Guide to the ΕU-US Privacy Shield
- 06/10/2016
- Michalopoulou & Associates
- No comments
On July 12, 2016, following a long negotiation period with the US authorities, the European Commission presented the EU-US Privacy Shield (Decision (EU) 2016/1250 of 12 July 2016, pursuant to Directive 95/46/EC) in order to ensure the protection of personal…
Up in Smoke: Recent EU and Greek Legislation Tries to Kill Ambiguity for Tobacco Products
- 22/09/2016
- Michalopoulou & Associates
- 481 Comments
Cigarette packages labelled with images that can dissuade humans from smoking habit, which were distributed last summer, come as a result of a new European legislation on the manufacture, marketing and sale of tobacco and related products, namely the Directive…
Biosimilars: the obvious alternative or a simmering source of future friction?
- 08/09/2016
- Michalopoulou & Associates
- 6 Comments
In the few past years, biosimilars have found their place in the pharmaceutical market. Having already played a significant role in European life, they continue to win market share in the EU and the international market. The constantly increasing state…
Consent provisions in a globalized research community: key-elements of the New European Regulation
- 23/06/2016
- Michalopoulou & Associates
- 117 Comments
A patient’s choice whether he will undergo a particular treatment or participate in a clinical trial constitutes an expression of his autonomy and human dignity. His consent ensures respect of his personality, dignity and free will. In the health sector,…
Clearing the Mist for Good: New EU Code of Conduct on privacy introduces a new era for mHealth apps and personalized medicine
- 27/05/2016
- Michalopoulou & Associates
- 8 Comments
In one of our previous articles, we have discussed the importance of developing mHealth apps and their significant benefits to individuals. Individual developers as well as SMEs across the world are currently developing a Cambrian explosion of business activity on…
Personal data protection and medical research: The new legal framework in the EU
- 26/05/2016
- Michalopoulou & Associates
- 6 Comments
On May 4th 2016, the official text of Regulation 2016/679 “on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC” (General Data Protection Regulation) has been published in the EU…
Blow the whistle without fear: The importance of whistleblowers’ protection
- 12/05/2016
- Michalopoulou & Associates
- 541 Comments
The importance of pharma and medical device company compliance in order to fight corruption was thoroughly presented in one of our previous articles. Here we examine whistleblowing as corruption-fighter, aka as a practice that deals with one of the most serious…
The new MedTech Code of Ethical Business Practice – Ethics at its best
- 19/04/2016
- Michalopoulou & Associates
- 7 Comments
Medtech Europe represents the medical technology industry in Europe. It is the alliance of the two leading medical technology industry associations, EUCOMED (which represents the European medical devices industry) and EDMA (which represents respectively the European in vitro diagnostic industry)….
Network and Information Security: Is it still utopia?
- 07/04/2016
- Michalopoulou & Associates
- 6 Comments
The rapid rise in the use of digital technologies in the healthcare sector is not lost to cyber criminals. In USA, in particular, cyber threat groups have alarmingly shown a growing interest in healthcare industry, with medical records of more…
Medicated Feed: A new area for legislative revision
- 24/03/2016
- Michalopoulou & Associates
- 7 Comments
On March, 15th, 2016 the European Parliament Committee on Agriculture and Rural Development adopted by a large majority the report on the Commission’s proposal regarding the manufacture, placing on the market and use of medicated feed. The new rules, which…