Medico-Legal Implications and Regulatory Frameworks of Regenerative Orthopaedics

Abstract

Regenerative orthopaedics has revolutionized traditional medicine, which represents a giant leap in science and research. The knowledge of the medico-legal implications and regulatory framework of this branch is vital for clinicians and researchers to go forward smoothly. This systematic review of the literature should shed light on these considerations and provide a comprehensive knowledge of the various implications and laws governing practice and research. The wide plethora of knowledge in the use of regenerative orthopaedics should be complemented by updated regulations and clinicians’ grasp of knowledge on regenerative medicine. The review focused on peer-reviewed published articles concerned with the topic and outlined common medico-legal issues and the current regulatory frameworks in various countries. The articles suggest that developed nations like the US have faced several lawsuits in this field, and a few countries in Europe like Italy and Germany, which were frontrunners in this field based on research, have fallen back due to emerging legal and regulatory policies. Undoubtedly, regenerative orthopaedics holds the key to future orthopaedics, but the world is skeptical of this concept, and laws and regulatory frameworks can curb it if not guided well. In India, this field has received prime attention, but at a slow pace when compared to the laws. After reviewing 113 articles, we analysed eight critically in this systematic review to emphasize the comparative global frameworks, daily medico-legal problems, and solutions for the branch of regenerative orthopaedics.