The Food and Drug Administration should take action and immediately release the final Mobile Medical Applications guidance document.

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.