GDPR- Changes in Data Privacy Protection Affects Multinational Businesses 

by Anna-Lena Hürter | May 23, 2018 | SMART Life Science

  This week, effective May 25th, 2018 the General Data Protection Regulation (GDPR) will be valid in the European Union (EU). This regulation harmonizes data privacy laws across Europe and replaces the current data protection directive 95/46...

Data Integrity- where GxP, IT-Security and Data Privacy come together

by KVALITO Consulting | Apr 24, 2018 | SMART Life Science

Data Integrity (DI), a vital part in the Compliance Framework of Life Science Companies, is mostly associated with GxP, but, it also applies to Information/IT-Security and Data Privacy.  Take patient data of clinical studies, for example.    Data Integrity in general ...

The Medical Internet of Things Is Here and It Must Be Secured

by KVALITO Consulting | Jan 21, 2016 | SMART Life Science

Security is like the brakes in your car. It slows you down, but it also makes it possible for you to go a lot faster. (Gary Hinson) On the Chaos Communication Congress in December 2015 in Hamburg, Germany, there was a talk about medical devices with new functions like...

Data Privacy In The Age Of Digital Health

by KVALITO Consulting | Aug 20, 2015 | SMART Life Science

  What do you think is the most valuable asset of every patient in the world? The thinking behind this question is shown in the implementation of digital health functions and solutions in the company and its products. The most valuable asset for a patient is his/her...

Digital Health Compliance

by KVALITO Consulting | Feb 10, 2015 | SMART Life Science

“I think the biggest innovation of the 21st century will be at the intersection of biology and technology. A new era is beginning” Steve Jobs On the Brink of Innovation You might not know it yet,but you are living in the digital era. You may have heard a friend talk...