SMART quality & compliance
GDPR- Changes in Data Privacy Protection Affects Multinational Businesses
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 EC. The GDPR is a complex piece of legislation comprising 11 chapters, 99 articles and 173 recitals. The aim of the GDPR is the protection of the data privacy of each individual (data subject). In short, the protection against abusive data processing, the protection of the right to informational self-determination, the protection of personal rights in data processing, as well as privacy protection must be ensured to be compliant with GDPR. The following article…
Read More >
SMART quality & compliance
Data Integrity- where GxP, IT-Security and Data Privacy come together
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 Data Integrity is the maintenance and assurance of the accuracy and consistency of data over its entire life-cycle, and is a critical aspect to the design, implementation and usage of any system which stores, processes, or retrieves data. Data Integrity in the GxP-Environment Data Integrity presents a major challenge to biotechnology and pharmaceutical companies as information needs to…
Read More >
SMART quality & compliance
The Medical Internet of Things Is Here and It Must Be Secured
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 a Bluetooth connection by a pacemaker to connect them to smartphones or a gateway for telemedicine. But with each connection to the outside world, a device becomes vulnerable which must be secured in a way that this connection cannot be used to harm patients. Last year the FDA pronounced a recall…
Read More >
SMART quality & compliance
Data Privacy In The Age Of Digital Health
“Without privacy there is no trust, which is what the best individual healthcare requires” – Florian Schnettelker 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 personal health data. This topic becomes more and more important with the rise of digital health solutions in our daily personal and business life. Laws and Regulations In many countries there are laws and regulations issued in…
Read More >
SMART quality & compliance
Digital Health Compliance
“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 about it, heard something on the news, or even downloaded an app. Whatever it is, digital healthcare is becoming the IT thing. More and more digital health applications are installed on smartphones, a number that is foreseen to grow exponentially. The United States alone is investing some 1.6 billion dollars…
Read More >