Patient Safety and Legal Regulations: A Total-Scale Analysis of the Scientific Literature

The aim of the study was to quantitatively analyze the scientific literature landscape covering legal regulations of patient safety.

This retrospective bibliometric analysis queried Web of Science database to identify relevant publications. The identified scientific literature was quantitatively evaluated to reveal prevailing study themes, contributing journals, countries, institutions, and authors, as well as citation patterns.

The identified 1295 publications had a mean of 13.8 citations per publication and an h-index of 57. Approximately 78.8% of them were published since 2010, with the United States being the top contributor and having the greatest publication growth. A total of 79.2% (n = 1025) of the publications were original articles, and 12.5% (n = 162) were reviews. The top authors (by number of publications published on the topic) were based in the United States and Spain and formed 3 collaboration clusters. The top institutions by number of published articles were mainly based in the United States and United Kingdom, with Harvard University being on top. Internal medicine, surgery, and nursing were the most recurring clinical disciplines. Among 4 distinct approaches to improve patient safety, reforms of the liability system (n = 91) were most frequently covered, followed by new forms of regulation (n = 73), increasing transparency (n = 67), and financial incentives (n = 38).

Approximately 78.8% of the publications on patient safety and its legal implications were published since 2010, and the United States was the top contributor. Approximately 79.2% of the publications were original articles, whereas 12.5% were reviews. Healthcare sciences services was the most recurring journal category, with internal medicine, surgery, and nursing being the most recurring clinical disciplines. Key relevant laws around the globe were identified from the literature set, with some examples highlighted from the United States, Germany, Italy, France, Sweden, Poland, and Indonesia. Our findings highlight the evolving nature and the diversity of legislative regulations at international scale and underline the importance of healthcare workers to be aware of the development and latest advancement in this field and to understand that different requirements are established in different jurisdictions so as to safeguard the necessary standards of patient safety.