Three U.S. companies have entered into consent agreements with the Federal Trade Commission (FTC) for allegedly misrepresenting their participation in the European Union-United States Privacy Shield framework. These are the FTC’s first actions to enforce the EU-US Privacy Shield framework that was put in place in 2016 to replace the US-EU Safe Harbor framework.
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HHS-OCR issued a limited waiver of HIPAA Sanctions and Penalties Notice for both Hurricane Harvey and Hurricane Irma. In late August and early September, Secretary Price declared Public Health Emergencies in Texas, Louisiana, Puerto Rico, the U.S. Virgin Islands, and Florida and President Trump shortly followed suit with emergency declarations for both hurricanes, as well. Since both President Trump and Secretary Price declared an emergency for Hurricane Harvey and Hurricane Irma, the Secretary of HHS may waive sanctions and penalties against a covered hospital that does not comply with certain provisions of the HIPAA Privacy Rule.
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The FTC reached a settlement with online tax preparation service TaxSlayer Online for allegedly violating the Gramm Leach Bliley Act’s (“GLBA”) Privacy Rule and Regulation P as well as the Safeguards Rule.
The Privacy Rule/Regulation P requires financial institutions to provide initial and annual notices to their customers informing them about what nonpublic personal information is shared with third parties. It also provides information about how consumers can opt out of certain information sharing. Both the FTC and the Consumer Financial Protection Bureau enforce the Privacy Rule.
The Safeguards Rule requires financial institutions to use reasonable procedures to safeguard their customers’ nonpublic information. The FTC enforces the Safeguards Rule.
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The new General Data Protection Regulation (GDPR) is the EU’s most important change in data privacy regulation in 20 years, replacing the 1995 Data Protection Directive.
In our ongoing series of GDPR-focused webinars, we guide attendees through the (GDPR) provisions, which will take effect on May 25, 2018 for all companies conducting business with EU citizens.
With the deadline for compliance quickly approaching, these sessions provide practical, detailed advice on preparations, as well as developments related to GDPR compliance preparations. We have included links to each of these sessions and a summary of what was covered below.
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The use of “big data” throughout all levels of the economy has led authorities in both Europe and the United States to begin examining how such data may be used as a commodity and, therefore, how it might regulated.
However, authorities on either side of the Atlantic seem to be offering different approaches on the matter; those in Europe are suggesting that big data should be subject to EU abuse of dominance law, whereas U.S. authorities are resisting the notion of big data as an “essential facility” and are suggesting it be considered as an asset within existing merger review processes.
Continue reading “The Era of “Big Data” and EU/U.S. Divergence for Refusals to Deal”
The FDA recently issued new guidance that allows institutional review boards (IRBs) to waive or alter the FDA’s informed consent requirements for certain minimal risk clinical investigations without objection from the FDA.
The statutory basis for the guidance comes from amendments made by the 21st Century Cures Act from late in 2016 (P.L 144-255). This guidance, which took effect on July 25, 2017, is the first step for the FDA on this issue. The FDA intends to implement subsequent regulations to permit IRB waiver or alterations of informed consent requirements for minimal risk clinical investigations.
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