Monday, September 23, 2013

Regulatory obsolescence

A recent article in Anesthesia & Analgesia points out that iPhones can already be equipped with Pulse Oximetry – currently only available through expensive and rather bulky equipment in the OR and preparation rooms. However, these devices on smart phones are not yet approved for use. This regulatory overhang is holding back the application of cutting edge technologies in medicine and other areas.

Regulatory agencies with rigid and prescriptive rules are ill-equipped to move at the speed of technology. In such a regime, regulations are likely to constrain the population to antiquated, costly and more risky methods than what may be afforded by contemporary technologies that are more effective but are not proven in the traditional tracks. Unfortunately, the education, skills and knowledge of regulators are unlikely to keep pace with rapidly changing technologies. Thus, decisions made by humans are increasingly less efficient in the creation and implementation of regulations.

A better regulatory regime may be one that describes the expected outcomes in quantitative terms and let technologies, that satisfy such end points, to be automatically approved.