As you may have guessed from the title of this post, my opinion is not widely held among my fellow mHealth business leaders. Most think it is counter-intuitive to argue that the FDA must be a key player in the development – and regulation – of the mHealth ecosystem. We all know the real reasons.
Remember that while some companies have been in the game for a number of years, mHealth is still a relatively new field. The FDA traditionally focuses on regulating hardware devices, but the time has come for companies producing software-only medical device applications and even websites to undergo a similar level of scrutiny.
For example, a number of websites and applications are now moving into FDA-regulated territory without review, in many cases adding functionality that positions them as clinical decision support systems. A website that leverages vital signs or physiological observations to power a decision flowchart that guides diagnoses can be extended out to a mobile platform. The result is essentially a medical device that conducts clinical support.
The bottom line is this: we are moving into a patient-centric model with an expected increase of millions of patients under the Affordable Care Act. An ongoing crisis in the form of a caregiver shortage will exacerbate the stress on the healthcare system. As a result, the importance of distributing data via multiple form factors with seamless user experience from desktops to mobile devices will become more pronounced.
The need for secure, diagnostic-quality clinical data access and knowledge-based prompting via mobility is no longer an option – it is the new reality. Therefore, regulation must by necessity become part of the process. With a goal of protecting the integrity of the mHealth ecosystem and ensuring the highest level of patient care quality, it is time for the FDA to take decisive action.