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
    Health
    Healthcare organizations are operating on slimmer profit margins than ever. One report in August showed that they are even lower than the beginning of the…
    Show More
    Top News
    An Expert’s Guide To Building and Improving Endurance
    June 30, 2022
    medical assistants
    What Do Medical Assistants Do On a Day to Day Basis?
    April 5, 2022
    superfoods to help with prostate health
    10 Healthy Foods That Can Help Protect Your Prostate
    August 29, 2022
    Latest News
    Why Custom Telemedicine Apps Outperform Off‑the‑Shelf Solutions
    July 20, 2025
    How Probate Planning Shapes the Future of Your Estate and Family Care
    July 17, 2025
    Beyond Nutrition: Everyday Foods That Support Whole-Body Health
    June 15, 2025
    The Wide-Ranging Benefits of Magnesium Supplements
    June 11, 2025
  • Policy and Law
    • Global Healthcare
    • Medical Ethics
    Policy and Law
    Get the latest updates about Insurance policies and Laws in the Healthcare industry for different geographical locations.
    Show More
    Top News
    How Powerful Patients Save the System Money
    November 11, 2015
    How Financial Barriers are Slowing Down Telehealth Adoption
    September 26, 2017
    No Resource Constraints in Dialysis: a Blessing and a Curse
    May 4, 2011
    Latest News
    How IT and Marketing Teams Can Collaborate to Protect Patient Trust
    July 17, 2025
    How Health Choices and Legal Actions Intersect After an Injury
    July 17, 2025
    How communities and healthcare providers can address slip and fall injuries with legal awareness
    July 17, 2025
    Let Your Lawyer Handle the Work Before You Pay Medical Costs
    July 6, 2025
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: Five Tips for Folding FDA’s New Medical App Oversight into Your Business Strategy
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 > Technology > Medical Innovations > Five Tips for Folding FDA’s New Medical App Oversight into Your Business Strategy
BusinesseHealthMedical InnovationsMobile HealthPolicy & LawTechnology

Five Tips for Folding FDA’s New Medical App Oversight into Your Business Strategy

Stephanie Kreml
Stephanie Kreml
Share
4 Min Read
mobile app regulation
SHARE

mobile app regulationIn my post for InformationWeek Healthcare, I discussed the implications of the U.S. Food and Drug Administration’s (FDA) final guidance for medical apps.

mobile app regulationIn my post for InformationWeek Healthcare, I discussed the implications of the U.S. Food and Drug Administration’s (FDA) final guidance for medical apps. While the September 2013 guidance specified that it would require clearance of any app intended to diagnose, treat, mitigate or prevent a disease, it left an open door to exercise “enforcement discretion” if an app meets the technical definition of a medical device but poses a low risk to the patient.

In this post, I will discuss the practical challenges resulting from this guidance, and how the evolving environment of app regulations should be folded into your business strategy.

The FDA does not want smartphones to become regulated medical devices—the sheer volume of phones and apps alone would overwhelm the agency’s resources. Hence, many apps will fall under “regulatory discretion.” For technical innovators moving into medical areas for the first time, this will present a number of new issues. Here are five considerations:

More Read

Video:How Gaming and Social Networking are Revolutionizing Healthcare?
Can Computers Replace Doctors?
AAMC: Medical College Admissions Testing to Be Overhauled
3 Ways Physicians Can Increase Their Social Media Following
How a New Patient Experience Model Will Drive the Future of Connected Healthcare?
  1. Make sure your technology is being used as intended. For example, who will use an app that calculates insulin doses for diabetics? If the intended user is the clinician, then the FDA regards this app as a tool for a licensed professional who will ultimately use clinical judgement in making treatment decisions. But if the intended user is the patient, then the app would fall into regulated territory. This distinction can make a huge difference in defining what is a high risk to the patient.
  2. Incorporate regulatory review time and costs into your business strategy. The cost of a 510(k) device regulatory submission, while not nearly as expensive as a PMA (pre-market approval), can be substantial, depending on the studies needed to meet safety and efficacy requirements, and can take one to two years for the FDA to review. Resubmissions, while typically less expensive, can still be equivalent to a significant portion of the original cost.
  3. Remember that any changes to software will have to be resubmitted to the FDA for clearance. Without good QC processes in place, this can be difficult to manage and control given the dynamics of software development. Also keep in mind that the FDA, some consultants and software developers tend to be more comfortable in the hardware environment and may not be able to provide the best guidance specific to medically oriented software development.
  4. Strive to ensure your new device performs any clinical decision algorithms on the device itself, and not in the “cloud.” If decisions are made wirelessly beyond your device, the FDA may require the entire system infrastructure to be included in the regulatory filing, which may be technology over which you have no control.
  5. A regulated device will require more quality control staff and processes (including HIPAA data encryption), which can be expensive if starting out new. Fortunately, other medical app companies could be available for partnerships that have QC processes in place, or can advise you on creating your own.

The FDA’s avoidance of clear delineation for when you are crossing into regulated territory will call for more engagements with the agency and possibly collaborations with other, perhaps more established, medical app players. Most important, you and your investors will need an abundance of patience in the regulated environment. Focusing on the clinical need for such an app, and its intended use, will help you create a clear regulatory and business plan.

(mobile apps / shutterstock)

TAGGED:FDAHIPAA
Share This Article
Facebook Copy Link Print
Share

Stay Connected

1.5kFollowersLike
4.5kFollowersFollow
2.8kFollowersPin
136kSubscribersSubscribe

Latest News

holistic dental
Holistic Dentist Services Are Natural and Safe
Dental health Specialties
July 28, 2025
botox certification
Help Improve People’s Skin Health Via Botox Certification
Skin Specialties
July 22, 2025
Telemedicine Apps
Why Custom Telemedicine Apps Outperform Off‑the‑Shelf Solutions
Health
July 20, 2025
Grounded Healing: A Natural Ally for Sustainable Healthcare Systems
How IT and Marketing Teams Can Collaborate to Protect Patient Trust
Global Healthcare Policy & Law
July 17, 2025

You Might also Like

Andrew Schorr at the Personalized Medicine World Conference
BusinessNewsTechnology

How Your Genes Will Drive Personalized Medicine

January 30, 2012
VESAG Mobile Diagnostics Watch
Medical Devices

VESAG Mobile Diagnostics Watch

December 22, 2011
Health careSpecialtiesWellness

How to Make the Decision Between a Long Term Facility and an In-Home Nurse for Elderly Relatives?

November 27, 2017
mckesson product recall
eHealthMedical DevicesMedical RecordsTechnology

A Medical Device Recall of an EHR-like Product

March 22, 2014
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?