Non-Interventional Studies in a Large Community Hospital and Implementation of the General Data Protection Regulation (GDPR)

Das Gesundheitswesen
Isabel Hach, Filiz Meseli

Abstract

The General Data Protection Regulation (GDPR) is applicable as of May 25, 2018 in all member states to harmonize data privacy laws across Europe. GDPR impacts also on medical data research. Non-interventional studies (NIS) in hospital are an important part of health services research and might need to be assessed by the local data protection officer. This study investigates all NIS (in house or sponsored) initiated between April 1, 2017 and July 31, 2018 in Nuremberg Hospital and their methods dealing with the GDPR. All studies in Nuremberg Hospital have to be reported to the study center of Nuremberg Hospital. We implemented some actions to fullfill GDPR, e. g. checklist for GDPR, quality circle, and all studies were assigned to a data protection officer specialized in scientific and clinical studies. We analyzed in each study the kind of data encryption (e. g., pseudonymous vs. anonymous), the need for approval from the official ethics commitee according to §15BO, and the need for approval from the hospital data protection officer. The data was analyzed using descriptive statistics. After GDPR came into effect, more NIS were started (n=77 vs. n=59), especially investigator-initiated NIS increased significantly (+84%, p<0.01)....Continue Reading

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.