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Salman Kasbati
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Salman Kasbati
December 4, 2017
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Taking physician consent has been there for a while under the EU transparency disclosure requirements. With the GDPR coming into effect soon, the need to acquire consent has now become more intense and with a much broader scope. Now, the scope applies to: Employees Patients HCPs and others For not just transparency disclosure reporting, but also: Clinical trials data ERP and CRM data Expense reporting and financial data HRMS and other kinds of data Lawfulness of processing according to Article 6(1) will be considered true if (unless there are exceptions): the data subject has given consent to the processing of his or her personal data for one or more specific purposes;  The right to restriction of processing, as per Article […]

Kristin Buske
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Kristin Buske
November 30, 2017
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“What Role Is Technology Playing In Helping You Become GDPR Compliant?” We asked this question, (or rather, a version of it) during a survey at our recent GDPR Life Sciences Bootcamp. The respondents were uniformly compliance/transparency professionals from the life sciences industry. Any guesses on what their response was? Less than 10% were able to identify the solution their company uses for GDPR Compliance. An equal number (at 9.09%) said, “No. We are not interested either.” Less than 10% were able to identify the solution their company uses for GDPR Compliance. Bad news, in the light of penalties laid out in the GDPR? Not really, compared to what the other responses were. A little over 27% of respondents acknowledged that […]

Salman Kasbati
Written By
Salman Kasbati
November 23, 2017
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Uber recently disclosed a security breach that put the personal data of 57 million users and drivers at risk. As a pharma compliance professional, what does that mean to you, and why should you care? What are the key lessons, and what are its implications for Big Pharma in the post-GDPR environment. Consider all personal data sensitive: In the Uber case, hackers stole names, email addresses and phone numbers, the names and driver’s license numbers of about 600,000 drivers in the United States. Barring license numbers, pharmaceutical companies collect similar data. And for the compliance professionals uninitiated into high-tech data security features, the vulnerabilities can go further. You’re seeing the tip, the iceberg isn’t that far away: News of the […]

Kristin Buske
Written By
Kristin Buske
November 20, 2017
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Pharma Compliance professionals, if you think data security is expensive, try doing without it. Data breach costs companies money. No debate there. And the cost can only go up as some of them underestimate the importance of GDPR compliance with respect to data protection. Quite a few of us, as it turned out at our GDPR Life Sciences Bootcamp last week, cannot see the relationship between our work as compliance professionals and data security. The latter, we assume, comes under IT. The numbers would suggest otherwise. Let’s start with how old some of these attacks are. Contrary to what the Merck incident will have you think, scaled attacks on organizational data have been going on for almost a decade. Notably, […]

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