Regulatory science has always been the cornerstone of Translational Medicine (TM) and clinical development. It warrants safety, conformity with ethical and moral issues, and a balance between the need for innovation and the duty to preserve the patients' integrity and safety.
Despite multiple studies showcasing how most ‘medical’ apps have little to no clinical research backing, there has been an influx of lifestyle and wellness apps flooding the market which offers illusionary benefits, faulty patient monitoring systems, and even wrong diagnosis. These apps often have exaggerated and unsubstantiated claims of condition monitoring, health benefits and treatments, making it difficult to differentiate and draw the line between apps and medical devices that actually helps patients.
To date, financial institutions have paid $320 billion in regulatory fines. With change as the only constant, global regulations are continually shifting and the digital revolution can either be a threat or a survival strategy for companies. The question is, who will survive it? For instance, companies that will succeed are those that comply with the increasingly complex regulations.