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
    benefits of using protein powder to build muscles
    Protein Powder for Muscle Mass: Everything You Need to Know
    December 12, 2021
    changes brought on by blockchain in healthcare
    Technology In The Healthcare Industry
    March 28, 2022
    What Does Core Body Temperature Say About Health?
    August 17, 2022
    Latest News
    Grounded Healing: A Natural Ally for Sustainable Healthcare Systems
    May 16, 2025
    Learn how to Renew your Medical Card in West Virginia
    May 16, 2025
    Choosing the Right Supplement Manufacturer for Your Brand
    May 1, 2025
    Engineering Temporary Hospitals for Extreme Weather
    April 24, 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
    FDA Approves Diabetes Pill
    May 2, 2011
    Patient Gets Drunk on Hand Sanitizer
    June 20, 2011
    Cultivating Health Improvement
    July 20, 2011
    Latest News
    Building Smarter Care Teams: Aligning Roles, Structure, and Clinical Expertise
    May 18, 2025
    The Critical Role of Healthcare in Personal Injury Recovery: A Comprehensive Guide for Victims
    May 14, 2025
    The Backbone of Successful Trials: Clinical Data Management
    April 28, 2025
    Advancing Your Healthcare Career through Education and Specialization
    April 16, 2025
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: A Consideration – Putting On the Brakes So We Can Move Faster…
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 > Policy & Law > A Consideration – Putting On the Brakes So We Can Move Faster…
Policy & Law

A Consideration – Putting On the Brakes So We Can Move Faster…

drkevin1951
Last updated: June 20, 2012 8:23 am
drkevin1951
Share
4 Min Read
SHARE

 

by Kevin Fickenscher

Kevin Fickenscher, MD, CEO AMIA

More Read

apple.jpg
Why Medical Marketers Should Use Patient Education as a Strategic Advantage
Medical Board Disciplinary Actions May Argue Against National Telehealth License
Medicaid: Not Just for the Poor Anymore
Heroes of Healing: The Trailblazers of Stem Cell Research
Dying in America? Bureaucrats Care

 

by Kevin Fickenscher

Kevin Fickenscher, MD, CEO AMIA

Recently, in the May 30 opinion section of The Wall Street Journal, Scott Glottlieb and J.D. Kleinke wrote an editorial chastising the FDA for moving in to quickly to regulate apps used by physicians and consumers alike (See “There’s a Medical App for That – Or Not”.  Gottlieb is the former Deputy Commission of the FDA and J.D. is a well known thought leader in healthcare.  Both are resident fellows at the American Enterprise Institute.  Their basic premise is that despite all of the partisan bickering on Capitol Hill, the one demilitarized zone of discussion over the last several years has been the promotion of information technology in healthcare.

In the last year, the FDA has moved more aggressively in the direction of regulating software used to support decisions by clinicians and patients much in the same way that they monitor other types of devices such as x-ray equipment, cardiac monitors and the like.  Gottlieb and Kleinke note that more than 60 percent of clinicians are now using technology –– most often in the form of tablets, iPhones, and other similar devices –– at the point of care.  This represents a dramatic shift from even a couple of years ago.  The hope, or, should we say, the anticipation is that the use of information technology will create more efficiency, result in better outcomes, reduce costs and enhance overall service.  There is a lot of literature pointing in the direction, but the final results are still to be fully captured and analyzed.  However, if we are intuitive, it seems to make sense that the anticipated results will yield the real results.  Or, at least most of us hope so…

However, the FDA’s move into the regulatory space is putting a crimp into creativity.  There are many, myself included, who believe that we should take a more measured approach to the regulation of these new software applications (= “apps”).  Senators Michael Bennett (D-CO) and Orrin Hatch (R-UT) agree and have introduced legislation to place a moratorium on the FDA move toward enhanced regulatory oversight of software apps.   I do not disagree with the notion that oversight is needed.  However, we are moving into new space.  Let’s not use the paradigm of past decades to create a structure and methodology for the new decade when that may not be the best approach.  Rather, those of us in healthcare who are involved in the use of technologies should work with the FDA to create a reasonable framework for effective regulatory oversight.  None of us – the FDA included – want to preclude creativity and new ideas.  The “apps” industry is exploding.  Let’s work together to solve this problem.   Rather than a unilateral approach toward regulation, it seems to me that FDA along with technology experts and policy makers should take a step back, examine the data, and develop new and reasonable guidelines before promulgating rigid regulations.  The industry is ready.  Sometimes putting on the brakes allows us all to move a bit faster down the road.  That would seem to be the case related to regulatory oversight of “apps.”

TAGGED:FDAmobile device regulation
Share This Article
Facebook Copy Link Print
Share

Stay Connected

1.5kFollowersLike
4.5kFollowersFollow
2.8kFollowersPin
136kSubscribersSubscribe

Latest News

Do You Grind Your Teeth at Night? Here’s How Night Guards and TMJ Treatments Can Help
Do You Grind Your Teeth at Night? Here’s How Night Guards and TMJ Treatments Can Help
Dental health
May 21, 2025
The Secret To A Confident Smile: Top Tips For Better Teeth
The Secret To A Confident Smile: Top Tips For Better Teeth
Dental health
May 21, 2025
Clinical Expertise
Building Smarter Care Teams: Aligning Roles, Structure, and Clinical Expertise
Health care
May 18, 2025
Grounded Healing: A Natural Ally for Sustainable Healthcare Systems
Grounded Healing: A Natural Ally for Sustainable Healthcare Systems
Health
May 15, 2025

You Might also Like

Syphilis Infections Increased by 11%, Solely Among Men, in 2012

January 15, 2014
Medical RecordsPolicy & LawTechnology

Cybersecurity in Healthcare: What’s Working?

August 2, 2017
FitnessHealth care

Treatments for Chronic Obstructive Pulmonary Disease (COPD)

October 23, 2020

Listen Here! Should We Bribe People to be Healthy? The Philosophical Argument – a Brilliant Debate

April 18, 2012
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?