ABSTRACT

In the contemporary world, almost all healthcare records are digitised and electronic health information is exchanged on the internet. Medical records are full of our most sensitive personal details including insurance records, social security numbers, home addresses, family details, credit-card information, list of medications and their costs. All that mass of information makes this area very attractive for hackers, and cyber attacks on healthcare providers are escalating. In health economics the term big data is often used interchangeably with real-world data (RWD). Among main stakeholders using big data in medicine and healthcare one can list: regulatory agencies, payers, insurance companies, healthcare providers, health-technology agencies, clinicians, patients, manufacturers and consultants. The current drug-development model uses placebo-controlled clinical trials in restricted groups of patients, within an idealised setting of many real-world treatment cases. This divergence carries risks that approved products will not deliver expected outcomes, something that can be controlled through the incorporation of real-world evidence.