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Processors of health data: How will they be affected by the GDPR?

Posted by on 28 September, 2017

Processors of health data: How will they be affected by the GDPR?

As we have mentioned in our previous articles, the General Data Protection Regulation 679/2016 will bring revolutionary changes in the healthcare sector. Among others, business activities of Internet service providers, cloud providers, pharmacovigilance service providers, Contract Research Organisations, patient service call centers who are considered as processors of personal data will also be influenced by the upcoming changes. 1) What differentiates the data controller from the data processor? “Data controller” is the natural or legal...

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Cosmetics in the Spotlight: Regulation 1223/2009 on cosmetic products sets new barriers for animal testing

Posted by on 20 September, 2017

Cosmetics in the Spotlight: Regulation 1223/2009 on cosmetic products sets new barriers for animal testing

The current European legislation on cosmetic products adequately regulates the legal status of cosmetics within the European Union. However, besides the safety measures that their manufacturers have to take to ensure compliance with the requirements of the Regulation having as primary concern consumer safety, cosmetic manufacturers must also never conduct any testing of product’s ingredients to animals.  This issue has been recently addressed by many companies and organizations worldwide, given that even though there is an explicit ban of...

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The new EU Directive on trade secrets enhances whistleblowers protection

Posted by on 11 September, 2017

The new EU Directive on trade secrets enhances whistleblowers protection

The protection of undisclosed know-how and trade secrets has long troubled businesses which irrespective of their size, value trade secrets as much as patents and other forms of intellectual property right. For many, confidentiality can be used as a business competitiveness and research innovation management tool, which covers a diverse range of information that extends beyond technological knowledge to commercial data such as information on customers and suppliers, business plans, and market research and strategies. In this context, the EU...

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Red Biotechnology: Legal Compatibility is Color-blind

Posted by on 11 September, 2017

Red Biotechnology:  Legal Compatibility is Color-blind

“No other sector holds the promise to enhance quality of life, productivity and environmental sustainability through innovation like biotechnology, while also benefiting Europe’s economy and research base”. Carlo Incerti, Chairman of EurapaBio, 3η EuropaBio event on the Benefits of Biotechnology, Brussels, 23 June 2015 As time goes by, the term Biotechnology becomes rifer with meaning – and color: Medical or red Biotechnology, Agricultural or green Biotechnology, Industrial or white Biotechnology and finally, Marine or blue...

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Pesticide residues in food and GM foods- Latest developments and questions

Posted by on 11 September, 2017

Pesticide residues in food and GM foods- Latest developments and questions

The use of pesticides in food, especially when growing fruit and vegetables, is now commonplace; farmers use pesticides in order to preserve or even increase their yields. Nevertheless, there are several risks regarding consumer safety and questions arise on the allowed pesticide residue quantities in food meant for consumption. In Europe, the first step towards a harmonized legal context on establishing maximum levels of pesticide residues in food (MRLs), was made by adopting European Regulation no 396/2005. The Regulation set harmonized...

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Medical devices & in-vitro diagnostics: What’s next?

Posted by on 11 September, 2017

Medical devices & in-vitro diagnostics: What’s next?

On October the 5th, 2015, the EU Council of Ministers agreed on its baselines on the looming two Regulations on medical devices and in-vitro medical devices. Closely related to the Commission’s relevant proposal and the adjacent EU Parliament and EU Council reports, both Regulations will aim to modernize the existing legislation, taking into account the latest advancements in medical technology and the need for high protection of patient safety. Main forthcoming changes are summarized as follows: The new rules will take the form of a...

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New Code of Conduct for E-Commerce: E-health business should be on alert!

Posted by on 24 August, 2017

New Code of Conduct for E-Commerce: E-health business should be on alert!

Why was the new Code adopted?          In the last years, following the technological development and Internet revolution, the number of regulatory initiatives has sharply risen since new social relations are born in the world web village. Our article will elaborate on the Greek Code of Practice for Consumer Protection in E-Commerce which was published in March 2017. The Code has been adopted in the form of a Ministerial Decision, which implies that it has binding effect on the interested stakeholders. Which businesses are bound by...

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New roads for compliance in research!

Posted by on 27 April, 2017

New roads for compliance in research!

New rules, binding or not, aimed to regulate research activities, have been recently adopted on a global level. Besides the provisions of General Data Production Regulation regarding research and the Regulation on clinical trials, new rules have been set in the revised edition of the European Code of Conduct for Research Integrity. The Code was published by the European Federation of Academies of Sciences and Humanities in the form of “soft law”.  1) Who are bound by the European Code of Conduct for Research Integrity? The Code sets...

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Big Data & Health: New Guidelines issued by the Council of Europe

Posted by on 23 March, 2017

Big Data & Health: New Guidelines issued by the Council of Europe

The rapid development of informatics and broad Internet use by the majority of institutions, enterprises and individuals has led to proliferation of transferred, collected and stored data. Most of data fall within the definition of personal data and they are subject to legal protection according to international, European and national legal texts. Moreover, health data processing is regulated by stricter rules. Big Data use is expected to contribute to greater efficiency of healthcare services, healthcare cost reduction and finally improvement...

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The new EU Directive on trade secrets enhances whistleblowers’ protection

Posted by on 22 February, 2017

The new EU Directive on trade secrets enhances whistleblowers’ protection

The protection of undisclosed know-how and trade secrets has long troubled businesses, which, irrespective of their size, value trade secrets as much as patents and other forms of intellectual property. For many, confidentiality can be used as a business competitiveness and research innovation management tool, which covers a diverse range of information that extends beyond technological knowledge, to commercial data such as information on customers and suppliers, business plans, market research and strategies. In this context, the EU...

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