What is Decision Algorithms

The advances in biotechnology and computer and data sciences opened the way for innovative approaches to human healthcare. Meanwhile, they created many ethical and regulatory dilemmas such as pervasive global inequalities and security and risk to data privacy. The assessment of health technology is a systematic multidisciplinary process that aims to examine the benefits and risks associated with its use including medical, social, economic, and ethical impacts. It is used to inform policy and optimize decision-making. The advance of technology is creating significant challenges to healthcare regulators who strive to balance patient safety to fostering innovation. The FDA and EMA are modernizing their regulatory approaches to foster innovation in digital technology and improve safety and applicability to patients. On the other hand, data analytic technologies have been introduced into regulatory decision processes.