What is HIPAA?

2021-12-12T19:52:41+00:00March 8th, 2020|

HIPAA is the acronym for the US Health Insurance Portability and Accountability Act.of 1996. HIPAA defines the requirements for protecting sensitive data and patient information. This law applies Read More >>>

What is GDPR?

2020-08-06T17:09:05+00:00March 8th, 2020|

GDPR is the acronym for the EU General Data Protection Regulation which came into force in 2018. It deals with confidentiality of information and privacy. The GDPR contains Read More >>>

Why is there a need for HIPAA?

2020-08-04T10:44:49+00:00March 8th, 2020|

HIPAA was created to protect sensitive data with two main purposes - to provide continuous health insurance coverage for workers who lose or change jobs, and to reduce Read More >>>

What is digital health?

2020-08-06T17:12:02+00:00March 8th, 2020|

The digital health field is an innovative technological field that connects the high-tech world to the healthcare world. Digital health is also called digital technology, e-Health or health-tech. Read More >>>

What is a CE Mark?

2020-08-04T10:58:40+00:00March 8th, 2020|

CE marking is a European system based on compliance of medical devices to regulatory requirements for maintenance of health, safety, effectiveness and performance, quality and the environment. The Read More >>>

What is ISO 13485?

2020-08-06T17:14:36+00:00March 8th, 2020|

ISO 13485 is an international standard relevant to quality management systems for medical devices. The latest version was published in 2016 and reconfirmed in 2020. This standard specifies Read More >>>

What is a medical device?

2020-08-04T11:46:46+00:00March 8th, 2020|

A harmonized, global definition of "medical device" (MD) does not yet exist. US law and regulations define a medical device as "instrument, apparatus, implement, machine, contrivance, implant, in Read More >>>

What is data integrity?

2020-08-04T12:38:52+00:00December 16th, 2019|

Data integrity is a cornerstone of the quality management system in pharma and medical device companies. It is a company's ability to make absolutely certain that the data used Read More >>>