New mobile health, EHR functionalities call medical devices into question

The incredible functionality of mobile health technologies such as smartphone and tablet applications has created new developments within the health care industry. This is evidence of the true goal of electronic health record systems, but those same EHRs have moved past the regulatory arms of federal bodies. The U.S. Food and Drug Administration has yet to publish comprehensive guidelines on the administration of health care on mobile applications.

However, in a recently published draft on the larger scope of health information technology, the lack of language relating to mobile health has prompted some health care professionals to call into question whether the FDA intends to regulate the platform at all, Health Data Management reported. The conversation gives valuable insight to the question of how medical professionals may operate in the future with patient engagement strategies.

No mobile health language in new regulatory bill
The questions of mobile health best practices when it comes to smartphone and tablet apps is one where both medical professionals and policy makers would rather have an answer. However, only light suggestions and industry-backed recommendations have resulted in any true activity in the effort to take care of patient data.

However, Health Data Management reported on the most recent draft in regulations between the FDA, the Office of the National Coordinator for Health Information Technology, the Federal Communications Commission and industry professionals. The last such draft was released in October 2013 and was in need of updates to reflect the current scenario of data proliferation following the implementation of more EHR systems across the country.  

Health Data Management explained how a major committee is scheduled to convene next month and will discuss important updates to the next draft policy. However, that committee may not even enter into a review of mobile health issues, as no language has been included in the most recent draft report.

"Platforms can change. Today, we have smartphones. Tomorrow, we can have something else. And, until now, we had laptops that evolved from desktops," Bakul Patel, senior policy advisor for the FDA, said in an April 10 webcast. "So, functionality really becomes the most important point in distinguishing patient safety risk."

Are modern mobile health care apps crossing that threshold of functionality to warrant FDA regulation? It would seem that with enough sensitive patient information flowing through their portals, health care professionals would rather have a definitive answer than be held up in the air.

Mobile health questioned
The FDA's speculative answer to the question of mobile health has caused some industry observers to inquire about the very nature of smartphone and tablet health apps. If a patient sees a marked improvement in quality and pain management from the use of an electronic health resource, then what is the barrier between more traditional equipment and a smartphone as a medical device?

Writing for Computer World, Andrew Witt, M.D., emphasized that professionals will want to pay attention to certain advantages and pitfalls of medical health apps as an unregulated industry.

Witt argued that though no changes have been definitively made yet, no subsequent issuance of guidance is likely to be final, either. Both the app development and health care worlds are rapidly evolving, and policy is expected to change with them. 

Also important for medical professionals was the need to balance risk versus reward for implementing strategies too soon. Is there a need to risk compliance violations with a more comprehensive campaign on social media and mobile health? Fines may count into the millions, so the overall applicability of each organization to handle that falls to personal interpretation.