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By Erik Vollebregt
On 8 June the European Commission published a draft regulation on e-labeling as part of their WTO Technical Barriers Trade activities.
By Heidi Salow, Alan Sutin, David Wheeler
On Tuesday, April 12, 2011, Senators John Kerry (D-MA) and John McCain (R-AZ) formally introduced the Commercial Privacy Bill of Rights Act of 2011.
By Erik Vollebregt, Erik De Bie
A recent case at the European Court of Justice can have important consequences for imports of accessories and disposables for medical devices, as these may be subject to a customs tariff of 6.5 percent.
By Erik Vollebregt
And now for something completely different: customs tariffs. Dry stuff, but it makes all the difference for the price of the device. Indeed, 'parts'; and/or 'accessories'; under heading 9018 of the Combined Nomenclature ("CN"), or 'articles of plastics'; under heading 3926 of the CN, that is the question.
By Heidi Salow, Daniel Feuerstein
In December of 2010, the Federal Trade Commission (FTC) issued its much anticipated staff privacy report, entitled "Protecting Consumer Privacy in an Era of Rapid Change" (Report).
By Heidi Salow, Tricia Asaro, Miki Kolton
The 2009 Health Information Technology for Economic and Clinical Health Act (HITECH Act) significantly expanded the privacy and security obligations associated with the Health Insurance Portability and Accountability Act (HIPAA).
By Erik Vollebregt, Heidi Salow
In November 2009, the European Parliament amended the 2003 Privacy and Electronic Communications ("e-Privacy") Directive.
By Erik Vollebregt
In a previous post I have analysed the consequences of the European Court of Justice’s Ker-Optika judgment for e-commerce in physical medical devices.
By Erik Vollebregt
On 21 July the FDA released Draft Guidance for Industry and Food and Drug Administration Staff Mobile Medical Applications, a document that I think has great significance for the regulation of the EU eHealth and medical device markets, even if it is presently only a draft.
By Erik Vollebregt
EU member states are not under all circumstances allowed to restrict the sale of medical devices to only brick-and-mortar shops that specialise in medical devices.