Posts Tagged: "data protection"

On September 13, U.S. Trade Representative Robert Lighthizer reportedly expressed a willingness to negotiate on several points of contention regarding the U.S.-Mexico-Canada Agreement (USMCA), including potentially reducing the 10-year period of intellectual property protection for biologic medicines. In response to this, the Pass USMCA Coalition is touting a memo penned by Former Department of Health and Human Services (HHS) Secretary Tommy Thompson aimed at “debunking the widespread myth that the USMCA will drive up drug prices.” Thompson, also a four-term governor of Wisconsin, now advises the Pass USMCA Coalition. Thompson’s memo focuses on three key arguments that he considers myths

The GDPR’s entry into force has forced HR teams across the US and EU to re-evaluate the ways in which they justify the use of personal data relating to their employees, applicants and contractors. Whilst compliance priorities will vary between businesses, all US headquartered organizations with a presence or personnel in the UK should be particularly mindful of their enhanced obligations to satisfy multiple conditions under both the GDPR and the UK’s new Data Protection Act 2018 (“DPA 2018”) before collecting certain special categories of personal data.

High value information—identified as trade secrets, IP mappings, product designs, financial data, confidential business information and similar files and documents—require an extra level of protection because of their value to cybercriminals and malicious insiders. The last thing an organization wants to do is make the theft of high value information easier by leaving vulnerability gaps in security practices. A malicious actor will exploit those each and every time.

Federal Communications Commission chairman Tom Wheeler has unveiled a proposed consumer data privacy rules for Internet service providers (ISPs), which would charge those telecom companies to provide more transparency on data privacy techniques to consumers. The proposal released by the FCC indicates that the agency is trying to apply the privacy requirements of the Communications Act to broadband Internet services to give consumers the choice over how broadband providers can use the data that consumer use of the service generates.

To replace the now-defunct Safe Harbor agreement, last week the European Commission published the first details of its transatlantic Privacy Shield. The Privacy Shield is meant to strengthen obligations on US companies to protect European personal data, and improve regulations regarding data monitoring by US government agencies. With the release of the draft Privacy Shield, many are skeptical that it will ensure proper privacy protection and some believe that it may be challenged after implementation.

The decision creates significant uncertainty for organizations who rely on Safe Harbor either for their own, internal data transfers, or because they use a service provider which, in turn, relies on Safe Harbor to provide adequacy for its transfers to the US. Alternative methods of addressing data transfers will be needed – such as implementing EU Commission approved data transfer agreements, or obtaining individual consent. Although the decision has invalidated Safe Harbor – with immediate effect – organizations will need to look to the reactions of national data protection authorities to determine how urgently to implement alternative data transfer solutions.

American business interests could be adrift at sea after the European Court of Justice invalidated the U.S.-EU Safe Harbor agreement, which governs the transfer of data from European citizens to data centers outside of Europe. Meanwhile, the high tech world of Silicon Valley is getting a new, well-heeled neighbor when Japanese automaker Toyota Motors Corp. (NYSE:TM) realizes its plans of establishing a new five-year corporate venture focused on developing artificial intelligence (AI) technologies. Google is also undertaking the push to develop its own processing chips in an effort to stem fragmentation of Android device development.

While patents protect innovations that are novel, nonobvious and useful, data exclusivity protects the extensive preclinical and clinical trial data required to establish new therapies as safe and effective. Regulatory data protection safeguards this data for a limited period of time, preventing competing firms from free-riding on the data that was generated at great expense. Specifically, biosimilar firms seeking regulatory approval are required to produce their own preclinical and clinical trial data to establish safety and efficacy, or wait the set period of time after which they are able to utilize the innovator’s prior approval in an abbreviated regulatory approval, eliminating the need for independently generated data.