Digital Regulations in mHealth Use


Of the over 3 million active mobile apps available in the iTunes app store, and the over 3.5 active apps in the Google Play store, 95,851 and 105,912 respectively, were categorized as Health and Fitness. Not surprisingly, those numbers are increasing exponentially. Overall, the digital health revolution is worth somewhere around $25 billion globally. As mobile health (mHealth) technological innovations increase, these tools can be transformative to patient care, especially for clinical trials and drug development.

With an increasing focus on mobile regulations, it is essential to stay up to date with the U.S. Food and Drug Administration (FDA). Where the FDA used to have to approve applications on a case-by-case basis, in 2017 the FDA started running pilot programs for digital health pre-certifications program. Big companies like Apple, Johnson & Johnson and Samsung were early participants. Most likely these big companies have been early participants as they would like approval for their development processes overall versus to have the red tape involved with case by case evaluations.

The new administrator at FDA, Dr. Scott Gottlieb, is a believer in innovation has already provided guidance on clinical decision support tools subject to regulation as wells as initial guidance as it relates to the use of mobile technologies in clinical trials.  Pilot programs under his watch also include reducing regulation for mobile solutions that automate simple tasks for providers or help patients track their health. He has also made it clear that mobile health apps that are designed for just encouraging a healthy lifestyle fall outside the scope of FDA regulation.

While the European Commission has adopted multiple mobile strategies in delivering ‘citizen-centric’ health care, there is likely to be an ongoing dialogue in Europe as it relates to social-demographic backgrounds in the use of e-health solutions. Dr. Gottlieb has the advantage of seeing how these conversations play out abroad, to help eliminate red tape in the United States.

These digital solutions are appealing to multiple stakeholders as they have potential in the United States to cut healthcare cost by over $7 billion. Given this wave innovation to improve client-centric care and reduce costs, regulators will need to provide more flexible solutions.

As the previous CEO of Rocky Mountain Cancer Centers, it always troubled me that the cost of bringing a new cancer drug to market could cost up to $2.7 billion and the median time of development was 7.3 years.

Implementing mHealth technologies in areas like clinical trials could provide game-changing care to patients in keeping stride with innovations in genomic and immunotherapy.  With the FDA’s new administrator at the helm, mHealth has the promise to transform patient’s lives.

#mHealth #ClinicalTrials #FDA


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