By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
Health Works CollectiveHealth Works CollectiveHealth Works Collective
  • Health
    • Mental Health
  • Policy and Law
    • Global Healthcare
    • Medical Ethics
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: Mobile Health App Regulations: FDA & HIPAA
Share
Notification Show More
Font ResizerAa
Health Works CollectiveHealth Works Collective
Font ResizerAa
Search
Follow US
  • About
  • Contact
  • Privacy
© 2023 HealthWorks Collective. All Rights Reserved.
Health Works Collective > eHealth > Mobile Health > Mobile Health App Regulations: FDA & HIPAA
Mobile Health

Mobile Health App Regulations: FDA & HIPAA

onlinetech
onlinetech
Share
4 Min Read
SHARE

Mobile healthcare and apps, mHealth, is, at times, quite literally a matter of life and death.

Mobile healthcare and apps, mHealth, is, at times, quite literally a matter of life and death. And from my recent research on the trend, there’s widespread agreement that the industry requires pre-defined standards and strong regulation to 1) protect the quality of patient care; and 2) ensure PHI is secure and handled properly.

Yet, being enveloped in the HIPAA realm for some time has skewed my thinking – when I heard about the FDA regulating healthcare apps, I was confused. Instinctually, albeit not intellectually, I’d always thought the FDA provided insight into topics like food poisoning and MSG – not smartphones and apps, or anything technology-related.

However a recent blog post by David Lee Scher, MD, opened my eyes to a few reasons why he believes the FDA needs to be the regulatory body of “digital health technologies.” And some reasons why those in the field aren’t very fond of the organization – he mentions the fact that the FDA slows the approval process for apps annually and raises review fees for device companies, increasing developer frustration over the increased time to market.

More Read

Mobile Medicine: Apps To Manage Your Health
Mobile Medical Diabetes Pump Devices–Hacking Possible
Improving Care Coordination for Aging New Yorkers
The Global Eye Tracking System Market Is Expected To Skyrocket In The US
Mobile Health Around the Globe: Smartphone Microscope for Nano Particle Detection

One of the points he brings up is the fact that the FDA’s mandate isn’t covered by other related agencies – including the ONC and FCC (broadband access). The ONC, acting on behalf of the HHS, is notorious for enforcing the HIPAA and HITECH compliance laws, yet Scher reduces that to, “oversees EHRs.” A slightly broader perspective might say the ONC oversees the handling of PHI, not just EHRs, since the majority of HIPAA breach cases involved some type of physical theft or loss, as you can see in my infographic breakdown of the 2011 HIPAA violation breach types.

While the FDA should and will be involved in evaluating apps for their ability to improve patient health, they need to make collaboration with the ONC/HHS a priority to test apps for their ability to keep PHI secure. Scher references commentary in The Washington Times by Joel White – White’s position is primarily against FDA app regulation, including the argument that the FDA’s “piecemeal and oftentimes conflicting structure” of regulation raises concerns on how these rules intend to coexist with rules established by other agencies.

White argues a point from a recent State of the Union speech in support of his opinion; “tearing down outdated regulatory structures” allows innovation to flourish and encourages economic growth. Although potentially initially true, I don’t think throwing every regulatory body or law out the window is productive – without mHealth oversight, patient care may decrease significantly in quality with the advent of untested apps released to market, causing more costly and potentially dangerous issues down the road.

A regulatory body may also serve to prevent a flooded healthcare app industry (perhaps prolonging its success) and work to inform consumers of their quality and security when it comes to keeping health records secure.

Ultimately, I think we need a cohesive and productive collaboration between every agency and organization that touches mHealth and a way of streamlining the process to prevent wasted resources and time.

References:
Five Reasons Why Digital Health Technologies Need FDA Oversight
White: FDA’s Assault on Mobile Technologies

TAGGED:data breachesFDAHIPAA compliant hostingHIPAA hostingHIPAA violationsmHealthmobile app regulationmobile healthmobile health appsONC
Share This Article
Facebook Copy Link Print
Share

Stay Connected

1.5kFollowersLike
4.5kFollowersFollow
2.8kFollowersPin
136kSubscribersSubscribe

Latest News

contamination
Batch Failures And The Hidden Costs Of Contamination
Health Infographics
October 21, 2025
Medication Management For Seniors
Simplifying Medication Management For Seniors
Infographics Senior Care
October 21, 2025
Guide To Pursuing a Career in Nursing as a Foreigner in the USA
Collaboration Is the Prescription for Better Patient Care
Health
October 20, 2025
Epidemiological Health Benefits
Personal and Epidemiological Health Benefits of Blood Pressure Management
Health
October 13, 2025

You Might also Like

Healthcare Innovation: Moving from Stewardship to Leadership

September 9, 2012
Care On The Road: How Telemedicine Can Reach Truck Drivers
Mobile Health

Care On The Road: How Telemedicine Can Reach Truck Drivers

August 21, 2017
medical device security
Medical RecordsMobile HealthTechnology

Medical Device Security and the FDA

December 4, 2014
mhealth
eHealthMobile HealthTechnology

mHealth Device Data to Eliminate Annual Checkup, Improve Disease Research

January 29, 2015
Subscribe
Subscribe to our newsletter to get our newest articles instantly!
Follow US
© 2008-2025 HealthWorks Collective. All Rights Reserved.
  • About
  • Contact
  • Privacy
Welcome Back!

Sign in to your account

Username or Email Address
Password

Lost your password?