is considered to be one of the most significant legislative privacy developments.

Like the GDPR, the CCPA’s impact is expected to be global, given California’s status as the fifth largest global economy. The CCPA went into effect January 1, 2020, but certain provisions under the Act require organizations to provide consumers with information about the preceding 12-month period, and therefore activities to comply with the CCPA may well be necessary sooner than the effective date.


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Pacino estimates “nine out of ten” investigator sties in the U.S. don’t know anywhere near enough about GDPR, and “don’t have the right tools to be in compliance.” Part of the problem, he says, is that just as the clinical trial industry was beginning to turn its attention to GDPR at the beginning of 2020, the COVID-19 pandemic came along and diverted energy and focus. “COVID-19 took it out of the news,” Pacino notes.

It’s time for investigator site leaders to “understand modern laws and regulations that protect one’s personal data and privacy, learn how to take ownership of [their site data], and leverage modern e-vehicles that benefit healthcare professionals, sponsors, contract research organizations, and others,” Pacino says.

Author: Michael Causey